Training Doctors to Support Patient Self-Care of Depression
2015년 11월 30일 업데이트: University of California, Davis
Physician Training to Support Patient Self-Efficacy for Depression Care Behaviors
This study will determine whether practicing primary care providers (PCPs) can be trained to support patient self-care of depression and co-existing diabetes during office visits, and begin to explore whether this might improve depression and diabetes outcomes, and whether the effects of the training generalize to patients with health conditions other than depression and diabetes.
This is important because most patients with chronic conditions struggle with self-care and are seen in primary care, yet PCPs are seldom trained to support self-care.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Many primary care patients struggle with health behaviors that can reduce depressive symptoms, such as adhering to prescribed treatments.
Bolstering patient self-efficacy can improve health behaviors and outcomes, including those related to depression.
However, current self-efficacy interventions are provided outside of primary care, and so cannot harness the power of therapeutic primary care provider (PCP)-patient relationships.
Teaching PCPs to employ self-efficacy enhancing interviewing techniques (SEE IT) with patients would build upon existing therapeutic relationships, greatly increasing the reach of self-efficacy enhancement.
The randomized controlled trial (RCT) in this proposal will examine whether, as compared with an attention control condition, a brief (< 1 hour) office-based intervention for practicing PCPs will lead to significantly greater use of SEE IT during unannounced follow-up SP encounters (postintervention and 3 months).
The interventions will be delivered to PCPs during their regular office hours by standardized patient (SP) instructors.
All study SPs will portray patients with both depression and diabetes, since these conditions commonly co-occur and entail a heavy burden of health-enhancing behaviors.
Exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with co-occurring depression and diabetes: self-efficacy for depression and diabetes self-care, actual self-care behaviors (e.g.
medication adherence), symptom severity, and health status.
Further exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with various chronic conditions (ie, not limited to depression and diabetes): self-care self-efficacy, actual self-care behaviors, symptom severity, and health status.
Pre- and post-RCT focus groups with stakeholders (PCPs, office staff, patients, and SP instructors) will guide refinement of the SEE IT intervention.
The proposed research activities will inform the design (e.g.
sample size) and conduct of a future R01-funded, multi-center, cluster RCT of the finalized intervention, adequately powered to examine effects on a range of patient outcomes; sustainability of effects on PCP interviewing over time; and generalizability to other practice settings and common co-morbid mental health and physical illness clusters.
The SEE IT intervention begins to address the broader health needs of individuals with depression in primary care, and has unique potential to reduce the tremendous burden of mental illness related morbidity and mortality.
연구 유형
연구 유형
중재적
등록 (실제)
등록
182
단계
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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California
-
Sacramento, California, 미국, 95817
- University Of California Davis Health System
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Sacramento, California, 미국, 95816
- Sutter Health Sacramento
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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
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria: Physicians (targeted enrollment=56; actual enrollment=50)
- Currently in practice at a participating office within one of the 2 participating health systems (University of California Davis Primary Care Network, Sutter Sacramento Health System)
- Trained as a family physician, general practitioner, and/or general internist
- Able to read and speak English
Inclusion Criteria: Group of patients with diabetes and depressive symptoms (targeted enrollment=168; actual enrollment=15)
- Receive primary health care in one of the participating offices, from one of the participating primary care physicians
- Aged 18 years or older
- Able to read and speak English
- Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer
- Have concurrent diagnoses of depression and diabetes, determined via medical record review
- Have at least mild depressive symptoms, manifested by a score of 10 or greater on a telephone-administered Patient Health Questionnaire (PHQ-9).
- Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening
- Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider
Inclusion Criteria: Group of patients with various health conditions, ie, not limited to diabetes and depression (targeted enrollment=336; actual enrollment=117)
- Receive primary health care in one of the participating offices, from one of the participating primary care physicians
- Aged 18 years or older
- Able to read and speak English
- Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer
- Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening
- Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider
Exclusion Criteria: Patients (applies to all study patients)
- Self-report or medical record evidence of unstable overall medical status
- Self-report or medical record evidence of terminal illness
- Self-report or medical record evidence of bipolar disorder, chronic psychosis (schizophrenia or other), or personality disorder
- Self-report or medical record evidence of a history of attempted suicide
- Planned transfer of care to a health system other than the 2 participating systems within 6 months
- Inability to understand any of the screening questions, after appropriate explanation (e.g. due to cognitive impairment, developmental delay, or other reasons)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: SEE IT training (interviewing skills)
Intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) with patients who have coexisting depression and diabetes
|
Standardized patient instructors provide a scripted intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) during office visits with patients who have coexisting depression and diabetes
|
|
활성 비교기: Control (knowledge enhancement)
Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes
|
Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Physician use of self-efficacy enhancing interviewing techniques
기간: During the 3 months after receiving intervention
|
During the 3 months after receiving intervention
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient self-efficacy for depression self-care
기간: 5 minutes after an index visit with primary provider
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5 minutes after an index visit with primary provider
|
|
|
Patient self-efficacy for diabetes self-care
기간: 5 minutes after an index visit with primary provider
|
5 minutes after an index visit with primary provider
|
|
|
General self-care self-efficacy (all health conditions)
기간: 5 minutes after an index visit with primary provider
|
5 minutes after an index visit with primary provider
|
|
|
Patient depressive symptoms
기간: 3 months after an index visit with their primary care provider
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3 months after an index visit with their primary care provider
|
|
|
Patient depression self-care behaviors
기간: 3 months after an index visit with their primary care provider
|
3 months after an index visit with their primary care provider
|
|
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Patient diabetes self-care behaviors
기간: 3 months after an index visit with their primary care provider
|
3 months after an index visit with their primary care provider
|
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Patient chronic illness self-care behaviors (generic)
기간: 3 months after an index visit with their primary care provider
|
3 months after an index visit with their primary care provider
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Patient adherence to depression and diabetes medications
기간: 3 months after an index visit with their primary care provider
|
3 months after an index visit with their primary care provider
|
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Patient adherence to chronic illness medications (generic)
기간: 3 months after an index visit with their primary care provider
|
3 months after an index visit with their primary care provider
|
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Patient adherence to depression counseling
기간: 3 months after an index visit with their primary care provider
|
3 months after an index visit with their primary care provider
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Patient mental health status
기간: 3 months after an index visit with their primary care provider
|
3 months after an index visit with their primary care provider
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Patient physical health status
기간: 3 months after an index visit with their primary care provider
|
3 months after an index visit with their primary care provider
|
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Patient glycemic control
기간: 3 months after an index visit with their primary care provider
|
3 months after an index visit with their primary care provider
|
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Wallston Multidimensional Health Locus of Control Scale
기간: 5 minutes after an index visit with their primary care provider
|
Perceived control over health
|
5 minutes after an index visit with their primary care provider
|
|
Healthcare Climate Questionnaire
기간: 5 minutes after an index visit with their primary care provider
|
Patient perception of degree to which primary care provider is autonomy supportive
|
5 minutes after an index visit with their primary care provider
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Anthony Jerant, MD, University of California, Davis
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Jerant A, Kravitz RL, Azari R, White L, Garcia JA, Vierra H, Virata MC, Franks P. Training residents to employ self-efficacy-enhancing interviewing techniques: randomized controlled trial of a standardized patient intervention. J Gen Intern Med. 2009 May;24(5):606-13. doi: 10.1007/s11606-009-0946-4. Epub 2009 Mar 19.
- Jerant A, Kravitz RL, Tancredi D, Paterniti DA, White L, Baker-Nauman L, Evans-Dean D, Villarreal C, Ried L, Hudnut A, Franks P. Training Primary Care Physicians to Employ Self-Efficacy-Enhancing Interviewing Techniques: Randomized Controlled Trial of a Standardized Patient Intervention. J Gen Intern Med. 2016 Jul;31(7):716-22. doi: 10.1007/s11606-016-3644-z. Epub 2016 Mar 8.
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
연구 시작
2013년 4월 1일
기본 완료 (실제)
기본 완료
2015년 2월 1일
연구 완료 (실제)
연구 완료
2015년 5월 1일
연구 등록 날짜
최초 제출
최초 제출
2012년 5월 8일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2012년 6월 11일
처음 게시됨 (추정)
처음 게시됨
2012년 6월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
마지막 업데이트 게시됨
2015년 12월 2일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2015년 11월 30일
마지막으로 확인됨
마지막으로 확인됨
2015년 11월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- 2012336397-1
- R34MH095893 (미국 NIH 보조금/계약)
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. .