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

NCT ID: NCT02046408

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 961 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-09-30

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.

Conditions

Nicotine Addiction; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Computer Tablet

Intervention Type: OTHER

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Computer Tablet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason M Satterfield, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California

Locations

San Francisco General Hospital

San Francisco, California, United States

UCSF Adult Primary Care Mt. Zion Clinic

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29929682 (View on PubMed)

Other Identifiers

1R01DA034253-01

Identifier Type: NIH

Identifier Source: org_study_id

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