Clinical trial NCT03603496: Post-Discharge Smoking Cessation Strategies: Helping HAND 4
Official title: Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: Tobacco
Cessation
Hospitalization
eReferral
Interactive Voice Response
Tobacco Quitline
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
name: Vanderbilt University Medical Center
First posted: 2018-07-27
Enrollment: 1416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This multi-site randomized controlled trial (RCT) will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers who are admitted to 3 large hospital systems in 3 U.S. regions (MA, PA, TN). All patients will receive guideline-based tobacco cessation treatment delivered in hospital by each site's existing Tobacco Treatment Service that is directed by a study investigator. Patients who plan to quit smoking after hospital discharge will be randomly assigned to 1 of 2 post-discharge tobacco treatment interventions and followed at 1, 3, and 6 months. One arm uses bidirectional electronic referral (eReferral) to the state tobacco quitline. The other arm, Personalized Tobacco Care Management (PTCM), combines proactive messages delivered by automated interactive voice response (IVR) phone calls, text messaging, and/or email with health coaching provided by a hospital-based tobacco counselor. Both groups will receive at least 1 month of nicotine replacement therapy.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Current cigarette smoker (\>=1 cigarette in the week before admission and \>=1 cigarette/day when smoking at a baseline rate in the month prior to admission)
* Admitted to a study hospital
* Seen by hospital smoking counselor during inpatient stay
* Plans to try to quit smoking after hospital discharge

Exclusion Criteria:

* Inability to give informed consent or participate in counseling due to serious cognitive or psychiatric disorder (e.g., dementia, psychosis)
* Life expectancy \<12 months
* Medical instability
* No reliable telephone access or inability to use telephone
* Non-English speaking
* Pregnant, breastfeeding, to planning to become pregnant in the next 6 months.

Primary outcomes:
measure: Tobacco Abstinence, Biochemically Confirmed
timeFrame: 6 months after hospital discharge
Secondary outcomes:
measure: Tobacco Abstinence, Self-report
timeFrame: 1 month after hospital discharge
measure: Tobacco Abstinence, Self-report
timeFrame: 3 months after hospital discharge
measure: Tobacco Abstinence, Self-report
timeFrame: 6 months after hospital discharge
measure: Engagement in Cessation Treatment
timeFrame: 1 month after hospital discharge
measure: Engagement in Cessation Treatment
timeFrame: 3 months after hospital discharge
measure: Self-reported Continuous Tobacco Abstinence Since Hospital Discharge
timeFrame: 6 months follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy A Rigotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Hilary A Tindle, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rigotti NA, Chang Y, Davis EM, Regan S, Levy DE, Ylioja T, Kelley JHK, Notier AE, Gilliam K, Douaihy AB, Singer DE, Tindle HA. Comparative Effectiveness of Postdischarge Smoking Cessation Interventions for Hospital Patients: The Helping HAND 4 Randomized Clinical Trial. JAMA Intern Med. 2022 Aug 1;182(8):814-824. doi: 10.1001/jamainternmed.2022.2300.
citation: Rigotti NA, Schnitzer K, Davis EM, Regan S, Chang Y, Kelley JHK, Notier AE, Gilliam K, Douaihy A, Levy DE, Singer DE, Tindle HA. Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial. Trials. 2020 Apr 16;21(1):336. doi: 10.1186/s13063-020-04257-7.