Clinical trial NCT02046408: Computer-Facilitated 5A's for Smoking Cessation in Primary Care
Official title: Computer-Facilitated 5A's for Smoking Cessation in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Addiction
Smoking Cessation
Keywords: Smoking
5A's for smoking cessation
tailored health messages
Patient-facing information technology
Mobile health
behavioral health
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 961
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study tests the use of handheld computer tablets to promote the integration of 5A's (Ask, Advise, Assess, Assist, Arrange) for smoking cessation in academic and community primary care clinics. Although most patients receive the "ask" and "advise" steps, only slightly more than half are "assessed" for readiness to change, less than half receive "assistance" in changing, and only 9% have an "arranged" follow-up. While the large majority of primary care providers support the 5A's model, negative attitudes and the lack of time, knowledge, and cessation skills are common obstacles. Alternate service delivery systems that address these obstacles and evidence-based strategies to promote their implementation are needed to improve provider adherence and 5A's fidelity.

Detailed description: This project develops and tests a computer-facilitated 5A's (CF-5A's) model that administers the 5A's intervention to patients then prompts providers for reinforcing next steps. CF-5A's could efficiently and effectively promote smoking cessation while educating providers about cessation resources and appropriate follow-up. Based on the Technology Acceptance Model, clinically tailored strategies to promote CF-5A's implementation will be developed and tested to ensure the appropriate use and uptake of this new service delivery model. Development of the model, materials, and strategies will occur in years 1 and 2.

Baseline data collection occurs in year 2, followed by a randomized trial of CF- 5A's where the provider is the unit of randomization. Provider use of the 5A's will primarily be assessed with a brief phone call to the patient after the primary care visit has occurred.

Although focused on 5A's for smoking cessation, this study examines the underlying implementation science of computer-aided service delivery models with important implications for the integration of other substance use or behavioral health interventions in primary care. Implementation factors will be assessed using qualitative interviews and brief pre-post surveys.

Eligibility criteria: Inclusion Criteria: All primary care providers and clinic staff are eligible to participate. Patients must have

* a primary care appointment
* smoked a cigarette in past 7 days
* smoked at least 100 cigarettes in lifetime
* speak English or Spanish
* be cognitively able to use computer tablet

Exclusion Criteria:

* Moderate to severe cognitive impairment
* Does not speak English or Spanish
* acute intoxication on alcohol or illicit drugs

Primary outcomes:
measure: 5A's Fidelity
timeFrame: Baseline assessment 2013-14; Intervention 2014-2015
Secondary outcomes:
measure: Tablet Usage
timeFrame: 7/2014-7/2015
Other outcomes:
measure: Implementation Factors
timeFrame: July 2013-2015
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Adult Primary Care Mt. Zion Clinic
state: California
Study officials:
affiliation: University of California
name: Jason M Satterfield, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Satterfield JM, Gregorich SE, Kalkhoran S, Lum PJ, Bloome J, Alvarado N, Munoz RF, Vijayaraghavan M. Computer-Facilitated 5A's for Smoking Cessation: A Randomized Trial of Technology to Promote Provider Adherence. Am J Prev Med. 2018 Jul;55(1):35-43. doi: 10.1016/j.amepre.2018.04.009. Epub 2018 Jun 18.