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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046408
• Other study ID #: 1R01DA034253-01
• Status: Completed
• Phase: N/A
• First received: January 23, 2014
• Last updated: September 5, 2017
• Start date: July 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 961
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Addiction
• Smoking Cessation

Intervention

Other:
• Computer Tablet

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California
United States	UCSF Adult Primary Care Mt. Zion Clinic	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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