Connection to Health for Smokers (CTHS)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Tobacco Use

Treatments: Behavioral: Enhanced Standard of Care; Behavioral: Connection to Health for Smokers

Study type: Interventional

Funder types: Other

Identifiers

NCT03680599

27IP-0024

Details and patient eligibility

About

The goal of the study is to develop and test Connection to Health for Smokers (CTHS), a comprehensive program to support smokers to quit and improve smokers' general health. The program will be designed for implementation by health educators in community health centers.

Full description

The investigators will use a participatory approach to develop and test the feasibility and acceptability of CTHS in community health center sites in Contra Costa County. Development of the program will be informed by active engagement with a patient advisory group composed of current smokers and clinical team members who serve current smokers in community health centers. Feasibility and acceptability will be assessed by implementing the CTHS program for patients in 3 clinical sites, using the RE-AIM evaluation framework. Primary outcomes will include the number and proportion of enrolled smokers who create at least one health-related action plan with a health educator, and stated intention of clinical teams to continue using CTHS after the research. The investigators will enroll 90 smokers in CTHS and 90 additional smokers in Enhanced Standard of Care (ESC) which will be the active comparison group. Participants will be randomly assigned. Smoking status will be reassessed after 3 months. Primary outcomes will include number of 24-hour quit attempts, and 7-day smoking abstinence, as well as changes in self-efficacy and readiness to quit smoking among participants who do not quit. Results of this pilot program will inform further development of the CTHS program for testing in larger scale clinical trials.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have smoked cigarettes in the last 7 days

Exclusion criteria

• Speaking languages other than English or Spanish

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Connection to Health for Smokers

Experimental group

Description:

Participants in this arm will participate in the Connection to Health for Smokers Arm of the study, wherein an electronic survey will be administered and participants will be guided through an evidence-based action planning sequence, taking into account each patient's unique social environment, health related behaviors, and behavioral health status, with multimodal follow up.

Treatment:

Behavioral: Connection to Health for Smokers

Enhanced Standard of Care

Active Comparator group

Description:

Participants in this arm will participate in Enhanced Standard Care, wherein participants will receive a brief electronic survey and receive standard smoking cessation program that does not include formal action planning and multimodal follow up.

Treatment:

Behavioral: Enhanced Standard of Care