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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03603496
Other study ID # 2017P000774/PHS
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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