- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01359371
Evaluation of Peer Telephone Cessation Counseling for Smokers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: As part of the nurse-administered Tobacco Tactics intervention, we developed a novel program to train veterans from Voluntary Services to provide peer telephone cessation counseling calls.
Objectives: The objective of this study is to conduct an in-depth evaluation of the volunteer peer telephone cessation counseling that has been implemented and continues to be implemented at the Ann Arbor Veterans Affairs (VA) hospital as part of the inpatient Tobacco Tactics intervention.
Methods: Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, this quasi-experimental study will collect both quantitative and qualitative data to evaluate the peer telephone cessation counseling component of the Tobacco Tactics intervention. The Reach of the program will be evaluated by determining differences in the demographics, health characteristics, and smoking characteristics of those who do and do not participate in the peer telephone cessation counseling. The Effectiveness of the program will be evaluated by determining if there were differences in quit rates between those that do and do not participate in the peer telephone cessation counseling. The Adoption and Implementation of the program will be evaluated by determining the satisfaction with the counseling, reasons for nonparticipation, the type and quality of counseling actually provided, and barriers and facilitators to implementing the counseling as perceived by staff. The Maintenance of the program will be evaluated by determining the estimated costs of implementing the peer telephone cessation counseling.
Impact: The Tobacco Use/Smoking Cessation goal of the VA Substance Use Disorders (SUD) Quality Enhancement Research Initiative (QUERI) is to develop, implement and evaluate cost-effective interventions for increasing access to and use of evidence-based smoking cessation treatment. Telephone counseling has been shown to be efficacious and teaching volunteer veterans to provide this service is an option that is likely to be cost effective. Hence, evaluating the peer cessation telephone counseling program at the Ann Arbor VA will provide valuable information as to whether or not the program is a viable option for wider scale dissemination.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The inclusion criteria: veterans who received the Tobacco Tactics intervention as an inpatient in the hospital.
Exclusion Criteria:
- The exclusion criteria: veterans who are too ill or impaired to consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Peer telephone cessation counseling
The cohort is 131 veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital follow up volunteer peer telephone cessation counseling
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For Veterans who received the inpatient Tobacco Tactics intervention, trained volunteers initiated follow-up telephone cessation counseling at 2, 14, 21 and 60 days after in-patient discharge; three attempts were made per time point.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking Quit Rate by Number of Calls Received
Time Frame: 7-day point prevalence self-reported smoking quit rate 60 days after discharge
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Smoking status around 60-days post-discharge (range 1 month to 5 months) was collected from electronic medical record text fields (smoked in the past 7 days-yes/no) or 60-day volunteer documentation (smoked in the last 24 hours-yes/no).
When smoking status data was missing, participants were considered to be a smoker.
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7-day point prevalence self-reported smoking quit rate 60 days after discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characteristics of Participants Stratified by High vs. Low Participation 60 Days Post Discharge
Time Frame: 60 days after discharge
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Demographics and health characteristics of those who had high participation (2-4 contacts) versus low (0 to 1 contacts) in the telephone counseling program (Reach) Row totals may vary due to missing data.
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60 days after discharge
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Participants' Attitudes About the Implementation of the Telephone Counseling
Time Frame: 60 days after discharge
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Thirty-minute qualitative telephone interviews were conducted with Veteran smokers that participated in the volunteer peer telephone cessation counseling.
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60 days after discharge
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Cost Per Quit of Volunteer Peer Telephone Counseling
Time Frame: 60 days after discharge
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The primary cost component of the intervention is the cost of labor by providers to train the volunteers and enter volunteer documentation into the electronic medical record.
These costs were estimated using VA salary and fringe benefit information obtained from the Financial Management System (FMS).
Number of hours spent by the volunteers providing telephone counseling was also tracked.
Other intervention costs included nominal supplies associated with training and the intervention.
Because the volunteers made their telephone calls in an unused office, the cost of space was not included.
Recruitment and other research-related costs were excluded.
The average cost per quit is a mean, but is reported here as a number, as no measures of dispersion were available.
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60 days after discharge
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Collaborators and Investigators
Investigators
- Principal Investigator: Sonia A. Duffy, PhD MS RN, VA Ann Arbor Healthcare System, Ann Arbor, MI
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RRP 11-020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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