Strategies to Connect Patients at Federally Qualified Health Clinics With Evidence Based Tobacco Cessation Treatment
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Current Smoker
- Tobacco Smoking
- Tobacco Use
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To evaluate clinic and patient level interventions with respect to increasing the reach of evidence-based treatment for tobacco use (delivered via the Utah Quitline). II. To evaluate clinic and patient level interventions with respect to increasing the impact of Quitline treat...
PRIMARY OBJECTIVES: I. To evaluate clinic and patient level interventions with respect to increasing the reach of evidence-based treatment for tobacco use (delivered via the Utah Quitline). II. To evaluate clinic and patient level interventions with respect to increasing the impact of Quitline treatment. Impact is defined as Reach X Efficacy. In calculating impact, efficacy is defined as the proportion of smokers who enroll in Quitline delivered treatment that successfully quit. III. To evaluate characteristics of both clinics and patients that may influence tobacco use outcomes. OUTLINE: PHASE I: Clinics are randomized to 1 of 2 groups. GROUP I: Clinics participate in Ask, Advise, Connect-Opt Out (AAC-Out) intervention consisting of an electronic health record (EHR)-based point of care alert that requires clinic staff to Advise and Connect tobacco users to the Utah Quitline, or to "opt out" (i.e. the default requires an action- Advise and Connect, or Opt Out). GROUP II: Clinics participant in Ask, Advise, Connect-Opt in (AAC-In) intervention consisting of an EHR based point of care reminder that allows medical staff to choose when to perform Advise and Connect (i.e. the default does not require a connection). PHASE II: Tobacco users who do not enroll in Quitline treatment in response to AAC-Out or AAC-In, will be individually randomized to one of two groups in a 4:1 ratio (4 to Group 1 for every 1 to Group II): GROUP I: Patients receive a monthly text message (TM) for 6 months following each tobacco user's clinic visit that includes a simple one-touch response to directly connect to the Quitline. Patients receive continued clinic level electronic health record (EHR) intervention following each tobacco user's clinic visit. GROUP II: Patients receive continued clinic level electronic health record (EHR) intervention following each tobacco user's clinic visit. PHASE III: Nonresponders (i.e., did not engage in Quitline treatment at 6 months) in Group 1 of Phase II (i.e., text messaging condition) will be randomized to 1 of 2 groups. GROUP I: Patients continue to receive a monthly text message with a simple one-touch response to directly connect to the Quitline during months 6-12 following each tobacco user's clinic visit GROUP II: Patients receive a monthly text message plus 2 brief telephone calls from patient navigators/health educators for 6-12 months following each tobacco user's clinic visit. After completion of study, patients are followed up at 12 months.
Tracking Information
- NCT #
- NCT03900767
- Collaborators
- National Cancer Institute (NCI)
- Patient-Centered Outcomes Research Institute
- Investigators
- Principal Investigator: David Wetter Huntsman Cancer Institute/ University of Utah