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Phase 4 Completed N=1,409 Randomized Single-blind Treatment

Post-Discharge Smoking Cessation Strategies: Helping HAND 4

Source: ClinicalTrials.gov NCT03603496 ↗
Enrolled (actual)
1,409
Serious AEs
Results posted
May 2022
Primary outcomePrimary: Tobacco Abstinence, Biochemically Confirmed — 110; 96 Participants — p=.19
◆ Published Evidence
Established
24citations · ~6 / year
Comparative Effectiveness of Postdischarge Smoking Cessation Interventions for Hospital Patients: The Helping HAND 4 Randomized Clinical Trial.
JAMA internal medicine · 2022 · Open access · Likely link

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.

Linked Publications (3)

  • Comparative Effectiveness of Postdischarge Smoking Cessation Interventions for Hospital Patients: The Helping HAND 4 Randomized Clinical Trial.
    JAMA internal medicine · 2022 · 24 citations · Open access · Likely link
  • Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial.
    Trials · 2020 · 14 citations · Open access · Likely link
  • Can Treatment Support Mitigate Nicotine Metabolism-Based Disparities in Smoking Abstinence? Secondary Analysis of the Helping HAND 4 Trial.
    Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2023 · 5 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Tobacco Abstinence, Biochemically Confirmed
110; 96 .19
SECONDARY
Tobacco Abstinence, Self-report
234; 202 .079
SECONDARY
Engagement in Cessation Treatment
434; 319 <.0001 sig
SECONDARY
Self-reported Continuous Tobacco Abstinence Since Hospital Discharge
120; 91 .033 sig

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03603496) and the linked publication. 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. Informational only — not medical advice.

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