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临床试验/NCT07752576
NCT07752576尚未招募不适用

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

University of Pennsylvania0 个研究点目标入组 265 人开始时间: 2027年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
265
主要终点
Primary Outcome

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

The Usual Care Arm

No Intervention

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).

The Multi-level Implementation Strategy Arm:

Experimental

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.

干预措施: Multi-level Implementation Strategy (Behavioral)

结局指标

主要结局

Primary Outcome

时间窗: 12 months

The primary outcome is rate of completed or scheduled SBIRT for alcohol misuse.

次要结局

  • the rate of completion of the alcohol misuse pre-screener(12 months)
  • the rate of patient and clinician nudge delivery(12 months)
  • The rate of completion of the alcohol misuse pre-screener.(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Schnoll

John H. Glick, MD Professor in Cancer Research Director, Center for Interdisciplinary Research on Nicotine Addiction Department of Psychiatry

University of Pennsylvania

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