- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02239367
Depression Decision Aid: Feasibility Pilot
Electronic Depression Decision Aid for Nurses in Primary Care: Development and Implementation in a Diverse Low-Income Population
연구 개요
상세 설명
The aims of this project are to evaluate the acceptability and feasibility of an electronic Depression Decision Aid protocol with nurses and patients using questionnaire and administrative data.
One to two nurses will deliver the Decision Aid protocol to 40 low-income patients (aged 21 and over) scoring >10 via routine PHQ-9 screening. Consenting nurses will be assessed regarding their satisfaction with the protocol following its use with each patient subject. Nurse fidelity to the protocol will be evaluated via their documentation of protocol use in the EHR. Consenting patient subjects will be assessed at baseline; week 1 to determine their decision about depression treatment, satisfaction with the decision-making process; and week 12 to determine treatment initiation or change, treatment adherence, and depressive status. Medical records will also be examined for documentation of medication prescription and other depression treatments.
The study will test the following hypothesis concerning the Depression Decision Aid protocol:
1. Feasibility and Acceptability: a) At least 85% of each nurse's intervention sessions will meet fidelity standards via Electronic Health Record (EHR) data; b) Nurses will report high levels of satisfaction with the Decision Aid; c) Patients will report high levels of satisfaction with the decision-making process;
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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Bronx, New York, 미국, 10451
- Lincoln Hospital- the New York City Health and Hospitals Corporation (HHC)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 21 years and older
- Medical outpatient presenting to the Lincoln Hospital ambulatory care clinic or geriatric sub-specialty clinic
- Screen positive for depression (Patient Health Questionnaire-9 score of 10 or greater)
Exclusion Criteria:
- Presence of significant alcohol or substance abuse, psychotic disorder, or bipolar disorder
- High suicide risk
- Cognitive impairment: Mini Mental Status Exam (MMSE) score less than 24.
- Acute or severe medical illness (ie. delirium, metastatic cancer, decompensated cardiac, liver, or kidney failure, major surgery, stroke, or myocardial infarction during the three months prior to entry.
- Inability to speak English or Spanish
- Aphasia interfering with communication
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Depression Decision Aid protocol
The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention.
Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision.
The focus of the intervention is to empower the elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
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The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Use of Depression Decision Aid protocol
기간: 12 weeks
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The number of nurse's intervention sessions based on Electronic Health Record data
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Satisfaction with the Decision Aid Measure
기간: 12 weeks
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The Nurse Satisfaction Scale includes a measure of usefulness, clarity, ease of use, and feasibility in terms of timing when using the Decision Aid.
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12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Patrick J Raue, Ph.D., Weill Medical College of Cornell University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (추정)
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. .
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