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NCT Number: NCT07752576

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, 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

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.

Primary outcomes

  1. Primary Outcome

    Time frame: 12 months

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

Secondary outcomes

  1. the rate of completion of the alcohol misuse pre-screener

    Time frame: 12 months

    the rate of completion of the alcohol misuse pre-screener

  2. the rate of patient and clinician nudge delivery

    Time frame: 12 months

    the rate of patient and clinician nudge delivery

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan B Richards, Masters

CONTACT

[email protected]

2157467149

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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