Rushing Through the Rushing Through the Implementation Pipeline: Implementation Pipeline:

Hypertension Self-ManagementHypertension Self-Management

Hayden B. Bosworth, Ph.D.Hayden B. Bosworth, Ph.D.George L. Jackson, Ph.D., MHAGeorge L. Jackson, Ph.D., MHA

Ben J. Powers, MD, MHSBen J. Powers, MD, MHS

Center for Health Services Research in Primary Care Center for Health Services Research in Primary Care Durham VA Medical CenterDurham VA Medical Center

VA Quality Enhancement Research Initiative (QUERI) VA Quality Enhancement Research Initiative (QUERI) 2008 Annual Meeting2008 Annual Meeting

QUERI’s Research/ImplementationQUERI’s Research/ImplementationPipeline…Pipeline…

Implementation Research

Implement Intervention & Document outcome

Clinical Research / Guideline

Development

Mainstream Health Services Research

Assess Existing Practice

Identify Research

AreaIdentify Best

Practice

Implementation Policy, Improved Health

Phase 1 Pilot Projects

Phase 1 Pilot Projects

Phase 2 Small-Scale

Demonstrations

Phase 2 Small-Scale

Demonstrations

Phase 3Regional

Demonstrations

Phase 3Regional

Demonstrations

Phase 4“National Rollout”

Slide presented developed by VA Quality Enhancement Research Initiative (QUERI)

Veteran Study To Improve The Control of Veteran Study To Improve The Control of HypertensionHypertension

(V-STITCH) Study (V-STITCH) StudyDesignDesign A randomized controlled trial testing two interventions A randomized controlled trial testing two interventions

designed to improve BP controldesigned to improve BP control– Patient Intervention: Early Self-ManagementPatient Intervention: Early Self-Management

– Provider Intervention: Decision Support Provider Intervention: Decision Support

Brief telephone intervention improved BP control by Brief telephone intervention improved BP control by 21% at 24 months21% at 24 months

• 12.6% improvement compared to the non-behavioral group12.6% improvement compared to the non-behavioral group

No increase in clinic utilizationNo increase in clinic utilization

Cost effectiveCost effective

Computer Decision Support did not significantly Computer Decision Support did not significantly improve BP control rates at 24 monthsimprove BP control rates at 24 months

Take Control of Your Blood pressure Take Control of Your Blood pressure (TCYB) Study(TCYB) Study

DesignDesign• A 2-year randomized controlled trial A 2-year randomized controlled trial • Focus on patient self-managementFocus on patient self-management

• The nurse administered patient intervention The nurse administered patient intervention • Home BP MonitoringHome BP Monitoring

Combined telephone intervention and home BP Combined telephone intervention and home BP improved BP control by 13% at 24 monthsimproved BP control by 13% at 24 months

• 17% improvement compared to the non-behavioral 17% improvement compared to the non-behavioral groupgroup

• SBP improved 6 mm/hgSBP improved 6 mm/hg• DBP improved 4 mm/hg DBP improved 4 mm/hg

No increase in clinic utilizationNo increase in clinic utilizationCost effective - ~$200 per yearCost effective - ~$200 per year

Hypertension Intervention Nurse Hypertension Intervention Nurse Telemedicine Study (HINTS)Telemedicine Study (HINTS)

DesignDesign• A 18 month randomized controlled trial A 18 month randomized controlled trial

• Focus on patient self-managementFocus on patient self-management• The nurse administered patient intervention The nurse administered patient intervention • Home BP MonitoringHome BP Monitoring• Medication management by MDsMedication management by MDs

Completed recruitmentCompleted recruitment• 600 patients600 patients• 50% recruitment rate50% recruitment rate• > 90% 12-motnth retention> 90% 12-motnth retention• 50% African American50% African American• 45% have diabetes45% have diabetes

Telephone InterventionTelephone Intervention

Behavioral interventions to enhance hypertension control

Intervention implemented in nontraditional setting - outside of the clinic, easily administered via the telephone

Delivered by nurses or other clinicians

Tailoring the intervention to patients’ needs - this ensures a more cost efficient method of implementing the intervention

Multiple hypertension-related behaviors addressed

Software allows the integration of patient, medical records, and provider information

Emphasis on cultural issues related to hypertension

HTN IMPROVE: HTN IMPROVE: Quality Improvement ProjectQuality Improvement Project

Hypertension Telemedicine Nurse Implementation Project for Veterans

In the Pipeline – Summary ofIn the Pipeline – Summary ofHTN-IMPROVEHTN-IMPROVE

The study is addressing four specific aims: – 1) Assess the implementation of an evidence-based

behavioral intervention to improve BP levels. – 2) Evaluate the clinical impact of the intervention to

promote and improve BP levels as it is implemented.

– 3) Assess the organizational factors associated with the sustainability of the intervention to improve BP levels.

– 4) Assess the cost of the intervention to improve BP levels as it is implemented by VA facilities.

In the Pipeline – Summary of HTN-In the Pipeline – Summary of HTN-IMPROVEIMPROVE

Methods: 12 geographically diverse VA sites within two Veteran Integrated Service

Networks (VISNs) – 6 sites implementing the behavioral telephone intervention– 6 control sites.

The unit of analysis is patients with an annual inadequate BP control. Phase I

– Conducting a needs assessment and evaluating barriers and facilitators for implementing the proposed behavioral intervention at each of the 6 intervention sites.

Phase II – Examining the impact of the interventions by comparing 12-month pre/post

changes in BP control obtained from medical records for individual patients who receive the intervention compared to a individuals from the 6 control sites.

Phase III– Examine the sustainability of the intervention and examine what organizational

factors facilitate or hinder the sustained implementation of the study. Phase IV.

– Examine the implementation costs of disseminating the telephone based behavioral interventions.

Intervention OverviewIntervention Overview

6 intervention and 6 control facilities .5 FTE interventionist (e.g., nurse) 500 patients per facility (250 enrolled every 6

months) Use centralized software on Durham server Call patient every 4 weeks Calls last approximately 5-10 minutes Interventionist may do several modules each

call

Eligibility and ReferralEligibility and Referral

Criterion 1 – Blood Pressure: Mean of outpatient BP measurements in the last 365 days. Systolic BP > 140 mmHg or Diastolic BP > 90 mmHg

Criterion 2 – Assigned Primary Care Provider at the VA The patient must have an assigned primary care provider at the VA

Criterion 3 – Previous Visits to VA Must have had 3 or more visits in the past 730 days at the facility to a primary care clinic.

Criterion 4 – Hypertension ICD-9 CM Diagnoses

Eligibility & ReferralEligibility & Referral

Primary Method: PDP/CPRS Referral

Step 1: Nurse-administered self-management support added as option to hypertension reminder

Step 2:Templated consult

Step 3: Feedback loop from interventionist to physician (initial note indicating participation co-signed by PCP)

Implementation StaffingImplementation Staffing

Implementation & Core Team: Site champion(s) Nurse interventionist(s) Site administrators Site IT

TimelineTimeline

August 2008 – Confirm facility participation September 2008 – January 2009

– Implementation preparation (surveys, interviews)– Training– Site visit to your facility– Monthly calls to learn from each other

January 2009 – Test system with hypothetical patients February 2009 – Fully implement intervention as part of study February 2009-Frebruay 2010 – implement intervention

recruitment– Monthly calls to learn from each other– Support from Durham

February 2010-February 2011 – Patient follow-up completed February 2011-February 2012 – Secondary data follow-up

Implementation Implementation ChallengesChallenges

EvaluatingIntervention

Impact

Working with IRB(s)

Developing SiteChampions

Integrating intoExisting clinic

Workflow

Identifying the Interventionist

Patient Recruitment

HTN Improve Challenges

Developing Site ChampionsDeveloping Site Champions

Clinical Trial– Investigators also part of

ambulatory care staff

– Local project coordinator keeps things moving

Implementation– Need for administrative,

PCP, and nursing champions

– Regular teleconference contact with Durham team

Key Questions: -How do you identify enthusiastic champions at willing facilities?

-Do the site champions have the necessary resources and facility backing?

Patient RecruitmentPatient Recruitment

Clinical Trial– Identified and

recruited through central data pull.

Implementation– Pts referred from

providers?

OR– Identified and recruited

centrally (i.e. central data pull)?

Key Questions: -Which recruitment procedure works best with existing clinic workflow?

- Which would be most acceptable and sustainable for clinics?

Identifying the InterventionistIdentifying the Interventionist

Clinical Trial– 1 FTE Research

Nurse

Implementation– 0.5 FTE Clinic nurse

• 1 person= 0.5FTE

OR• 5 people =0.5FTE?

Key Questions: - How did the clinics prefer to allocate their nursing resources?

- Can we still maintain the fidelity of the intervention with different models?

Integrating into WorkflowIntegrating into Workflow

Clinical Trial– Intervention operates

independently of usual care.

– Call schedule negotiated between study nurse and patient

Implementation– Scheduled nurse

telephone appointments

OR– Nurse adds to workflow

when possible

Key Questions: -Can we fit this into usual clinic operating hours?

- How do we document nurse workload credit for time spent on intervention?

Working with IRB(s)Working with IRB(s)

Clinical Trial– IRB approval

Implementation– Addressing multiple

interpretations– Is it research at

Durham, but QI elsewhere?

Key Questions: -What constitutes quality improvement?

-Collaborating with people not accustomed to working with IRBs.

Evaluating intervention ImpactEvaluating intervention Impact

Clinical Trial– Clearly defined

control groups– Intent to treat

analysis starts at randomization

Implementation– Must define control

groups• Same-site controls• Different-site controls

– Intent to treat not as clear

Key Questions: -Who are the most appropriate control patients/sites?

-What causes a patient to become part of the analysis?

SummarySummary

Intervention tested in 3 separate trials with > 2500 subjects – takes along time

Moving into the realm of implementation New challenges

– Identifying partners– Integrating into regular work of clinic– Obtaining resources– Measuring success

Expanding beyond hypertension to other CVD

Acknowledgements•VA Health Services Research Investigator Initiated VA Health Services Research Investigator Initiated Award, 2001-06Award, 2001-06•NHLBI Grant R01 HL070713 (2003-2009)•Pfizer Health Communication Initiative Award (2004-2006)•Established Investigator Award, American Heart Association (2006-2011)

Danny Almirall Bryan Weiner Eugene OddoneMike Newell Teresa Damush Amy Kaufman Pam Gentry Daniel Lee

Contact Information

•Hayden Bosworth – hayden.bosworth@duke.edu

•George L. Jackson – george.l.jackson@duke.edu

•Ben Powers – power017@mc.duke.edu

Relevant Publications

1. Bosworth HB, Olsen MK, McCant F, et al. Hypertension Intervention Nurse Telemedicine 1. Bosworth HB, Olsen MK, McCant F, et al. Hypertension Intervention Nurse Telemedicine Study (HINTS). Study (HINTS). Am Heart JAm Heart J 2007;153(6):918-24. 2007;153(6):918-24. 2. Bosworth HB, Olsen MK, Goldstein MK, et al. The veterans' study to improve the control 2. Bosworth HB, Olsen MK, Goldstein MK, et al. The veterans' study to improve the control of hypertension (V-STITCH): design and methodology. of hypertension (V-STITCH): design and methodology. Contemp Clin TrialsContemp Clin Trials 2005;26:155-68. 2005;26:155-68. 3. Chan AS, Coleman RW, Martins SB, et al. Evaluating provider adherence in a trial of a 3. Chan AS, Coleman RW, Martins SB, et al. Evaluating provider adherence in a trial of a guideline-based decision support system for hypertension. guideline-based decision support system for hypertension. MedinfoMedinfo 2004;11(Pt 1):125-9. 2004;11(Pt 1):125-9. 4. Goldstein MK, Coleman RW, Tu SW, et al. Translating research into practice: 4. Goldstein MK, Coleman RW, Tu SW, et al. Translating research into practice: organizational issues in implementing automated decision support for hypertension in organizational issues in implementing automated decision support for hypertension in three medical centers. three medical centers. J Am Med Inform AssocJ Am Med Inform Assoc 2004;11(5):368-76. 2004;11(5):368-76. 5. Goldstein MK, Hoffman BB, Coleman RW, et al. Implementing clinical practice guidelines 5. Goldstein MK, Hoffman BB, Coleman RW, et al. Implementing clinical practice guidelines while taking account of changing evidence. while taking account of changing evidence. Proc AMIA SympProc AMIA Symp 2000:300-4. 2000:300-4. 6. Goldstein MK, Hoffman BB, Coleman RW, et al. Patient safety in guideline-based decision 6. Goldstein MK, Hoffman BB, Coleman RW, et al. Patient safety in guideline-based decision support for hypertension management: ATHENA DSS. support for hypertension management: ATHENA DSS. Proc AMIA SympProc AMIA Symp 2001:214-8. 2001:214-8. 7. Lin ND, Martins SB, Chan AS, et al. Identifying barriers to hypertension guideline 7. Lin ND, Martins SB, Chan AS, et al. Identifying barriers to hypertension guideline adherence using clinician feedback at the point of care. adherence using clinician feedback at the point of care. AMIA Annu Symp ProcAMIA Annu Symp Proc 2006:494-8. 2006:494-8. 8. Bosworth HB, Oddone EZ. Telemedicine and Hypertension. 8. Bosworth HB, Oddone EZ. Telemedicine and Hypertension. J Clin Outcomes ManagementJ Clin Outcomes Management 2004;11(8):517-522.2004;11(8):517-522. 9. Bosworth HB, Oddone EZ, Weinberger M. Patient treatment adherence: Concepts9. Bosworth HB, Oddone EZ, Weinberger M. Patient treatment adherence: Concepts interventions, and measurement. Mahwah, NJ: Lawrence Erlbaum Associates, 2006.interventions, and measurement. Mahwah, NJ: Lawrence Erlbaum Associates, 2006.10. Bosworth HB, Dudley T, Olsen MK, et al. Racial differences in blood pressure control: 10. Bosworth HB, Dudley T, Olsen MK, et al. Racial differences in blood pressure control: potential explanatory factors. potential explanatory factors. Am J MedAm J Med 2006;119(1):70. 2006;119(1):70.11. Bosworth HB, Oddone EZ. A model of psychosocial and cultural antecedents of 11. Bosworth HB, Oddone EZ. A model of psychosocial and cultural antecedents of blood pressure control. blood pressure control. Journal of the National Medical AssociationJournal of the National Medical Association 2002;94:236-248. 2002;94:236-248.12. Bosworth HB, Olsen MK, Gentry P, et al. Nurse administered telephone intervention for 12. Bosworth HB, Olsen MK, Gentry P, et al. Nurse administered telephone intervention for blood pressure control. blood pressure control. Patient Educ Couns Patient Educ Couns 2005;57(1):5-14.2005;57(1):5-14.13. Bosworth HB, Olsen MK, Oddone EZ. Improving blood pressure control by tailored 13. Bosworth HB, Olsen MK, Oddone EZ. Improving blood pressure control by tailored feedback to patients and clinicians. feedback to patients and clinicians. Am Heart JAm Heart J 2005;149(5):795-803. 2005;149(5):795-803.

Single disease vs. Single disease vs. multimorbidity self-mgmt?multimorbidity self-mgmt?

Two key questions1.) Is there a “spillover” effect from

disease-focused self-mgmt onto other conditions?

2.) Is it possible to address multiple conditions simultaneously in a self-management intervention?

Self-management spilloverSelf-management spillover

VSTITCH– HbA1c among patients with diabetes:

• 0.46% reduction in HbA1c over two years compared to usual care (95% CI, 0.04% to 0.89%; p=0.03).

– LDL cholesterol:• 0.9mg/dl between group difference (95% CI,

-7.3mg/dl to 5.6mg/dl; p=0.79).

Powers et al. SGIM annual meeting 2008.

Comprehensive self-Comprehensive self-managementmanagement

Cholesterol, Hypertension, and Glucose Education (CHANGE) study– RWJ Disparities Research for Change

Supporting Post-MI Risk Modification Intervention via Telemedicine Evaluation (SPRITE)– AHA Pharmaceutical Roundtable Outcome

Research

Eligibility & ReferralEligibility & Referral

Secondary Method: Physician referral from general clinic

Step 1:Physician refers patient to interventionist

Step 2: Feedback loop from interventionist to physician

Eligibility & ReferralEligibility & Referral

Tertiary Method: Interventionist referral

Step 1: Patient pull list reviewed for eligible participant

Step 2: Nurse contacts patients based on eligibility criteria

Step 3: Patients with most recent outpatient BP measurements contacted first

Step 4: PCP gets note and can opt out of patient contact within 72 hours

Evaluating Successful Evaluating Successful ImplementationImplementation

Clinical Trial– Quantitative results

patient level

Implementation– Qualitative and

quantitative results both organization and patient

Key Questions:-How do you develop a research team with needed expertise?

-What frameworks will be used for doing the evaluation?