MedStar Pathway to Diabetes Control Demonstration Project

Principal Investigator: Michelle Magee, MD

Sub-Investigators: John Reyes-Castano, MD, Gretchen Youssef, MS, RD, CDE, Carine

Nassar MS, RD, CDE, Nawar Shara PhD.

OBJECTIVE

The MedStar Diabetes Institute (MDI), in partnership with key MedStar Health system

diabetes stakeholders, seeks to implement an evidence-based innovative integrated care

pathway for MedStar patients with uncontrolled diabetes which will demonstrate

improvement in diabetes care outcomes.

I- Introduction

A. Making the case for glycemic control in preventing diabetes morbidity and

complications: the evidence is unequivocal.

Diabetes Mellitus (DM) is a high cost, complex, chronic medical condition. Large scale

clinical trials have definitively demonstrated that targeted control of blood glucose (BG)

reduces type 2 diabetes complications1-3

. Diabetes self-management education (DSME)

has also been shown to improve outcomes for those living with the disease4-9

.

Methodology to facilitate effective and timely delivery of evidence-based medication

management and DSME for type 2 diabetes is needed. Implementation of targeted

glycemic control initiatives across the continuum of acute and chronic care delivery

settings presents a challenge to health care delivery systems, including MedStar Health,

and is an evolving area of investigation.

B. Best practice guidelines for diabetes management are well-established in the

literature.

Nationally, best practice guidelines are in place for outpatient type 2 diabetes

management10

and medication management algorithms have been published11-13.

These

tools have helped to improve attainment of diabetes care benchmark indicators,

including A1C nationally with most recent NHANES data showing that 55.7% of those

with diabetes now attain an A1C of <7%.)14

. While a recent report shows that diabetes

complication rates in the United States are declining15

a substantial percentage of patients

with diabetes do not receive guideline recommended surveillance testing to assess

glycemic control and diabetes complications status and/or remain above glycemic control

targets placing them at increased risk for the development and progression of diabetes-

related complications.

C. Attainment of diabetes-related NCQA/HEDIS measures within the MedStar

Health Ambulatory Care Practices

As of 2013, there were 13,309 patients with diabetes being treated in 43 MedStar Health

Ambulatory practices. Of these: 2,153 (16.2%) had very poorly controlled diabetes with

an A1C >9% and 7,863 (58.5%) did not meet the national benchmark of an A1C <7%.

Rates of meeting NCQA and HEDIS measures for diabetes care among these practices

are summarized below on Table 1.

Table 1. 2013 MedStar Ambulatory Practices (n=43)

Diabetes-related Performance Data

MSH

Ambulatory

Diabetes Patients (n) 13309

HbA1C Control greater than 9.0 % (Goal 15% or Less) 16.18%

HbA1C Control less than 7.0 % (Goal 40% or More) 41.51%

LDL-C Control greater than or = 130 mg/dl (Goal 37% or Less) 11.44%

LDL-C Control less than 100 mg/dl (Goal 36% or More) 53.77%

Nephropathy Assessment (Goal 80% or More) 90.92%

Blood Presssure Control greater than or = 140/90 mm Hg (Goal

35% or Less) 26.22%

Blood Pressure less than 130/80 mm Hg (Goal 25% or More) 39.09%

Smoking Status and Cessation Advice or Treatment

(Goal 80% or More) 93.05%

Eye Examination (Goal 60% or More) 36.13%

Foot Examination (Goal 80% or More) 71.64%

Confidential data provided by MedStar Medical Group.

There is a need for strategies to support patients and providers in reducing the percentage

of patients with A1C >9% and to increase the percentage receiving eye examinations and

foot examinations in MedStar Ambulatory practices. In addition, in the long-term, as the

system’s percentage attainment of A1C < 7% is well below the most recently reported

NHANES average, as a system we should strive to meet or exceed that target as part of a

system-wide effort to deliver high quality care to our patients living with this prototype

chronic, complex medical condition.

D. Emergency Department visits and hospitalizations with uncontrolled diabetes

present an opportunity to identify and engage MedStar practices’ patients in a

glycemic management care delivery program.

In 2012, there were 18,800 unique patient admissions to MedStar Hospitals and 24,480

Emergency Department (ED) admissions for patients with diabetes (Explorys 2012 data).

These acute care encounters offer an opportunity to identify and engage patients with

uncontrolled diabetes in a quality improvement care delivery system.

E. Barriers to improvement in glycemic management: vercoming clinical inertia in

medication management and diabetes self-management education.

Among the many patient, provider and system variables which contribute to lack of

further improvement in overall progress to glycemic control in diabetes, clinical inertia in

advancement of the anti-hyperglycemic medication regimen remains common16-17

and

despite evidence that DSME reduces ED visits, A1C and hospital admissions18-20

fewer

than 55% of all diabetes patients in the United States receive any DSME during the

course of their illness21-23

. The MedStar Pathway to Diabetes Control will address each of

these barriers in an effort to support both patient and provider in improving glycemic

control. We will specifically undertake timely advancement of the diabetes medication

management regimen and delivery of concise, focused DSME among high risk, high cost

type 2 diabets patients with A1C > 9% enrolled in the program.

F. Economic implications of uncontrolled diabetes

The economic costs of diabetes in the U.S. are high and continue to rise. Persons with

diabetes have medical expenditures that are 2.3 times higher than those without diabetes.

The annual medical expenditures average $13,700 per diabetes patient, of which about

$7,900 is attributed to diabetes24

. . About 43% of all diabetes-related expenditures can be

attributed to inpatient stays. In addition to the medical costs associated with DM, there

are costs associated with decreased productivity and increased absenteeism. Persons with

diabetes have 2-10 more days of absenteeism from work per year than those without

diabetes. Uncontrolled diabetes contributes both to absenteeism and to decreased

productivity in the workplace. As the rates of diabetes continue to increase in the U.S.,

these economic implications will continue to impact MedStar Health as a healthcare

provider, as a medical home for patients enrolled in MedStar managed care plans,

including MedStar Family Choice, and as an employer providing insurance to employees

and their families. Efficient and effective management of diabetes and diabetes-related

illness will contribute to the success MedStar’s transition to being a national leader in the

provision of value-based care.

The MedStar Diabetes Institute (MDI), in collaboration with partners across the MedStar

Health system seeks to implement an innovative integrated care pathway for high risk,

high cost MedStar patients with uncontrolled diabetes in order to demonstrate

improvement in care outcomes and reduce costs.

II- MDI-generated Evidence for Best Practices for Uncontrolled Diabetes Clinical Care

and Diabetes Self-Management Education Relevant to this Project

MDI has completed several studies, that have informed the development of best practices

for diabetes clinical care and education delivery. These results have been reported at

national meetings, received awards, and been published in peer-review journals.

Following in a summary of those studies that will be relevant to the current project:

A. STEP-Diabetes, American Diabetes Association (ADA) Core Research Award:

This study assessed the impact of a care delivery intervention focused on glycemic management

for adults with type 2 diabetes (T2DM) presenting to the emergency department (ED) of the

MedStar Washington Hospital Center with uncontrolled hyperglycemia.

A 4 week randomized controlled trial provided algorithm-based antihyperglycemic medications

management; survival skills diabetes self-management education (DSME); and navigation to

primary care for adults presenting to the ED with BG>200mg/dL. Medications were titrated and

DSME content delivered by endocrinologist-supervised certified diabetes educators at each visit.

Controls received standard ED care. One hundred and one patients were enrolled and

randomized and 78 completed the week 4 visit.

In both the intervention (INT) and control (CON) groups mean BG decreased (403+132

to 192+ 93 mg/dL and 412 +120 to 259+124mg/dL, respectively), p< 0.001 but the post-

BG was significantly lower only for the INT, p<0.01. A1C went down within each

group, (11.8+ 2.4 to 10.5+1.9% , p < 0.001 for INT, and 11.5+2.0 to 11.1+2.1% ,p=0.012

for CON). Absolute reduction in A1C was -0.9% greater in the INT than the CON group

(p=0.01). The ADA recommended BG level of <180 mg/dl was reached by 65% of

intervention and 29% of control subjects, p=0.002. Hypoglycemia rates between groups

did not differ and no severe hypoglycemia was reported.

Medication adherence improved. Modified Morisky Medication Adherence Scale©

(MMMAS) total scores decreased from 3.2 +2.0 (low adherence) pre- to 1.4 +1.4

(medium adherence) at 4 weeks (p<0.001) for the intervention and were sustained to 12

weeks. Improvement was greater for INT when compared to CON subjects (-2.0 +2.5 vs.-

0.3+2.43 respectively), p=0.001.

The STEP-Diabetes study generated evidence that ED visits made by adults with

uncontrolled type 2 diabetes can be used as an opportunity to initiate a focused

intervention providing timely titration of antihyperglycemic medications and survival

skills DSME to improve medication adherence and short-term glycemic outcomes,

without increasing risk for hypoglycemia.

A late breaking abstract (LB-143) containing the results of this study was presented as a

poster at the American Diabetes Association Annual Scientific Sessions in June 2014. A

manuscript reporting preliminary pilot data which served as the rationale for this

randomized trial was published in The Diabetes Educator May-June 20138. A manuscript

for submission to Diabetes Care reporting the results of this RCT is in preparation for

submission.

B. ABCs of Diabetes.

This prospective nonrandomized program examined the preliminary impact of a concise

community-based diabetes self-management education (DSME) program on outcomes. A

free community-based DSME program was placed in a public library. Adults with

uncontrolled diabetes (N, 360) volunteered to participate in this cohort study with pre-

intervention-post-intervention design. The small group interactive DSME (two 2.5-hour

classes) focused on glycemic control, improving cardiovascular disease risk factors and

facilitating communication with the primary care physician.

We demonstrated that offering concise, focused DSME for African Americans at a public

library was both feasible and significantly affected 6-month outcomes, including an

increase in knowledge of American Diabetes Association–recommended targets for A1C,

blood pressure, and LDL cholesterol, and a 0.5% reduction in A1C. The percent of

patients with A1C <7% increased from 35.4% at baseline to 51.9% at 6 months, p<

0.001. An increased likelihood of attaining the A1C target of < 7% was observed if

insulin was started during the intervention period compared to those who either did not

take or stopped taking insulin during the study. A two thirds reduction in ED visits for

uncontrolled diabetes was also shown with p =0.0043. These results support the use of

concise, focused DSME in improving glycemic outcomes. Manuscript published in the

The Diabetes Educator in 20117.

C. Diabetes to Go (D2go)

This pilot study generated further evidence demonstrating the feasibility of providing

concise, focused knowledge-based Diabetes (DM) “survival skills” education (SSE) and

a preliminary impact of the SSE intervention on outcomes. It was conducted in the

inpatient setting among adults admitted with uncontrolled diabetes. DM knowledge,

medication adherence, hospital admissions, and Emergency Department (ED) admissions

in patients admitted to the hospital with uncontrolled diabetes were examined pre- and

post-intervention. Based on the rationale that hospital admissions present an opportunity

to deliver education and that DSME improves outcomes, we generated evidence

supporting the hypothesis that an SSE approach in the hospital for persons with

uncontrolled diabetes would successfully impact outcomes. The SSE content was

delivered using a DVD with the patient being instructed to view specific content areas

correlating to knowledge deficits identified on his/her program pre-test and mandatory

content on each DM medication being taken and when to call the doctor or go to the ED.

This was a prospective, non-randomized pilot study conducted at MedStar Washington

Hospital Center. Adults, n=125, majority African American women, with uncontrolled

DM, BG>200mg/dL or <40mg/dL upon admission to general medicine units were

consented. Mean admitting BG was 283 + 128 mg/dl. Improvement in DM knowledge

was observed. Medication adherence was significantly improved by 2 weeks following

discharge from the hospital and this change was sustained to 3 months. A trend toward

reduction in ED and/or hospital admissions from self-reported 3 months pre-intervention

to 3 months post- discharge for uncontrolled diabetes was also observed.

This concise knowledge-based program successfully provided SSE to hospital patients

with uncontrolled diabetes and demonstrated preliminary evidence of a positive impact

on medication adherence and a trend toward reduction in hospital and ED admissions.

Education content delivery was largely provided using a video tool. Manuscript

published in The Diabetes Educator May/June 20149.

III- THE MEDSTAR PATHWAY TO DIABETES CONTROL

Outline of Key Program Components

- The program is designed to bring diabetes specialty services to MMG Primary

Care practices to support PCPs and their patients in improving diabetes-related

outcomes.

- High-risk patients from MedStar Primary Care practices who have uncontrolled

type 2 diabetes and meet the target population inclusion and exclusion criteria will

be invited to participate in an intensive and concise medication management and

education intervention of ~4-8 weeks duration.

- The intervention will consist of three key components: (1) intensive, algorithm-

based medication management (Appendix A), based on continuous review and

management of blood sugars; (2) survival skills diabetes self-management

education; (3) enhanced patient-provider communication, all provided by

Endocrinologist supervised allied health professionals (in this instance CDEs).

- Survival skills DSME (Appendix B) will focus on nutrition and meal plan basics,

blood glucose targets, taking medications as prescribed, hyper- and hypoglycemia

recognition and treatment, and when to seek medical help.

- The intervention will start with one to two face-to-face meetings with the CDE, to

be followed by weekly phone or virtual meetings scheduled at the patient’s

convenience. .

- Various technology tools will be used to facilitate patient engagement and

attainment of glycemic targets, including smart meters, virtual meeting

platforms,web-based education content and surveys via tablets, etc.

- Concurrent matched charts of patients receiving standard care at the three

MedStar locations will serve as a basis of comparison in assessing the impact of

MDI on clinical and education outcomes and process of care.

- Based on patient progress towards improved glycemic control, the patient will

‘graduate’ from the program and the CDE will refer the patient back to their PCP

in 4-8 weeks with a full report of medication changes, blood glucose readings and

further diabetes management recommendations eg referrals; further DSME, etc.

Demonstration Project Goals

To demonstrate the feasibility, effectiveness, and potential financial benefits of a patient-

centered medical neighborhood (PCMN) that provides short-term, clinically-focused

diabetes management to established MedStar primary care patients with uncontrolled

diabetes who are at high risk for complications based on specific characteristics. The

results of the pilot study will inform refinements to the program model and its

deployment throughout the MedStar Health System.

A. Clinical outcomes:

Among intervention group participants we will demonstrate

– Reduction in A1C by > 1% over 3 months

– Increased adherence to diabetes medications as measured using MMS by

25% from baseline to 3 months for intervention subjects

– Improved adherence to DM Rxs refills when compared to chart control

patients

– Reduction in self-reported absenteeism (or days missed from usual daily

activities) during the intervention period when compared to 6 months prior

to enrollment

– Increase the proportion of patients receiving an eye exam by 20% in the 6

months following the start of the intervention as compared to baseline and

to concurrent chart controls.

We will also:

Examine the trend in the composite endpoint of diabetes-related ED visits and

hospitalizations compared to both 6 month pre-intervention and among concurrent chart

controls.

The effectiveness of the demonstration project will be ascertained by showing that the

average HbA1c and the percentage of patients with ED visits/hospitalizations achieved

after 3-months of treatment will be smaller in the intervention group compared to the

controls who receive the standard Diabetes treatment.

B. Provider and patient experience:

– Identify facilitators and barriers to pathway implementation among both

patient and provider participants

– Assess primary care provider and endocrinologist satisfaction with the

program (support /reducing burden of care delivery)

– Assess patientsatisfaction with the services received

Assess CDE satisfaction with the program

C. Financial outcomes

– Quantify fixed and variable program costs

– Estimate potential return on investment based on total cost of care for

controlled and uncontrolled diabetes patients as reported in the published

literature (contingent upon health economist support and availability of

system and allied partners data)

DIABETES PATHWAY DESIGN AND METHODS

This is a prospective, concurrent 1:3 case-chart- control study. Up to 150 patients with

uncontrolled Diabetes will be recruited into the demonstration project as a first-come

first-serve basis in physician offices. After all qualifying patients are selected into the

study with their consent, data on three-hundred seventy-five patients with uncontrolled

Diabetes with available 3-month visits will be extracted from the electronic medical

records. The sample of the chart-controls will be frequency-matched to the study sample

on gender and age to the extent possible to balance the groups. Those patients who were

approached by the study team to participate in the project will not be included into the

pool of control patients if they refused to consent to the study.

Sample Size Calculation.

The power analysis was conducted using the end of study HbA1C as the primary

outcome measure. Based on the hypothesized differences in the intervention and chart-

control groups, the study will achieve 80% power at a significance level (alpha) of 0.05

to detect a difference of 0.5 unit in HbA1C between the groups at the end of follow-up

period (the intervention group=7%, SD=1.5; control group=7.5%, SD=1.5) by recruiting

95 patients to the intervention and 285 to the control group (3 controls per 1 case). This

sample size will also allow us to detect a difference of 10 percentage points (5% to 15%)

in the rate of ED visits/hospitalizations based on a one-sided two-sample proportions test

(78:234 patients) at 80% power at alpha=0.05. Based on previous studies, we expect a

drop-out rate of approximately 25%. By incorporating the drop-out rate, we propose to

enroll up to 150 patients into the intervention group and extract data for 375 chart

controls.

Target population:

Inclusion Criteria

Active and established patienti of a designated MedStar Medical Group

Ambulatory Primary Care practice provider:

o MWHC Internal Medicine and MPP - DLK practices,

o MGSH Internal Medicine and MPP MetroMed practice.

o MUMH Internal Medicine and Resident practices

Diagnosis of type 2 diabetes on Centricity problem list for >=1 year

Active practice patient as evidenced by one or more visits to PCP in the past 12

months

Age > 21 to < 75 years

A1C > 9.0% at their last visit to MedStar Medical Home, ED or hospital

admission.

Primary Care Provider willing to have patient enter the program

Patient is able and willing to participate in the program

Proficient in English

-AND- one or more of the following high risk characteristics:

Acute care encounter(s) including) ED visit(s) or hospital admission(s) in the past

year with uncontrolled diabetes (BG> 200mg/dL or A1C >9%; severe

hypoglycemia = BG <40mg/dL requiring assistance to treat)

Evidence of low medication adherence as evidenced by no refills since one or

more prescribed DM RXs “ran out” (based on last Rx for each DM med and time

period was prescribed for on Centricity/SureScripts medications list); or any other

circumstance that has been identified by the health care team which indicates

poor adherence to prescribed medication.

Does not meet HEDIS diabetes measures for two or more of: no MA/Cr, no DM

retinal exam, no lipid profile

SBP >140 mmHg

LDL>100 mg/dL

Depression diagnosis on problem list (or depression medication on med list)

BMI >32

Exclusion Criteria

Known history of DKA

No MedStar PCP visit within past 12 months

Endocrine or Diabetes Education consult referral order in the past 6 months which

resulted in Endo visit(s) or DSME visit(s) documented in chart or self-reported by

patient during initial screen

Active additional medical issues which in the opinion of the care team would

preclude concentrating on BG control and/or would predispose to ED visits and/or

hospital admits independent of glycemic control, e.g.: severe CHF, severe COPD;

severe mental illness.

Resident of skilled nursing facility, nursing home or receiving home health care

services.

Active cancer in the preceding 3 years excluding nonmalignant basal cell cancer

Supraphysiologic doses of glucocorticoids (hydrocortisone > 30mg/day;

prednisone > 5-6mg daily; dexamethasone > 2mg daily).

Pregnant or anticipates attempting conception in the following year

Patient and/or custodial caregiver unwilling and/or unable to participate in

program-related activities

Methods: intervention group.

Patient identification and initial contact

1- Obtain list of patients at each location that meet study inclusion/exclusion

criteria (Centricity EMR search based on inclusion/exclusion criteria; PCP

referral; current ED visit or hospital admit from hospital database(s) –

MedConnect/Cerner, Amalga)

2- With knowledge/approval of PCP, site CDEs approach patient in PCP office

at next scheduled office visit to explain the program. Provides IRB approved

patient information sheet and review with patient to ensure comprehension.

Intervention.

3- If patient agrees to participate in the program ,

a. PCP signs Centricity order for program entry, including authorization for

medication management using the pathway algorithm by Endo-supervised

CDE, and referral for pathway diabetes self-management education

b. Patient is scheduled to see site CDE within the next 7 days. Parking

validation will be provided for on-site visits with CDE. Patient is advised

that first 1 to 2 visits will be in person in his/her PCPs office location or

the CDE’s office and that the first full visit will take up to two hours.

Patient will be asked to bring all medications and BG meter and strips, if

taking/using to first program visit. On-site CDE visits will be provided

during the pilot program free of charge (and will not be billed to the

participants’ insurance)

c. Based on the CDEs assessment of the patients engagement with the

program and skills required for virtual interaction, the patient will

‘graduate’ to phone call and/or virtual visits following the first or second

on-site visit with the educator. . Phone call and virtual visits will also be

provided free of charge during this demonstration program.

Intervention activities by visit.

A. On-site visits with CDE

Visit 1:

1- Confirm key demographic and clinical data autopopulated to program database

from Centricity with patient. Supplement as necessary to assure baseline data set

complete.

2- Patient completes Diabetes Survival Skills Knowledge test, and MMMAS .

Based on knowledge test responses, views relevant video content correlating to

knowledge deficits and mandatory content. (Scripts for all the section of the

Diabetes to Go Video submitted separately from protocol due to length).

3- CDE confirms current medications (name, dose(s), timing), reviews prior BGs if

patient currently using a meter, sets individual BG targets with patient. CDE

provides Telcare telcom network enabled BG meter, with instructions on use and

registers the patient with telcare to allow on-line review of blood glucose. Patient

demonstrates competency in use of meter.

4- Medical Nutrition Therapy (MNT) provided based on STEP-Diabetes survival

skills

5- CDE uses approved project algorithm to escalate DM therapy. If basal insulin or

non-insulin injectable to be started, CDE teaches injection and has patient self-

demonstrate. DM medication changes entered on Centricity medications list.

Prescriptions flagged to Pathway provider of the day (MDI Endo or NP provider)

for signature.

6- Patient sent home with: D2go book, meter, BG targets, medication instructions

and appropriate prescriptions transmitted to patient’s pharmacy via centricity.

7- F/up appointment set within 2-14 days.

8- Patient receives $25.00gift card and parking token if needed

9- Flag to PCP at end of visit to inform patient has successfully entered the program.

10- If patient has not had a screening exam for DM retinopathy in the past 12

months, work with patient on scheduling appointment.

Visit 2:

Preferably conducted in-person to enhance patient engagement with CDE and program;

however, if patient deemed competent in all program-related skills and would be difficult

to attend second on-site visit due to extenuating circumstances, eg cannot take time from

work, may be conducted as virtual visit.

1- Knowledge post test re-administered

2- Review of BG records, and fingerstick and insulin injection techniques if needed.

3- Reinforce diet teaching and BG targets

4- Modify DM therapy as needed based on algorithm. Data entry and meds sign-off

as per visit 1 above. If using basal insulin, use outpatient algorithm to escalate

dose as needed.

5- Refer patient to Diabetes control center

6- Patient receives $25.00 CVS/store gift card, and will be given parking

sticker/token if needed

B. Transition to Phone call and/or virtual visits for ongoing intervention s

1- CDE contacts patient by phone or vitual platmorm at date and time scheduled at

the end of visit 2.

2- Review current status, BG levels, any important issues, etc.

3- CDE works intensively with patient for 4-6 weeks to optimize diabetes self-

management, DM meds regimen and BG control. Document each interaction in

Centricity note and route to provider as necessary.FYI. Flag provider or program

NP for any orders required.

4- Refer patient back to PCP

5- Ensure patient has a visit scheduled with PCP within 12 weeks of baseline

program contact at PCP office. CDE will meet patient in the PCP office on that

date and complete the following steps: 1) obtain patient satisfaction survey

(Appendix G) and final questionnaires (MMMAS, Knowledge test ) ensure follow

up A1C is ordered 3) provide $25 gift card.

6- 8- Final phone visit with patient at 6 months from baseline to inquire about, visits

to the ED, hospitalizations and missed days from work. Arrange with patient for

delivery of final $25 gift card.

C. Transition back to PCP 1- Summary of participant status (glycemic control and DM meds), outcomes achieved

and further recommendations for ongoing DM management and option to re-enroll in

program should the need arise provided to PCP via Centricity with personal

communication at the end of the 6-8 week intervention and as needed throughout.

2- Participant provided with copy of same summary information in lay language.

Key Data Elements & timing of collection:

- Demographics and past medical history

- A1C baseline and at subsequent PCP visits

- BG average, % </= 180mg/dL and % < 70mg/dL during a. first week and b. last

week of participation in intervention

- D2go Knowledge test, Modified Morisky scale and QOL (SF12)

- Annual Eye exam done (Y/N) via iExaminer procedure and/or full

ophthalmologic exam

- Missed days of work or usual activities of daily living due to diabetes 6 months

pre and post enrollment in intervention

- ED and hospital visits in 6 months prior and 6 months following start of the

intervention

- Insurance costs incurred 6 months pre and post baseline for MedStar insured

patients

- Provider satisfaction with intervention: PCP, CDE, endocrinologist and MA/PCP

office staff (Appendix H)

- Patient and family member satisfaction with intervention

- Program cost components, staffing, visit duration, supplies, transportation, etc.

- Meet with a sub-group of patients to discuss their experience with this

intervention as compared to usual care.

Identification of Chart Controls

Three concurrent Centricity patient charts will be identified for each intervention

participant to serve as controls for the study There will therefore be 375 control charts,

which will be drawn from the cohort of patients who receive care in the designated

practices where the pathway is being delivered: MedStar Union Memorial Hospital

(MUMH) Adult Medicine Center, MUMH Adult Medicine Specialists 33rd

Street,

MedStar Medical Group Dibble Lee King and Harris, Metropolitan Medical Associates

Union Location, Metropolitan Medical Associates, MedStar Good Samaritan Hospital

Internal Medicine Specialists and MedStar Washington Hospital Center Internal

Medicine.

The MHRI data manager will extract the data for potential cases and controls from

Centricity using the Pathway inclusion/exclusion criteria as specified in this protocol.

Controls will be frequency-matched by age and sex to balance the groups Due to the

limitation of the available pool of patients it may not be possible to match the groups on

other characteristics. In that case, the analyses conducted to test the differences between

the groups will be adjusted for the covariates that may be significantly different at initial

enrollment/encounter.

Data Management

The MedStar Health Research Institute will provide data management services for all

aspects of the program, including preparation of the program REDCap database, quality

checks of data and developing processes for bringing data into REDCap from available

data sources held by system partners which will be leveraged for the program. All data

will be de-identified prior to presentation to the Biostatician for analysis.

Key data elements for program outcomes and other data elements which will be

examined are shown on the accompanying table with their respective collection strategies

and the data resource from which each will be obtained.

Data Analysis and Reporting Plan

Data analysis will be performed by the MHRI Biostatistician. All data will be de-

identified prior to submission to the biostatistician for analysis. The timeline for data

analysis and reporting is shown on Table 2. Results will be presented at a national

meeting or meetings and one or more manuscripts will be prepared for submission to

peer-reviewed journals.

Project Activities and Timeline

Project activities and timeline are shown on Table 2.

Table 2. Project Activities and Timeline

Timeline and Activities Year 1 Year 2

Quarter Q1 Q2 Q3 Q4 Q5 Q6

Groundwork for Implementation

Clinical Protocol Development and Approval

X

Tonic Health Platform preparation for survey and educational tools

X

Validate knowledge survey X

System data management plan development

X

Program Team Training X

PCP champions and Patient Advisors Group identified and provide input to program design

X

Demonstration Project

Intervention

Patient Identification and enrollment X X

Patient visits (1 on 1 onsite and virtual) X X X X

Control Group

Identification of concurrent matched control patients

X X

Control group data collection by chart review

X X X X

Intervention participant experience focus group

X

Sustainability and Scalability Activities

Plan for system dissemination of Best Practice and explore adding other chronic medical conditions such as Hypertension to the program

X X

Research future funding application X X

Data Reporting and Analysis

Data reports X X X X

Data Analysis, ROI and Outcomes reporting

X

Table 3. MedStar Pathway to Diabetes Control Program Partners and Resources

Proposal Partners Resources and/or role/relationship to program

MedStar Executive Board and

Vice Presidents for Medical

Affairs

Pathway Advocacy and core program infrastructure funding support.

MDI – MedStar Diabetes Institute

25+ Endocrinologists; 25+ Educators; Endo & Diabetes Centers; clinical management guidelines and

education expertise; CDE mentoring and oversight.

MedStar Hospitals Inpatient Glycemic management teams; Diabetes Nurse Champions; Hospitalists as as referral source of high risk

patients

MedStar Emergency Physicians MedStar EDs referral of high risk patients

MSH Ambulatory Practices MMG, MPP Medical Home; (Prompt Care) referral of high risk practice patiens

MedStar Family Choice Providers and Case Managers referral source and diabetes case managers will be participating in in program

Evolent Case Managers (RN, PharmD) referrals; risk stratification; Claims data; Economic. analyses

High risk diabetes patients BG > 200mg/dL; A1C > 9%; Acute care encounters

MI2 – MedStar Institute for Innovation

Virtual Control Center; SiTEL learning management systems

MedStar Information Systems Centricity, (HIE and Control Center integration)

MedStar Quality & Resources

Management

(Rapid cycle QI implementation and assessment expertise); system data; ROI

MedStar Managed Care Claims data; ROI

MHRI – MedStar Health Research Institute

Health Services Research Expertise; Data management & Health Economic Analyses with

ROI; Future Research Funding

Core Program Infrastucture Budget and Funding Support Sources

Financial core infrastructure support for the 18 month MedStar Pathway to Diabetes

Control demonstration project is being provided by MedStar Corporate. Staffing and

other programmatic costs including hardware, software and licenses for the virtual

control center and for use by CDEs, printing of education tools and program aids are

supported by this funding. Staffing which is being supported is as follows: FT CDE

Program Manager; PT NP for medical oversight, PT CDEs for MGSH and MUMH sites;

PT Administrative Assistant; Endos (3 x 0.1 FTE); PT data manager; PT health

economist; PT Research Associate for chart reviews.

Participants will receive stipends at completion of program milestones as outlined in the

methods section which total $100 per participant during 6 months of their participation

and they will also be reimbursed for parking expenses for onsite visits.

Many of the pathway partners are providing in-kind services to support this

demonstration pathway, including: a number of MDI Endos; MMG lead physicians

whom are championing the program; several MDI CDEs who will deliver the program;

MedStar Family Choice case managers; MI2 and SITEL-MS staff; Evolent team

members; MedStar Managed Care (for data provision); hospital-based physician

providers from ED and Hospitalist teams, etc.

References

1- UK Prospective Diabetes Study Group: Intensive blood-glucose control with

sulphonylureas or insulin compared with conventional treatment and risk of

complications in patients with type 2 diabetes (UKPDS 33). Lancet 352:837–853,

1998

2- UK Prospective Diabetes Study Group: Effect of intensive blood-glucose control

with metformin on complications in overweight patients with type 2 diabetes

(UKPDS 34). Lancet 352:854–865, 1998

3- American Diabetes Association. Implications of the United Kingdom Prospective

Diabetes Study. Diabetes Care January 2002 vol. 25 no. suppl 1 s28-s32

4- Lorig KR, Sobel D, Ritter PL, Hobbs M, Laurent D. Effect of a self-management

program on patients with chronic disease. Eff Clin Pract 2001;4:256-262

5- Norris SL, Nichols PJ, Caspersen CJ,. Glasgow RE, Engelgau MM, Jack L,

Snyder SR, Carande-Kulis VG, Isham G, Garfield S, Briss P, McCulloch D and

the Task Force on Community Preventive Services. Increasing Diabetes Self-

Management Education in Community Settings: A Systematic Review. Am J Prev

Med 2002;22(4S):39–66)

6- Norris S, Lau J, Smith SJ, Schmid CH and Engelgau MM. Self-Management

Education for Adults with Type 2 Diabetes. Diabetes Care, 25:1159–1171, 2002

7- Magee M, Bowling A, Copeland J, Fokar A, Pasquale P, Youssef G. ABCs of

Diabetes Self-Management Education Program for African Americans at an

Urban Public Library Impacts A1C, Lipid Lowering Prescriptions and Emergency

Department Visits. Diabetes Educator. 37(1):95-103, 2011.

8- Magee MF, Nassar C, Copeland J, Fokar A, Sharretts JM, Dubin JS and Smith

MS. Synergy to Reduce ED Visits for Uncontrolled Hyperglycemia" The

Diabetes Educator, 39(3):354-64, 2013

9- Magee M, Khan N, Desale, S and Nassar, C. Diabetes to Go: Knowledge- and

Competency-Based Hospital Survival Skills Diabetes Education Program

Improves Postdischarge Medication. The Diabetes Educator, 40(3)344 – 350,

2014.

10- American Diabetes Association. Standards of Medical Care in Diabetes- 2014.

Diabetes Care Volume 37, Supplement 1, January 2014

11- Nathan DM, Buse JB, Davidson MB, Heine RJ, Holman RR, Sherwin RS and

Zinman B. Management of Hyperglycemia in Type 2 Diabetes: A Consensus

Algorithm for the Initiation and Adjustment of Therapy: A consensus statement

from the American Diabetes Association and the European Association for the

Study of Diabetes. Diabetes Care, August 2006 vol. 29 no. 8 1963-1972

12- Nathan DM, Buse JB, Davidson MB, Ferrannini E, Hollman RR, Sherwin R and

Zinman B. Medical Management of Hyperglycemia in Type 2 Diabetes: A

Consensus Algorithm for the Initiation and Adjustment of Therapy. A consensus

statement of the American Diabetes Association and the European Association for

the study of Diabetes. Diabetes Care 2009, 32 (1) 193-203

13- American Association of Clinical Endocrinologists’ Comprehensive Diabetes

Management Algorithm 2013 Consensus Statement. Endocrine Practice Vol 19

(Suppl 2) May/June 2013

14- Hoerger T, Segel J, Gregg E and Saadine J. Is Glycemic Control Improving in

U.S. Adults? Diabetes Care 2008, 31(1):81-86.

15- Changes in Diabetes-Related Complications in the United States, 1990–2010 ...

January 2, 2014; Schulte J.M.Rothaus C.S.Adler J.N Engl J Med 2014; 370:1514-

1523 April 17

16- Shah BR, Hux JE, Laupacis A, Zinman B, Van Walraven C. Clinical inertia in

response to inadequate glycemic control: do specialists differ from primary care

physicians? Diabetes Care. 2005;28:600-606.

17- Griffith M, Boord J, Eden S, and Matheny M. Clinical Inertia of Discharge

Planning among Patients with Poorly Controlled Diabetes Mellitus. J Clin

Endocrinol Metab, June 2012, 97(6):2019–2026

18- Mühlhauser I, Bruckner I, Berger M, Cheţa D, Jörgens V, Ionescu-Tîrgovişte C,

Scholz V, Mincu I. Evaluation of an intensified insulin treatment and teaching

programme as routine management of type 1 (insulin-dependent) diabetes. The

Bucharest-Düsseldorf Study. Diabetologia. 1987 Sep;30(9):681-90.

19- Norris S, Lau J, Smith SJ, et. al. Self-Management Education for Adults with

Type 2 Diabetes. Diabetes Care, 25:1159–1171, 2002

20- Boren S , Fitzner K, Panhalkar P and Specker J. Costs and Benefits Associated

With Diabetes Education: A Review of the Literature. The Diabetes Educator

2009; 35(1); 72-96

21- American Association of Diabetes Educators. Diabetes Education Fact Sheet.

https://www.diabeteseducator.org/export/sites/aade/_resources/pdf/research/Diabe

tes_Education_Fact_Sheet_09-10.pdf Accessed 08-14-2014.

22- Ali MK. Achievement of DM goals in US 1999-2020. NEJM 2013, 368:1613-

1624 April 25

23- The Diabetes Educator 2012 38:142 Diabetes Inpatient Management- AADE

position statement

24- American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2012.

Diabetes Care. 2013 Apr;36(4):1033-46

Appendix A

MedStar Health Diabetes Pathway Medication Management Guidelines & Algorithm

Diabetes Diagnostic Criteria

Prediabetes Fasting BG 100-125 mg/dL; OR A1C =5.7-6.4%; OR--2-hour 75 gm OGTT > 140-199 mg/d

Diabetes Fasting BG > 126 mg/dL (positive result should be confirmed with repeat test another day)

OR Casual plasma glucose > 200 mg/dL with symptoms of hyperglycemia

OR A1C>6.5%

OR -2-hour 75 gm OGTT > 200 mg/d

No Prior Anti-hyperglycemic Agent Therapy*

BG (mg/dL) Action

126-139

(fasting)

Follow-up BG with MD within 2 weeks. BG is not completely normal. Possible pre-diabetes or

diabetes.

140-199

(random)

Follow-up BG with MD within 2 weeks. Sooner if symptoms of hyperglycemia. Probable diagnosis

of diabetes or pre-diabetes.

> 200mg Inform patient of diabetes diagnosis.

200-250 Start metformin 500mg po bid, unless contraindicated;

If metformin contraindicated DPP-4i OR GLP-1A OR SGLT2i (OR low dose SU)

251-300 START Metformin 500 mg po bid unless contraindicated.

PLUS DPP-4i OR GLP-1A OR SGLT2i (OR starting dose SU)

OR basal or premix insulin: one dose daily

301-400 Correction dose of rapid-acting insulin

Metformin 500 mg po bid

PLUS Basal insulin or premix 1-2 times daily OR GLP-1a

>400 Correction dose of rapid-acting insulin analog (see algorithm.)

START Metformin 500 mg po bid.

PLUS Basal insulin or premix 1-2 times daily

Pre-existing Diabetes on Oral Anti-hyperglycemic Agents*

BG

(mg/dL

)

One agent

2-3 oral agents

On metformin

On

sulfonylurea Other oral agent

80-139 No change. Follow up with MD.

140-

199

< 1000 mg daily: to

1000 mg twice daily:

Add DPP-4i OR

SGLT2i (OR SU)

Add metformin

OR DPP-4i

OR SGLT2i

OR uptitrate SU

Add metformin

OR DPP-4i

OR SLGT2i

Titrate one or more agents to higher or

maximal dose(s)

OR add third oral agent

OR add GLP-1a

200-

300

If not already on metformin, add 500 mg po bid, unless contraindicted

Titrate to higher or maximal dose AND/OR add second oral agent

OR add basal insulin OR GLP-1a

If not already on metformin, add 500 mg po

bid

START Basal insulinOR GLP-1A.

Continue SGLT-2i and/or DPP-4i when

starting insulin as actions synergistic.

Discontinue DPP-4i if start GLP-1a as actions

redundant.

Stop SU as increased risk for hypoglycemia

with insulin and GLP-1a

301-

400

Correction dose of insulin. (See CD algorithm)

If not already on Metformin, add 500 mg po bid, unless

contraindicated

START Basal or premix insulin 1-2 times/day OR GLP-1a

Continue SGLT2-i

Continue DPP-4i , unless starting GLP-1a, then stop DPP-4i

STOP SU

> 400 Correction dose of rapid-acting insulin analog (see CD algorithm.) ).

Metformin 500 mg po bid if not already taking.

PLUS Basal insulin or premix insulin

When a choice of two or more agents is possible based upon the algorithm, the options and potential benefits and risks of each should be discussed with the patient whom

should be invited to participate in the decision as to which agent will be used preferentially in the next treatment step to help promote medication adherence.

MedStar Hypoglycemia Treatment Algorithm.

For symptoms of low blood sugar (hungry, shaky, dizziness, sweating, palpitations),

and/or if realize is not thinking clearly, or for FSBG less than 70 mg/dL:

1) Treat for low blood sugar, then check a fingerstick blood sugar reading:

a. Give one 15 gram serving of carbohydrate such as:

1) 4 oz. of unsweetened apple or orange juice (avoid orange juice in

renal disease)

2) 4 oz. of regular soda

3) 8 oz. of milk (skim or 1% preferred)

4) 3-4 glucose tablets

b. If patient cannot take PO and/or is unconscious and family member or

caregiver has been trained in use of glucagon, give1 mg Glucagon IM,

place in side-lying position

c. Call 911 after glucagon is given

d. Check fingerstick blood sugar as soon as treatment has been given and

record value

2) If hypoglycemia was because a meal was delayed or skipped, eat that meal, or if a

meal is not due, eat a snack. A snack is something such as: half sandwich or

snack bar or 6 cheese/peanut butter crackers.

3) Recheck FSBG every 15 minutes until reading is greater than or equal to 100

mg/dL, and again one hour later to be sure it is not low again.

a. If taking insulin and If low blood sugar was due to extra physical activity,

eating less than usual or to taking extra insulin, resume your usual doses

once hypoglycemia resolved.

b. If taking insulin and you do not know why your blood sugar got so low

and/or you have more than one blood sugar under 70mg/dL in two days,

call for recommendations about your insulin doses.

c. If on oral hypoglycemics, do not resume previous therapy until after

discussion with provider to evaluate current orders.

4) If the patient has a severe hypoglycemic reaction, he/she should call his/her

doctor or go to the emergency room to obtain recommendations for what to do

with doses of diabetes medications

Hard stops for Allied Health Professional use of algorithm

Consult team Endocrinologist in the presence of any of the following:

Recurrent severe hypoglycemia (BG </= 40mg/dL on two consecutive days or 3

days in one week) in spite of reduction(s) in insulin dose per hypoglycemia

management guidelines.

Recurrent hypoglycemia (BG < 70mg/dL) in spite of two reductions in insulin

dose per algorithm

ED visit or hospitalization for severe hypoglycemia in patient being treated using

pathway algorithm

2-3 increases in insulin dose per algorithm without BG improvement

BG > 400 or patient continues to be symtomatic in spite of 2-3 increases in insulin

dose per algorithm

A serious or severe or medically significant adverse reaction to any DM

medication prescribed per the algorithm.

o Serious adverse reaction will be defined as any unfavorable and unintended

sign, symptom, or disease temporally associated with the use of medications

prescribed using the algorithm that may or may not be considered related to

the medical treatment or procedure and which are medically significant but

not immediately life-threatening.

o Severe adverse reaction will be defined as any unfavorable and unintended

sign, symptom, or disease temporally associated with the use of medications

prescribed using the algorithm that results in a life threatening circumstance,

an ED visit or hospitalization; death; or is disabling or limits self care ADL.

(Ref. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-

14_QuickReference_5x7.pdf)

Rationale for adding GLP-a to the basal insulin regimen

In general, GLP-1a will be added to the regimen as next agent of choice when

basal insulin therapy has been optimized or when an additional agent is deemed

necessary for treatment. In addition it has been found beneficial in

overweight/obese patients due to potential weight loss/neutral effects.

Advantages:

Less likely to cause weight gain; may lose weight as glycemic control improves

Increase in satiety

Less complex injection regimen/less shots daily than for multiple daily insulin

injections, which may be a key determinant of medication regimen adherence.

Dosing: Byetta®/exenatide twice daily with breakfast and dinner;

Bydureon/exenatide extended release once weekly; Victoza®/onglyza once daily.

Choice of GLP-1a agent(s) is determined by provider formulary.

Up to 25% nonresponders, therefore, If no response in 6-12 weeks, GLP-1a should be

discontinued.

Appendix B

INSULIN START Dosing Guidelines for Type 2 Diabetes

Type of Insulin Starting Dose Timing of dose(s) Comments

Basal Insulin 0.2units/kg/day *see comment section for special situations

one dose daily at same time of the day* (B, D, or hs)

Large doses, ( >50 units/day) split into 2 doses/day Detemir may not last for 24 hours and need to be split into 2 doses/day √ Special situations

A dose of 0.3 or 0.4 units/kg/day may be considered if marked

symptomatic hyperglycemia, BMI > 30 and no obvious lifestyle

intervention which might significantly impact BG levels present (

such as drinking sugared sweetened beverages).

Use 0.1units/kg/day if ESRD/CKD stage 4 or the elderly/frail

patient.

NPH may require bedtime snack to prevent nocturnal

hypoglycemia

glargine or detemir

NPH Split dose- Before breakfast, and dinner or bedtime*

Premixed Insulin 70/30, 75/25

0.2units/kg/day Split dose before breakfast and dinner

Can start with one dose before largest meal of the day.* Emphasize consistent CHO intake at each meal. Use for pts requiring a simple regimen if anticipate will need meal insulin. Also see √ special situations under basal insulin above. May require bedtime snack to prevent nocturnal hypoglycemia if pm dose.

Mealtime/prandial Aspart, lispro, glulisine

0.1 units/kg/meal Right before –or- right after meal*

Can start with single dose with the largest meal of the day, and then add to each remaining meal as needed.

* to promote adherence to the insulin dosing regimen, discuss timing preference with the patient

INSULIN ADJUSTMENT Guidelines

METHODS for making insulin dose adjustments, select one of:

BG-based dose adjustment algorithm

Titrate insulin* dose(s) 1-2 times per week based on blood glucose patterns during the preceding 2-7 days.

For BG: Change responsible insulin dose:

<80 mg/dl decrease 1-3 units

80-120 mg/dl no change

121-200 mg/dl increase 1-3 units

>200 mg/dl increase by 3-5 units

*Applies to all types of insulin

% of prior dose

If clinical judgment suggests that a greater incremental change in insulin dose is required to correct BG, then the dose of the responsible insulin can be adjusted by 10-20% in order to effect a clinically meaningful change, eg. If patient has insulin resistance and is on high dose(s) of insulin, and/or BGs running particularly high.

PATTERN MANAGEMENT

BASAL – glargine or detemir

If no response to basal insulin dose of 0.2 units/kg/day, double basal insulin dose to 0.4 units/kg/day. This is often necessary in presence of marked hyperglycemia (BG >300-400), BMI > 30 and no obvious lifestyle intervention which might significantly impact BG levels, eg elimination of sweetened beverages.

CHECK FSBG as: Fasting and before dinner

Titrate basal insulin until fasting and pre-meal BGs at goal

Then, if A1C still high and/or post-meal BGs above target, start another agent: GLP-1 analog; prandial insulin; or an insulin mix.

BASAL – NPH

Adjust morning NPH dose based on pre- dinner BG values Adjust bedtime NPH dose based on next day fasting BG values**.

Fasting and before dinner

Premixed Insulin- 70/30, 75/25

Start with one shot of premix insulin with largest meal of the day, usually dinner. Add second dose of premix insulin once single daily dose optimized. Adjust morning dose of premix insulin based on pre- lunch and/or pre- dinner BG values Adjust dinner dose based on bedtime and/or next day fasting BG values Note that premix insulin may not control post-lunch BG if meal large. Lower CHO content of lunch or add a third (smaller) dose of premix to lunch.

Fasting and vary pre- lunch, dinner or bedtime

**Suspect nocturnal hypoglycemia if fasting BG pattern is erratic (highs and lows), history of insomnia, night sweats, nightmares, in which case- decrease basal insulin glargine or detemir, or the PM NPH or premix insulin dose by 10-20%. Rapid acting insulin dosed with a late dinner can also cause nocturnal

hypoglycemia. Can confirm nocturnal hypoglycemia by checking 2-3am FSBG.

PATTERN MANAGEMENT, cont’d

Rapid-acting

PRANDIAL-

Aspart,

lispro,

glulisine

Pre-lunch BG is elevated adjust breakfast rapid-acting insulin dose

Pre-dinner BG is elevated, adjust lunch rapid-acting insulin dose

Bedtime BG is elevated, adjust dinner rapid-acting insulin dose

OR

Use the adjustment algorithm shown in the table below:

Mealtime dose

of insulin

Pattern of mealtime blood glucose

values below target*

Pattern of mealtime blood glucose

values above target†

< 10 units Decrease by 1 unit Increase by 1 unit

11-19 units Decrease by 2 units Increase by 2 units

> 20 units Decrease by 3 units Increase by 3 units

*If more than one-half of the mealtime blood glucose values for the week were below target. †If more

than one-half of the mealtime blood glucose values for the week were above target.

OR

Base meal insulin adjustments on BG change from pre- to post-meal:

If post-meal BG is more than 40 mg/dL higher than pre-meal BG increase meal insulin

dose by 1-3 units.

If there is a pre- to post-meal drop in BG of concern, decrease the pre-meal insulin dose

by 1-3 units. This is important as pre-meal BGs approach target values to help prevent

hypoglycemia. OR

Carbohydrate Counting Method

If patient counts CHO choices/grams of carbohydrate or is on consistent CHO diet

Start at one unit of prandial insulin per 15 grams of CHO or per 1 CHO Choice

CHECK FSBG as: Before next meal (or 120 minutes after meal)

Select method for adjusting rapid-acting insulin based on patient and clinical care team preference.

For further information on BG pattern management, see resource binder for chapter on pattern management from Magee reference.

Correction Dose Insulin Algorithm

Use rapid-acting insulin analog (lispro, aspart or glulisine) when hyperglycemia is present as an

add-on dose to usual daily insulin regimen .

Low Dose: < 40 units of

insulin/day, weight < 70 kg

Medium Dose: 40-100

units of insulin/day, weight

70-125 kg

High Dose: > 100 units of

insulin/day, weight > 125 kg

BG (mg/dL) Insulin Dose BG

(mg/dL)

Insulin Dose BG

(mg/dL)

Insulin Dose

150-199 1 unit 150-199 1 unit 150-199 2 units

200-249 2 units 200-249 3 units 200-249 4 units

250-299 3 units 250-299 5 units 250-299 7 units

300-349 4 units 300-349 7 units 300-349 10 units

> 349 5 units > 349 8 units > 349 12 units

Appendix C

MedStar Health Diabetes Survival Skills

KNOW Your Diabetes Numbers:

Target blood sugar (glucose) for MOST people with diabetes should be:

In the morning before eating (fasting) and before meals: 80 to 140

2 hours after eating: under 180

What blood sugar is too LOW (also called hypoglycemia)?

Less than 70

What blood sugar is too HIGH (also called hyperglycemia)?

Over 180: Discuss with your doctor at your next visit

Over 300: for 2 or more readings over 12-24 hours: Call your doctor at his/her

office

Over 500, “HI” or “HHH” on your meter: Call your doctor right away or go to

the emergency room

When to check your blood sugar:

Always check: Every day when you wake up in the morning, and at least one

more time during the day

If you take pills for your diabetes: check before breakfast and two hours after your

biggest meal of the day, usually this will be 2 hours after dinner.

If you take insulin for your diabetes: check before each meal and bedtime.

Your doctor may ask you to check your blood sugar at other times as well

Check any time you feel like your sugar might be too high or too low

How do you feel if your blood sugar is LOW (hypoglycemia)?

Sweaty

Shaky

Fast heartbeat

Dizzy

Headache

Not thinking clearly

Hungry

Tired

Blurry vision

Confused

Moody or angry

How to treat low blood sugar (hypoglycemia):

1. First eat 15 grams of carbohydrate, such as:

o ½ cup of juice

o ½ cup of regular (NOT diet) soda

o 1 cup of milk (skim is best)

o 1 tablespoon of honey, jelly, syrup, or sugar

o 1 small tube of gel mate cake frosting

o 3-4 glucose tablets of tube of glucose gel

2. Test your blood sugar again in 15 minutes

o If sugar is not over 70, eat another 15 grams of carbohydrate

o Repeat step1 and 2 until your blood sugar is greater than 70.

3. Eat a sandwich, cheese and cracker or peanut butter and crackers or the missed

meal to prevent your blood sugar from getting low again.

How do you feel if your sugar is HIGH (hyperglycemia)?

Increased urination

Increased thirst

Tired

Blurred vision

Dry skin/dry mouth

What to do if you think you have high blood sugar:

Check your blood sugar as soon as you can

Eating: What to do until you get a meal plan or see a dietitian:

Here are some tips to help keep your blood sugar under control before you learn more

about diet and diabetes.

Eat 3 meals a day

Eat your main meals 4-5 hours apart

Do not skip meals

Eat less food

Do not eat seconds

Do not snack between meals

Do not drink fruit juice, regular sodas or sweet tea

Drink calorie-free liquids such as diet soda, Crystal-Lite®, unsweetened tea,

coffee or water

Stay away from foods that are high in sugar, such as cake, pie, doughnuts,

sweetened cereal, honey, jam and jelly.

Do not add sugar to your food; instead use

sugar substitutes like Equal®, Sweet ‘n Low® or Splenda®

When to call your doctor or go to the emergency room:

Blood sugar is higher than 300 mg/dL two or more times over 12-24 hours

More than two low blood sugars (less than 70 mg/dL) in one day

Vomiting or diarrhea for more than 6 hours

Moderate or large urine ketones (if you have Type 1 Diabetes)

Other medical problem that requires immediate attention

Appendix D

Diabetes Knowledge Test

Please answer the following questions checking the best answer.

If you do not know the answer check “Do not know”.

1. A person with diabetes should test his or her blood sugar at home at least:

a. One to two times per day

b. Once a week

c. Once a month

d. Do not know

2. Checking blood sugar at home:

a. Provides me with information on my diabetes control

b. Helps me understand the effect of physical activity and food on my

blood sugar

c. Both a and b.

d. Do not know

3 A good blood sugar in the morning before you eat anything is:

a. 80-140

b. less than 150

c. less than 200

d. Do not know

4. The highest a blood glucose should be 2 hours after a meal or at any other time

of the day is

a. 120

b. 180

c. 250

d. Do not know

5. The A1C blood test gives you your average blood glucose in the past 3 months.

The A1C target or goal for most people with diabetes is less than:

a. 7

b. 8

c. 9

d. Do not know

6. High blood sugar may make you:

a. Feel shaky and nervous

b. Feel full of energy

c. Have increased urination, thirst and hunger

d. Do not know

7. One cause of high blood sugar is:

a. Exercising more than usual

b. Illness and infection

c. Skipping meals

d. Do not know

8. Your blood sugar is greater than 300 for two or more tests in one day. You should :

a. Call your doctor

b. Go to bed

c. Stop taking diabetes medication

d. Do not know

9. It is Saturday morning and your meter reads “ High” and you feel sick. You

should:

a. Call your doctor on Monday to schedule an appointment

b. Wait until your next scheduled appointment with your doctor in one

month

c. Go to the hospital emergency room

d. Do not know

10. Low blood sugar may make you feel:

a. Shaky and nervous

b. Full of energy

c. Itchy

d. Do not know

11. Low blood sugar can be caused by

a. a cold or infection

b. skipping a meal

c. eating a large meal

d. Do not know

12. Your blood sugar is 62, you

a. lie down and rest

b. drink ½ cup of juice and check your blood sugar again in 15

minutes

c. take a shot of insulin

d. Do not know

13.Low blood sugar should not be treated with:

a. ½ cup of diet soda

b. 1 cup skim milk

c. 1 tablespoon of jelly, syrup, sugar or honey

d. Do not know

14. Fruit juice, soda and sweet tea makes blood sugar:

a. go down

b. go up

c. stay the same

d. Do not know

15. Foods high in carbohydrates such as bread, potatoes, fruit , and milk make blood

sugar:

a. go down

b. go up

c. stay the same

d. Do not know

16. It is recommended the person with diabetes”

a) Eats 3 meals per day and eat less food

b) Drink plenty of natural fruit juice and fruit shakes

c) Avoids all foods that contain carbohydrates

d) Do not know

Answer question 17_ only if you take pills for diabetes.

17. Store diabetes pills:

a. At room temperature in a dry place away from the sunlight

b. On the window sill

c. In the medicine cabinet

d. Do not know

Answer question _18 only if you take insulin using a vial and syringe.

18. Insulin vials that are open and in use should be stored :

a. In the freezer b. At room temperature or in the refrigerator c. On top of the refrigerator d. Do not know

Answer question _19 only if you take insulin using an insulin pen.

19. Insulin vials or insulin pens that are open and in use should be stored :

a. In the freezer b. At room temperature away from the sunlight c. In the refrigerator d. Do not know

Appendix E

8. How often do you have difficulty remembering to take all your medication(s)?

(Please circle the correct number)

Never/Rarely……………………………………....4

Once in a while……………………………………3

©Morisky Medication Adherence Scale (MMAS-8-Item). This is a generic adherence scale and the name of the health

concern can be substituted in each question item.

You indicated that you are taking medication(s) for your (identify health concern, such as “high blood pressure”).

Individuals have identified several issues regarding their medication-taking behavior and we are interested in your

experiences. There is no right or wrong answer. Please answer each question based on your personal experience with

your [health concern] medication.

(Please circle the correct number)

No=1 Yes

=0

1. Do you sometimes forget to take your [health concern] medication(s)?

2. People sometimes miss taking their medications for reasons other than forgetting. Thinking over

the past two weeks, were there any days when you did not take your [health concern]

medication(s)?

3. Have you ever cut back or stopped taking your medication(s) without telling your doctor,

because you felt worse when you took it?

4. When you travel or leave home, do you sometimes forget to bring along your [health concern]

medication(s)?

5. Did you take your [health concern] medication(s) yesterday?

6. When you feel like your [health concern] is under control, do you sometimes stop taking your

medication(s)?

7. Taking medication(s) everyday is a real inconvenience for some people. Do you ever feel hassled

about sticking to your [health concern] treatment plan?

Sometimes………………………………………....2

Usually…………………………………………….1

All the time………………………………………..0

Appendix F

(This Questionnaire has been deleted from the protocol)

Appendix G

MedStar Health Pathway to Diabetes Control

Patient Satisfaction Survey

Please answer the following questions by circling the answer that best describes how

you feel.

1- How satisfied are you with the overall quality of the care that you have received

from the Pathway to Diabetes Control program?

Very satisfied Satisfied Somewhat Satisfied Not Satisfied

2- Did you find the care provided to you helpful to improve your ability to take care of

your diabetes?

Very helpful Helpful Somewhat Helpful Not Helpful

3- How satisfied are you with the structure of the program: one on one in person visits

followed by phone visits scheduled at your convenience?

Very satisfied Satisfied Somewhat Satisfied Not Satisfied

4- How satisfied are you with the knowledge and teaching skills of the Certified

Diabetes Educator that you worked with?

Very satisfied Satisfied Somewhat Satisfied Not Satisfied

5- How helpful was the program in helping you reach your diabetes control goals?

Very helpful Helpful Somewhat Helpful Not Helpful

6- How likely are you to recommend this program to friends and relatives that need to

improve their diabetes control?

Very likely Likely Somewhat Likely Not likely

7- Is there anything that you would like to tell us about your experience with MedStar

Pathway to Diabetes Control Program? Please use the other side of this paper to

respond.

Appendix H

MedStar Health Pathway to Diabetes Control

Physician Satisfaction Survey

Please answer the following questions by selecting or circling the answer that best

describes how you feel.

1- How satisfied are you with the overall quality of the care that your patients received

from the Pathway to Diabetes Control program?

Very satisfied Satisfied Somewhat Satisfied Not Satisfied

3- How satisfied are you with the structure of the program offered to your patients: one

on one in person visits followed by phone visits scheduled at their convenience?

Very satisfied satisfied Satisfied Somewhat Satisfied Not Satisfied

4- How satisfied are you with the communication that you have received from the

Certified Diabetes Educator regarding the intervention provided?

Very satisfied Satisfied Somewhat Satisfied Not Satisfied

5- How likely are you to recommend this program to additional patients with

uncontrolled diabetes?

Very likely Likely Somewhat Likely Not likely

6- Did you find that the program met the overall goal of improving your patients’

glycemic control?

Strongly Agree Agree Disagree Strongly Disagree

7- Do you think that the MedStar Pathway to Diabetes Control Program should become a

permanent referral option for your patients?

Strongly Agree Agree Disagree Strongly Disagree

8- Is there anything that you would like to tell us about your experience with MedStar

Pathway to Diabetes Control Program?

Thank you