Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02046408
Other study ID # 1R01DA034253-01
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04617444 - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function N/A
Completed NCT02796391 - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes Phase 2
Completed NCT03397511 - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City N/A
Not yet recruiting NCT05188287 - A Culturally Tailored Smartphone Application for African American Smokers N/A
Recruiting NCT05264428 - The Effect of Honey on Lessening the Withdrawal Symptoms N/A
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT04133064 - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study N/A
Completed NCT03187730 - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants Phase 4
Completed NCT03474783 - To Explore the Factors Affecting the Effectiveness of Smoking Cessation N/A
Completed NCT04635358 - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center N/A
Terminated NCT03670264 - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation N/A
Not yet recruiting NCT06307496 - VIDeOS for Smoking Cessation N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02905656 - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit N/A
Completed NCT02997657 - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial N/A
Completed NCT02562521 - A Smoking Cessation Intervention for Yale Dining Employees Phase 4
Completed NCT02239770 - Pharmacokinetics of Nicotine Film in Smokers N/A
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A