Controlling Hypertension Outcomes by Improved Communication & Engagement

NCT ID: NCT01134887

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-01
• Study Completion Date: 2017-01-30

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.

Conditions

Hypertension; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Informational Guide for Patients

Intervention Type: OTHER

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.

Educational Coaching

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Informational Guide for Patients

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Video-Assisted Coaching

Intervention Type: BEHAVIORAL

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.

Monograph for Physicians

Intervention Type: OTHER

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.

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 \[Control\].

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard M. Frankel, PhD

Role: PRINCIPAL_INVESTIGATOR

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Locations

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States

Richard Roudebush VA Medical Center, Indianapolis

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

RRP 09-190

Identifier Type: -

Identifier Source: org_study_id