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Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01134887
First received: May 28, 2010
Last updated: November 14, 2014
Last verified: November 2014
History of Changes
  Purpose

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 Intervention
Hypertension
Stroke
 Behavioral: Four Habits Model

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • self-management of hypertension [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Enrollment: 40
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1

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.

 Behavioral: Four Habits Model
The providers randomized to the intervention arm received training in Habit 1 of the Four Habits Model.
No Intervention: Arm 2
Two clinic visits between each participating provider-patient pair were videotaped and coded.

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 proposed project enrolled 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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134887

Locations
United States, Indiana
Richard Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202-2884
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Richard M. Frankel, PhD Richard Roudebush VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01134887     History of Changes
Other Study ID Numbers: RRP 09-190
Study First Received: May 28, 2010
Last Updated: November 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
hypertension
physician-patient relations
communication

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015