Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain
2019年3月21日 更新者：Jordan Miller, PT, PhD、Queen's University
Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial
This is a pilot cluster randomized controlled trial to determine the feasibility of a cluster randomized trial to evaluate the individual and health system impact of implementing a new physiotherapist-led primary care model for back pain in Canada.
調査の概要
詳細な説明
This study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in Ontario to evaluate the individual health outcomes and health system impact of implementing a new physiotherapist-led primary care model for people with back pain.
The primary purpose of this pilot study is to determine the feasibility including recruitment and retention of primary care teams (sites) and patient participants, carrying out the assessment procedures, and implementing the physiotherapist-led primary care intervention including training the physiotherapist to adopt this role.
研究の種類
介入
入学 (実際)
100
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。
研究場所
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Ontario
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Kingston、Ontario、カナダ、K7L 3N6
- Queen's University
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Adults (18 years and over) with back pain of any duration
- Seeking primary care for back pain at a participating site
- Primary care visit may be a first or repeat visit
Exclusion Criteria:
- Patients who do not consent to participation
- Patients who report being unable to understand, read, and write English
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：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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実験的：背中の痛みのための理学療法士主導のプライマリケアモデル
背部痛の PT 主導のプライマリ ケア モデルでは、背部痛を持つ人々の最初の連絡先であるプライマリ ケア チーム内に PT を組み込み、患者に費用はかかりません。
このモデルの患者は、PT またはかかりつけの医師のいずれかを選択できます。
訪問の主な理由が投薬の更新である場合、または患者が同じ訪問で医師の注意を必要とする追加の健康上の懸念がある場合を除き、PT で予約することをお勧めします。
PT 主導のプライマリケア介入には 4 つの重要な要素があります。1) 初期評価とスクリーニング。 2) 初回来院時の簡単な個別介入。 3) 医療サービスのナビゲーション。 4) ニーズが満たされていない人々に追加の PT ケアを提供する。
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アクティブコンパレータ：Usual care
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
This usually includes a visit to a primary care physician, who would perform a history and physical examination, provide LBP education, and prescribe medications and/or refer based on their assessment findings and patient preferences.
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The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
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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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Recruitment of primary care teams
時間枠：Baseline
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Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
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Baseline
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Recruitment of patient participants
時間枠：Baseline to 14 weeks
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Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
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Baseline to 14 weeks
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Assessment completion
時間枠：Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
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Percentage of all assessment items completed by participants completing each assessment
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Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
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Retention of patient participants
時間枠：Retention of participants at 6-week, 12-week, 6, 9, and 12-month follow-up assessments. The primary timeline for this outcome is 12-month follow-up.
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Attrition rate
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Retention of participants at 6-week, 12-week, 6, 9, and 12-month follow-up assessments. The primary timeline for this outcome is 12-month follow-up.
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Physiotherapist confidence in carrying out the interventions
時間枠：Baseline
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The PT will rate his/her confidence in each component of the intervention after the training on a scale from 0-10 with higher scores indicating greater confidence in carrying out that component of the intervention.
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Baseline
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Treatment fidelity
時間枠：6-week follow-up
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Treatment fidelity will be measured by consistency with the intervention described in the protocol measured through an intervention checklist completed by the physiotherapist and an audit of the EMR notes.
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6-week follow-up
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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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Self-reported disability
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Self-reported pain intensity
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity (measured at rest, during walking, and during a lifting task)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health Related Quality of Life
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Global rating of change
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using an 11-point scale (-5 to +5 with negative scores indicating a worsening of physical functioning related to back pain and positive scores indicating an improvement of physical functioning related to back pain)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Satisfaction with health care
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using an 11-point scale(-5 to +5 with negative scores indicating a dissatisfaction with health care received and positive scores indicating satisfaction with health care received)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Catastrophic Thinking
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Depressive symptoms
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using the 9-item Patient Health Questionnaire (PHQ-9) (0 to 27 with greater scores indicating increased depressive symptoms)
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Adverse events
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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measured using an adverse events questionnaire that asks 1) if the patient has experienced any adverse events as a result of the treatments received (yes/no); 2) how long the event lasted (hours or days); 3) how severe the adverse event was (0-10 scale); 4) what adverse events were experienced.
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health care accessibility
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Percentage of patients receiving care within 48 hours.
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health care accessibility
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Health care utilization
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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All health care visits (aggregated and dis-aggregated) including: primary care visits, emergency department visits, hospitalizations, surgeries, consultations with other health care providers, diagnostic imaging, medications, and other care received by the patient
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Costs (piloted for a cost utility analysis in a future trial)
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Includes all health care costs plus societal costs using a human capital approach for loss of productivity
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Medications prescribed
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Diagnostic imaging ordered
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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referrals to other health care providers made
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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notes made by primary care provider to employers or insurers
時間枠：Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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Measured as a process outcome
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Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
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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：Jordan Miller, PhD、Queen's University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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 (実際)
2017年9月20日
一次修了 (実際)
2019年1月15日
研究の完了 (実際)
2019年1月15日
試験登録日
最初に提出
2017年10月16日
QC基準を満たした最初の提出物
2017年10月24日
最初の投稿 (実際)
2017年10月25日
学習記録の更新
投稿された最後の更新 (実際)
2019年3月25日
QC基準を満たした最後の更新が送信されました
2019年3月21日
最終確認日
2019年3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?
いいえ
IPD プランの説明
There is no plan to share individual participant data from this pilot study.
This data will be used to inform the protocol for a fully powered cluster randomized trial.
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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