Post-Discharge Smoking Cessation Strategies: Helping HAND 4

NCT03603496 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2017P000774/PHS
• Study Type: interventional
• Target: 1,416
• Locations: 1 country
• Sites: 3

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.

Conditions

Smoking Cessation

Keywords

Tobacco; Cessation; Hospitalization; eReferral; Interactive Voice Response; Tobacco Quitline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Tobacco Abstinence, Self-report

  1 month after hospital discharge

• Tobacco Abstinence, Self-report

  3 months after hospital discharge

• Tobacco Abstinence, Self-report

  6 months after hospital discharge

• Engagement in Cessation Treatment

  1 month after hospital discharge

• Engagement in Cessation Treatment

  3 months after hospital discharge

Study Arms (2)

Transitional Tobacco Care Management (TTCM)

EXPERIMENTAL

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); Drug: Nicotine replacement therapy

eReferral to State Tobacco Quitline (QL)

ACTIVE COMPARATOR

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); Drug: Nicotine replacement therapy

Interventions

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.

Transitional Tobacco Care Management (TTCM)

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.

eReferral to State Tobacco Quitline (QL)

Nicotine replacement therapy DRUG

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

Transitional Tobacco Care Management (TTCM); eReferral to State Tobacco Quitline (QL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Pittsburgh Medical Center: collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (3)

• Lee SS, Chang Y, Rigotti NA, Singer DE, Levy DE, Tyndale RF, Davis EM, Freiberg MS, King S, Wells QS, Tindle HA. Can Treatment Support Mitigate Nicotine Metabolism-Based Disparities in Smoking Abstinence? Secondary Analysis of the Helping HAND 4 Trial. Nicotine Tob Res. 2023 Aug 19;25(9):1575-1584. doi: 10.1093/ntr/ntad079.

  PMID: 37209421 DERIVED

• 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.

  PMID: 35759282 DERIVED

• 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.

  PMID: 32299470 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Nancy Rigotti, MD
• Organization: Massachusetts General Hospital

nrigotti@partners.org

617-724-3548

Study Officials

• Nancy A Rigotti, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Hilary A Tindle, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 27, 2018
• Study Start: September 1, 2018
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: May 5, 2022
• Results First Posted: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)