A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research

NCT05852860 | Active Not Recruiting DMC

• 3 other identifiers: UPCC 01023K24DA045244852850
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to evaluate the effectiveness of "nudges" to clinicians, patients, or both in increasing referral to, and engagement with, tobacco use treatment services (TUTS) for HIV patients versus usual care. This will be a four-arm pragmatic cluster randomized clinical trial. The investigators hypothesize that each of the implementation strategy arms will significantly increase TUTS referral and engagement compared to usual care and that the combination of nudges to clinicians and to patients will be the most effective.

Conditions

HIV; Smoking; Tobacco Use; Nicotine Dependence

Keywords

Smoking; HIV; Tobacco Use; Nicotine Dependence; Tobacco Use Treatment Service; Behavioral Economics

Outcome Measures

Primary Outcomes (2)

• Rate of referral to tobacco treatment

  Defined as the number of TUTS orders signed in the electronic medical record, divided by the total number of pended orders

  through study completion, up to one year

• Rate of engagement in tobacco treatment

  Defined as the total number of patients who enroll in a tobacco treatment trial, complete at least one session with a tobacco treatment specialist from the investigators' cessation program, or use a tobacco medication divided by the total number of patients

  through study completion, up to one year

Study Arms (4)

Usual Care

NO INTERVENTION

Clinicians and patients will receive no further interventions beyond usual practice.

Clinician Nudge

EXPERIMENTAL

Clinicians will receive a nudge via a Best Practice Alert within the electronic medical record.

Other: Clinician Nudge

Patient Nudge

EXPERIMENTAL

Patients will receive a message sent through the patient portal or via text.

Other: Patient Nudge

Combined Nudge: Clinician and Patient Nudge

EXPERIMENTAL

Both the clinician nudge and the patient nudge will be used.

Other: Clinician Nudge; Other: Patient Nudge

Interventions

Clinician Nudge OTHER

The clinician nudge will use the BPA functionality within the electronic medical record to deliver a message with a defaulted option to refer to the health system's tobacco treatment program. Changing the default to "no referral" will require an explanation using the options provided or by entering free text.

Clinician Nudge; Combined Nudge: Clinician and Patient Nudge

Patient Nudge OTHER

The patient nudge will deliver a message within 72 hours of a patient's next scheduled clinic visit. The message will be delivered through the Penn patient portal (MyPennMedicine) or by text with security measures for privacy.

Combined Nudge: Clinician and Patient Nudge; Patient Nudge

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinician participants must meet the following criteria for enrollment:
• Penn Division of Infectious Disease
• Prescribing authority in Pennsylvania (i.e., physician, nurse practitioner, physician assistant)
• Clinical oversight of HIV patients for the past six months
• English-speaking (messages will be in English)
• Patient participants must be diagnosed with HIV and report current tobacco smoking (self-report daily smoking for last 6 months)

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 10, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

US (1)