Delivery of Health CareNCT01004276
Increasing Smoking Cessation Counselling in Primary Care Using a Chronic Disease Management System
A study testing New, improved smoking cessation management module in people with Delivery of Health Care and Smoking Cessation, run by McMaster University at 2 sites in Canada.
Trial summary
This pilot study will determine the feasibility of studying a new smoking cessation management module in an existing chronic disease management system. The new module is intended to help healthcare providers deliver more smoking cessation counselling to their patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Delivery of Health Care, Smoking Cessation
- What is being tested?
- New, improved smoking cessation management module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Physician subscribers to P-PROMPT CDMS
Who cannot join
- Paper users
- Physicians expected to retire during the course of the study
- Physicians whose billing files are not set-up with DataSynch
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University
Hamilton, Ontario, L8S 4L8
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1
About this study
Official title: A Cluster Randomized Controlled Pilot Trial of the Effect of a New, Improved Smoking Cessation Management Module, Compared With Use of the Standard Version of Such a Management Module, on Smoking Counselling Initiation and Continuation Rates in Primary Care Practices Currently Using P-PROMPT Chronic Disease Management System in Ontario
This pilot study will determine the feasibility of studying a new smoking cessation management module in an existing chronic disease management system. The new module is intended to help healthcare providers deliver more smoking cessation counselling to their patients.
- Conditions
- Delivery of Health Care, Smoking Cessation
- Being tested
- New, improved smoking cessation management module
- Keywords
- primary health care, delivery of health care, smoking cessation, chronic disease, disease management, pilot projects
- Medical subject headings
- Smoking Cessation, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New, improved smoking cessation management moduleOther
The intervention that will be tested is an improved smoking cessation management module in an existing chronic disease management system, P-PROMPT CDMS. This module includes the following components: a) the Patient Care Status and Update Form, b) the smoking registry and c) patient prompts.
| Study group | Role | What they receive |
|---|---|---|
| Improved module | Experimental | Not described Receives: Other: New, improved smoking cessation management module |
| Standard module | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoker Identifying Cards
Measured: 3 months post-intervention
Chronic disease management system's activity log
Measured: monthly post-intervention
Secondary outcomes (1)
Smoking cessation counselling billing codes from physician's remittance advice files
Measured: monthly post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery of Health CareStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Investigators
- Natalie T. MacLeod, M.Sc. Candidate, Principal investigator, McMaster UniversityRolf J. Sebaldt, MD, Principal investigator, McMaster UniversityPeter Selby, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004276
- Sponsor's protocol ID
- 09-341
- Status last verified
- Oct 2009
- First submitted
- 28 Oct 2009
- Last updated
- 29 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Pilot Trial of the Effect of a New, Improved Smoking Cessation Management Module, Compared With Use of the Standard Version of Such a Management Module, on Smoking Counselling Initiation and Continuation Rates in Primary Care Practices Currently Using P-PROMPT Chronic Disease Management System in Ontario
- ClinicalTrials.gov ID
- NCT01004276
- Acronym / sponsor ID
- 09-341
- Conditions
- Delivery of Health Care, Smoking Cessation
- Keywords
- primary health care, delivery of health care, smoking cessation, chronic disease, disease management, pilot projects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will determine the feasibility of studying a new smoking cessation management module in an existing chronic disease management system. The new module is intended to help healthcare providers deliver more smoking cessation counselling to their patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Improved module | Experimental | Other: New, improved smoking cessation management module |
| Standard module | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Physician subscribers to P-PROMPT CDMS
Key exclusion criteria (3 listed)
- Paper users
- Physicians expected to retire during the course of the study
- Physicians whose billing files are not set-up with DataSynch
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 |
|---|---|---|
| New, improved smoking cessation management moduleThe intervention that will be tested is an improved smoking cessation management module in an existing chronic disease management system, P-PROMPT CDMS. This module includes the following components: a) the Patient Care Status and Update Form, b) the smoking registry and c) patient prompts. | Other | Improved module |
Primary outcome
Smoker Identifying Cards
Time frame: 3 months post-intervention
Chronic disease management system's activity log
Time frame: monthly post-intervention
1 secondary outcome
Smoking cessation counselling billing codes from physician's remittance advice files
Time frame: monthly post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2009.
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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.
Natalie T. MacLeod, M.Sc. Candidate principal investigator
McMaster University
Rolf J. Sebaldt, MD principal investigator
McMaster University
Peter Selby, MD principal investigator
Centre for Addiction and Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New, improved smoking cessation management module in people with Delivery of Health Care and Smoking Cessation, run by McMaster University at 2 sites in Canada.
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 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: status not confirmed, as of the sponsor's last update on 29 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Results are not available in the source record.
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?
Smoker Identifying Cards (time frame: 3 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2009.