SmokingNCT01359371
Evaluation of Peer Telephone Cessation Counseling for Smokers
An observational study of Smoking, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Peer telephone cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Mar 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatient veterans at the Ann Arbor VA
Who may be able to join
- The inclusion criteria: veterans who received the Tobacco Tactics intervention as an inpatient in the hospital.
Who cannot join
- The exclusion criteria: veterans who are too ill or impaired to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Peer telephone cessation counseling
- Keywords
- Smoking Cessation, Telephone, Hospital Volunteers
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer telephone cessation counselingBehavioural
Also called Tobacco Tactics
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Peer telephone cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7-day point prevalence self-reported smoking quit rate 60 days after discharge
Secondary outcomes (3)
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.
Measured: 60 days after discharge
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.
Measured: 60 days after discharge
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.
Measured: 60 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startJun 2012
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sonia A. Duffy, PhD MS RN, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359371
- Sponsor's protocol ID
- RRP 11-020
- Status last verified
- Oct 2020
- First submitted
- 20 May 2011
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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 5;13(1):4. doi: 10.1186/s12971-015-0028-9. eCollection 2015.
PubMed 25674045
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peer Telephone Cessation Counseling for Smokers
- ClinicalTrials.gov ID
- NCT01359371
- Acronym / sponsor ID
- RRP 11-020
- Conditions
- Smoking
- Keywords
- Smoking Cessation, Telephone, Hospital Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Posted 1 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer telephone cessation counseling | – | Behavioral: Peer telephone cessation counselingThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient veterans at the Ann Arbor VA
Key inclusion criteria (1 listed)
- The inclusion criteria: veterans who received the Tobacco Tactics intervention as an inpatient in the hospital.
Key exclusion criteria (1 listed)
- The exclusion criteria: veterans who are too ill or impaired to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer telephone cessation counselingAlso: Tobacco TacticsFor 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. | Behavioural | Peer telephone cessation counseling |
Primary outcome
Smoking Quit Rate by Number of Calls Received
Time frame: 7-day point prevalence self-reported smoking quit rate 60 days after discharge
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.
3 secondary outcomes
Characteristics of Participants Stratified by High vs. Low Participation 60 Days Post Discharge
Time frame: 60 days after discharge
Participants' Attitudes About the Implementation of the Telephone Counseling
Time frame: 60 days after discharge
Cost Per Quit of Volunteer Peer Telephone Counseling
Time frame: 60 days after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25674045Duffy 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 5;13(1):4. doi: 10.1186/s12971-015-0028-9. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia A. Duffy, PhD MS RN principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Quit Rate by Number of Calls Received (time frame: 7-day point prevalence self-reported smoking quit rate 60 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01359371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.