Connection to Health for Smokers (CTHS)

• ClinicalTrials.gov Identifier: NCT03680599
• Recruitment Status: Completed
• First Posted: September 21, 2018
• Last Update Posted: April 1, 2020
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Tobacco Use	Behavioral: Connection to Health for Smokers; Behavioral: Enhanced Standard of Care	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 123 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Connection to Health for Smokers -- A Comprehensive Program to Reduce Tobacco-Related Health Disparities in CHCs
• Actual Study Start Date: January 3, 2019
• Actual Primary Completion Date: March 31, 2020
• Actual Study Completion Date: March 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Connection to Health for Smokers; 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.	Behavioral: Connection to Health for Smokers; Connection to Health for Smokers includes 5 core components supported by online tools: (1) comprehensive electronic patient survey, (2) automated summary report to flag areas of difficulty (3) interactive priority setting, (4) interactive action planning, and (5) electronic text reminders and followup.
Active Comparator: Enhanced Standard of Care; 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.	Behavioral: Enhanced Standard of Care; Participants will complete a survey and receive standard one-on-one smoking cessation according to a usual care protocol delivered by health educators

Outcome Measures

Primary Outcome Measures :

1. Program Reach, Effectiveness, Adoption, Implementation, and Maintenance [ Time Frame: 3 months ]
   The RE-AIM Framework will be used to assess program feasibility

Secondary Outcome Measures :

1. 7-day smoking abstinence [ Time Frame: 3 months ]
   Not smoking cigarettes (not even a puff) in the last 7 days

Eligibility Criteria

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

Criteria

Inclusion Criteria:

- Must have smoked cigarettes in the last 7 days

Exclusion Criteria:

- Speaking languages other than English or Spanish

Contacts and Locations

Locations

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Michael Potter, M.D.; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03680599
• Other Study ID Numbers: 27IP-0024
• First Posted: September 21, 2018
• Last Update Posted: April 1, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No