NCT02046408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
961

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

3.2 years

First QC Date

January 23, 2014

Last Update Submit

September 5, 2017

Conditions

Nicotine AddictionSmoking Cessation

Keywords

Smoking5A's for smoking cessationtailored health messagesPatient-facing information technologyMobile healthbehavioral health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Tablet Usage

    7/2014-7/2015

Other Outcomes (1)

  • Implementation Factors

    July 2013-2015

Study Arms (2)

Tablet Intervention

EXPERIMENTAL

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

Control

NO 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.

Interventions

Computer TabletOTHER
Tablet Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Moderate to severe cognitive impairment
  • Does not speak English or Spanish
  • acute intoxication on alcohol or illicit drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

UCSF Adult Primary Care Mt. Zion Clinic

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • 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.

    PMID: 29929682DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking CessationSmoking

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Study Officials

  • Jason M Satterfield, PhD

    University of California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 27, 2014

Study Start

July 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 7, 2017

Record last verified: 2017-09

Locations

US(2)