- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00971139
Implementing Online Patient-Provider Communication Into Clinical Practice (OPPC)
Implementing Online Patient-Provider Communication Into Clinical Practice: Implementation Research
연구 개요
상세 설명
A rapidly growing research literature documents the importance of Health IT to improve communication between health care providers and their patients. Patient Internet portals and online patient-provider communication (OPPC) allow patients to stay connected with their care providers between clinical encounters, get help and advice for their symptoms and problems from home, better understand and manage their illness, and become more engaged in their care. Through better patient-provider partnerships and communication independent of face-to-face visits, health problems and side-effects of treatment can be more easily detected, prevented, and treated more quickly.
Therefore, the overall goal of this international collaboration study is to implement and evaluate the effects and use of a primarily nurse-administered OPPC service, including access to advice from physicians, dietitians and social counselors, as part of regular patient care; and using methods consistent with effectiveness research to bridge the gap between research evidence and translation into routine practice.
The specific aims of this study are twofold:
In Phase I the investigators will refine and implement an Internet-based OPPC service where patients can ask questions and receive advice and support from care providers and social counselors. The investigators will use participatory design methods to adapt an OPPC service to patients' needs; care providers' requirements; and the workflow and organizational and technical infrastructure of clinical practice by answering the following research questions:
What are the predisposing, enabling and reinforcing factors related to successful adoption, implementation and maintenance of the OPPC service such as: potential barriers to successful implementation; workflow adjustments, support and resources needed to implement and maintain the OPPC in daily clinical practice?
In Phase II we will offer study participants access to the OPPC service to understand implementation issues. In addition, we will conduct a pilot randomized clinical trial (usual care; OPPC) with 40 patients in each group that will be followed over 6 months to evaluate:
- participation rate and OPPC use;
- characteristics of high/low volume users, patient-caregiver communication and use patterns;
- perceived usefulness and ease of use and
- impacts on organizational change and interdisciplinary collaboration.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oslo, 노르웨이, 0027
- Oslo University Hospital - Rikshospitalet
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years of age.
- Able to read/speak Norwegian and have Internet with secure access (BankID) at home.
Exclusion Criteria:
- Excluded are patients who have brain metastasis and patients with cerebral affection caused by the disease (e.g., encephalopathy) as this may affect their abilities to reliably report their symptoms.
- Excluded are also patients who receive a liver transplant indicated by cancer coli, as they participate in another study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Access to an OPPC service
Access to an Internet-based messaging system where patients can ask questions and receive advice and support from care providers at the hospital and social counsellors
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Access to an Internet-based messaging system where patients can ask questions and receive advice and support from care providers at the hospital and social counsellors
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간섭 없음: Control group
Patients receiving usual care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Impacts of the OPPC service on organizational processes/organizational change such as care processes
기간: End of study at 6 (8) months after last included patient
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End of study at 6 (8) months after last included patient
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Participation rate and OPPC use, perceived usefulness and ease of use
기간: End of study at 6 (8) months after last included patient
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End of study at 6 (8) months after last included patient
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Characteristics of high/low volume users, patient-caregiver communication and use patterns
기간: End of study at 6 (8) months after last included patient
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End of study at 6 (8) months after last included patient
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공동 작업자 및 조사자
수사관
- 수석 연구원: Cornelia M Ruland, PhD, Oslo University Hospital
간행물 및 유용한 링크
일반 간행물
- Ruland CM, Borosund E, Varsi C. User requirements for a practice-integrated nurse-administered online communication service for cancer patients. Stud Health Technol Inform. 2009;146:221-5.
- Varsi C, Gammon D, Wibe T, Ruland CM. Patients' reported reasons for non-use of an internet-based patient-provider communication service: qualitative interview study. J Med Internet Res. 2013 Nov 11;15(11):e246. doi: 10.2196/jmir.2683.
- Wibe T, Helleso R, Varsi C, Ruland C, Ekstedt M. How does an online patient-nurse communication service meet the information needs of men with recently diagnosed testicular cancer? ISRN Nurs. 2012;2012:260975. doi: 10.5402/2012/260975. Epub 2012 Dec 4.
- Wibe T, Ekstedt M, Helleso R, Varsi C, Ruland C. "You are not at all bothersome" - nurses' online communication with testicular cancer patients. NI 2012 (2012). 2012 Jun 23;2012:453. eCollection 2012.
- Varsi C, Ekstedt M, Gammon D, Ruland CM. Using the Consolidated Framework for Implementation Research to Identify Barriers and Facilitators for the Implementation of an Internet-Based Patient-Provider Communication Service in Five Settings: A Qualitative Study. J Med Internet Res. 2015 Nov 18;17(11):e262. doi: 10.2196/jmir.5091.
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RCN191008/V50
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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