- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01808664
Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests
Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests: Randomized Clinical Trial
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Resident physician in family medicine or internal medicine who deliver primary care at one of two hospital-based primary care clinics at the University of California, Davis Medical Center Sacramento
Exclusion Criteria:
- Anticipated graduation in less than one year from enrollment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Standardized Patient Instructor Intervention
Primary care physicians (PCPs) randomized to intervention will receive over a three month run-in period two visits by standardized patient instructors portraying: 1) a 48 year-old patient with low back pain for less than six-weeks and no "red flags" for immediate spinal imaging; and 2) a 50 year-old recently menopausal woman establishing care with concerns about osteoporosis risk.
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In each case, patients will harbor underlying concerns about a serious underlying condition (e.g., either disc herniation or osteoporosis) and will request inappropriate tests. Standardized patient instructors (SPIs) will portray new patients visiting the clinic for the first time, and electronic medical records will be identical to that of actual new patients. During the initial part of intervention visits, SPIs will assess the extent to which PCPs engage in patient-centered techniques specified in the final intervention model. SPIs will then break of their role and either teach or reinforce PCP use of the techniques, presenting techniques in a logical sequence while emphasizing flexibility in their use. SPIs will use scripts to deliver the interventions, providing opportunities for PCPs to ask questions, discuss concepts, and practice (by role playing) patient-centered techniques. |
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활성 비교기: Control
In the latter half of visits with control PCPs, standardized patient instructors (SPIs) will share information regarding low back pain or bone health that are unrelated to diagnostic testing, but will not discuss patient-centered techniques or conduct training.
The total duration of the control "information sharing" will be about one-third the SPI intervention to enhance patient-centeredness.
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In the latter half of visits with control PCPs, standardized patient instructors will share information with physicians regarding the acute low back pain self-care and bone health, but will not discuss patient-centered techniques or conduct training.
The total duration of the control "information sharing" will be about one-third the SPI intervention to enhance patient-centeredness.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of inappropriate diagnostic tests ordered
기간: 9 months
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Investigators will assess via blinded, standardized chart review whether study physicians ordered inappropriate diagnostic tests for unannounced standardized patients who request testing during three follow-up visits occurring 3 to 9 months post-randomization.
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9 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Use of patient-centered counseling techniques
기간: 9 months
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Physician use of patient-centered counseling techniques as assessed via masked recordings of three standardized patient visits
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9 months
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Actual diagnostic test ordering among real patients
기간: 9 months post-intervention
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Among real patients seen by study physicians, we will assess diagnostic test ordering among actual adult patients during the post-intervention period.
We will also assess comparable diagnostic test ordering during the pre-intervention period to enable adjustment for baseline test ordering.
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9 months post-intervention
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Standardized Patient Satisfaction
기간: 9 months
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Standardized patients will complete a measure of patient satisfaction based on the Consumer Assessment of Health Plans Survey (CAHPS) during each of three unannounced visits occuring during the follow-up period
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9 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- May L, Franks P, Jerant A, Fenton J. Watchful Waiting Strategy May Reduce Low-Value Diagnostic Testing. J Am Board Fam Med. 2016 Nov 12;29(6):710-717. doi: 10.3122/jabfm.2016.06.160056.
- Fenton JJ, Kravitz RL, Jerant A, Paterniti DA, Bang H, Williams D, Epstein RM, Franks P. Promoting Patient-Centered Counseling to Reduce Use of Low-Value Diagnostic Tests: A Randomized Clinical Trial. JAMA Intern Med. 2016 Feb;176(2):191-7. doi: 10.1001/jamainternmed.2015.6840.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .