Designing and Evaluating Multi-level Implementation Strategies to Address Alcohol Use Within Oncology Care
2026年8月7日 更新者:Robert Schnoll、University of Pennsylvania
To assess the potential effects of our multi-level implementation strategies for increasing SBIRT for alcohol use among cancer patients and to refine our methods, the investigators are conducting a pilot-trial with 4 clinics and will be doing interviews with patients and clinicians.
The investigators will use a pragmatic, randomized clinical trial design, with 2 clinics randomized to our multi-level implementation strategies and 2 clinics randomized to usual care (prescreening assessment of alcohol use and patient information about alcohol use).
Clinicians will include physicians as well as nurses and nurse practitioners who complete patient visits.
Patients will include those diagnosed with cancer who have completed the alcohol use prescreening at a visit within the previous 30 days; the investigators will not deliver implementation strategies until at least 7 days following the initial prescreening given the informatics need to deliver messages to eligible patients at the point of care.
Patients in the usual care arm will receive the prescreening and information about alcohol use and cancer outcomes and who to contact for further assessment integrated into their "After Visit Summary"; clinicians in the usual care sites will receive information about alcohol as a determinant of cancer outcomes and who to contact for referrals for screening at the outset of the pilot trial.
Each patient who completes the subsequent clinic visit where the patient and clinician directed nudges are delivered (in the multi-level intervention arm) or not (usual care) will be tracked for 6 months to determine if SBIRT for alcohol use was completed (the primary outcome variable).
Lastly, 10 patients and 10 clinicians will be invited to complete key informant interviews to provide feedback about their experiences with the implementation strategies.
調査の概要
研究の種類
介入
入学 (推定)
265
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:Jonathan B Richards, M.Sc
- 電話番号:2157467149
- メール:Jonathan.Richards@pennmedicine.upenn.edu
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:
- Over age 18 and diagnosed with cancer
- Receiving care at one of our pilot study sites
Exclusion Criteria:
- None
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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし:The Usual Care Arm
Patients who are assessed and treated by clinicians at sites randomized to usual care will receive the alcohol use prescreening by the Medical Assistant and will receive information about the adverse effects of alcohol and resources available for further evaluation through the Penn health system during their subsequent encounters with clinicians within usual care sites.
This information will be provided on the After Visit Summary and will include contact information for the Center for Addiction Medicine and Policy, where SBIRT for alcohol use can be obtained (Note: We will use a generic term for the referral such as Cancer Support Services to reduce stigma).
No additional implementation strategies will be provided.
No changes will be made to the EMR for clinicians within usual care sites (i.e., no Best Practice Alert).
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実験的:The Multi-level Implementation Strategy Arm:
Patients assessed and treated by clinicians at sites randomized to our multi-level implementation arm will receive the alcohol use prescreening by the Medical Assistant and will receive the patient-directed nudge developed prior to study launch.
The clinician who they see for their subsequent appointments will receive the clinician nudge also developed prior to study launch.
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The patient nudge will be designed to "prime" the patient to engage with SBIRT for alcohol use and/or discuss the potential benefits of SBIRT for alcohol use with their clinician ahead of their next appointment.
The patient nudge will be delivered through our patient portal (MyPennMedicine) and via text message directly to the patient's cell phone.
The patient nudge will be delivered within 72 hours prior to their medical appointment and will include normalizing language about alcohol use and cancer care with a clear message of endorsement.
The patient nudge will contain a defaulted link to be connected to our SBIRT navigators.
The clinician nudge will be delivered through Epic using the BPA function and will address clinician stated barriers to providing alcohol misuse treatment to patients.
The BPA will have a default for an automated electronic referral so they must toggle to "dismiss" and, if so, an explanation is required.
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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 |
|---|---|---|
|
Primary Outcome
時間枠:12 months
|
The primary outcome is rate of completed or scheduled SBIRT for alcohol misuse.
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12 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 rate of patient and clinician nudge delivery
時間枠:12 months
|
the rate of patient and clinician nudge delivery
|
12 months
|
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The rate of completion of the alcohol misuse pre-screener.
時間枠:12 months
|
The rate of completion of the alcohol misuse pre-screener.
|
12 months
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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。
捜査官
- 主任研究者:Robert A Schnoll, Ph.D.、University of Pennsylvania
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)
2027年10月1日
一次修了 (推定)
2028年8月31日
研究の完了 (推定)
2028年8月31日
試験登録日
最初に提出
2026年8月3日
QC基準を満たした最初の提出物
2026年8月3日
最初の投稿 (実際)
2026年8月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月12日
QC基準を満たした最後の更新が送信されました
2026年8月7日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- UG3CA315306 (その他の助成金/資金番号:NCI)
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
To protect participant identities, only aggregated data by treatment arm will be made available for sharing.
The final cleaned and de-identified dataset will include variables related to: demographics, disease-related information, and SBIRT engagement data.
The rationale for sharing only cleaned data is to foster ease of data reuse.
Only summary variables will be provided for the behavioral data.
Appropriate procedures required by federal and state guidelines regarding protected health information (PHI) and SPHI will be followed, including removal of direct identifiers and any sensitive indirect identifiers, and re-coding of dates and test sites.
Only properly de-identified data will be shared, and the informed consent forms will reflect those plans.
To facilitate the interpretation and reuse of the shared data, a README file and a data dictionary will be generated and deposited into a repository along with the dataset.
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
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