- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04496713
Pilot Study of Video and Telephone Primary Care Visits
Pilot Study - Randomized Controlled Trial of Video and Telephone Primary Care Visits
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins Outpatient Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult patients scheduled for telephone-based visits who are doing so because of a lack of ability to conduct a video visit (i.e. no tablet/laptop; no access to internet) who live in Baltimore City
Exclusion Criteria:
- Patients with significant visual or hearing impairment
- Patients that have legal guardians or who are marked as lacking healthcare decision-making capacity
- Patients that have not selected English as their preferred language
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: Telemedicine - Phone
Patients will continue with their telephone-based telemedicine visit as scheduled.
There will be no change to their care.
Patients will receive a survey by mail about the visit.
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실험적: Telemedicine - Audio/Video
Patients will be given an internet-connected tablet to have their upcoming visit with their physician by audio/video.
A survey can be completed on the tablet.
The devices will be sent back to the research time after their single use.
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An internet-connected tablet provided to patient for upcoming visit with physician by audio/video which can also be used to complete a survey.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Provider rating as assessed by the Consumer Assessment of Healthcare Providers and Systems question on provider rating
기간: Within 2 weeks of the study visit
|
Provider rating will be assessed with the Consumer Assessment of Healthcare Providers and Systems question on provider rating of 0-10; 0 being worst provider possible and 10 being best provider possible.
|
Within 2 weeks of the study visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Satisfaction with telemedicine visit for patient as assessed by a Likert scale
기간: Within 2 weeks of the study visit
|
Satisfaction with telemedicine visit for patient will be assessed with Likert-scale questions related to satisfaction. Satisfaction (1=strongly disagree to 5=strongly agree).
Overall score 3 to 15 with higher scores signifying better satisfaction. |
Within 2 weeks of the study visit
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Satisfaction with telemedicine visit for provider as assessed by a Likert scale
기간: Within 2 weeks of the study visit
|
Satisfaction with telemedicine visit for provider will be assessed with Likert-scale questions related to satisfaction. [1=Strongly Disagree. 5=Strongly Agree].
Overall score 2 to 10 with higher scores signifying better satisfaction. |
Within 2 weeks of the study visit
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Efficacy of telemedicine visit for provider as assessed by a Likert scale
기간: Within 2 weeks of the study visit
|
Efficacy of telemedicine visit for provider will be assessed with Likert-scale questions related to efficacy. [1=Strongly Disagree. 5=Strongly Agree]. b. I was able to understand the patient's explanation of their medical problems well enough. c. In general, this telemedicine visit was effective in improving this patient's medical care d. An in-person visit would likely have provided additional clinically-relevant information e. An in-person visit would likely have led to a change in management |
Within 2 weeks of the study visit
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Provider communication as assessed by yes/no question
기간: Within 2 weeks of the study visit
|
The ability of a provider to communicate will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to communication. Did this provider explain things in a way that was easy to understand? Yes/No |
Within 2 weeks of the study visit
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Provider listening as assessed by yes/no question
기간: Within 2 weeks of the study visit
|
Provider listening will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to listening. Did this provider listen carefully to you? Yes/No |
Within 2 weeks of the study visit
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Provider respect as assessed by yes/no question
기간: Within 2 weeks of the study visit
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Provider respect will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to respect. Did this provider show respect for what you had to say? Yes/No |
Within 2 weeks of the study visit
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Provider time spent as assessed by yes/no question
기간: Within 2 weeks of the study visit
|
Provider time spent will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to time spent during the clinical encounter. Did this provider spend enough time with you? Yes/No |
Within 2 weeks of the study visit
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Patient health rating as assessed by a likert scale
기간: Within 2 weeks of the study visit
|
Patient health will be assessed with Likert-scale questions related to patient health. In general, how would you rate your overall health?
In general, how would you rate your overall mental or emotional health?
Overall score 2 to 10 with lower scores signifying better health. |
Within 2 weeks of the study visit
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jeremy A Epstein, MD, Johns Hopkins University
- 수석 연구원: Casey Overby Taylor, PhD, Johns Hopkins 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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- IRB00257994
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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