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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02046408
First Posted: January 27, 2014
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  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 Other: Computer Tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
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 ]
    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 ]
    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 ]
    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.


Enrollment: 961
Study Start Date: July 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046408


Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
UCSF Adult Primary Care Mt. Zion Clinic
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jason M Satterfield, PhD University of California
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02046408     History of Changes
Other Study ID Numbers: 1R01DA034253-01 ( U.S. NIH Grant/Contract )
First Submitted: January 23, 2014
First Posted: January 27, 2014
Last Update Posted: September 7, 2017
Last Verified: September 2017

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