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

Primary Purpose

Nicotine Addiction, Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer Tablet
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Nicotine Addiction focused on measuring Smoking, 5A's for smoking cessation, tailored health messages, Patient-facing information technology, Mobile health, behavioral health

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • San Francisco General Hospital
  • UCSF Adult Primary Care Mt. Zion Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tablet Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 23, 2014
Last Updated
September 5, 2017
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02046408
Brief Title
Computer-Facilitated 5A's for Smoking Cessation in Primary Care
Official Title
Computer-Facilitated 5A's for Smoking Cessation in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Addiction, Smoking Cessation
Keywords
Smoking, 5A's for smoking cessation, tailored health messages, Patient-facing information technology, Mobile health, behavioral health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
961 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tablet Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Computer Tablet
Primary Outcome Measure Information:
Title
5A's Fidelity
Description
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.
Time Frame
Baseline assessment 2013-14; Intervention 2014-2015
Secondary Outcome Measure Information:
Title
Tablet Usage
Description
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.
Time Frame
7/2014-7/2015
Other Pre-specified Outcome Measures:
Title
Implementation Factors
Description
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.
Time Frame
July 2013-2015

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Satterfield, PhD
Organizational Affiliation
University of California
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
UCSF Adult Primary Care Mt. Zion Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29929682
Citation
Satterfield JM, Gregorich SE, Kalkhoran S, Lum PJ, Bloome J, Alvarado N, Munoz RF, Vijayaraghavan M. Computer-Facilitated 5A's for Smoking Cessation: A Randomized Trial of Technology to Promote Provider Adherence. Am J Prev Med. 2018 Jul;55(1):35-43. doi: 10.1016/j.amepre.2018.04.009. Epub 2018 Jun 18.
Results Reference
derived

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

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