Rushing Through the Implementation Pipeline: Hypertension SelfManagement Hayden B' Bosworth, Ph'D' G

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Rushing Through the Implementation Pipeline
Hypertension Self-ManagementHayden B. Bosworth,
Ph.D.George L. Jackson, Ph.D., MHABen J.
Powers, MD, MHSCenter for Health Services
Research in Primary Care Durham VA Medical
CenterVA Quality Enhancement Research
Initiative (QUERI) 2008 Annual Meeting
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QUERIs Research/ImplementationPipeline
Identify Research Area
Implement Intervention Document outcome
Identify Best Practice
Clinical Research / Guideline Development
Implementation Research
Implementation Policy, Improved Health
Mainstream Health Services Research
Assess Existing Practice
Phase 1 Pilot Projects
Phase 2 Small-Scale Demonstrations
Phase 3 Regional Demonstrations
Phase 4 National Rollout
Slide presented developed by VA Quality
Enhancement Research Initiative (QUERI)
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Veteran Study To Improve The Control of
Hypertension (V-STITCH) Study

• Design
• A randomized controlled trial testing two
  interventions designed to improve BP control
• Patient Intervention Early Self-Management
• Provider Intervention Decision Support
• Brief telephone intervention improved BP control
  by 21 at 24 months
• 12.6 improvement compared to the non-behavioral
  group
• No increase in clinic utilization
• Cost effective
• Computer Decision Support did not significantly
  improve BP control rates at 24 months

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Take Control of Your Blood pressure (TCYB) Study

• Design
• A 2-year randomized controlled trial
• Focus on patient self-management
• The nurse administered patient intervention
• Home BP Monitoring
• Combined telephone intervention and home BP
  improved BP control by 13 at 24 months
• 17 improvement compared to the non-behavioral
  group
• SBP improved 6 mm/hg
• DBP improved 4 mm/hg
• No increase in clinic utilization
• Cost effective - 200 per year

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Hypertension Intervention Nurse Telemedicine
Study (HINTS)

• Design
• A 18 month randomized controlled trial
• Focus on patient self-management
• The nurse administered patient intervention
• Home BP Monitoring
• Medication management by MDs
• Completed recruitment
• 600 patients
• 50 recruitment rate
• gt 90 12-motnth retention
• 50 African American
• 45 have diabetes

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Telephone 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

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HTN IMPROVE Quality Improvement Project
Hypertension Telemedicine Nurse Implementation
Project for Veterans
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In the Pipeline Summary ofHTN-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.

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In the Pipeline Summary of HTN-IMPROVE

• 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.

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Intervention 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

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Eligibility and Referral

• Criterion 1 Blood Pressure Mean of outpatient
  BP measurements in the last 365 days. Systolic BP
  gt 140 mmHg or Diastolic BP gt 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

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Eligibility Referral

• Primary Method PDP/CPRS Referral
• Step 1 Nurse-administered self-management
  support added as option to hypertension reminder
• Step 2Templated consult
• Step 3 Feedback loop from interventionist to
  physician (initial note indicating participation
  co-signed by PCP)

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Implementation Staffing

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

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Timeline

• 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

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Implementation Challenges
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Developing 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?

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Patient 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?

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Identifying 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?

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Integrating 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?

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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.
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Evaluating 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?
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Summary

• Intervention tested in 3 separate trials with gt
  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

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Acknowledgements

• VA Health Services Research Investigator
  Initiated Award, 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 Oddone
• Mike Newell Teresa Damush Amy Kaufman
• Pam Gentry Daniel Lee

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Contact Information

• Hayden Bosworth hayden.bosworth_at_duke.edu
• George L. Jackson george.l.jackson_at_duke.edu
• Ben Powers power017_at_mc.duke.edu

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Relevant Publications
1. Bosworth HB, Olsen MK, McCant F, et al.
Hypertension Intervention Nurse Telemedicine
Study (HINTS). Am Heart J 2007153(6)918-24.
2. Bosworth HB, Olsen MK, Goldstein MK, et al.
The veterans' study to improve the control
of hypertension (V-STITCH) design and
methodology. Contemp Clin Trials 200526155-68.
3. Chan AS, Coleman RW, Martins SB, et al.
Evaluating provider adherence in a trial of a
guideline-based decision support system for
hypertension. Medinfo 200411(Pt 1)125-9. 4.
Goldstein MK, Coleman RW, Tu SW, et al.
Translating research into practice
organizational issues in implementing automated
decision support for hypertension in three
medical centers. J Am Med Inform Assoc
200411(5)368-76. 5. Goldstein MK, Hoffman BB,
Coleman RW, et al. Implementing clinical practice
guidelines while taking account of
changing evidence. Proc AMIA Symp 2000300-4.
6. Goldstein MK, Hoffman BB, Coleman RW, et al.
Patient safety in guideline-based decision
support for hypertension management ATHENA DSS.
Proc AMIA Symp 2001214-8. 7. Lin ND, Martins
SB, Chan AS, et al. Identifying barriers to
hypertension guideline adherence using
clinician feedback at the point of care. AMIA
Annu Symp Proc 2006494-8. 8. Bosworth HB,
Oddone EZ. Telemedicine and Hypertension. J Clin
Outcomes Management 200411(8)517-522.
9. Bosworth HB, Oddone EZ, Weinberger M. Patient
treatment adherence Concepts
interventions, and measurement. Mahwah, NJ
Lawrence Erlbaum Associates, 2006. 10. Bosworth
HB, Dudley T, Olsen MK, et al. Racial differences
in blood pressure control potential
explanatory factors. Am J Med 2006119(1)70. 11.
Bosworth HB, Oddone EZ. A model of psychosocial
and cultural antecedents of blood pressure
control. Journal of the National Medical
Association 200294236-248. 12. Bosworth HB,
Olsen MK, Gentry P, et al. Nurse administered
telephone intervention for blood pressure
control. Patient Educ Couns 200557(1)5-14. 13.
Bosworth HB, Olsen MK, Oddone EZ. Improving blood
pressure control by tailored feedback to
patients and clinicians. Am Heart J
2005149(5)795-803.
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Single disease vs. multimorbidity self-mgmt?

• Two key questions
• 1.) 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?

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Self-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 p0.03).
• LDL cholesterol
• 0.9mg/dl between group difference (95 CI,
  -7.3mg/dl to 5.6mg/dl p0.79).

Powers et al. SGIM annual meeting 2008.
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Comprehensive self-management

• 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

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Eligibility Referral

• Secondary Method Physician referral from general
  clinic
• Step 1Physician refers patient to
  interventionist
• Step 2 Feedback loop from interventionist to
  physician

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Eligibility 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

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Evaluating Successful Implementation

• 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?