Protocol Highway

8/2/2019 Protocol Highway

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Lean Applications inHealthcare

Muhanad Hirzallah

Mayo Clinic

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What is Lean?



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Background

Clinical trial protocol development consists of thedocumentation, logistical and scientific reviews, approvals,and financial planning required for conveying a study fromconcept to activation and the beginning of patient accrual.

Stakeholder input from verbal and formal surveyinformation:

The process is

Too slow

Costly Redundant

Too many steps

Difficult to keep track

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DMAIC MethodologyDefine

Improve

Analyze

Measure

Control

What problem needs to be solved.

Compliance with the target

Best practices and deficiencies

Generate creative solutions

Monitor the improvement



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Scope

Multidisciplinary – Cancer, Cardiovascular, Transplant research

Multisite – Jacksonville, Scottsdale, Rochester

Primary measure – time from protocol submission to coordinatorsto IRB submission.

Goals

To reduce timeframe from 39 weeks to a maximum of:

10 weeks for internally-authored protocols.

4 weeks for externally-authored protocols.

Reduce rework.

Standardize, streamline, and eliminate redundancy in the protocoldevelopment process across 3 sites.

Develop a system that allows the capture of data for qualityassurance.

Define What problem needs to be solved.

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Define What problem needs to be solved.



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Benchmarking

Deliverables

PI Manual

Training Tools

Access database for tracking

Measurement

Readiness Checklist

Deployment Plan

All tools replicable to the research community

DefineDefine What problem needs to be solved.

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DMAIC MethodologyDefine

Improve

Analyze

Measure

Control








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Measure Compliance with the target

Value Stream Map

Define and measure individual subprocesses

Count the number of items in queue

Calculate total process time, total actual time, and the value

added ratio

Total time > 188 days

Process time ≈ 14 days

Value added ratio ≈ 7.4%

Current State Kaizens

Protocol template standardization FDF improvements

Communication/Approvals plan

Committee approvals process

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ConceptApproval &

Protocol

8.5d 30+15d 7.7+10d 10.8+30d 4.6d 15.4+20 21.5d

1-9 hrs 1.5-24 hrs 3.5-8 hrs 6-24 hrs 0.05 hrs 18-127 hrs 1.5-8 hrs

20 days15 days 10 days 30 days

ProtocolDevelopment

Coordinator

ReviewForConsistency&

Accuracy

P/T: 1-9 hrs

ErrorsFrom Upstream: 100%

Batch Size: 1 Protocol

Staff:22

Protocol Development

Coordinator,Protocol

Coordinator,Research

Secretarial Assistant

DevelopConsent Form & Send

toPI

Develop Budget & Send to

Preaward

DevelopContract Checklist &

SendtoLCA

ProtocolDevelopment

Coordinator, Protocol

Coordinator, Research

SecretarialAssistant

Compile& Send Protocol,BudgetwithConsenttoPeer

Review,Dept.Review, Funding

Agency

GetFinancialDisclosure Form

& Conflict ofInterest

PrepareOtherRegulatory

Documents




MakeChangesandRespond

toPeer Reviewers

11 39 10 14 28

PrincipalInvestigator/ Study

TeamCommunication&

ApprovalsPlan

StandardizeCoding

ProcessTools& Training




UpdateFundingAgency with

FinalProtocol

Sponsor Funding Agency


Coordinator

DataManagement Services

Meeting

ProtocolDevelopment

Coordinator, Protocol

Coordinator

Fillin IRBeApplication

IRB

6 20

P/T: 1.5-24 hrs

ErrorsFrom Upstream:100%

Batch Size: 1 Protocol

Staff: 40

P/T:3.5-8 hrs


BatchSize: 1 Protocol

Staff: 40

P/T: 6-24 hrs


BatchSize: 1Protocol

Staff: 22

P/T: 0.05hrs


Batch Size:1 Protocol

Staff: 36

P/T: 18-127 hrs

ErrorsFrom Upstream:100%

Batch Size:1 Protocol

Staff: 22

P/T: 1.5-8hrs


BatchSize: 1Protocol

Staff: 26

ExpeditedIRB Review

for ExternallyAuthored

Standardize within/with

Protocol Template

Financial Disclosure

Form Improvements

Committee Approval

Process

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DMAIC Methodology

Define

Improve

Analyze

Measure

Control






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Root Cause Analysis Fish diagrams were used to discover the root causes of process defects

as discovered through surveys and customer feedback

Brainstorming Team members brainstormed ideas and circulated for review and

approval. Higher rated ideas were given higher priority due to limitedresources.

Box plot The peer review process was measured and shown to be highly

variable. Average process time = 17 weeks

Range = 1.1-49.3 weeks

Analyze Best practices and deficiencies



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Time From PR to

IRB/NCI Final

Submission

Min(IQR): 1.1

1st

Quartile: 7.1

Median: 13.1

Mean: 17.1

3rd

Quartile: 24.0

Max(IQR): 49.3 1

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Minimum 1 3

Minimum 1 5

Minimum 1 4

25th 7.142857143 4

25th 7.142857143 6

25tj 7.142857143 2

75th 24 275th 24 6

25th 7.142857143 6

Median 13 6

Median 13 2

75th 24 2

75th 24 4

1 Max 49 4

Max 49 5

Max 49 3

Mean 17 4

Summary Range

1.11.1

7

13

24

49

0

10

20

30

40

50

60

Time From PR to IRB/NCI Final

Submission



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DMAIC Methodology

Define

Improve

Analyze

Measure

Control






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Future State Value Stream Map

3-4 week process

First in First Out mentality

Total process time = 4 working days

Total wait time – Non value added essential = 10 working days

Value added ratio = 27.5%

Additional Future State Kaizens

Clarify principal investigator roles

Provide project management training for coordinators

Improve fist time quality (checklist creation)

Improve Generate creative solutions



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Clean 9

Protocol

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10w. days

16-22 hrs 3 hrs 8-9 hrs


Coordinator

ReviewProtocolDevelop Consent form andemail toPI

Prepare LCAchecklistandsendto LCA

StartIRBe ApplicationAsk for codesStartregulatorydocuments(FDF…)Addonagendas (committee,

reviewers..)

P/T:12-18hrs

Errors From Upstream: 0%

Batch Size:1Protocol

Staff:22

Multipleconcurrenttasks

PI reviews consent(3days)

Peer review(upto 10 days)

FDFs (7 days)CommitteeApproval(14days)

Protocol DevelopmentCoordinator

Attend PIMConductreviewmeeting

FinishIRBapplicationandsubmit

DMS meeting(if applicable)

PrincipalInvestigator / StudyTeam

Communication& Approvals

Plan

StandardizeCoding

ProcessTools &

Training

IRB

P/T:2hrs

Within 14 days

P/T: 4-5 hrs

ExpeditedIRB

Review for

ExternallyAuthored

Standardize within/with

ProtocolTemplate

Financial Disclosure

FormImprovements

CommitteeApproval

Process

DMSSpecialist

Mock upforms

P/T:4 hrs

Errors From Upstream: 0%

Batch Size:1Protocol

Staff:5

FIFO

FIFO

StudyTeam

Reviewforms

P/T:1 hr

WAIT 3days

FIFO

ClarifyPIroles

PDCtrainingin

projectmgmt

Multidept

checklist forDMS

DMS Specialist/Assistant

Combinecomments & finalizeforms

P/T:4hrs

FIFO

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Step 1 Step 2 Step 31 Week 1-2 Weeks 1 Week

Step 1 Step 2 Step 31 Week 1-2 Weeks 1 Week

•Review protocol•Define study in NCCS

•Complete CorrelativeResearch Informationform

•Draft Consent and sendto PI/Sponsor

•Start IRBe application

•Obtain CPT codes fromsponsor (if applicable)

•Start regulatory

•Send out for Peer Review

•Add on to PRC/HRCagenda

•LCA-drug only, nofunding

•Review protocol•Define study in NCCS

•Complete CorrelativeResearch Information

form•Draft Consent and send

to PI/Sponsor

•Start IRBe application

•Obtain CPT codes fromsponsor (if applicable)

•Start regulatory

•Send out for Peer Review

•Add on to PRC/HRCagenda

•LCA-drug only, nofunding

•PI/SponsorReviews Consent

•PIM Requestedthrough MIRIS

•PRC/HRCapproval obtained

•PI/SponsorReviews Consent

•PIM Requestedthrough MIRIS

•PRC/HRCapproval obtained

•Conduct post peerreview meeting tofinalize protocol(and possiblyforms)

•Complete IRB

application andsubmit – OR- NCIsubmission

•Attend PIM(OSPA)

•Conduct post peerreview meeting tofinalize protocol(and possiblyforms)

•Complete IRBapplication andsubmit – OR- NCIsubmission

•Attend PIM(OSPA)


3 Week FIFO Process



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Logistics Review Meeting

Replaces Peer Review

Replaces multiple disconnected emails

Transitions into fully electronic environment

Allows for open discussion and debate

Brings in study team members from across the country and

across the world

Eliminates inconsistencies & contradictory language

Positive customer feedback


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Standardized Templates

Color coded for responsible party

Reduction from 64 total templates to 22

1-on-1 PI education

Available to community PI upon request




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Happy Customers

Ultimate Goal:

Accelerating the

time to improve

patient access to

trials

Meet customer

demands

Improve staff

satisfaction

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QuestionsProject Process Owner:

Terre McJoynt

Unit Head, Protocol Development

[email protected]

Quality Improvement Advisor:

Muhanad Hirzallah

Director, Business [email protected]