CancerCOMBATNCT03108144
Personalized Alerts and Care Pathways to Prompt Prevention Interventions for Alcohol and Tobacco Users in Primary Care
A study testing Brief alcohol intervention in people with Cancer, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Tobacco and alcohol use present multiplicative risk for aerodigestive cancers. Reducing alcohol consumption improves smoking cessation outcomes and reduces cancer risk. Risky alcohol consumption and smoking are often treated separately despite concurrent treatment potentially leading to better outcomes for each. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Brief alcohol intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,222 participants
- Where
- 1 siteCanada
- Study dates
- 11 Apr 2016to Apr 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participating clinics must be Family Health Team, Community Health Centre, or Nurse Practitioner-Led Clinic (primary care clinics) participating in the Smoking Treatment for Ontario Patients (STOP) program
- Clinic must use online portal to complete STOP questionnaires, in English, in real-time with patient
Who cannot join
- Non-primary care clinics participating in STOP program
- Clinics who conduct STOP questionnaires exclusively on paper, or in French, or not in real-time with patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Patient Alerts and Care Pathways to Prompt Prevention Interventions for Combined Alcohol and Tobacco Users in Primary Care
Tobacco and alcohol use present multiplicative risk for aerodigestive cancers. Reducing alcohol consumption improves smoking cessation outcomes and reduces cancer risk. Risky alcohol consumption and smoking are often treated separately despite concurrent treatment potentially leading to better outcomes for each. However, no rapidly scalable program exists for combined interventions in primary care clinics spread across wide geographic areas. This cluster randomized trial aims to report on the effects of a novel clinical decision support system (CDSS) on intervention rates by primary care practitioners addressing risky alcohol use in a smoking cessation program.
The investigators will be implementing a clinical decision support system (CDSS) in 221 primary care sites participating in the Smoking Treatment for Ontario Patients (STOP) program across Ontario, Canada. Sites will be blindly allocated to one of two clinical decision support systems guiding practitioners to provide a risky alcohol use intervention to smokers attempting to quit using nicotine replacement therapy (NRT). Risky alcohol use is defined as drinking above the Canadian Cancer Society's low-risk drinking guidelines. Primary analysis will measure the proportion of risky drinkers offered an alcohol intervention in each CDSS arm at baseline. Patients will be contacted by phone or email to track smoking cessation and alcohol consumption rates at 6- and 12-month follow up.
Upon completion of the trial, the effect of different clinical decision support systems on practitioner behavior, and on client tobacco and alcohol use, will be discussed. If the CDSS successfully promotes SBIRT for risky alcohol use in a primary care setting and/or improves patient-level outcomes, including smoking cessation rates and alcohol use reduction, this tool can be used as a model for other web-based behavior change interventions integrated into primary care practice.
Read the detailed description
Background: Primary care providers work in busy settings responding to a variety of acute and chronic problems. Implementing even brief evidence-based interventions for cancer risk behaviors, such as tobacco smoking and excess alcohol consumption, is sub-optimal due to time and knowledge constraints. These behaviors cluster in the same person and confer a multiplicative, positively associated risk for aero-digestive cancers but are often addressed separately, if at all, despite alcohol consumption undermining smoking cessation. Processes that reduce time and effort and yet increase practitioner effectiveness show promise to increase adoption of such practices. Computerized clinical decision support systems (CDSS) within practices allow for prompt procedural knowledge for practitioners, simplifies the decision-making process, and provides recommendations for patient care.
The initiation of the STOP Program (Smoking Treatment for Ontario Patients - an Ontario-wide initiative providing smoking cessation to eligible smokers who wish to quit), has demonstrated that such a system allows for rapid adoption of smoking cessation interventions in primary care with 189 sites (80% of eligible sites) in Ontario treating 40,000 smokers in 2 years. Approximately 36% consume alcohol above Canadian Cancer Society (CCS) guidelines (less than one drink per day for women; less then two drinks per day for men; no engagement in binge drinking) and those that do have a lower quit rate.
A combined alcohol and tobacco intervention delivered systematically using such a platform has never been studied before, which constitutes a missed opportunity to simultaneously address two closely related risk factors for cancer. Thus, implementation of a CDSS within the daily clinical workflow is a novel concept for cancer prevention with high potential to address the lack of brief interventions by health care providers.
Objective: Assess the effectiveness of a CDSS to increase the rates of brief alcohol intervention by healthcare providers and to reduce alcohol consumption in adult smokers making a quit attempt.
Methodology: Organizations from the STOP Program will be randomly allocated (1:1) to Group A or Group B.
Patient Population: Adult consenting smokers of the STOP Program identified as drinking above the sex-specific cut off at baseline will be eligible for the intervention.
Intervention: Half the sites will have a computer prompt built into STOP's data collection system, which will appear for any participant identified as drinking above the sex-specific cut off at baseline (Group A). The reminder will provide the practitioners with a five minute script advising their patient to reduce alcohol consumption to increase their chances of quitting smoking, and will be prompted to provide a self-help booklet to reduce alcohol intake. Sites without the prompt (Group B) will not receive reminders but will have access to the same resources.
- Conditions
- Cancer
- Being tested
- Brief alcohol intervention
- Keywords
- smoking cessation, alcohol, primary care, screening, brief intervention, referral to treatment, cancer risk
- Medical subject headings
- Neoplasms, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief alcohol interventionBehavioural
The intervention is a clinical decision support system (CDSS) that provides a computerized prompt in the clinic's online portal. The CDSS prompts a practitioner to intervene when a patient is screening above recommended drinking guidelines. The prompt appears as an alert message, recommending intervention. The portal suggests scripted brief intervention language, designed based on the College of Family Physicians of Canada and Canadian Centre on Substance Abuse's resource on conducting evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Control - Group A | No intervention | When a patient is identified as consuming alcohol above CCS guidelines (based on mandatory baseline questionnaire) the practitioner in Group A will not receive computer alerts but will still have access to the alcohol consumption data as part of the baseline assessment (Screening). Healthcare providers will have access to all the same resources available as the intervention clinic (Treatment as usual). |
| Intervention - Group B | Experimental | When a patient is identified as consuming alcohol above CCS guidelines (based on mandatory baseline questionnaire) the practitioner in Group B will receive computer alerts (Screening). The alert will provide a 5 minute script (Brief Intervention) for the health care providers to relay to patients and the ability to print or email a self-help resource to the patient each time the patient visits (Referral to Treatment). Receives: Behavioral: Brief alcohol intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention offer by practitioner
The study's primary outcome is the proportion of health practitioners who offer the brief alcohol intervention (with educational resource) to eligible patients.
Measured: Approximately 10 minutes during 1-hour appointment between practitioner and patient
Secondary outcomes (2)
Intervention delivery by practitioner
The study's secondary outcome is the proportion of health practitioners who deliver the brief alcohol intervention (with educational resource) to eligible patients (patient accepts practitioner's offer of intervention).
Measured: Approximately 10 minutes during 1-hour appointment between practitioner and patient
Smoking cessation and non-risky drinking
The study's tertiary outcome is the proportion of eligible participants who report being abstinent from smoking and meet CCS alcohol guidelines at follow-up.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start11 Apr 2016
- Primary completionSep 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Organizations will be randomly allocated in a 1:1 allocation ratio to Group A (Test) or Group B (Control) accounting for rurality, organization type, practice size and academic affiliation.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15,222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Dr. Peter Selby, Centre for Addiction and Mental Health
- Investigators
- Peter Selby, MBBS CCFP FCFP MHSc DipABAM, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108144
- Sponsor's protocol ID
- 035-2015
- Acronym
- COMBAT
- Status last verified
- Jun 2018
- First submitted
- 5 Apr 2017
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Minian N, Noormohamed A, Lingam M, Zawertailo L, Le Foll B, Rehm J, Giesbrecht N, Samokhvalov AV, Baliunas D, Selby P. Integrating a brief alcohol intervention with tobacco addiction treatment in primary care: qualitative study of health care practitioner perceptions. Addict Sci Clin Pract. 2021 Mar 16;16(1):17. doi: 10.1186/s13722-021-00225-x.
PubMed 33726843Minian N, Baliunas D, Noormohamed A, Zawertailo L, Giesbrecht N, Hendershot CS, Le Foll B, Rehm J, Samokhvalov AV, Selby PL. The effect of a clinical decision support system on prompting an intervention for risky alcohol use in a primary care smoking cessation program: a cluster randomized trial. Implement Sci. 2019 Aug 23;14(1):85. doi: 10.1186/s13012-019-0935-x.
PubMed 31443663Minian N, Noormohamed A, Zawertailo L, Baliunas D, Giesbrecht N, Le Foll B, Rehm J, Samokhvalov A, Selby PL. A method for co-creation of an evidence-based patient workbook to address alcohol use when quitting smoking in primary care: a case study. Res Involv Engagem. 2018 Feb 5;4:4. doi: 10.1186/s40900-018-0086-2. eCollection 2018.
PubMed 29445521Minian N, Baliunas D, Zawertailo L, Noormohamed A, Giesbrecht N, Hendershot CS, Le Foll B, Rehm J, Samokhvalov A, Selby PL. Combining alcohol interventions with tobacco addictions treatment in primary care-the COMBAT study: a pragmatic cluster randomized trial. Implement Sci. 2017 May 18;12(1):65. doi: 10.1186/s13012-017-0595-7.
PubMed 28521782
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Patient Alerts and Care Pathways to Prompt Prevention Interventions for Combined Alcohol and Tobacco Users in Primary Care
- ClinicalTrials.gov ID
- NCT03108144
- Acronym / sponsor ID
- COMBAT / 035-2015
- Conditions
- Cancer
- Keywords
- smoking cessation, alcohol, primary care, screening, brief intervention, referral to treatment, cancer risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,222 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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.
Tobacco and alcohol use present multiplicative risk for aerodigestive cancers. Reducing alcohol consumption improves smoking cessation outcomes and reduces cancer risk. Risky alcohol consumption and smoking are often treated separately despite concurrent treatment potentially leading to better outcomes for each. However, no rapidly scalable program exists for combined interventions in primary care clinics spread across wide geographic areas. This cluster randomized trial aims to report on the effects of a novel clinical decision support system (CDSS) on intervention rates by primary care practitioners addressing risky alcohol use in a smoking cessation program.
The investigators will be implementing a clinical decision support system (CDSS) in 221 primary care sites participating in the Smoking Treatment for Ontario Patients (STOP) program across Ontario, Canada. Sites will be blindly allocated to one of two clinical decision support systems guiding practitioners to provide a risky alcohol use intervention to smokers attempting to quit using nicotine replacement therapy (NRT). Risky alcohol use is defined as drinking above the Canadian Cancer Society's low-risk drinking guidelines. Primary analysis will measure the proportion of risky drinkers offered an alcohol intervention in each CDSS arm at baseline. Patients will be contacted by phone or email to track smoking cessation and alcohol consumption rates at 6- and 12-month follow up.
Upon completion of the trial, the effect of different clinical decision support systems on practitioner behavior, and on client tobacco and alcohol use, will be discussed. If the CDSS successfully promotes SBIRT for risky alcohol use in a primary care setting and/or improves patient-level outcomes, including smoking cessation rates and alcohol use reduction, this tool can be used as a model for other web-based behavior change interventions integrated into primary care practice.
Detailed description
Background: Primary care providers work in busy settings responding to a variety of acute and chronic problems. Implementing even brief evidence-based interventions for cancer risk behaviors, such as tobacco smoking and excess alcohol consumption, is sub-optimal due to time and knowledge constraints. These behaviors cluster in the same person and confer a multiplicative, positively associated risk for aero-digestive cancers but are often addressed separately, if at all, despite alcohol consumption undermining smoking cessation. Processes that reduce time and effort and yet increase practitioner effectiveness show promise to increase adoption of such practices. Computerized clinical decision support systems (CDSS) within practices allow for prompt procedural knowledge for practitioners, simplifies the decision-making process, and provides recommendations for patient care.
The initiation of the STOP Program (Smoking Treatment for Ontario Patients - an Ontario-wide initiative providing smoking cessation to eligible smokers who wish to quit), has demonstrated that such a system allows for rapid adoption of smoking cessation interventions in primary care with 189 sites (80% of eligible sites) in Ontario treating 40,000 smokers in 2 years. Approximately 36% consume alcohol above Canadian Cancer Society (CCS) guidelines (less than one drink per day for women; less then two drinks per day for men; no engagement in binge drinking) and those that do have a lower quit rate.
A combined alcohol and tobacco intervention delivered systematically using such a platform has never been studied before, which constitutes a missed opportunity to simultaneously address two closely related risk factors for cancer. Thus, implementation of a CDSS within the daily clinical workflow is a novel concept for cancer prevention with high potential to address the lack of brief interventions by health care providers.
Objective: Assess the effectiveness of a CDSS to increase the rates of brief alcohol intervention by healthcare providers and to reduce alcohol consumption in adult smokers making a quit attempt.
Methodology: Organizations from the STOP Program will be randomly allocated (1:1) to Group A or Group B.
Patient Population: Adult consenting smokers of the STOP Program identified as drinking above the sex-specific cut off at baseline will be eligible for the intervention.
Intervention: Half the sites will have a computer prompt built into STOP's data collection system, which will appear for any participant identified as drinking above the sex-specific cut off at baseline (Group A). The reminder will provide the practitioners with a five minute script advising their patient to reduce alcohol consumption to increase their chances of quitting smoking, and will be prompted to provide a self-help booklet to reduce alcohol intake. Sites without the prompt (Group B) will not receive reminders but will have access to the same resources.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Organizations will be randomly allocated in a 1:1 allocation ratio to Group A (Test) or Group B (Control) accounting for rurality, organization type, practice size and academic affiliation.
| Arm | Type | Receives |
|---|---|---|
| Control - Group A | No intervention | –When a patient is identified as consuming alcohol above CCS guidelines (based on mandatory baseline questionnaire) the practitioner in Group A will not receive computer alerts but will still have access to the alcohol consumption data as part of the baseline assessment (Screening). Healthcare providers will have access to all the same resources available as the intervention clinic (Treatment as usual). |
| Intervention - Group B | Experimental | Behavioral: Brief alcohol interventionWhen a patient is identified as consuming alcohol above CCS guidelines (based on mandatory baseline questionnaire) the practitioner in Group B will receive computer alerts (Screening). The alert will provide a 5 minute script (Brief Intervention) for the health care providers to relay to patients and the ability to print or email a self-help resource to the patient each time the patient visits (Referral to Treatment). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participating clinics must be Family Health Team, Community Health Centre, or Nurse Practitioner-Led Clinic (primary care clinics) participating in the Smoking Treatment for Ontario Patients (STOP) program
- Clinic must use online portal to complete STOP questionnaires, in English, in real-time with patient
Key exclusion criteria (2 listed)
- Non-primary care clinics participating in STOP program
- Clinics who conduct STOP questionnaires exclusively on paper, or in French, or not in real-time with patient
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 |
|---|---|---|
| Brief alcohol interventionThe intervention is a clinical decision support system (CDSS) that provides a computerized prompt in the clinic's online portal. The CDSS prompts a practitioner to intervene when a patient is screening above recommended drinking guidelines. The prompt appears as an alert message, recommending intervention. The portal suggests scripted brief intervention language, designed based on the College of Family Physicians of Canada and Canadian Centre on Substance Abuse's resource on conducting evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) guidelines. | Behavioural | Intervention - Group B |
Primary outcome
Intervention offer by practitioner
Time frame: Approximately 10 minutes during 1-hour appointment between practitioner and patient
The study's primary outcome is the proportion of health practitioners who offer the brief alcohol intervention (with educational resource) to eligible patients.
2 secondary outcomes
Intervention delivery by practitioner
Time frame: Approximately 10 minutes during 1-hour appointment between practitioner and patient
Smoking cessation and non-risky drinking
Time frame: 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Derived from this study: PubMed 33726843Minian N, Noormohamed A, Lingam M, Zawertailo L, Le Foll B, Rehm J, Giesbrecht N, Samokhvalov AV, Baliunas D, Selby P. Integrating a brief alcohol intervention with tobacco addiction treatment in primary care: qualitative study of health care practitioner perceptions. Addict Sci Clin Pract. 2021 Mar 16;16(1):17. doi: 10.1186/s13722-021-00225-x.
- Derived from this study: PubMed 31443663Minian N, Baliunas D, Noormohamed A, Zawertailo L, Giesbrecht N, Hendershot CS, Le Foll B, Rehm J, Samokhvalov AV, Selby PL. The effect of a clinical decision support system on prompting an intervention for risky alcohol use in a primary care smoking cessation program: a cluster randomized trial. Implement Sci. 2019 Aug 23;14(1):85. doi: 10.1186/s13012-019-0935-x.
- Derived from this study: PubMed 29445521Minian N, Noormohamed A, Zawertailo L, Baliunas D, Giesbrecht N, Le Foll B, Rehm J, Samokhvalov A, Selby PL. A method for co-creation of an evidence-based patient workbook to address alcohol use when quitting smoking in primary care: a case study. Res Involv Engagem. 2018 Feb 5;4:4. doi: 10.1186/s40900-018-0086-2. eCollection 2018.
- Derived from this study: PubMed 28521782Minian N, Baliunas D, Zawertailo L, Noormohamed A, Giesbrecht N, Hendershot CS, Le Foll B, Rehm J, Samokhvalov A, Selby PL. Combining alcohol interventions with tobacco addictions treatment in primary care-the COMBAT study: a pragmatic cluster randomized trial. Implement Sci. 2017 May 18;12(1):65. doi: 10.1186/s13012-017-0595-7.
- Individual participant dataSharing planned: No
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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.
Peter Selby, MBBS CCFP FCFP MHSc DipABAM principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief alcohol intervention in people with Cancer, run by Centre for Addiction and Mental Health at 1 site 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 2 inclusion and 2 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 21 Jun 2018. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intervention offer by practitioner (time frame: Approximately 10 minutes during 1-hour appointment between practitioner and patient). 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 NCT03108144, which also lists 4 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 21 Jun 2018.