RECRUITMENT, ADHERENCE, RECRUITMENT, ADHERENCE, AND RETENTION STRATEGIESAND RETENTION STRATEGIES

TALES FROM CLINICAL TRIALS TALES FROM CLINICAL TRIALS

Kelley R. Branch, MD, MSc, FACCKelley R. Branch, MD, MSc, FACCAssociate Director, Clinical Trials Services UnitAssociate Director, Clinical Trials Services Unit

Medical Director, CCU/5NEMedical Director, CCU/5NE

A Clinical Trial Story…A Clinical Trial Story…

Once upon a time, there were 4 Once upon a time, there were 4 hypertension trials…hypertension trials…

COMPARISON OF SHEP, STOP-H, COMPARISON OF SHEP, STOP-H, MRC-92 AND SYST-EUR CHARACTERISTICSMRC-92 AND SYST-EUR CHARACTERISTICS

SHEP STOP-H MRC-92 Syst-Eur

Sample Size 4736 1627 4396 4695

Mean Age 71.5 75.6 70.3 70.3

BP Criteria

SBP 160-219 180-230 160-209 160-219

DBP <90 90+ <114 <95

Primary Outcome

Total Stroke Total mortality Total stroke Total stroke

Design P R DB P R DB P R SB P R DB

Sys-Eur Trial: AccrualSys-Eur Trial: Accrual

Trial AdherenceTrial Adherence

SHEP STOP-H MRC-92 Syst-EurMean F/U Time 54 mo 25 mo 70 mo 30 mo

Mean Baseline BP 170/77 190/104 185/91 174/86

BP Differential 41247.00 19.5/8 14/6 11/5Adherence

Lost to F/U 6% 0% 25%P 5% (116)A 5% (121)

% Crossovers 33% 23% 31% 23%

% Adherence 90%/67% 84%/77% 52%D37%B47%P

85%/72%

SYST - EURSYST - EURA WORST CASE ANALYSIS?A WORST CASE ANALYSIS?

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Late Recruitment = Fewer EventsLate Recruitment = Fewer Events

High Lost to Follow Up = No Definitive High Lost to Follow Up = No Definitive Conclusions from the TrialConclusions from the Trial

Major Trial IssuesMajor Trial Issues

• Recruitment - Timely EnrollmentRecruitment - Timely Enrollment

• AdherenceAdherence

• Complete Follow UpComplete Follow Up

RECRUITMENTRECRUITMENT

MANTRA: “Get Sufficient MANTRA: “Get Sufficient Population In a Reasonable Population In a Reasonable

Time”Time”

RECRUITMENTRECRUITMENTFUNDAMENTAL POINTFUNDAMENTAL POINT

Successful recruitment depends on developing Successful recruitment depends on developing a careful plan with multiple strategies, a careful plan with multiple strategies,

maintaining flexibility, establishing interim maintaining flexibility, establishing interim goals and preparing to devote the necessary goals and preparing to devote the necessary

effort.effort.

Friedman, Furberg and DeMetsFriedman, Furberg and DeMets

RECRUITMENTRECRUITMENT

• Successful recruitment has been Successful recruitment has been documented in many trialsdocumented in many trials

• Clinical SitesClinical Sites: Past performance predicts : Past performance predicts futurefuture

• Centers carefully selected by past Centers carefully selected by past performanceperformance

(http://www.fhcrc.org/science/phs/swog/recrcct/)

RECRUITMENT:BASIC ISSUES RECRUITMENT:BASIC ISSUES • PlanningPlanning

– Sources and supportSources and support– StrategiesStrategies

• Conduct - Implementation Conduct - Implementation

• Monitoring - Short and long term goalsMonitoring - Short and long term goals

• Problems - Expect them to happen Problems - Expect them to happen

• Solutions - Make them occurSolutions - Make them occur

• Have reasons for participationHave reasons for participation

RECRUITMENT: CAREFUL RECRUITMENT: CAREFUL PLANNINGPLANNING

• BE CONSERVATIVE IN YOUR ESTIMATESBE CONSERVATIVE IN YOUR ESTIMATES

• Design easy recruitmentDesign easy recruitment

• Establish interim goalsEstablish interim goals

• Have contingency plansHave contingency plans

• 3 TO 6 MONTH PERIOD TO SEE RESULTS3 TO 6 MONTH PERIOD TO SEE RESULTS

TRIAL PLANNINGTRIAL PLANNING

• Increase likelihood of getting sufficient participants Increase likelihood of getting sufficient participants

• Staff – Organized, experienced Staff – Organized, experienced

• Institutional support - proper facilities Institutional support - proper facilities

• Publicity - start before trial Publicity - start before trial

• Multiple recruitment strategies - at least 3 Multiple recruitment strategies - at least 3

• Pilot test strategiesPilot test strategies

• Contingency plansContingency plans

• Statistical power - assumes constant enrollment Statistical power - assumes constant enrollment

ADVANTAGES: WIDE ENTRY ADVANTAGES: WIDE ENTRY CRITERIACRITERIA

• Easier screening and recruitmentEasier screening and recruitment

• More More feasible and affordablefeasible and affordable

• Broader range of variables and Broader range of variables and larger study sizelarger study size

• Reliable overall resultReliable overall result

• Greater public health impactGreater public health impact

• Testing subgroup hypotheses Testing subgroup hypotheses 14

RECRUITMENT DATA: Variable RECRUITMENT DATA: Variable Success in 13 NHLBI StudiesSuccess in 13 NHLBI Studies

Number of Participants

Recruited Recruitment

Time

Person-Years in Planned Recruitment

Period Study Actual Actual/Planned Actual/Planned Actual/Planned (R)

AMIS 4,524 1.06 1.00 0.83 BHAT 3,837 0.95 1.21 0.82 CAPS 502 1.00 1.08 0.82 CARDIA 5,182 1.02 1.00 0.86 CDP 8,345 1.00 1.22 0.55 CSSCD 3,241 1.01 1.13† 1.16 HDFP 10,940 1.04 1.50 1.02 LRC 3,843 1.08 1.54 0.34 MILIS 985 0.82 2.71 0.35 MRFIT 12,886 1.07 1.13† 0.81 POSCH 838 0.84 1.58† 0.25 SHEP Pilot 551 1.10 1.17 0.71 TIMI-1* 316 0.93 0.96 0.98 *TIM-1 was stopped on the recommendation of Data and Safety Monitoring Committee; the treatment showed strong evidence of efficacy. † The ‘projected’ time was revised after additional clinics joined the study.

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SELECT Trial AccrualSELECT Trial AccrualProjected and ActualProjected and Actual

Projected

ACCORD Initial TrialACCORD Initial Trial

ACCORD Main Trial AccrualACCORD Main Trial Accrual

ACTUALGOAL

Num

ber

Random

ized

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

10000

Weeks

0 10

20

30

40

50

60

70

80

90

10

0

11

0

12

0

13

0

14

0

15

0

Num

ber

of S

ites A

ctive

0

20

30

40

50

60

70

80

RECRUITMENT STRATEGIES (N=3)RECRUITMENT STRATEGIES (N=3)

How to Get PatientsHow to Get PatientsChart ReviewChart Review WebsitesWebsites

Media EffortsMedia Efforts RegistriesRegistries

Direct MailDirect Mail Blood Bank DonorsBlood Bank Donors

Mass ScreeningMass Screening Occupational Occupational ScreeningScreening

Laboratory ListsLaboratory Lists Medical Referrals Medical Referrals20

Checklist: OVERALL Checklist: OVERALL RECRUITMENT PROGRAMRECRUITMENT PROGRAM

Start recruitment on Start recruitment on target datetarget date

Choose Choose physically accessible locationphysically accessible location

Use at least Use at least three recruitment strategiesthree recruitment strategies

Recruitment Coordinator - overall responsibilityRecruitment Coordinator - overall responsibility

Trial-wide recruitment coordinator networkTrial-wide recruitment coordinator network

Accurate tracking systemAccurate tracking system

Match staff and screenees Match staff and screenees

OVERALL RECRUITMENT OVERALL RECRUITMENT PROGRAMPROGRAM

Provide staff back-upProvide staff back-up

Be aware and anticipate staff burnoutBe aware and anticipate staff burnout

Inform medical and lay communities Inform medical and lay communities

Recruits - Recruits - Solicit in simple languageSolicit in simple language

Medical associations and hospital staffs - Medical associations and hospital staffs - contacted by the Principal Investigator contacted by the Principal Investigator

OVERALL RECRUITMENT OVERALL RECRUITMENT PROGRAMPROGRAM

Identify excellent, experienced staffIdentify excellent, experienced staff

Calendar for ENTIRE recruitment periodCalendar for ENTIRE recruitment period

Pretest your recruitment strategiesPretest your recruitment strategies

Regular review and evaluation Regular review and evaluation of programof program

Develop contingency plansDevelop contingency plans

Flexible clinic hoursFlexible clinic hours

PATIENT REASONS FOR PATIENT REASONS FOR PARTICIPATIONPARTICIPATION

• Answer scientific question accurately Answer scientific question accurately

• AltrusimAltrusim: Benefit other patients - current and : Benefit other patients - current and futurefuture

• Benefit to themselvesBenefit to themselves– additional monitoringadditional monitoring– second opinion of their condition second opinion of their condition – reassurance regarding diagnosisreassurance regarding diagnosis

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RECRUITMENT OF STUDY RECRUITMENT OF STUDY POPULATIONPOPULATION

RECRUITMENT FAILURE CAUSES:RECRUITMENT FAILURE CAUSES:

• Late startLate start

• Inadequate planningInadequate planning

• Insufficient effortInsufficient effort

• Overly optimistic expectationsOverly optimistic expectations

MANTRA: “Get Sufficient Population MANTRA: “Get Sufficient Population In a Reasonable Time”In a Reasonable Time”

POTENTIAL PROBLEMSPOTENTIAL PROBLEMSExpect them-they will occurExpect them-they will occur

• Inadequate funding for screening processInadequate funding for screening process

• Unwillingness to refer or allow participationUnwillingness to refer or allow participation

• Overestimation of prevalenceOverestimation of prevalence

• Overly rigorous entry criteriaOverly rigorous entry criteria

POSSIBLE RECRUITMENT SOLUTIONSPOSSIBLE RECRUITMENT SOLUTIONS

• EXTEND THE TIME FOR ENROLLMENT-EXTEND THE TIME FOR ENROLLMENT-X?X?

• RELAX INCLUSION/EXCLUSION CRITERIA-RELAX INCLUSION/EXCLUSION CRITERIA-XX

• ACCEPT A SMALLER SAMPLE SIZE-ACCEPT A SMALLER SAMPLE SIZE-XX

• RECYCLE PREVIOUS INELIGIBLES-RECYCLE PREVIOUS INELIGIBLES-OO

• CHANGE THE DESIGN-CHANGE THE DESIGN-XXXXXX

Recruitment: SummaryRecruitment: Summary

• Plan, plan, planPlan, plan, plan

• Design for success with recruitment programDesign for success with recruitment program

• At least 3 recruitment strategiesAt least 3 recruitment strategies

• Problems happenProblems happen

• Sufficient population in reasonable timeSufficient population in reasonable time

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Clinical TrialsClinical TrialsADHERENCEADHERENCE

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ADHERENCE DEFINITIONADHERENCE DEFINITION

Adherence is the extent to which a Adherence is the extent to which a person’s behavior coincides with medical person’s behavior coincides with medical

or health advice in terms of taking or health advice in terms of taking medications, following diets, using medications, following diets, using

devices, or executing life-style changes.devices, or executing life-style changes.

TERMINOLOGY: TERMINOLOGY: ADHERENCE VS. COMPLIANCEADHERENCE VS. COMPLIANCE

• AdherenceAdherence is preferred term is preferred term

• Adherence: Active, choice, interactiveAdherence: Active, choice, interactive

• Compliance: Passive, non-selectiveCompliance: Passive, non-selective

NHLBI Workshop, Bethesda, MD 1987NHLBI Workshop, Bethesda, MD 1987

OVERALL ADHERENCE PLANOVERALL ADHERENCE PLAN

• Develop a bottom line Develop a bottom line - cannot be transgressed- cannot be transgressed– Minimum amount of data which is essentialMinimum amount of data which is essential

• Set adherence goals Set adherence goals depending on protocoldepending on protocol– ““Acceptability” trialAcceptability” trial– ““Alteration of natural history” trialAlteration of natural history” trial

• Teach adherence techniques, plan for poor adherenceTeach adherence techniques, plan for poor adherence– Run-inRun-in and and test dosing test dosing proceduresprocedures– Have a maintenance plan for everyoneHave a maintenance plan for everyone

BOTTOM LINE:BOTTOM LINE:MINIMUM ACCEPTABLE ADHERENCEMINIMUM ACCEPTABLE ADHERENCE

• Know primary outcome status on every Know primary outcome status on every randomized participant.randomized participant.

• Human behavior will allow few to purposely Human behavior will allow few to purposely harm a worthy scientific project.harm a worthy scientific project.

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Adherence is bad in clinical trials.Adherence is bad in clinical trials.

Get over it.Get over it.

SAMPLE SIZE ADJUSTMENT FOR SAMPLE SIZE ADJUSTMENT FOR REDUCED ADHERENCEREDUCED ADHERENCE

• Key Point Key Point - Adherence correction - Adherence correction term-sample size formula, a term-sample size formula, a squared function.squared function.

2N = 2N = 22(z(z + z + z))2 2 ( (11 - - 22))22(1-p)(1-p)22

p = Reduction in Adherencep = Reduction in Adherence

pp SS IncreaseSS Increase

.01.01 1.021.02

.05.05 1.111.11

.10.10 1.231.23

.20.20 1.561.56

.30.30 2.042.04

.50.50 4.004.00

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MRCMRC

““ALTERATION OF NATURAL ALTERATION OF NATURAL HISTORY” TRIALHISTORY” TRIAL

• Enrolled group must do the interventionEnrolled group must do the intervention

• Looking for efficacy on clinical outcomesLooking for efficacy on clinical outcomes

• Adherence is crucialAdherence is crucial

• e.g., Phase IV trialse.g., Phase IV trials

LRC: ANALYSIS FOR PREDICTORS LRC: ANALYSIS FOR PREDICTORS OF ADHERENCEOF ADHERENCE

Adherence after first month associated with:Adherence after first month associated with:•Adherence in first month- Adherence in first month- most powerful predictor most powerful predictor (r=.59 or r²=.34)(r=.59 or r²=.34)

– r²=.36 with smoking and other factors addedr²=.36 with smoking and other factors added

•Smoking statusSmoking status

•AgeAge

•Extent of Psychological DistressExtent of Psychological Distress

•No statistical association with:No statistical association with:– ExerciseExercise -Overall risk status-Overall risk status

– WeightWeight -Motivational level-Motivational level

– Vitamin consumptionVitamin consumption

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FACTORS AFFECTING ADHERENCEFACTORS AFFECTING ADHERENCE TO INTERVENTIONS TO INTERVENTIONS

Effect on Adherence Positive Negative No Effect

Patient Education Low social class “Blue collar: occupation Social isolation

Age Sex Race

Regimen Supervised Parental

administration Cardiac drugs Respiratory drugs Diabetic drugs

Therapy duration Number of drugs Dosing frequency Symptomatic drugs

Adverse effect

Illness Disability Severity of symptoms Severity of illness Psychiatric illness

Disease duration Clinical improvement Concurrent illness

“ “RUN-IN” PERIODRUN-IN” PERIOD

• Pre-randomization procedurePre-randomization procedure

• Single blindSingle blind

• Placebo usedPlacebo used

• Stress test for "pill-taking behavior”Stress test for "pill-taking behavior”

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• Identifies a group of individuals who don’t adhere well during designated run-in

• Successful repeat run-in performers (6.9%) adhere less well during trial

• Those identified representative of those enrolled

What does it do

What doesn’t it do

• Identify all who will adhere poorly to intervention

Uncertainties

• If those who “fail” would all be poor adherers• Cost/Benefit-advantageous

CONCLUSIONS ABOUT CONCLUSIONS ABOUT “PLACEBO RUN-IN PERIOD”“PLACEBO RUN-IN PERIOD”

““TEST-DOSING” PERIODTEST-DOSING” PERIOD

• Pre-randomization procedurePre-randomization procedure

• Single blindSingle blind

• Active drug usedActive drug used

• Identify those with severe adverse effectsIdentify those with severe adverse effects

Non-AdherenceNon-Adherence

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SIGNS OF POTENTIAL NON-SIGNS OF POTENTIAL NON-ADHERENCE: “RED FLAGS”ADHERENCE: “RED FLAGS”

1.1. Missed visitsMissed visits

2.2. Difficulty in reaching by phone or failure to return callsDifficulty in reaching by phone or failure to return calls

3.3. Rescheduling appointment twice Rescheduling appointment twice (change in behavior)(change in behavior)

4.4. Complaints about office visitsComplaints about office visits

5.5. Impatience during clinic visitImpatience during clinic visit

6.6. Length of time (mandatory) at each visitLength of time (mandatory) at each visit

7.7. ““Distance” during interviewDistance” during interview

8.8. Length of time since participation in study was discussed between Length of time since participation in study was discussed between physician and participantphysician and participant

9.9. Humor dealing with negative aspects of trial medicationHumor dealing with negative aspects of trial medication

SIGNS OF POTENTIAL NON-SIGNS OF POTENTIAL NON-ADHERENCE: “RED FLAGS”ADHERENCE: “RED FLAGS”

10.10. Sarcasm about trial or study medicationSarcasm about trial or study medication

11.11. Any expression by participant that he/she may discontinue study Any expression by participant that he/she may discontinue study medicationmedication

12.12. Unusual or unexplained change in adherence to study medicationUnusual or unexplained change in adherence to study medication

13.13. Unconcern by participant about adherence rateUnconcern by participant about adherence rate

14.14. Reassignment to new primary-care managerReassignment to new primary-care manager

15.15. Reassignment to other new clinic personnelReassignment to other new clinic personnel

16.16. Illness with increased attention to “trial related disease”Illness with increased attention to “trial related disease”

17.17. Hospitalization for any reasonHospitalization for any reason

18.18. Any major change in life style which is imminentAny major change in life style which is imminent

DISTRIBUTION OF ADHERENCE PROBLEMS IN A DISTRIBUTION OF ADHERENCE PROBLEMS IN A CADRE OF DROPOUTS AND OTHERS IN AN RCTCADRE OF DROPOUTS AND OTHERS IN AN RCT

Type of Problem Percent Dropouts Others* Adverse effects 19 22

Medical problems 11 20

Psychosocial problems 69 58 * Those who experienced either a 10% drop in medication adherence or a 10 day delay from their clinic visit window

MECHANISMS INVOLVED IN PARTICIPANT MECHANISMS INVOLVED IN PARTICIPANT NON-ADHERENCENON-ADHERENCE

• Lack motivationLack motivation

• Lack of knowledge (disease, intervention)Lack of knowledge (disease, intervention)

• Rejects medical diagnosisRejects medical diagnosis

• Denies significance of disease processDenies significance of disease process

• Self-debate over intervention regimenSelf-debate over intervention regimen

• Rejects intervention regimenRejects intervention regimen

MEDICAL THERAPEUTICS TEAMMEDICAL THERAPEUTICS TEAM

PhysicianPhysician

Nurse-ClinicianNurse-Clinician

Therapeutic PlanTherapeutic Plan

ParticipantParticipant(Patient)(Patient)

Intervention ScheduleIntervention Schedule

Psychologist-BehavioristPsychologist-Behaviorist

PhysicianPhysicianAssistantAssistant

Dietitian-NutritionistDietitian-Nutritionist

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Principles for Counseling Corresponding Goals

1. To establish contact with participants

1. To maintain contact with participants.

2. To “undercut” participant’s resistance for reinstitution of some aspect of the trial protocol.

2. To complete as much of the trial protocol as possible.

3. To convey a caring attitude to the participant about his overall health status and the importance of health care to these participants.

3. To resolve any somatic, adverse drug effects, or behavioral problems preventing protocol adherence.

4. To maximize the participant’s opportunities for success of protocol completion using standardized behavioral techniques.

4. To reinstate the protocol in small increments using informal contracts and shaping.

5. To give positive reinforcement for fulfillment of protocol activities

5. To emphasize the positive contribution at any level of protocol adherence.

6. To resume study drug at a low but definite priority for the participant.

6. To restore and maintain study power.

PRINCIPLES AND GOALS: PARTICIPANT PRINCIPLES AND GOALS: PARTICIPANT COUNSELING IN DROPOUT RECOVERY COUNSELING IN DROPOUT RECOVERY

RECOVERY OF DROPOUTS RECOVERY OF DROPOUTS BAYLOR-METHODIST CLINIC OF CPPTBAYLOR-METHODIST CLINIC OF CPPT

• 94 % were recovered 94 % were recovered for some regular visit with clinic for some regular visit with clinic personnel (90% within 6 months )personnel (90% within 6 months )

• Remaining participant was contacted regularly by Remaining participant was contacted regularly by telephonetelephone

• 3% recidivism3% recidivism

• 70% reinstituted study medication70% reinstituted study medication

• Average adherence: study medication 35 %Average adherence: study medication 35 %

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Adherence: Key PointsAdherence: Key Points

• Adherence is key to knowing the magnitude of effectAdherence is key to knowing the magnitude of effect– Withdrawal may be an outcomeWithdrawal may be an outcome– Good trial = Good AdherenceGood trial = Good Adherence

• Plan, set goals, make contingenciesPlan, set goals, make contingencies

• Enhancing and actively monitoring participant Enhancing and actively monitoring participant adherence essential through trialadherence essential through trial

• KNOW FINAL OUTCOME FOR EACH SUBJECTKNOW FINAL OUTCOME FOR EACH SUBJECT

Adherence:Adherence:Contingency PlansContingency Plans

Contingency PlansContingency Plans

• Identify cause for non-adherenceIdentify cause for non-adherence

• MotivationMotivation

• NegotiationNegotiation

• Withdrawl of consentWithdrawl of consent

MOTIVATIONMOTIVATION

• Waning motivation is a common element for Waning motivation is a common element for trial participants with adherence difficulties, trial participants with adherence difficulties, e.g. e.g. clinical trial fatigueclinical trial fatigue..

• Strong resolve is critical, if one is to cope Strong resolve is critical, if one is to cope with problems of life and continue trial with problems of life and continue trial participation.participation.

PARTICIPANT MOTIVATIONPARTICIPANT MOTIVATIONHow staff can contribute to itHow staff can contribute to it

• Must know continuing importance of the trial.Must know continuing importance of the trial.

• Information from other studies.Information from other studies.– Be proactive-don’t wait for them to ask/tell you.Be proactive-don’t wait for them to ask/tell you.

• Remind them that the DSMB meets regularly.Remind them that the DSMB meets regularly.– Considers potential benefit and harm.Considers potential benefit and harm.

– Last meeting ended-vote for continuation.Last meeting ended-vote for continuation.

• Reassure participant of your position. Reassure participant of your position.

NEGOTIATIONNEGOTIATION

““YOU DON’T GET IN LIFE WHAT YOU YOU DON’T GET IN LIFE WHAT YOU DESERVE--DESERVE--

YOU GET WHAT YOU NEGOTIATE!”YOU GET WHAT YOU NEGOTIATE!”

Ronald Karass-in Flight AddRonald Karass-in Flight Add

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NEGOTIATED ADHERENCE REGIMENSNEGOTIATED ADHERENCE REGIMENS(Informal Contracts)(Informal Contracts)

• Reduced DoseReduced Dose

• “ “Drug Holiday”Drug Holiday”

• Follow-up onlyFollow-up only

• Final assessment at trial endFinal assessment at trial end

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RECHALLANGE: RESTARTINGRECHALLANGE: RESTARTING STUDY MEDICATION STUDY MEDICATION

• INFORMAL CONTRACT -BE CAUTIOUS.INFORMAL CONTRACT -BE CAUTIOUS.

• What was the reason for stopping?What was the reason for stopping?– Has that reason gone away?Has that reason gone away?

• Can you make small steps to your goal?Can you make small steps to your goal?

• Part of a “Win, Win” is participant successPart of a “Win, Win” is participant success

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WITHDRAWAL OF CONSENT:WITHDRAWAL OF CONSENT:HOW TO DEAL WITH ITHOW TO DEAL WITH IT

• Use your “Pause Button” immediately.Use your “Pause Button” immediately.

• Few will want to harm what is worthwhile. Few will want to harm what is worthwhile.

• You get what you negotiate.You get what you negotiate.– ““Seek first to understand, then be understood.”Seek first to understand, then be understood.”

• Know EXACTLY what your participant means.Know EXACTLY what your participant means.

• Make it clear you understand their position.Make it clear you understand their position.

• Make clear your goal of minimum adherence.Make clear your goal of minimum adherence.

• ““Is there a way both can achieve goals?”Is there a way both can achieve goals?”

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DROPOUTS:DROPOUTS:HOW TO DEAL WITH THEMHOW TO DEAL WITH THEM

• ““Sense it coming”- use the “red flags”Sense it coming”- use the “red flags”

• A lesson in using your “Pause Button”A lesson in using your “Pause Button”

• ““Seek first to understand, then be Seek first to understand, then be understood.”understood.”

• Issues frequently complex.Issues frequently complex.

• May not be solvable at the first interaction. May not be solvable at the first interaction.

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DROPOUTS:DROPOUTS:HOW TO DEAL WITH THEMHOW TO DEAL WITH THEM

• You are playing for- “Win, Win!”You are playing for- “Win, Win!”– Forcing resolution-may lead to “No.”Forcing resolution-may lead to “No.”

• Get agreement to talk again.Get agreement to talk again.

• Maintaining contact is your first principle. Maintaining contact is your first principle.

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BOTTOM LINE:BOTTOM LINE:MINIMUM ACCEPTABLE ADHERENCEMINIMUM ACCEPTABLE ADHERENCE

Know primary outcome status on every Know primary outcome status on every randomized participant.randomized participant.

Human behavior will allow few to purposely Human behavior will allow few to purposely harm a worthy scientific project.harm a worthy scientific project.

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SummarySummary

• RecruitmentRecruitment– Plan, design for successPlan, design for success– Timely EnrollmentTimely Enrollment– 3 Recruitment Strategies3 Recruitment Strategies

• AdherenceAdherence– Develop a bottom line Develop a bottom line – Set adherence goals Set adherence goals depending on protocoldepending on protocol– Teach adherence techniques, plan for poor adherenceTeach adherence techniques, plan for poor adherence

SummarySummary

• Complete Follow UpComplete Follow Up– Know primary outcome status on every Know primary outcome status on every

randomized participantrandomized participant

– Dropouts can drop back inDropouts can drop back in