Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial SCORE-IT)
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE IT)
調査の概要
詳細な説明
Stroke is a leading cause of disability in Canada and frequently causes hemiparesis (upper limb and lower limb weakness on one side of the body). Approximately one third of stroke survivors require physical rehabilitation to improve their motor and functional recovery (1). Although many strategies have been shown to be effective in promoting recovery after stroke, the uptake of evidence-based practice by rehabilitation professionals across Canada is variable. The aim of this project is to evaluate whether using an implementation intervention promotes use of best practices by rehabilitation professionals and leads to improvements in patient outcomes for individuals with stroke.
This project is a cluster randomized implementation trial for upper and lower limb interventions. Rehabilitation centres across Canada will be randomized to receive either an outcome-oriented implementation strategy (OOI) to facilitate implementation of the EIPRs or a process-oriented implementation strategy (POI). At the onset, rehabilitation professionals practicing in all centres will receive education in using best practice outcome measures related to stroke rehabilitation. All centres will be assessed for baseline adherence to the EIPRs. Centres in the OOI will receive "usual care" (i.e. passive dissemination of the written protocols and information about outcome measures). Centres in the POI arm will receive a combination of strategies to facilitate EIPR uptake (i.e., use of a local facilitator, practice audits with feedback, reminder systems and educational sessions). Following exposure to the EIPRs, all centres will document adherence to the EIPRs, and patient outcomes as assessed by the measures. An analysis of the costs associated with rehabilitation interventions and the incremental expense of a POI strategy will be undertaken. These data will be used to compare the OOI and POI centres with respect to the level of uptake and implementation of EIPRs and related expenses.
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
-
-
Ontario
-
Toronto、Ontario、カナダ、M5G 2A2
- 募集
- Toronto Rehabilitation Institute
-
コンタクト:
- Amanda Hurdowar, MSc
- 電話番号:7859 416-597-3422
- メール:Hurdowar.Amanda@TorontoRehab.on.ca
-
主任研究者:
- Mark T Bayley, MD
-
-
Quebec
-
Montreal、Quebec、カナダ、H3G 1Y5
- まだ募集していません
- McGill University
-
コンタクト:
- Sharon Wood-Dauphinee, PhD
- 電話番号:(514) 398-5326
- メール:sharon.wood.dauphinee@mcgill.ca
-
主任研究者:
- Sharon Wood-Dauphinee, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Rehabilitation Hospitals/Research Sites:
Inclusion Criteria:
- hospital with designated rehabilitation beds;
- regularly treats stroke patients;
- has access to at least one physical (PT) and one occupational (OT) therapist on the health professional team
Exclusion Criteria:
- Inadequate staffing to administer the outcome measures consistently
Patients:
Inclusion Criteria:
- medically stable;
- stroke with residual disability;
- requires complex rehabilitation interventions from at least 3 health care professionals, one of them being an OT or a PT;
- admitted to rehabilitation centre within 90 days of stroke onset;
- and age >18 years
Exclusion Criteria:
- having a medical condition that is expected to result in death within 6 months;
- presence of a serious chronic disabling condition that impacts on either the rehabilitation process or rehabilitation outcomes such as severe arthritis, dementia, Parkinson's disease;
- active suicidal ideation or symptoms of psychosis
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
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 |
|---|
|
Arm function as measured by the Box and Block test
|
|
Walking speed as measured by the 6 minutes walk test
|
二次結果の測定
結果測定 |
|---|
|
Arm function as measured by the Chedoke Arm and Hand Activity Inventory (CAHAI- 9)
|
|
Impairment as measured by the Chedoke-McMaster Stroke Assessment Scale (CMSA)
|
|
Independence of daily living as measured by the 3. Functional Independence Measure (FIM)
|
|
Economic outcomes measured by the Quality Adjusted Life Years (QALY)
|
協力者と研究者
捜査官
- 主任研究者:Mark T Bayley, MD、Toronto Rehabilitation Institute
- 主任研究者:Sharon Wood-Dauphinee, PhD、McGill University
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。