Computer-Facilitated 5A's for Smoking Cessation in Primary Care

Not Applicable

Completed

• Conditions: Nicotine Addiction; Smoking Cessation
• Interventions: Other: Computer Tablet

• Registration Number: NCT02046408
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 961

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tablet Intervention	Computer Tablet	Primary care providers will be randomized into intervention or control conditions. The patients of intervention providers will be given a computer tablet that provides 5A's for smoking cessation counseling. Patients of control providers will not receive a tablet intervention.

Primary Outcome Measures

Name	Time	Method
5A's Fidelity	Baseline assessment 2013-14; Intervention 2014-2015	Baseline and post-tablet intervention assessments of primary care provider adherence to 5A's protocol for smoking cessation. Patients are called after their primary care appointment and asked a series of questions to determine if (and which of) the 5A's were used during that visit.

Secondary Outcome Measures

Name	Time	Method
Tablet Usage	7/2014-7/2015	Intervention includes system strategies to improve usage of computer tablets in primary care waiting rooms. Outcome = tablet saturation or proportion of patients given a tablet.

Trial Locations

Locations (2)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States

UCSF Adult Primary Care Mt. Zion Clinic; 🇺🇸 San Francisco, California, United States