Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)

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ClinicalTrials.gov Identifier: NCT01134887

Recruitment Status : Completed

First Posted : June 2, 2010

Results First Posted : April 14, 2016

Last Update Posted : August 1, 2017

Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development

Study Description

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


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

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

Primary Outcome Measures :

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134887

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


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 Key Record Dates
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

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