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

NCT07752576 | Not Yet Recruiting

• 1 other identifier: UG3CA315306
• Study Type: interventional
• Target: 265
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alcohol Misuse Treatment; Alcohol Misuse

Keywords

Implementation Reserach; Implementation Science; Alcohol Misuse; Behavioral Economics

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

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

  12 months

Secondary Outcomes (2)

• The rate of completion of the alcohol misuse pre-screener.

  12 months

• the rate of patient and clinician nudge delivery

  12 months

Study Arms (2)

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.

Behavioral: Multi-level Implementation Strategy

Interventions

Multi-level Implementation Strategy BEHAVIORAL

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.

The Multi-level Implementation Strategy Arm:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator

Study Officials

• Robert A Schnoll, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan B Richards, M.Sc

CONTACT

2157467149; Jonathan.Richards@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John H. Glick, MD Professor in Cancer Research Director, Center for Interdisciplinary Research on Nicotine Addiction Department of Psychiatry

Model Details: This is a pilot implementation science project that involves testing a multi-level implementation package compared to usual care for improving engagement in alcohol misuse treatment among cancer patients.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share