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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Nicotine Addiction
• Intervention / Treatment: Other: Computer Tablet

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 Type: Interventional
• Enrollment (Actual): 961
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • San Francisco General Hospital
    • San Francisco, California, United States, 94115
      • UCSF Adult Primary Care Mt. Zion Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tablet Intervention; 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.	Other: Computer Tablet
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5A's Fidelity	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.	Baseline assessment 2013-14; Intervention 2014-2015

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tablet Usage	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.	7/2014-7/2015

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation Factors	Qualitative interview data to assess the utility of the "Technology Acceptance Model" in explaining tablet and 5A's usage. Variables assessed include perceived usefulness, social norms and influence, and facilitating conditions.	July 2013-2015

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Jason M Satterfield, PhD, University of California

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: January 23, 2014
• First Posted (Estimate): January 27, 2014

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Smoking; Mobile health; 5A's for smoking cessation; tailored health messages; Patient-facing information technology; behavioral health
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 1R01DA034253-01 (U.S. NIH Grant/Contract)