Controlling Hypertension Outcomes by Improved Communication & Engagement
CHOICE
1 other identifier
interventional
26
1 country
2
Brief Summary
This randomized control study tested the feasibility of two communication enhancement interventions: one with veterans who had a stroke and demonstrated poorly controlled hypertension; the other with VA primary care providers who provided routine outpatient medical care to these veterans. This study intervened with both members of the provider-patient dyad in an attempt to improve the self-management of hypertension by improving communication during visits to the VA outpatient clinic, specifically by enabling veterans to communicate their questions and concerns about chronic disease self-management to their providers more effectively, and to help providers improve their ability to communicate more effectively with this population of veterans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Sep 2009
Longer than P75 for not_applicable hypertension
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2012
CompletedResults Posted
Study results publicly available
April 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2017
CompletedAugust 1, 2017
June 1, 2017
3.1 years
May 28, 2010
February 3, 2015
June 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Activation Measure
Veteran self-management of hypertension measured via the 13-item, (0-100 point range), Patient Activation Measure (PAM). Administered at baseline (1st visit) and after each additional follow-up visit during the next 12-months (+2 max). Rasch conversion changed raw scores to the PAM interval measure. Reported outcome is difference in mean PAM scores at baseline and during 12-month follow-up. If a participant had two PAM scores during the follow-up period, the average of the two was taken to calculate a combined follow-up score. Higher PAM scores represent higher levels of self-activation. Research on the PAM measure indicates that each point increase in PAM score correlates to a 2% decrease in hospitalization and a 2% increase in medication adherence. Ranges for Baseline PAM scores: Intervention = 46.1 (min) to 84.3 (max); Control = 43.2 (min) to 77 (max). Ranges for Follow-up PAM scores: Intervention = 48.4 (min) to 100 (max); Control = 45.1 (min) to 80.1 (max).
12 months
Study Arms (4)
Arm 1: Intervention-Veterans
EXPERIMENTALVeterans enrolled in the "Intervention-Veterans" arm received a copy of the NIA guide for "Talking with Your Doctor" \[Informational Guide for Patients\]. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor \[Educational Coaching\]. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
Arm 2: Control-Veterans
ACTIVE COMPARATORVeterans enrolled in the "Control-Veterans" arm received a copy of the NIA guide for "Talking with Your Doctor" \[Informational Guide for Patients\]. This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
Arm 3: Intervention-Physicians
EXPERIMENTALPrimary care providers randomly assigned to the "Intervention-Physicians" arm of this study received a copy of the Four Habits of Highly Effective Physicians \[Monograph for Physicians\]. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients \[Video-Assisted Coaching\], but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management.
Arm 4: Control-Physicians
ACTIVE COMPARATORPrimary care providers randomly assigned to the "Control-Physicians" arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual \[Control\].
Interventions
Veterans received a copy of the NIA guide for "Talking with Your Doctor". This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
Physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this video-assisted coaching session was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management.
Primary care providers randomly assigned to the "Intervention-Physicians" arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication.
an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor \[Coaching\]. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
The primary care providers randomly assigned to the "Control-Physicians" arm did not receive any additional coaching or resources and conducted their practice as usual.
Eligibility Criteria
You may qualify if:
- Veteran:
- Veteran is a patient of the enrolled provider
- History of prior stroke
- Poorly controlled hypertension with at least one measurement \>140/90 mm Hg in the past 12 months
- Complete a 6-item screen for cognitive and language impairment with a score of 3 or higher
- Sign the VA Media consent for use of picture and/or voice
- Provider:
- Primary care provider, Medicine Service
- Sign VA media consent for use of picture and/or voice
You may not qualify if:
- Life expectancy is less than 6 months
- Non-English language patients
- Inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884, United States
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard M. Frankel Ph.D.
- Organization
- Veterans Administration Health Services Research and Development
Study Officials
- PRINCIPAL INVESTIGATOR
Richard M. Frankel, PhD
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2010
First Posted
June 2, 2010
Study Start
September 1, 2009
Primary Completion
September 30, 2012
Study Completion
January 30, 2017
Last Updated
August 1, 2017
Results First Posted
April 14, 2016
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share