Patient-Centred Care for Warfarin Management: A Pilot Study to Transition Care to High Risk Patients
調査の概要
詳細な説明
50 patients will receive a cover letter outlining their random selection for this study, along with the patient information sheet and consent form (with a return addressed, postage paid envelope). Patients will be encouraged to contact the AC and speak with the Principal Investigator (TB) regarding the research study, and all questions will be addressed. We will continue this mailing process until a total of 50 patients have consented to study. PSM within the context of this study may use either POC technology or standard venipuncture with the patient accessing the laboratory for results. After receipt of consent, patients will be required to pass a foundational exam (outlining the basics of anticoagulation therapy, most of which should be simple review for the patients managed within our AC).4,10 Upon successfully passing this multiple choice exam, patients will be randomized to AC care (with no changes implemented) or to PSM.
PSM Phase I: Preparatory Phase of Patient Training (~6weeks) During the initial preparatory phase lasting 6 weeks + 2 weeks, the AC will create a patient specific warfarin dosing nomogram, discuss the same with the patient and ensure clear understanding, while working through various scenarios with the patient (Appendix 1). The AC will ensure the patient has an established system to both retrieve INR results (via POC technology or standard venipuncture) as well as to document the INR results, warfarin dosing, any pertinent assessment factors, and next date to test the INR. The AC will empower the patient to be proactive with coming up with warfarin dose changes during this preparatory phase.
PSM Phase II: Patient Practical Training:
The AC will enrol the patient into the PSM practical training phase (lasting 3 months + 1 month). At this time, the patient will retrieve their result and establish a future warfarin dose and follow-up plan. This information will be transmitted to a single AC team member. Contact with anotherdiscussed with an AC team member and the ultimate dosing decision will be tracked to ascertain concordance of the patient's original plan to what was implemented during the follow-up visit with the to perform standard AC teamcare and management will occur, thereby enabling comparison of the patient's plan and the AC plan. During this phase, the AC plan will be implemented. At the end of this phase, patients must pass a multiple choice exam that provides practical cases targeting warfarin dose adjustment with next scheduled follow-up visit, and will then be positioned into the PSM arm of the study.
Patient Self-Management During the PSM phase (6 months +/- 1 month), contact will occur with the AC monthly to retrieve INR results and warfarin dose adjustments (information from the patient-based charting system). Key points of contact between the patient and the AC will be required, such as: INR results either > 5.0 or 0.5 INR units below the lower limit of their desired target INR range, initiation of interacting medications, illness, etc. Patients not demonstrating the ability to self-manage their own warfarin therapy will be encouraged to cross-over to AC care. At the end of 6 months, patient choice of AC care or PSM will be identified.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Alberta
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Edmonton、Alberta、カナダ、T6G 2J3
- University of Alberta
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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
Inclusion Criteria:
- mechanical heart valve as the indication for warfarin
- > 16 years of age
- Warfarin therapy managed by the AC for at least the preceding 6 months
- Anticipated duration of warfarin therapy to be lifelong
- Previously adherent with medication
- Competence judged by demonstrated ability to use drug-adjustment nomograms
Exclusion Criteria:
• Severe psychiatric disease
- Significant language barrier
- Clinician's judgment that the patient would be a poor candidate for study (with reason specified)
- Known or anticipated procedure/surgery/intervention in the next year
- Active participation in another study
- Lack of access to the internet / email
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: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 |
---|---|
実験的:Patient Self-Management
Patients will go through a preparatory phase (creation of warfarin dosing chart, process for documentation and retrieval of labs), a practical training phase (formulate warfarin management plan with support) and then perform patient-self management of their own warfarin.
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Patient will manage their own warfarin therapy.
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介入なし:Anticoagulation Clinic Care
Patients will not have their care altered, and will continue to be managed by our Anticoagulation Clinic.
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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 |
---|---|---|
The change in quality of life score (using the validated instruments DASS and Sawicki scale) between PSM and AC care.
時間枠:6 months
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Duke Anticoagulation Satisfaction Scale (DASS) and Sawicki Scale
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6 months
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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 |
---|---|---|
The proportion of patients completing PSM
時間枠:9 months
|
Beginning from consent and capturing stage at which patients withdrew (if applicable) namely the preparatory and practical training phases or PSM as well as those electing to continue PSM after study
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9 months
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Difference in the time in therapeutic INR range between those randomized to AC care versus PSM.
時間枠:6 months
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Time in range will be calculated using the Rosendaal method.
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6 months
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The rate of ER and hospitalization for anticoagulant and non-anticoagulant reasons between AC care and PSM.
時間枠:6 months
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presentations to hospital
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6 months
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The amount of time spent by the AC team for the AC group relative to the PSM group.
時間枠:9 months
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the number of minutes taken for each arm, as a measure of resource use within the AC team.
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9 months
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Amongst the PSM group, to determine if strategies for self-managing warfarin therapy have made patients do so for other chronic diseases.
時間枠:6 months
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a descriptive measure of translation of proactive management
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6 months
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Number of participants in AC care vs PSM that are dead at 5 years.
時間枠:5 years following study completion
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mortality measure
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5 years following study completion
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Number of encounters in the PSM group that put forward warfarin dosing that is concordant with that of the AC and to provide descriptions of warfarin dose changes.
時間枠:3 months
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assessed prior to entering the PSM phase
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3 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Tammy Bungard, BSP, PharmD、University of Alberta
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
その他の研究ID番号
- Pro00052090
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?
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
米国FDA規制機器製品の研究
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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