Phase 4
N=1,409
Post-Discharge Smoking Cessation Strategies: Helping HAND 4
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT03603496 ↗Enrolled (actual)
1,409
Serious AEs
—
Results posted
May 2022
Primary outcome: Primary: Tobacco Abstinence, Biochemically Confirmed — 110; 96 Participants — p=.19
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Transitional Tobacco Care Management (TTCM) (Behavioral); eReferral to State Tobacco Quitline (QL) (Behavioral); Nicotine replacement therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tobacco Abstinence, Biochemically Confirmed |
110; 96 | .19 |
| SECONDARY Tobacco Abstinence, Self-report |
234; 202 | .079 |
| SECONDARY Tobacco Abstinence, Self-report |
234; 202 | .079 |
| SECONDARY Tobacco Abstinence, Self-report |
234; 202 | .079 |
| SECONDARY Engagement in Cessation Treatment |
434; 319 | <.0001 sig |
| SECONDARY Engagement in Cessation Treatment |
434; 319 | <.0001 sig |
| SECONDARY Self-reported Continuous Tobacco Abstinence Since Hospital Discharge |
120; 91 | .033 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03603496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.