- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03854045
Exploratory Study Providing Telepsychiatry in the Home With a Clinician Present
Team-based Telemedicine
연구 개요
상세 설명
The goal of this project is to document the benefits and barriers to expanding reimbursement for telemedicine to older patient's home as the originating site. The objectives are:
- Develop training module for midlevel clinicians to be ready for dissemination
- Improved patient outcomes measures on satisfaction with care; functioning and symptoms (anxiety, depression, traumatic stress, sleep apnea, alcohol use and problems)
- Reductions in emergency healthcare utilization and medications prescribed as obtained from electronic health record (EHR) at the Federally Qualified Health Center (FQHC) and self-reports
- Summarize activities and barriers, including communication with primary care provider, identification and improvement of home environmental risks, and assistance to support system
This is an observational study of team-based telepsychiatry in the home for one group and team-based psychiatry in the clinic for the comparison group. The initial assessment will include information and informed consent for treatment, biopsychosocial assessment, summary for the psychiatrist, psychiatric evaluation and recommendations (all standard of care). To that the investigators are adding informed consent for program evaluation with 6 month follow-up with information for re-contacting (3 sources, addresses, email-telephone numbers), and brief administration of selected instruments before informed consent for treatment. If an eligible patient does not want to participate in the research study, the patient would still receive services.
Additional telemedicine sessions and/or therapy sessions will be conducted as medically needed in accordance with quality care. At six months (with one month window on either side) the evaluation packet will be re-administered by the clinician if convenient or by the research assistant either in person or by phone.
The sample size was selected to provide robust indicators of barriers to home based assessments. The comparison group was included to provide a context for the findings. It is anticipated that the home group will have greater problems at baseline than the clinic based comparison group but both will show improvements.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Michigan
-
Detroit, Michigan, 미국, 48201
- Wayne State University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patient at FQHC
- referred for psychiatric services
- 50 or older
Exclusion Criteria:
- does not speak English
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Home-based
Clinicians at the FQHC will identify and offer the opportunity to receive telepsychiatry in the home with 2 clinicians present.
The patients are not required to agree to the evaluation to receive the services.
The services are entered into their EHR but are not eligible for Medicaid reimbursement.
|
Receive telepsychiatry with clinician obtaining initial data and presenting it to the psychiatrist
|
|
활성 비교기: Clinic-based
Clinicians at the FQHC will identify and offer the opportunity to receive telepsychiatry in the clinic with 1 clinican present.
The patients are not required to agree to the evaluation to receive the services.
The services are entered into their EHR and eligible for Medicaid reimbursement.
|
Receive telepsychiatry with clinician obtaining initial data and presenting it to the psychiatrist
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
PHQ-9
기간: 6 months
|
depressiive symptoms
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
GAD7
기간: 6 months
|
anxiety symptoms
|
6 months
|
|
Home checklist
기간: 6 months
|
Problems detected in the home
|
6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Cynthia L Arfken, PhD, Wayne State University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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 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. .