SmokingTeleQuit MHNCT00724308
Telephone Care Coordination for Smokers in VA Mental Health Clinics
A study testing Telephone Care Coordination and Telephone Care Coordination with state Quitline in people with 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 whether a smoking cessation telephone care coordination program is effective and feasible in VA Mental Health Clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Telephone Care Coordination and Telephone Care Coordination with state Quitline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 577 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2013
- Phase
- Interventional
- 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
Who may be able to join
- Smokers who are referred from Mental Health Clinics in VA VISNs 1 and 3.
- Patients must have access to a telephone and a regular mailing address.
Who cannot join
- No access to a telephone
- no mailing address
- not receiving care from a VISN 1 or VISN 3 Mental Health provider
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010
About this study
Official title: Telephone Care Coordination for Smokers in Mental Health Clinics
The purpose of this study is to evaluate whether a smoking cessation telephone care coordination program is effective and feasible in VA Mental Health Clinics.
Read the detailed description
Smoking is the leading preventable cause of death in the United States and is a particular problem among VA users and among persons with a diagnosed mental illness. The prevalence of smoking among VA mental health patients has remained high, in part because smoking cessation treatment rates have remained low. Telephone-based counseling represents the most feasible approach to increasing smoking cessation treatment among VA patients. The approach used in this study has been used very effectively in a primary care-based population that includes a large percentage of mental health patients. This project would target the program specifically at patients seen in VA Mental Health Clinics.
- Conditions
- Smoking
- Being tested
- Telephone Care Coordination, Telephone Care Coordination with state Quitline
- Keywords
- Smoking, Smoking Cessation, Tobacco, Mental Health
- Medical subject headings
- Smoking, Smoking Cessation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Care CoordinationOther
The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from TeleQuit MH study counselors; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
Telephone Care Coordination with state QuitlineOther
The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from the patient's state "Quitline"; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from TeleQuit MH study counselors; and (4) follow-up at 2 and 6 months to check the patient's smoking status. Receives: Other: Telephone Care Coordination |
| Arm 2 | Experimental | The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from the patient's state smoking cessation "Quitline"; and (4) follow-up at 2 and 6 months to check the patient's smoking status. Receives: Other: Telephone Care Coordination with state Quitline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)
Measured: 6 months after enrollment
Secondary outcomes (4)
30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment)
Measured: 2 months after enrollment
Quit Attempt Rate
Measured: 2 and 6 months after enrollment
Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)
Measured: 2 and 6 months after enrollment
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Measured: Quarterly after study implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startNov 2009
- Primary completionOct 2012
- Study completionSep 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 (5)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott E Sherman, MD MPH, Principal investigator, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724308
- Sponsor's protocol ID
- SDP 07-034
- Acronym
- TeleQuit MH
- Status last verified
- Oct 2020
- First submitted
- 23 Jul 2008
- Last updated
- 17 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rogers E, Fernandez S, Gillespie C, Smelson D, Hagedorn HJ, Elbel B, Kalman D, Axtmayer A, Kurowski K, Sherman SE. Telephone care coordination for smokers in VA mental health clinics: protocol for a hybrid type-2 effectiveness-implementation trial. Addict Sci Clin Pract. 2013 Mar 15;8(1):7. doi: 10.1186/1940-0640-8-7.
PubMed 23497630Rogers ES, Gillespie C, Zabar S, Sherman SE. Using standardized patients to train telephone counselors for a clinical trial. BMC Res Notes. 2014 Jun 5;7:341. doi: 10.1186/1756-0500-7-341.
PubMed 24903609Swong S, Nicholson A, Smelson D, Rogers ES, El-Shahawy O, Sherman SE. The effectiveness of a telephone smoking cessation program in mental health clinic patients by level of mental well-being and functioning: a secondary data analysis of a randomized clinical trial. BMC Public Health. 2023 Nov 7;23(1):2190. doi: 10.1186/s12889-023-16975-z.
PubMed 37936218Swong S, Nicholson A, Smelson D, Rogers ES, El-Shahawy O, Sherman SE. The Effectiveness of a Telephone Smoking Cessation Program in Mental Health Clinic Patients by Level of Mental Well-Being and Functioning: A Secondary Data Analysis of a Randomized Clinical Trial. Res Sq [Preprint]. 2023 Aug 24:rs.3.rs-3179446. doi: 10.21203/rs.3.rs-3179446/v1.
PubMed 37674733Rogers ES, Smelson DA, Gillespie CC, Elbel B, Poole S, Hagedorn HJ, Kalman D, Krebs P, Fang Y, Wang B, Sherman SE. Telephone Smoking-Cessation Counseling for Smokers in Mental Health Clinics: A Patient-Randomized Controlled Trial. Am J Prev Med. 2016 Apr;50(4):518-527. doi: 10.1016/j.amepre.2015.10.004. Epub 2015 Dec 17.
PubMed 26711163
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Care Coordination for Smokers in Mental Health Clinics
- ClinicalTrials.gov ID
- NCT00724308
- Acronym / sponsor ID
- TeleQuit MH / SDP 07-034
- Conditions
- Smoking
- Keywords
- Smoking, Smoking Cessation, Tobacco, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Nov 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Posted 5 Aug 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 whether a smoking cessation telephone care coordination program is effective and feasible in VA Mental Health Clinics.
Detailed description
Smoking is the leading preventable cause of death in the United States and is a particular problem among VA users and among persons with a diagnosed mental illness. The prevalence of smoking among VA mental health patients has remained high, in part because smoking cessation treatment rates have remained low. Telephone-based counseling represents the most feasible approach to increasing smoking cessation treatment among VA patients. The approach used in this study has been used very effectively in a primary care-based population that includes a large percentage of mental health patients. This project would target the program specifically at patients seen in VA Mental Health Clinics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Telephone Care CoordinationThe telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from TeleQuit MH study counselors; and (4) follow-up at 2 and 6 months to check the patient's smoking status. |
| Arm 2 | Experimental | Other: Telephone Care Coordination with state QuitlineThe telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from the patient's state smoking cessation "Quitline"; and (4) follow-up at 2 and 6 months to check the patient's smoking status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Smokers who are referred from Mental Health Clinics in VA VISNs 1 and 3.
- Patients must have access to a telephone and a regular mailing address.
Key exclusion criteria (3 listed)
- No access to a telephone
- no mailing address
- not receiving care from a VISN 1 or VISN 3 Mental Health provider
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 |
|---|---|---|
| Telephone Care CoordinationThe telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from TeleQuit MH study counselors; and (4) follow-up at 2 and 6 months to check the patient's smoking status. | Other | Arm 1 |
| Telephone Care Coordination with state QuitlineThe telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from the patient's state "Quitline"; and (4) follow-up at 2 and 6 months to check the patient's smoking status. | Other | Arm 2 |
Primary outcome
Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)
Time frame: 6 months after enrollment
4 secondary outcomes
30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment)
Time frame: 2 months after enrollment
Quit Attempt Rate
Time frame: 2 and 6 months after enrollment
Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)
Time frame: 2 and 6 months after enrollment
VA Site-level Performance Rates on the VA Tobacco Performance Measures
Time frame: Quarterly after study implementation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23497630Rogers E, Fernandez S, Gillespie C, Smelson D, Hagedorn HJ, Elbel B, Kalman D, Axtmayer A, Kurowski K, Sherman SE. Telephone care coordination for smokers in VA mental health clinics: protocol for a hybrid type-2 effectiveness-implementation trial. Addict Sci Clin Pract. 2013 Mar 15;8(1):7. doi: 10.1186/1940-0640-8-7.
- Results publication: PubMed 24903609Rogers ES, Gillespie C, Zabar S, Sherman SE. Using standardized patients to train telephone counselors for a clinical trial. BMC Res Notes. 2014 Jun 5;7:341. doi: 10.1186/1756-0500-7-341.
- Derived from this study: PubMed 37936218Swong S, Nicholson A, Smelson D, Rogers ES, El-Shahawy O, Sherman SE. The effectiveness of a telephone smoking cessation program in mental health clinic patients by level of mental well-being and functioning: a secondary data analysis of a randomized clinical trial. BMC Public Health. 2023 Nov 7;23(1):2190. doi: 10.1186/s12889-023-16975-z.
- Derived from this study: PubMed 37674733Swong S, Nicholson A, Smelson D, Rogers ES, El-Shahawy O, Sherman SE. The Effectiveness of a Telephone Smoking Cessation Program in Mental Health Clinic Patients by Level of Mental Well-Being and Functioning: A Secondary Data Analysis of a Randomized Clinical Trial. Res Sq [Preprint]. 2023 Aug 24:rs.3.rs-3179446. doi: 10.21203/rs.3.rs-3179446/v1.
- Derived from this study: PubMed 26711163Rogers ES, Smelson DA, Gillespie CC, Elbel B, Poole S, Hagedorn HJ, Kalman D, Krebs P, Fang Y, Wang B, Sherman SE. Telephone Smoking-Cessation Counseling for Smokers in Mental Health Clinics: A Patient-Randomized Controlled Trial. Am J Prev Med. 2016 Apr;50(4):518-527. doi: 10.1016/j.amepre.2015.10.004. Epub 2015 Dec 17.
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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.
Scott E Sherman, MD MPH principal investigator
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Care Coordination and Telephone Care Coordination with state Quitline in people with 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 2 inclusion and 3 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 17 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 5 Aug 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?
Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) (time frame: 6 months after enrollment). 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 NCT00724308, which also lists 5 linked publications.
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 17 Nov 2020.