Condition category
Mental and Behavioural Disorders
Date applied
19/08/2013
Date assigned
17/09/2013
Last edited
18/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Since smoking has a deep impact on socioeconomic inequality in illness and death, it is important that vulnerable populations of smokers be targeted with treatment. The US Public Health Service recommends that all patients be asked about their smoking at every visit, and that smokers be given brief advice to quit and referred to treatment. Initiatives to facilitate these practices include the five A’s (i.e., Ask, Advise, Assess, Assist, Arrange) and Ask Advise Refer (AAR). Unfortunately, primary care referrals are low, and most smokers referred fail to enroll. This study evaluated the effectiveness of the Ask Advise Connect (AAC) approach to linking smokers with treatment in a large, safety-net public healthcare system.

Who can participate?
Participants were patients who presented for care at any of the 10 clinics participating in the trial, reported any level of current smoking, and were age 18 or older.

What does the study involve?
AAC was evaluated in 10 community health clinics that are part of the Harris Health System, a large multi-specialty safety-net medical organization with three hospitals, two specialty clinics, 13 community health clinics, and eight school-based clinics. The Harris Health System community health clinics serve nearly 200,000 unique patients over the age of 18 per year, and the majority of patients (90%) are members of racial/ethnic minority groups. Nearly half have annual household incomes below the poverty level and more than 80% qualify for Harris Health System’s charity care program or other insurance programs for the poor (e.g., Medicaid). Their secure electronic health record (EHR) system was in place before the start of this study.
Five community health clinics were randomly allocated to AAC (intervention) and five were randomized to a control condition (AAR). In both AAC and AAR, Licensed Vocational Nurses (LVNs) were trained to assess and record the smoking status of all patients at all visits in the EHR when vital signs were collected. They were also trained to provide all patients reporting current smoking with brief advice to quit consistent with the Guideline. An initial 30-minute training session on how to assess smoking status, deliver brief advice to quit, and connect (in AAC) or refer (in AAR) patients to the Quitline was held at the beginning of the study. The intervention delivered by the Quitline comprised five proactive telephone calls that were delivered over a period of up to 3 months and the total study duration was 19 months.

What were the possible benefits and risks of participating?
Participants were provided with referrals to smoking cessation programs other than the Quitline when desired or appropriate. There were minimal risks associated with this study. It was unlikely that connections and referrals to the Quitline, or counseling provided by the Quitline, would lead to any potential legal, social or psychological problems.

Where is the study run?
This study was a collaboration between the University of Texas MD Anderson Cancer Center, the Harris Health System and the Texas Quitline. Data were collected at the Harris Health System and sent to MD Anderson. Data regarding Quitline treatment enrollment were collected by the Texas Quitline and provided to MD Anderson.

When is the study starting and how long is it expected to run for?
The intervention period for AAC and AAR within each clinic was 18 months. All data were collected between June 2010 and March 2012.

Who is funding the study?
Centers for Disease Control and Prevention (CDC) (USA).

Who is the main contact?
Jennifer Irvin Vidrine, PhD
jirvinvidrine@mdanderson.org

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jennifer Vidrine

ORCID ID

Contact details

Department of Health Disparities Research
University of Texas MD Anderson Cancer Center
1400 Pressler St.
Unit 1440
TX 77030-3906
Houston
77030-3906
United States of America
+1 713 745 2383
jirvinvidrine@mdanderson.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2008-0608

Study information

Scientific title

Dissemination of a smoking Quitline to the underserved: a group-randomized trial

Acronym

Study hypothesis

It was hypothesized that Ask Advise Connect (AAC) would have greater reach than Ask Advise Refer (AAR) because many of the barriers to successful treatment enrollment were eliminated in AAC relative to AAR. It was also hypothesized that the efficacy of AAR would exceed that of AAC because smokers who contacted the Quitline would be more motivated to enroll in cessation treatment. Finally, it was hypothesized that the impact of AAC would greatly exceed the impact of AAR because of its much broader reach.

Further reading: Conceptual paper describing the Ask Advise Connect (AAC) approach: Vidrine JI, Rabius V, Alford MH, Li Y, Wetter DW. Enhancing dissemination of smoking cessation quitlines through T2 translational research: A unique partnership to address disparities in the delivery of effective cessation treatment. J Public Health Manag Pract 16(4):304-308, Jul-Aug, 7/2010.

Ethics approval

The study was originally approved by the MD Anderson IRB on November 7, 2008. It was approved by the Texas Department of State Health Services IRB on March 17, 2009. The protocol was approved by the Harris Health System IRB on November 12, 2009.

Study design

Pair-matched-two-treatment arm group-randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tobacco cessation treatment delivery in primary care

Intervention

Clinics were randomized to AAC (n=5; intervention) or AAR (n=5; control).

Licensed Vocational Nurses (LVNs) were trained to assess and record the smoking status of all patients at all visits in the electronic health record (EHR). Smokers were given brief advice to quit. In AAC, the names and phone numbers of smokers who agreed to be connected were sent electronically to the Texas Quitline daily, and patients were proactively called within 48 hours. In AAR, smokers were offered a Quitline referral card and encouraged to call on their own.

The intervention delivered by the Quitline comprised five proactive telephone calls that were delivered over a period of up to 3 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Impact – was defined as the proportion of identified smokers that enrolled in treatment.

1. Whether or not smokers agreed to be connected (AAC) with or referred (AAR) to the Quitline at the time of the clinic visit
2. Whether or not those individuals enrolled in the treatment program offered by the Quitline.
Quitline counsellors attempted to reach participants within 48 hours of receiving their contact information, and they made five attempts to reach each participant before declaring them unreachable. The time period over which the call attempts were made spanned a period of approximately 2 weeks.

Secondary outcome measures

1. Reach was defined as the number of smokers visiting the clinics that talked with the Quitline / total number of smokers that visited the clinics.
2. Efficacy was defined as the total number of smokers visiting the clinics that enrolled in treatment with the Quitline / total number of smokers visiting the clinics that talked with the Quitline.

Overall trial start date

15/06/2010

Overall trial end date

30/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants were patients who presented for care at any of the 10 participating clinics
2. Reported any level of current smoking
3. Aged 18 or older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6,700

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

15/06/2010

Recruitment end date

30/03/2012

Locations

Countries of recruitment

United States of America

Trial participating centre

Department of Health Disparities Research
Houston
77030-3906
United States of America

Sponsor information

Organisation

Centers for Disease Control and Prevention (CDC) (USA)

Sponsor details

Lucy Picciolo
Grants Management Specialist
CDC
Procurement and Grants Office
Acquisition and Assistance Branch B
2920 Brandywine Road
Suite 3000
MS E-09
GA 30341-4146
Atlanta
30333
United States of America
+1 770 488 2683
lip6@cdc.gov

Sponsor type

Government

Website

http://www.cdc.gov/

Funders

Funder type

Government

Funder name

Centers for Disease Control and Prevention (CDC) (USA) Grant Number R18DP001570

Alternative name(s)

CDC

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24237916

Publication citations

  1. Results

    Vidrine JI, Shete S, Li Y, Cao Y, Alford MH, Galindo-Talton M, Rabius V, Sharp B, Harmonson P, Zbikowski SM, Miles L, Wetter DW, The Ask-Advise-Connect approach for smokers in a safety net healthcare system: a group-randomized trial., Am J Prev Med, 2013, 45, 6, 737-741, doi: 10.1016/j.amepre.2013.07.011.

Additional files

Editorial Notes