중증 대동맥 협착증에 대한 의사결정 공유 촉진 (IMPACT SDM)
PCORI-CDR-2022C1-26333 중증 대동맥 협착증 치료에 대한 결정을 위한 공유 의사결정 촉진(IMPACT SDM 연구)
The goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are:
- Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations?
- Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course?
All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. Participants will complete surveys before and after their specialist visit.
Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions.
연구 개요
상세 설명
The goal of this study is to promote shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are:
- Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations?
- Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course?
This study is a batched stepped wedge cluster randomized trial with 8 sites, about 56 surgeons and interventional cardiologists, and will enroll about 1300 patients. All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. The interventions include a patient decision aid that was created by the American College of Cardiology CardioSmart program and a online shared decision making skills training course for clinicians. The coordinating center will provide implementation support to sites when they transition to the intervention arm. Data collection is similar across usual care and intervention groups. Patient participants will complete surveys before and after their specialist visit. Clinician participants will be randomly selected to complete a survey after the patient visit. Limited clinical data will be collected from the medical record.
Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions. Researchers will also calculate percentage of patients reached with decision aids and percentage of clinicians who complete training at each site to measure the success of the implementation.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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San Francisco, California, 미국, 94117
- The Regents of the University of California, San Francisco
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Colorado
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Aurora, Colorado, 미국, 80045-7202
- University of Colorado Denver
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Georgia
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Atlanta, Georgia, 미국, 30308-0000
- Emory University
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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Missouri
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St Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-1350
- The University of North Carolina at Chapel Hill
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania
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Texas
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Dallas, Texas, 미국, 75390-9020
- UT Southwestern Medical Center
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Between 65-85 years of age
- Language is English or Spanish
- Diagnosed with severe aortic stenosis defined as (e.g. an aortic valve area < 1 cm2 or as determined by clinician)
- Attend a scheduled visit with an Interventional Cardiologist and/or Cardiac Surgeon from the Heart Valve Team at a participating site
Exclusion Criteria:
- Prior aortic valve replacement surgery
- High risk for either SAVR or TAVI (e.g., Society of Thoracic Surgery score >8% or clinician determined)
- Prior coronary artery bypass surgery (CABG)
- End stage renal disease on dialysis
- Severe lung disease (chronic obstructive pulmonary disease; COPD) requiring home oxygen
- Advanced Cirrhosis
- Unable to consent for self (proxy respondents are not allowed)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Control (usual care)
This group will receive usual care without any support for using the decision aid and without any access to the clinician training. |
|
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활성 비교기: Intervention
The patients in this group will receive a decision aid that covers the main treatment options for aortic stenosis. The clinicians in this group will receive a 60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies |
The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery 60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Shared Decision Making
기간: About 1 week post visit
|
Shared Decision Making Process scale; Scores range 0-4 with higher scores indicating greater shared decision making occurred. |
About 1 week post visit
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Reach
기간: About 1 week post visit
|
% of eligible patients who receive decision aid |
About 1 week post visit
|
|
Patient Knowledge
기간: About 1 week post visit
|
Multiple choice knowledge score ranging from 0-100; higher scores indicate higher knowledge |
About 1 week post visit
|
|
Preference-treatment concordance
기간: About 1 week post visit
|
% of patients who received preferred treatment within 6 months of visit |
About 1 week post visit
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Patient experience
기간: About 1 week post visit
|
CAHPS MD-patient communication subscale and visit rating score |
About 1 week post visit
|
|
Clinician satisfaction
기간: About 1 week post visit
|
% of clinicians who mark "very" or "extremely" satisfied with visit |
About 1 week post visit
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Adoption
기간: 4 weeks from the start of intervention period for each site
|
% of eligible clinicians who complete the shared decision making skills training |
4 weeks from the start of intervention period for each site
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Timeliness (time to decision)
기간: About 1 week post visit
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% of patients who report stage of decision making is "made a decision" |
About 1 week post visit
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Timeliness (burden)
기간: About 1 week post visit
|
% of visits where clinicians report visit length is "longer than normal" |
About 1 week post visit
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Karen Sepucha, PhD, Massachusetts General Hospital
- 수석 연구원: Sammy Elmariah, MD, University of California, San Francisco
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2023P001413
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
To promote research replicability, transparency and future use of the data, de-identified data sets will be created and will be available, by request, to outside researchers. The Data Package (comprised of the de-identified Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan, and analytic code from the project) will be deposited in the Patient-Centered Outcomes Research Institute's Data Repository at the ICPSR. Participant information sheets for the study will indicate that de-identified information will be deposited in an open access service to promote use of the data by other researchers. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set. No data will be provided from qualitative transcripts as this may lead to identifying information about participants. However, codes abstracted from qualitative transcripts may be made available.
IPD 공유 기간
The PCORI-designated repository will make the data available for third-party requests when PCORI makes the Final Research Report available, or at the time of publication the primary results, whichever comes first.
IPD 공유 액세스 기준
Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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