We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-Discharge Smoking Cessation Strategies: Helping HAND 4 (HH4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03603496
Recruitment Status : Completed
First Posted : July 27, 2018
Results First Posted : May 5, 2022
Last Update Posted : May 5, 2022
Sponsor:
Collaborators:
University of Pittsburgh Medical Center
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Nancy A. Rigotti, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Transitional Tobacco Care Management (TTCM) Behavioral: eReferral to State Tobacco Quitline (QL) Drug: Nicotine replacement therapy Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : November 17, 2020
Actual Study Completion Date : November 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking

Arm Intervention/treatment
Experimental: Transitional Tobacco Care Management (TTCM)
TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.
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.

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

Active Comparator: 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. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603496


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Massachusetts General Hospital
University of Pittsburgh Medical Center
Vanderbilt University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital
Principal Investigator: Hilary A Tindle, MD, MPH Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Nancy A. Rigotti, Massachusetts General Hospital:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nancy A. Rigotti, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03603496    
Other Study ID Numbers: 2017P000774/PHS
First Posted: July 27, 2018    Key Record Dates
Results First Posted: May 5, 2022
Last Update Posted: May 5, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nancy A. Rigotti, Massachusetts General Hospital:
Tobacco
Cessation
Hospitalization
eReferral
Interactive Voice Response
Tobacco Quitline
Additional relevant MeSH terms:
Layout table for MeSH terms
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action