Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)
2017년 6월 26일 업데이트: VA Office of Research and Development
Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)
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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
26
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Indiana
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Indianapolis, Indiana, 미국, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Indianapolis, Indiana, 미국, 46202-2884
- Richard Roudebush VA Medical Center, Indianapolis
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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.
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활성 비교기: 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.
|
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.
|
|
실험적: 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.
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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.
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.
|
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활성 비교기: 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].
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Activation Measure
기간: 12 months
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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).
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12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Richard M. Frankel, PhD, Richard L. Roudebush VA Medical Center, Indianapolis, IN
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2009년 9월 1일
기본 완료 (실제)
2012년 9월 30일
연구 완료 (실제)
2017년 1월 30일
연구 등록 날짜
최초 제출
2010년 5월 28일
QC 기준을 충족하는 최초 제출
2010년 6월 1일
처음 게시됨 (추정)
2010년 6월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 8월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 6월 26일
마지막으로 확인됨
2017년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .