Feasibility Study: Effect of Patient Decision Aids for Total Joint Replacement on Surgical Referrals
Feasibility Study: Does Screening Plus Patient Decision Aids Reduce Unnecessary Surgical Referrals for Total Joint Arthroplasty in Practices With Long Waiting Lists for Surgical Consults?
Ministries of Health consider wait lists for total joint replacement a top priority. Research priorities to manage wait lists indicate the need to establish benchmarks that consider patient preferences. However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indicators for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. When decision aids are used in combination with assessing surgical eligibility, there may be a reduction in unnecessary referrals for surgery either because the patient is ineligible or because the eligible candidates make informed decisions to forgo this option.
The study objective is to pilot test the feasibility of a trial evaluating the effects of patient decision aids on reducing unnecessary surgical referrals for total joint replacement, when used in combination with a general practitioner run clinic to screen patients with hip or knee osteoarthritis for surgical eligibility.
The investigators expect to provide evidence of feasibility (e.g. ease of recruiting patients, delivering the interventions, measuring patient outcomes) and sample size needed for a larger scale study. This study should also provide evidence for planning implementation of the interventions and standardized training across other centers.
調査の概要
詳細な説明
Background:
Current research priorities to manage wait times for total joint arthroplasty (TJA) indicate the need to establish benchmarks that consider patient preferences. Among clinically appropriate candidates for this procedure, patients' preferences for surgery is very low; between 8.5 and 14.9% of clinically ideal candidates were definitely willing to consider TJA.However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indications for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. Therefore, patient decision aids may have a role in ensuring that wait list reforms address under-use of surgical procedures that informed patients need and want, while preventing the over-use of procedures that informed patients do not value. If they were used in combination with screening for surgical eligibility, they might also prevent inappropriate referrals for surgery (i.e., patients who are not clinically eligible or who would not want surgery even if they were clinically eligible).
Objective:
To pilot test the feasibility of a trial evaluating the incremental effects of patient decision aids on reducing unnecessary surgical referrals for TJA, when used in combination with a general practitioner intake clinic that screens patients for surgical eligibility.
Participants & Setting:
Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited. Excluded are those with inflammatory arthritis, previous TJA, or those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.
Design:
In this pilot study, patients will be screened for surgical eligibility by a trained general practitioner using a standardized examination of the hip/knee and questionnaire assessing joint symptoms and disability. Eligible patients will be stratified by affected joint (hip/knee) and randomly allocated to either: a) usual education; or b) a patient decision aid which presents balanced evidence-based information on the treatment options, including the risks and benefits. Automated reports will be sent to the surgeon for all patients.
Primary Outcomes:
- Feasibility of participant recruitment, intervention provision, and data collection; sample size needed to detect differences in the rates of unnecessary referral
Secondary Outcomes
- Proportion of unnecessary surgical referrals.
- Decision quality, the extent to which patients' decisions are informed and values-based.
- Perception of Preparation for Decision Making.
Timeline and Deliverables:
By the end of this one year study, we will prepare a report and policy brief on the evidence of feasibility to support a larger scale multi-centre trial and a fully implementable set of interventions, with standardized training, to facilitate replication elsewhere.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Ontario
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Ottawa、Ontario、カナダ、K1Y 1J7
- The Ottawa Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited
Exclusion Criteria:
- Patients with inflammatory arthritis
- Previous TJA
- Those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.
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
- 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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:1 Patient decision aid
Patient decision aid about treatment options for osteoarthritis
|
Patients will receive: i)patient education booklet ii) a video/DVD PtDA for either hip (Treatment choices for hip osteoarthritis) or knee (Treatment choices for knee osteoarthritis) © Health Dialog 2005. iii) a personal decision form is an interactive form used by patients after the DVD to elicit their knowledge, values, preferred option, and perceptions of the decision making process. iv) Referral to the surgeon with a standardized report of their clinical findings plus decisional data (knowledge, values, preference). Patient will be given i) education booklet from local hospital which is a standardized teaching booklet given to all patients describing preparation for surgery, recovery after surgery, discharge plans. ii) Referral to the surgeon with a standardized report of their clinical findings. |
アクティブコンパレータ:2 Usual care
Usual patient educational materials
|
Patient will be given i) education booklet from local hospital which is a standardized teaching booklet given to all patients describing preparation for surgery, recovery after surgery, discharge plans. ii) Referral to the surgeon with a standardized report of their clinical findings. |
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 |
時間枠 |
---|---|
Feasibility of participant recruitment, intervention provision, and data collection; sample size needed to detect differences in the rates of unnecessary referral
時間枠:April 2009
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April 2009
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Decision quality
時間枠:June 2008
|
June 2008
|
Satisfaction with preparation for decision making
時間枠:June 2008
|
June 2008
|
Proportion of unnecessary surgical referrals
時間枠:April 2009
|
April 2009
|
協力者と研究者
捜査官
- 主任研究者:Dawn Stacey, PHD、University of Ottawa
出版物と役立つリンク
一般刊行物
- Stacey D, Hawker G, Dervin G, Tomek I, Cochran N, Tugwell P, O'Connor AM. Management of Chronic Pain: Improving shared decision making in osteoarthritis. BMJ. 2008 Apr 26;336(7650):954-5. doi: 10.1136/bmj.39520.701748.94. Epub 2008 Apr 8.
- Stacey D, Hawker G, Dervin G, Tugwell P, Boland L, Pomey MP, O'Connor AM, Taljaard M. Decision aid for patients considering total knee arthroplasty with preference report for surgeons: a pilot randomized controlled trial. BMC Musculoskelet Disord. 2014 Feb 24;15:54. doi: 10.1186/1471-2474-15-54.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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。
1 Patient decision aidの臨床試験
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Assistance Publique - Hôpitaux de ParisNational Research Agency, France完了関節リウマチ | ブドウ膜炎 | 血管炎 | 1型糖尿病 | クローン病 | 筋炎 | 健康ボランティア | 強直性脊椎炎 | FMF | 全身性エリテマトーデス/抗リン脂質症候群 | クリオピリン関連周期性症候群/TNF受容体関連周期性症候群 | 潰瘍性直腸炎 | 未分類 IAD 膝および/または股関節炎、筋ジストロフィーフランス
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Steno Diabetes Center CopenhagenRigshospitalet, Denmark募集