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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02046408
First received: January 23, 2014
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Nicotine Addiction
Smoking Cessation
Implementation of Information Technology in Medical Clinics
Provider Adherence to Guidelines
Other: Computer Tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
Official Title: Computer-Facilitated 5A's for Smoking Cessation in Primary Care

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 5A's Fidelity [ Time Frame: Baseline assessment 2013-14; Intervention 2014-2015 ] [ Designated as safety issue: No ]
    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:
  • Tablet Usage [ Time Frame: 7/2014-7/2015 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Implementation Factors [ Time Frame: July 2013-2015 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1500
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02046408

Contacts
Contact: Jason Satterfield, PhD 415-353-2104

Locations
United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Soraya Azari, MD    415-206-2372    soraya.azari@ucsf.edu   
Contact: Paula Lum, MD    415-476-4082 ext 411    plum@php.ucsf.edu   
UCSF Adult Primary Care Mt. Zion Clinic Recruiting
San Francisco, California, United States, 94115
Contact: Jason Satterfield, PhD    415-353-2104    jsatter@medicine.ucsf.edu   
Sub-Investigator: Ralph Gonzales, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jason M Satterfield, PhD University of California
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02046408     History of Changes
Other Study ID Numbers: 1R01DA034253-01
Study First Received: January 23, 2014
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Smoking
5A's for smoking cessation
tailored health messages
Patient-facing information technology
Mobile health
behavioral health

ClinicalTrials.gov processed this record on October 23, 2014