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| ID | Type | Description | Link |
|---|---|---|---|
| K23MD018640 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - Usual Rehab | Active Comparator | 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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| Intervention - Optimized Rehab | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKA Journey - patient education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | 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. | 3 months post-TKA surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rehab timing | 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. | For most patients, this will occur approximately 2 weeks post-operatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allyn M Bove, DPT, PhD | Contact | 412-624-9255 | allyn.bove@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Allyn M Bove, DPT, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15219 | United States |
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.
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.
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.
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The new care pathways will be implemented from the practice level and downward, meaning that all patients receiving TKA from the "intervention" surgical practice within the three-month study period will be guided by surgical and rehabilitation staff to follow the new pathways.
In the 'control' practice, the investigators will simply obtain information regarding patients' rehabilitation utilization and functional outcomes during the 3-month study period from an institutional data warehouse. The 'control' practice is located in a similarly-sized hospital less than 2 miles from the 'intervention" practice, and internal data indicate that patient demographics are very similar between the two.
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| Optimized Rehab Scheduling | Other | 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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| Usual Rehab | Behavioral | 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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| Completion of in-depth, semi-structured focus group interviews (study participants) | 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. | 3 months post-operatively |
| Completion of in-depth, semi-structured 1-on-1 interviews (physical therapists who treat patients post-total knee arthroplasty) | 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. | 4 months after enrollment of the first participant in the study |