Alcohol Misuse TreatmentNCT07752576
Designing and Evaluating Multi-level Implementation Strategies to Address Alcohol Use Within Oncology Care
A study testing Multi-level Implementation Strategy in people with Alcohol Misuse Treatment and Alcohol Misuse, run by University of Pennsylvania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Misuse Treatment, Alcohol Misuse
- What is being tested?
- Multi-level Implementation Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2027to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over age 18 and diagnosed with cancer
- Receiving care at one of our pilot study sites
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Multi-level Implementation Strategy
- Keywords
- Implementation Reserach, Implementation Science, Alcohol Misuse, Behavioral Economics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-level Implementation StrategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multi-level Implementation Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
The primary outcome is rate of completed or scheduled SBIRT for alcohol misuse.
Measured: 12 months
Secondary outcomes (2)
The rate of completion of the alcohol misuse pre-screener.
The rate of completion of the alcohol misuse pre-screener.
Measured: 12 months
the rate of patient and clinician nudge delivery
the rate of patient and clinician nudge delivery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Oct 2027 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Misuse TreatmentStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Robert Schnoll, University of Pennsylvania
- Investigators
- Robert A Schnoll, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752576
- Sponsor's protocol ID
- UG3CA315306
- Other IDs
- UG3CA315306
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing and Evaluating Multi-level Implementation Strategies to Address Alcohol Use Within Oncology Care
- ClinicalTrials.gov ID
- NCT07752576
- Acronym / sponsor ID
- UG3CA315306
- Conditions
- Alcohol Misuse Treatment, Alcohol Misuse
- Keywords
- Implementation Reserach, Implementation Science, Alcohol Misuse, Behavioral Economics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Oct 2027 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Multi-level Implementation StrategyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over age 18 and diagnosed with cancer
- Receiving care at one of our pilot study sites
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-level Implementation StrategyThe 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. | Behavioural | The Multi-level Implementation Strategy Arm: |
Primary outcome
Primary Outcome
Time frame: 12 months
The primary outcome is rate of completed or scheduled SBIRT for alcohol misuse.
2 secondary outcomes
The rate of completion of the alcohol misuse pre-screener.
Time frame: 12 months
the rate of patient and clinician nudge delivery
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert A Schnoll, Ph.D. principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing Multi-level Implementation Strategy in people with Alcohol Misuse Treatment and Alcohol Misuse, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan B Richards, M.Sc (2157467149, Jonathan.Richards@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.