Knee Replacement Rehabilitation Care Pathways
2026년 5월 13일 업데이트: Allyn Bove, University of Pittsburgh
Development and Implementation of Optimal Rehabilitation Care Pathways to Reduce Disparities in Rehabilitation Outcomes After Joint Replacement
Previous research has shown that use of rehabilitation (including physical therapy) and the recovery of function after knee replacement surgery may differ depending on patients' race, sex, income or insurance, and geographic location.
In this study, the investigators will develop and test a new care pathway for knee replacement rehabilitation that is designed to maximize functional recovery for all patients and reduce differences between different groups of patients.
Findings from this project will lead to improved rehabilitation quality after knee replacement surgery.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
In previous work, the investigators used quantitative and qualitative data to identify sociodemographic disparities in physical function and use of rehabilitation following total knee arthroplasty (TKA), or knee replacement surgery.
The investigators also identified patient and provider impressions regarding areas of the post-TKA rehabilitation pathway and recommendations for improvements.
Based on all of this information, the investigative team has developed a newly-optimized rehabilitation care pathway and will pilot test this approach in this study.
연구 유형
중재적
등록 (추정된)
275
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Allyn M Bove, DPT, PhD
- 전화번호: 412-624-9255
- 이메일: allyn.bove@pitt.edu
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15219
- University of Pittsburgh
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연락하다:
- Allyn M Bove, DPT, PhD
- 전화번호: 412-624-9255
- 이메일: allyn.bove@pitt.edu
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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
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- scheduled to receive unilateral TKA surgery at a University of Pittsburgh Medical Center hospital
- plans to utilize UPMC Home Health and/or UPMC Rehab Institute for home health and/or outpatient rehabilitation post-operatively
Exclusion Criteria:
- does not undergo planned surgery
- does not receive any post-TKA rehabilitation at UPMC facilities
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Control - Usual Rehab
Participants in the 'control' practice will receive post-TKA rehabilitation according to the current usual pathway.
This typically involves discharge to home on post-operative day 0 or 1, followed by 5 visits of home health physical therapy, followed by outpatient physical therapy at a frequency and duration deemed appropriate by the care team.
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Participants in the usual rehab group will continue to follow the current standard-of-care rehabilitation pathway for patients post-TKA.
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실험적: Intervention - Optimized Rehab
Participants receiving TKA in the 'intervention' practice will be guided by clinical staff to follow the new "optimized" pathway.
The progression from inpatient to home health to outpatient physical therapy will remain the same, but with the addition of the interventions described below.
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The investigators' team developed a new patient education booklet containing information that walks the patient through their TKA journey, from pre-operative to hospital-based rehabilitation prior to discharge, to outpatient physical therapy, and after discharge from formal physical therapy services.
All patients in the intervention arm will receive this booklet from their surgeon's office and will receive a phone call from study personnel to review it and answer any questions.
For all patients in the 'intervention' practice, the home health referral will include instructions for the home health physical therapist to assist the patient with scheduling their first outpatient physical therapy session, to avoid unnecessary gaps in care between home health discharge and outpatient physical therapy evaluation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Satisfaction
기간: 3 months post-TKA surgery
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A patient satisfaction survey will be collected at 3 months post-operative, to query all patients' satisfaction with pre-operative education, ease of scheduling of post-TKA rehabilitation, and perceptions of the overall post-TKA rehab pathway.
A modified version of the PSQ-III patient satisfaction survey will be used, in which each construct is rated by the patient on a 1-5 scale, with higher scores indicating greater satisfaction with care.
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3 months post-TKA surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rehab timing
기간: For most patients, this will occur approximately 2 weeks post-operatively.
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In days, the investigators will calculate the time between the patient's last home health visit and their first outpatient physical therapy visit.
This enables the quantitative assessment of gaps in care.
The investigators will obtain this information from the electronic health record.
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For most patients, this will occur approximately 2 weeks post-operatively.
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Completion of in-depth, semi-structured focus group interviews (study participants)
기간: 3 months post-operatively
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The investigators will conduct focus groups with patients who followed the optimized post-TKA rehab pathway to learn in-depth about their impressions of the pathway.
The focus group interview guide will include questions about patient perception of their post-TKA rehab, transitions between home health and outpatient physical therapy, the completeness of educational information they received from their surgical care team and physical therapists, and any difficulties they may have encountered during any phase of post-TKA rehabilitation.
These focus groups will be recorded, transcribed verbatim, and then coded by two independent trained coders using a codebook created iteratively by the coders and the investigators.
Themes will be identified and summarized by the investigators.
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3 months post-operatively
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Completion of in-depth, semi-structured 1-on-1 interviews (physical therapists who treat patients post-total knee arthroplasty)
기간: 4 months after enrollment of the first participant in the study
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The investigators will conduct 1-on-1 semi-structured interviews to assess home health and outpatient physical therapist perceptions of the optimized post-TKA rehab pathway.
The interview guide will include questions about physical therapist perception of the optimized post-TKA rehabilitation pathway, transitions between home health and outpatient physical therapy, the completeness of educational information patients received from their surgical care team and physical therapists, and any difficulties they may have experienced while implementing the new optimized care pathway.
These interviews will be recorded, transcribed verbatim, and then coded by two independent trained coders using a codebook created iteratively by the coders and the investigators.
Themes will be identified and summarized by the investigators.
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4 months after enrollment of the first participant in the study
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Allyn M Bove, DPT, PhD, University of Pittsburgh
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 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 3월 31일
연구 완료 (추정된)
2027년 6월 30일
연구 등록 날짜
최초 제출
2026년 5월 8일
QC 기준을 충족하는 최초 제출
2026년 5월 13일
처음 게시됨 (실제)
2026년 5월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 13일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Any requests for data sharing should be directed to the Principal Investigator by e-mail or postal mail.
The identity of human subjects will be protected. Data that is shared will be stripped of any remaining patient identifiers including the date that subjects were entered into the study. Original data elements that contain protected health information will not be shared, but relevant transformed or computed variables will be available.
Investigators requesting data will be required to sign a data sharing agreement.
The Principal Investigator will be available by e-mail, telephone, or written correspondence to assist other investigators in the use of the data.
Data will be made available no later than when a relevant manuscript is published.
Data will be made available in SAS or Excel format.
Investigators will make the analytical codes used to process and analyze quantitative data available to other researchers.
Data files will be shared using a secure cloud-based service.
IPD 공유 기간
Data will be made available no later than when the relevant manuscript is published, or at the end of the study's award period, whichever comes first.
IPD 공유 액세스 기준
Access: Researchers who request access to the IPD and sign a data use agreement will be granted access to the IPD and supporting information.
Information available: De-identified IPD will be available in SAS or Excel format. The investigators will also make the analytical codes used to process and analyze quantitative data available to other researchers upon request.
Mode: Data files will be shared using a secure, cloud-based service. The School of Health and Rehabilitation Sciences Data Center at the principal investigator's institution will assist with ensuring the security of the data to be shared and placing the files in a secure cloud-based location for the requesting researcher to access.
For more details: A copy of the full data sharing plan that was submitted to the study funder is available by contacting the principal investigator by email or postal mail.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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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