Clinical trial NCT01134887: Controlling Hypertension Outcomes by Improved Communication & Engagement
Official title: Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Stroke
Keywords: hypertension
physician-patient relations
communication
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-06-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Patient Activation Measure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
city: Indianapolis
country: United States
facility: Richard Roudebush VA Medical Center, Indianapolis
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Richard M. Frankel, PhD
role: PRINCIPAL_INVESTIGATOR
References: