# Presentation: 010685

## Rushing Through the Implementation Pipeline: Hypertension Self-ManagementHayden B. Bosworth, Ph.D.George L. Jackson, Ph.D., MHABen J. Powers, MD, MHSCenter for Health Services Research in Primary Care Durham VA Medical CenterVA Quality Enhancement Research Initiative (QUERI) 2008 Annual Meeting

**Notes:**
Thank Morris et al

## QUERI’s Research/ImplementationPipeline...

**Implementation Research**

**Implement Intervention & Document outcome**

**Clinical Research / Guideline Development**

**Mainstream Health Services Research**

**Assess Existing Practice**

**Identify Research Area**

**Identify Best Practice**

**Implementation Policy, Improved Health**

**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)**

## 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**

## 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**

## 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**
**> 90% 12-motnth retention**
**50% African American**
**45% have diabetes**

## 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**

**Notes:**
While there has been an increase in self-management interventions, most of this literature has focused on White, middle class samples, thus telling us little about how best to deliver self-management interventions to low-income, racial minorities, and underserved patients who often bear the largest burden of hypertension.
.  

## HTN IMPROVE: Quality Improvement Project

_**H**_ypertension _**T**_elemedicine _**N**_urse _**Im**_plementation _**Pro**_ject for _**Ve**_terans

## In the Pipeline – Summary ofHTN-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-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. **

## 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**

## Eligibility 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 & 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 Staffing	

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

## 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 **

## Implementation Challenges

**Notes:**
This research often takes place in parallel and many of the techniques are similar:
For example: group visits, self-mgmt support, telephone

## 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?

## 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?

## 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?

## 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?

## 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 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?

## Summary

**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 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

## Contact Information

**Hayden Bosworth – **_[hayden.bosworth@duke.edu](mailto:hayden.bosworth@duke.edu)_
**George L. Jackson – **_[george.l.jackson@duke.edu](mailto:george.l.jackson@duke.edu)_
**Ben Powers – **_[power017@mc.duke.edu](mailto:power017@mc.duke.edu)__ _

## Relevant Publications

**  ****1. Bosworth HB, Olsen MK, McCant F, et al. Hypertension Intervention Nurse Telemedicine **
**      ****Study (HINTS). *****Am Heart J***** 2007;153(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***** 2005;26:155-68.**
**  ****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***** 2004;11(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***** 2004;11(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***** 2000:300-4.**
**  ****6. Goldstein MK, Hoffman BB, Coleman RW, et al. Patient safety in guideline-based decision **
**      ****support for hypertension management: ATHENA DSS. *****Proc AMIA Symp***** 2001:214-8.**
**  ****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***** 2006:494-8.**
**  ****8. Bosworth HB, Oddone EZ. Telemedicine and Hypertension. *****J Clin Outcomes Management***** **
**      ****2004;11(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***** 2006;119(1):70.**
**11. Bosworth HB, Oddone EZ. A model of psychosocial and cultural antecedents of **
**      ****blood pressure control. *****Journal of the National Medical Association***** 2002;94:236-248.**
**12. Bosworth HB, Olsen MK, Gentry P, et al. Nurse administered telephone intervention for **
**      ****blood pressure control. *****Patient Educ Couns *****2005;57(1):5-14.**
**13. Bosworth HB, Olsen MK, Oddone EZ. Improving blood pressure control by tailored **
**      ****feedback to patients and clinicians. *****Am Heart J***** 2005;149(5):795-803.****	**

## 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?**

## 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%; 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-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**

## Eligibility & Referral	

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

## 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**

## 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?