Designing and Evaluating Multi-level Implementation Strategies to Address Alcohol Use Within Oncology Care

Обзор

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, we are conducting a pilot-trial with 4 clinics and will be doing interviews with patients and clinicians. We 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; we cannot 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.

Вмешательства

• Поведенческое Multi-level Implementation Strategy
  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 ca

Первичные конечные точки

• Primary Outcome [Срок оценки: 12 months]

Вторичные конечные точки (2)

• the rate of completion of the alcohol misuse pre-screener [Срок оценки: 12 months]
• the rate of patient and clinician nudge delivery [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Over age 18 and diagnosed with cancer
• Receiving care at one of our pilot study sites

Критерии исключения

• None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07752576 · UG3CA315306 · UG3CA315306

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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