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

Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Transitional Tobacco Care Management (TTCM); Drug: Nicotine replacement therapy; Behavioral: eReferral to State Tobacco Quitline (QL)

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.

• Study Type: Interventional
• Enrollment (Actual): 1416
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco Abstinence, Biochemically Confirmed	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.	6 months after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco Abstinence, Self-report	Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).	1 month after hospital discharge
Tobacco Abstinence, Self-report	Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).	3 months after hospital discharge
Tobacco Abstinence, Self-report	Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).	6 months after hospital discharge
Engagement in Cessation Treatment	Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at the 1 month post-discharge assessment.	1 month after hospital discharge
Engagement in Cessation Treatment	Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at 3 month post-discharge assessment	3 months after hospital discharge
Self-reported Continuous Tobacco Abstinence Since Hospital Discharge	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	6 months follow-up

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Vanderbilt University Medical Center; University of Pittsburgh Medical Center
• Investigators: Principal Investigator: Hilary A Tindle, MD, MPH, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Trials. 2020 May 4;21(1):375.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): November 17, 2020
• Study Completion (Actual): November 17, 2020

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Tobacco; Cessation; Hospitalization; Interactive Voice Response; Tobacco Quitline; eReferral
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2017P000774/PHS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No