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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01359371
Other study ID # RRP 11-020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2012
Est. completion date March 2013

Study information

Verified date October 2020
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the peer telephone cessation counseling that has been and continues to be implemented at the Ann Arbor VA as part of the Tobacco Tactics intervention.


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.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date March 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Peer telephone cessation counseling
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.

Locations

Country Name City State
United States VA Ann Arbor Healthcare System, Ann Arbor, MI Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Duffy SA, Ewing LA, Louzon SA, Ronis DL, Jordan N, Harrod M. Evaluation and costs of volunteer telephone cessation follow-up counseling for Veteran smokers discharged from inpatient units: a quasi-experimental, mixed methods study. Tob Induc Dis. 2015 Feb — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking Quit Rate by Number of Calls Received 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. 7-day point prevalence self-reported smoking quit rate 60 days after discharge
Secondary Characteristics of Participants Stratified by High vs. Low Participation 60 Days Post Discharge 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. 60 days after discharge
Secondary Participants' Attitudes About the Implementation of the Telephone Counseling Thirty-minute qualitative telephone interviews were conducted with Veteran smokers that participated in the volunteer peer telephone cessation counseling. 60 days after discharge
Secondary Cost Per Quit of Volunteer Peer Telephone Counseling 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. 60 days after discharge
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