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Completed

NCT Number: NCT03603496

Post-Discharge Smoking Cessation Strategies: Helping HAND 4

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transitional Tobacco Care Management (TTCM)

Behavioral

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.

eReferral to State Tobacco Quitline (QL)

Behavioral

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.

Nicotine Replacement Therapy

Drug

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

Primary outcomes

  1. Tobacco Abstinence, Biochemically Confirmed

    Time frame: 6 months after hospital discharge

    Participant self-report of no use of any tobacco product (cigarettes, cigars, little cigars, pipes, smokeless tobacco product) in the past 7 days AND either a saliva sample with a cotinine concentration <=10 ng/ml OR breath sample with a carbon monoxide concentration <=9 ppm.

Secondary outcomes

  1. Tobacco Abstinence, Self-report

    Time frame: 1 month after hospital discharge

    Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).

  2. Tobacco Abstinence, Self-report

    Time frame: 3 months after hospital discharge

    Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).

  3. Tobacco Abstinence, Self-report

    Time frame: 6 months after hospital discharge

    Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).

  4. Engagement in Cessation Treatment

    Time frame: 1 month after hospital discharge

    Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at the 1 month post-discharge assessment.

  5. Engagement in Cessation Treatment

    Time frame: 3 months after hospital discharge

    Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at 3 month post-discharge assessment

  6. Self-reported Continuous Tobacco Abstinence Since Hospital Discharge

    Time frame: 6 months follow-up

    Number of participants who self-report having smoked no cigarettes and used no other tobacco products (cigars, little cigars, pipes, smokeless tobacco) since index hospital discharge

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • University of Pittsburgh Medical Center
  • Vanderbilt University Medical Center

Registry information

Official study title

Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers

Acronym: HH4

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2018
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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