Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Stroke	Other: Informational Guide for Patients; Behavioral: Video-Assisted Coaching; Other: Monograph for Physicians; Behavioral: Educational Coaching; Other: Control	Not Applicable

Detailed Description:

The communication intervention had two goals; (a) coaching to enhance veteran's abilities to communicate their questions and concerns about self-management for hypertension to their physician; and (b) improving provider's communication skills for enhancing and encouraging self-management of hypertension.

A health educator met with each participating veteran in the intervention arm prior to the 2nd visit to develop a plan for enhancing communication about self-management of hypertension.

The PI provided the Four Habits communication training to the 5 primary care providers in the intervention arm. Two clinic visits between each participating provider-patient pair were videotaped and coded.

This project had a goal of enrolling 10 VA primary care providers to participate in the randomized control trial and 30 veterans (3 veterans from the panel of each of the 10 participating providers) who had a stroke and now demonstrated poorly controlled hypertension. The study evaluated the difference between the two groups, and compared the content of the provider-patient conversations around hypertension management.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	26 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)
Actual Study Start Date :	September 1, 2009
Actual Primary Completion Date :	September 30, 2012
Actual Study Completion Date :	January 30, 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Arm 1: Intervention-Veterans; Veterans 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.	Other: Informational Guide for Patients; 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. Behavioral: Educational Coaching; 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.
Active Comparator: Arm 2: Control-Veterans; Veterans 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.	Other: Informational Guide for Patients; 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.
Experimental: Arm 3: Intervention-Physicians; Primary 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.	Behavioral: Video-Assisted Coaching; 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. Other: Monograph for Physicians; 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.
Active Comparator: Arm 4: Control-Physicians; Primary 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].	Other: Control; 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.

Outcome Measures

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Primary Outcome Measures :

1. Patient Activation Measure [ Time Frame: 12 months ]
   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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Life expectancy is less than 6 months
• Non-English language patients
• Inability to provide informed consent

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator:	Richard M. Frankel, PhD	Richard L. Roudebush VA Medical Center, Indianapolis, IN

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT01134887 History of Changes
Other Study ID Numbers:	RRP 09-190
First Posted:	June 2, 2010
Results First Posted:	April 14, 2016
Last Update Posted:	August 1, 2017
Last Verified:	June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No
Product Manufactured in and Exported from the U.S.:		No

Keywords provided by VA Office of Research and Development:

hypertension; physician-patient relations; communication

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases