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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Misuse; Alcohol Misuse Treatment
• Intervention / Treatment: Behavioral: Multi-level Implementation Strategy

• Study Type: Interventional
• Enrollment (Estimated): 265
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan B Richards, M.Sc; Phone Number: 2157467149; Email: Jonathan.Richards@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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).
Experimental: 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.	Behavioral: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	The primary outcome is rate of completed or scheduled SBIRT for alcohol misuse.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of patient and clinician nudge delivery	the rate of patient and clinician nudge delivery	12 months
The rate of completion of the alcohol misuse pre-screener.	The rate of completion of the alcohol misuse pre-screener.	12 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Robert A Schnoll, Ph.D., University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: August 3, 2026
• First Submitted That Met QC Criteria: August 3, 2026
• First Posted (Actual): August 7, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Implementation Science; Behavioral Economics; Alcohol Misuse; Implementation Reserach
• Other Study ID Numbers: UG3CA315306 (Other Grant/Funding Number: NCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No