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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07752576
Enrollment
265
Registered
2026-08-07
Start date
2027-10-01
Completion date
2028-08-31
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Misuse, Alcohol Misuse Treatment

Keywords

Implementation Reserach, Implementation Science, Alcohol Misuse, Behavioral Economics

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.

Interventions

BEHAVIORALMulti-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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome12 monthsThe primary outcome is rate of completed or scheduled SBIRT for alcohol misuse.

Secondary

MeasureTime frameDescription
The rate of completion of the alcohol misuse pre-screener.12 monthsThe rate of completion of the alcohol misuse pre-screener.
the rate of patient and clinician nudge delivery12 monthsthe rate of patient and clinician nudge delivery

Contacts

CONTACTJonathan B Richards, M.Sc
Jonathan.Richards@pennmedicine.upenn.edu2157467149
PRINCIPAL_INVESTIGATORRobert A Schnoll, Ph.D.

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026