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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT05852860
Status
Enrolling By Invitation

Conditions

  • HIV
  • Nicotine Dependence
  • Smoking
  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
May 10, 2023
Start date
Dec 1, 2023
Status verified
Aug 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • No Intervention: Usual Care
    Clinicians and patients will receive no further interventions beyond usual practice.
  • Experimental: Clinician Nudge
    Clinicians will receive a nudge via a Best Practice Alert within the electronic medical record.
  • Experimental: Patient Nudge
    Patients will receive a message sent through the patient portal or via text.
  • Experimental: Combined Nudge: Clinician and Patient Nudge
    Both the clinician nudge and the patient nudge will be used.

Primary Outcome Measure

Rate of referral to tobacco treatment [ Time Frame: through study completion, up to one year ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

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HIV
By specialty
Infectious disease
By research site
University of Pennsylvania· Philadelphia, PA

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