Post-Discharge Smoking Cessation Strategies: Helping HAND 4

Smoking Cessation Clinical Trial

— HH4  

Official title:

Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603496
• Other study ID #: 2017P000774/PHS
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2018
• Est. completion date: November 17, 2020

Study information

• Verified date: May 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1416
• Est. completion date: November 17, 2020
• Est. primary completion date: November 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	University of Pittsburgh Medical Center, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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