Knee Replacement Rehabilitation Care Pathways
2026年5月13日 更新者：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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
275
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Allyn M Bove, DPT, PhD
- 電話番号：412-624-9255
- メール：allyn.bove@pitt.edu
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15219
- University of Pittsburgh
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コンタクト：
- Allyn M Bove, DPT, PhD
- 電話番号：412-624-9255
- メール：allyn.bove@pitt.edu
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient Satisfaction
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rehab timing
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Allyn M Bove, DPT, PhD、University of Pittsburgh
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年3月31日
研究の完了 (推定)
2027年6月30日
試験登録日
最初に提出
2026年5月8日
QC基準を満たした最初の提出物
2026年5月13日
最初の投稿 (実際)
2026年5月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月20日
QC基準を満たした最後の更新が送信されました
2026年5月13日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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