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Knee Replacement Rehabilitation Care Pathways

13 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

275

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15219
        • University of Pittsburgh
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Comportamentale: Usual Rehab
Participants in the usual rehab group will continue to follow the current standard-of-care rehabilitation pathway for patients post-TKA.
Sperimentale: 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.
Comportamentale: TKA Journey - patient education
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.
Altro: Optimized Rehab Scheduling
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient Satisfaction
Lasso di tempo: 3 months post-TKA surgery
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rehab timing
Lasso di tempo: For most patients, this will occur approximately 2 weeks post-operatively.
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.
Completion of in-depth, semi-structured focus group interviews (study participants)
Lasso di tempo: 3 months post-operatively
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)
Lasso di tempo: 4 months after enrollment of the first participant in the study
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pittsburgh

Collaboratori

National Institute on Minority Health and Health Disparities (NIMHD)

Investigatori

  • Investigatore principale: Allyn M Bove, DPT, PhD, University of Pittsburgh

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

31 marzo 2027

Completamento dello studio (Stimato)

30 giugno 2027

Date di iscrizione allo studio

Primo inviato

8 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 maggio 2026

Primo Inserito (Effettivo)

20 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • K23MD018640 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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