Knee Replacement Rehabilitation Care Pathways
Development and Implementation of Optimal Rehabilitation Care Pathways to Reduce Disparities in Rehabilitation Outcomes After Joint Replacement
研究概览
地位
条件
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Allyn M Bove, DPT, PhD
- 电话号码：412-624-9255
- 邮箱：allyn.bove@pitt.edu
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15219
- University of Pittsburgh
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接触：
- Allyn M Bove, DPT, PhD
- 电话号码：412-624-9255
- 邮箱：allyn.bove@pitt.edu
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient Satisfaction
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rehab timing
大体时间：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)
大体时间：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)
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Allyn M Bove, DPT, PhD、University of Pittsburgh
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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 共享时间框架
IPD 共享访问标准
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 共享支持信息类型
- 研究方案
- 树液
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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