Transitions of Care Stroke Disparities Study

Site Initiation Presentation

Outline

• Introductions

• Background

• Study aims and design

• Site responsibilities

• Study procedures

• Contact info

Transitions of Care Stroke Disparities Study Team

University of Miami• Ralph Sacco, PI• Tanja Rundek, PI• Jose Romano, PI• Carolina Gutierrez, project manager• Iszet Campo-Bustillo, regulatory &

training liaison• Hannah Gardener, epidemiologist• Chuanhui Dong, biostatistician• Kefeng Wang, data manager• Erika Marulanda-Londono,

Investigator• Adina Zekki Al Hazzouri, Co-

Investigator

Participating Sites• Baptist Jacksonville

– Ricardo Hanel, PI– Mark Fafard, Coord

• Baptist Miami– Felipe de los Rios, PI– Josette Elysee, Coord

• Jackson Memorial– Jose Romano, PI– Digna Cabral, Coord

• Sarasota Memorial– Mauricio Concha, PI– Jeanette Wilson, Coord

• UF/Shands– Anna Khana, PI– Stephen Ruggles, Coord

• USF/Tampa– Scott Burgin, PI– Corbin Hilker, Coord

Worldwide Stroke Burden

Worldwide Incidence/ Prevalence

1990(‘000)

2013(‘000)

Ischemic Incident 4,310 6,900

Prevalent 10,040 18,310

Hemorrhagic Incident 1,890 3,370

Prevalent 3,890 7,360

Total Incident 6,200 10,270

Prevalent 13,930 25,670

V Feigin, B Norving, GA Mensah. Circ Res. 2017; GBD 2017

US Stroke Mortality Trends

Age-standardized stroke mortality trends; >35 years, 2000-2015

Q Yang et al. MMWR 2017

• Reversal or stagnation in mortality trend• Worse in South (Florida), Hispanics• 33,000 excess deaths more than expected,

1/3 in young adults (age 35-64)

In-hospital care has improved in FL

Defect Free Care - Ischemic OnlyAdjusted Odds Ratio (95% CI)

FL-B vs FL-W FL-H vs FL-W PR-H vs FL-W PR-H vs FL-H

1.03 (0.96, 1.09) 1.03 (0.92, 1.16) 0.62 (0.27, 1.46) 0.60 (0.26, 1.41)

Adjusted for: age, smoker, HTN, diabetes, dyslipidemia, afib/flutter, CAD, PVD, TIA/stroke, prior ambulation, insurance, mode of arrival (EMS), academic status

RL Sacco et al. JAHA 2017; N Asdaghi et al. Stroke 2016.

FL-W

FL-B

FL-H

PR-H

6469

8492 93 93 95 94

6672

8492 94 92 95 94

6067

8592 94 94 94

91

3139

63

77

6166

70 71

0

10

20

30

40

50

60

70

80

90

100

2010 2011 2012 2013 2014 2015 2016 2017

DFC for Women (86%) vs. Men (85%) Adj OR 0.94 (0.91-0.98)

Stroke recurrence and readmission

• 25% of all strokes are recurrent events1

• 18% of all Medicare readmissions cost $18B2

• After stroke, 25% readmitted within 30 days3

• In GWTG-Stroke, death and readmission after discharge 21% at 30 days4

• The drivers of readmissions are not well understood• Disparities in readmission exist and reasons for these

disparities are not well studied

1 Mozzafarian et al. Circulations 2016; 2 Medicare Payment Policy Report to Congress 2017; 3 Bravata et al. Stroke 2007; 4 Fonarow et al. Stroke 2011

Readmissions after acute stroke hospitalization in FSR & CMS linked data

• All-cause 30-day readmission was 15% (n=16,952)– 14.4% for Whites (reference*)– 17.2% for Blacks: HR 1.19 (95% CI 0.99-1.44)– 16.7% for Hispanics: HR 1.02 (95% CI 0.87-1.20)– 14.7% for Others: HR 1.03 (95% CI 0.72-1.46)

• Median time d/c to readmission: 11 d • 23.9% readmissions due to stroke

– 16.6% IS or TIA– 1.5% ICH– 5.2% CEA/A&S

• 6.0% NHW, 1.8% NHB, 3.8% H, 7.5% other• 8.2% readmission due pneumonia or UTI

*Adjusted for demographics, comorbities, NIHSS, LOS, d/c destination

H Gardener et al. ISC 2017

Disparities in Lifestyle Education for AISin FL-PR Stroke Registry

MA Ciliberti et al. ISC 2017

Adjusted Odds Ratio (95% CI)(NH-W in FL as reference) FL-NHB FL-H

Physical Activity/Weight Counseling (BMI > 25)

0.97 (0.91-1.04)

0.94 (0.83-1.05)

Diet Recommendation 0.97 (0.92-1.02)

1.01 (0.90-1.13)

Low Sodium Diet Recommendation

0.95 (0.92-0.99)

0.89 (0.74-1.06)

Diabetes Teaching 1.26 (1.12-1.42)

1.11 (0.91-1.36)

Smoking Cessation Counseling 0.73 (0.61-0.87)

1.05 (0.61-1.81)

Data 2010-2016Adjusted for: Age, Race-Ethnicity, Sex, Aphasia and NIHSSBold p<0.05

Disparities in Lifestyle Education for AISin FL-PR Stroke Registry

MA Ciliberti et al. ISC 2017

Transitions of Care Stroke Disparity Study

Goal: Improve stroke outcomes and reduce readmissions

• Identify race-ethnic and sex disparities in hospital-to-home transition of care and outcomes after stroke.

• Identify the key stroke-related and social health-related determinants in hospital-to-home TOSC and stroke outcomes.

– Develop a Transitions of Stroke Care Performance Index

• Develop effective hospital-initiated system level initiatives to reduce disparities

Transition of Care Stroke Disparities Study, NIMHHD R01 MD-012467

Acute Hospital Home Care Transition

Medication adherence• Filled stroke meds• Taking stroke medsLifestyle & behavior• Exercise as indicated• Diet modification• Tobacco/alcohol/drug

cessation treatmentRehabilitation• Attended therapy• Using DMEMedical attention• Scheduled follow-up• Seen by provider

Outcomes (30, 90 days)

• Readmission • Stroke/TIA recurrence• Other CV events and

revascularization• Death

Study Design

Home Care Transition

Medication adherence• Filled stroke meds• Taking stroke medsLifestyle & behavior• Exercise as indicated• Diet modification• Tobacco/alcohol/drug

cessation treatmentRehabilitation• Attended therapy• Using DMEMedical attention• Scheduled follow-up• Seen by provider

Outcomes (30, 90 days)

• Readmission• Stroke/TIA recurrence• Other CV events and

revascularization• Death

Disparities

Individual Characteristics• Demographics• Risk Factors & PMH• Premorbid status• Baseline meds• Arival mode, on/off time• NIHSS, symptoms• Treatment type & times• Disability (mRS) at DC• Education/counsellingHospital characteristics• Region• Volume: Beds, stroke, tPA • Status: JC/DNV/HFAP

Social Determinants• Community

characteristics• Household

characteristics

TOSC PI

Initiatives for TOSC Disparities

• TOSC Index will be developed in first 1,200 participants after which initiatives will be implemented to assess their effect on the TOSC-I and on outcomes.

• Feedback to sites on TOSC metrics, disparities, TOSC-I– Dashboard benchmarked against group

• Educational programs for hospital personnel involved in discharge and TOSC to improve outcomes– Creating multidisciplinary advisory group: patients,

caregivers, therapists, pharmacist, nutritionist, nurses, physicians

Acute Hospital

GWTG/FSR

• Demographics• Risk Factors & PMH• Premorbid status• Baseline meds• Arival mode, on/off time• NIHSS, symptoms• Treatment type & times• Disability (mRS) at DC• Education/counselling

Care Transitions

Interview at 30 days

Medication adherence• Filled stroke meds• Taking stroke medsLifestyle & behavior• Exercise, Diet• Tobacco/alcohol/drug

cessation treatmentRehabilitation• Attended therapy• Using DMEMedical attention• Scheduled follow-up• Seen by provider

Outcomes

Interview at 30, 90 days

• Hospital Readmission• Disability (mRS)• Stroke/TIA recurrence• Other CV events and

revascularization

Hospital charateristics• Region• Volume: Beds, stroke, tPA • Status: JC/DNV/HFAP

Public Sources/Sciera

Social Determinants• Community

characteristics• Household

characteristics

Data source for TOSC-PI

AHCA/JC/DNV/survey

Planned enrollment

• 2400 patients /5 years – 1200 to develop TOSC-PI– 1200 to validate TOSC-PI, evaluate disparities, develop

initiatives to reduce disparities in TOSC• 400 participants per site Baptist Jacksonville Baptist Miami Jackson Memorial Sarasota Memorial UF/Shands USF/Tampa

Site ResponsibilitiesRegulatory and overall conduct of the study• Designate of site principal investigator and study coordinator. • Obtain local IRB approval to cede review to UMiami IRB.• Protect participants' rights and welfare.• Maintain and retain study regulatory records.Study-specific activities• Actively identify, screen and recruit participants prior to d/c. • Obtain informed consent (participant or LAR).• Collect study data (Baseline, 30 and 90 day interviews).• Enter data within 15 days of each encounter (baseline, 30, 90 d).• Maintain a master list of study ID number and GWTG identifier.• In 2nd part of study: help implement initiatives to improve TOSC.

Eligibility

• Acute ischemic stroke or intracerebral hemorrhage, age >18 • Discharge directly home• mRS 1 or greater at discharge• Patient or LAR signs informed consent-willing to take 2 f/u calls

Exclusion: • mRS = 0 (no residual symptoms, able to carry all activities)• TIA, SAH, Stroke NOS, elective admission for procedure• Children, prisoners

Schedule of Assessments

Eligibility

Add to master list to link with GWTG

Important to obtain social determinants

Contact sheet not entered into database,

kept by site

Baseline Information

• Premorbid independence: Y/N• Discharge mRS: 1-5• Final diagnosis: ICH, IS (TOAST for IS)• Language at home• Country of birth: US, other (name)• Zip code + 4• Level education: <HS, HS, some college or more• Premorbid work status: full, part-time, retired, unemployed• Difficulty paying for food and utility bills?• Difficulty paying for medical care?• Who do you live with?• How many people do you feel close to?

From contact sheet

30+/-7 day telephone interview

• Returned to hospital? Y/N– Ambulance/private– Admitted/released– Cause for hospital visit (list of symptoms)– Final diagnosis (from EHR if available)

• mRS• Medications

– Fill prescriptions: Y/N-why: no scripts, not gone to pharmacy, too expensive, other

– Do you take as prescribed: <50%, 50%, 75-90%, 90-100% time– Reasons (<90%): feel poorly, forget, ran out, can’t afford, don’t

know, other

If deceased, complete mortality CRF

30+/-7 day telephone interview

• Diet– Provided info on diet modification at discharge: Y, N, unsure– Modified diet: Y, N, feeding tube, only shakes, unsure– Changes to diet: sodium, fat, calories, fruit & veggies,

Mediterranean or DASH, no vit K, other– Reasons for no diet change: already ideal, can’t get to market,

can’t afford, don’t cook, other• Toxic habits (at time of stroke): Y/N

– Provided info at discharge: Y, N, unsure– Referred to program/clinic: Y, N, unsure– Prescribed medication: Y, N, unsure– Stopped use: Y, reduced <50%, reduced >50%, N

30+/-7 day telephone interview

• Therapy and DME– Was therapy prescribed (PT, OT, ST): Y, N– Attended therapy: N, Y completed, Y-times/week – If no: insurance, transportation, felt worse, plan to start, other– Cane, WC, other equipment prescribed: Y, N– Barriers to use: don’t need, insurance, felt worse, other

• Exercise: – Walking for exercise: <1, 1, 2, >3/wk– Other aerobic, stretching/strengthening exercise: <1, 1, 2, >3/wk– If no: can’t do to physical condition, fatigue, no access-tranport,

expensive, unsafe area, other

30+/-7 day telephone interview

• Medical follow-up– Received appointments: Y, N, unsure– Have seen provider: Y (PCP, neuo, NRS, other), N (scheduled Y/N)– If not scheduled: no insurance, no provider, missed appt, other

90+/-14 day telephone interview

• Returned to hospital? Y/N– Ambulance/private– Admitted/released– Cause for hospital visit (list of symptoms)– Final diagnosis (from EHR if available)

• mRS

If not reached at 30-d, complete 30-d CRF

If deceased, complete mortality CRF

Entering data in the TCSD-S databaseREDCap (after IRB approval)

– Levels of Access: • Limited to 3 people per site• Site PI has viewing access; coordinator (2) has data entry access

– Obtaining REDCap Access: Overview1. Site provides UM the names of those (coordinators) who will enter

data to REDCap > UM will verify those names were approved by Central IRB

2. UM will provide instructions to the sites on how to obtain a CaneID(CID)• Each designated individual from each site will need to obtain

CID to obtain access to REDCap for data entry3. Site emails UM the obtained CIDs along with associated names 4. UM will add site/individuals to user to REDcap User list and alert

site when process complete.

Obtaining Cane ID• Obtain a CaneID www.caneid.miami.edu• Please note, will have to provide SSN

• Site emails newly obtained CIDs along with associated names to UM

• UM will add site/individuals to user to REDcap User list and alert site when process complete.

Site master list

• Site creates and maintains a log with GWTG-S ID and Study-ID, DOA, DOD

• Quarterly, site provides UM data from the enrollment log (first 4 columns only and excluding the HPI)

• Sharing this information with UM is important in order to link the data with the GWTG-S record

Site master list

Enrollment log must be kept in the Site Study Binder.Only the first four columns will be shared with the U of Miami Coordinating Center

Data Linkage

TCSD-S CRFs-Database

GWTG/FSR

Analysis: Disparities,

Predictors, TOSC-I

SDHSciera

Study ID GWTG ID

ZIP + 4

Master list

Contact information• Iszet Campo-Bustillo 305-243-8018

icampo@med.miami.edu

• Carolina Gutierrez 305-243-7850cgutierrez2@med.miami.edu

• Jose Romano 305-788-2039jromano@med.miami.edu

• Tatjana Rundek 786-449-5447trundek@med.miami.edu

• Erika Marulanda-Londono 305-243-4457etm42@med.miami.edu

• Chuanhui Dong 305-243-9274cdong@med.miami.edu

• Kefeng Wang 305-243-8331k.wang3@med.miami.edu