NCT Number: NCT02046408
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
San Francisco General Hospital, San Francisco, California, United States
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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 outcomes
-
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 outcomes
-
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.
Sponsors and collaborators
Lead sponsor
University of California, San Francisco
Other
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jan 27, 2014
- Registry last updated
- Sep 7, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Circuitry-Guided Smoking Cessation in Schizophrenia
NCT03281629
Behavior, Chemically-Induced Disorders
Baltimore, Maryland, United States
View Trial DetailsExtinction Updating in Reconsolidation
NCT02154685
Behavior, Behavior, Addictive
Charleston, South Carolina, United States
View Trial DetailsEvaluation of a Smoking Cessation Program for Long-Term Abstinence
NCT06746025
Behavior, Behavior, Addictive
Naples, Florida, United States
View Trial DetailsFactors Sustaining Tobacco Abstinence in Cancer Patients Treated With Radio-chemotherapy or Radiotherapy
NCT06910566
Behavior, Chemically-Induced Disorders
Lille, France
View Trial Details