Post-Discharge Smoking Cessation Strategies: Helping HAND 4

NCT03603496 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1416

Last updated 2022-05-05

Study results available
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Summary

This randomized controlled trial will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers admitted to 3 U.S. hospitals.

Conditions

  • Smoking Cessation

Interventions

BEHAVIORAL

Transitional Tobacco Care Management (TTCM)

PTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.

BEHAVIORAL

eReferral to State Tobacco Quitline (QL)

Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.

DRUG

Nicotine replacement therapy

Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.

Sponsors & Collaborators

  • University of Pittsburgh Medical Center

    collaborator OTHER
  • Vanderbilt University Medical Center

    collaborator OTHER
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Nancy A Rigotti, MD · Massachusetts General Hospital

  • Hilary A Tindle, MD, MPH · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2020-11-17
Completion
2020-11-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03603496 on ClinicalTrials.gov