DepressionNCT03130998
Cluster Randomized Trial of Knowledge Brokering to Integrate Mood and Smoking Cessation in Ontario Primary Care
A study testing Remote Knowledge Broker (rKB) and Emails in people with Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Compared to smokers who are not depressed, smokers with depression who try to quit smoking are 10% less likely to succeed when given standard treatment. A simple program with a detailed handout on relaxation exercises and a journal to record mood and urges to smoke when trying to quit has been shown to increase quit… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression
- What is being tested?
- Remote Knowledge Broker (rKB) and Emails
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,765 participants
- Where
- 1 siteCanada
- Study dates
- 27 Feb 2018to 4 Mar 2020
- 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
- Must be Family Health Team (FHT) participating in the Smoking Treatment for Ontario Patients (STOP) program
- FHT must use online portal to complete STOP questionnaires, in English, in real-time with patient
Who cannot join
- Non-FHTs 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: A Cluster Randomized Trial of Tailored vs Generic Knowledge Brokering to Integrate Mood Management Into Smoking Cessation Interventions in Primary Care Settings in Ontario, Canada
Compared to smokers who are not depressed, smokers with depression who try to quit smoking are 10% less likely to succeed when given standard treatment. A simple program with a detailed handout on relaxation exercises and a journal to record mood and urges to smoke when trying to quit has been shown to increase quit success in depressed smokers by 12 to 20%. However, it remains unclear how to best implement this knowledge into primary care settings.
Through this study, the investigators will seek to answer the following questions:
- Does a knowledge broker communicating via generic email reminders engage clinicians to provide patients resources for mood management more or less frequently than via interactive technology (eKB)?
- Which Knowledge Translation (KT) strategy used to change clinicians' behavior (emails vs. eKB) has the greatest effect on smoking quit rates in depressed smokers?
- What is the incremental cost effectiveness of the two KT strategies?
Read the detailed description
Given the cost-effectiveness of smoking cessation programs, the Centre for Addiction and Mental Health implemented the STOP program in 147 Family Health Teams (FHTs) treating 47,888 smokers with nicotine replacement therapy and counselling. Following the knowledge to action framework every FHT in STOP uses a web portal with an integrated decision aid, data collection, and feedback tool. Though STOP data finds lower quit rates among smokers with depression, it currently does not offer specialized clinical pathways for depressed smokers.
Both smoking and depression are major public health problems with high morbidity and mortality. Individuals with depression are almost twice as likely to be smokers, have lower long-term smoking abstinence (OR=0.81, 95% CI=0.67-0.97), and experience greater addiction severity and negative mood when quitting smoking. In the STOP Program, 38% of smokers have current or past depression; their 6-month quit rates are significantly lower than participants without depression (33% vs. 40%, p<0.001). This has led FHT-STOP practitioners to express the need for specialized clinical pathways for depressed smokers.
Self-help mood management (relaxation exercises and mood monitoring) integrated with smoking cessation treatment increases long-term quit rates by 12 to 20%. More research is needed to test the effectiveness of an integrated care pathway (ICP) for depression as part of cessation treatment. It is unclear which KT strategy would be more effective in engaging clinicians and driving behavior change. A randomized controlled trial in Public Health Units (PHUs) found no difference in health care provider behavior when prompted by a knowledge broker, emails or websites. However , similar to other studies, it showed the need to match organizational research culture to KT strategy; emails worked better in PHUs with a strong research culture, while KBs seemed more suitable in PHUs where research culture was low. Given that FHTs range anywhere from academic- to community-based research cultures, it is unclear which KT strategy will be most effective.
CAMH's existing Smoking Treatment for Ontario Patients (STOP) program works in partnership with 80% of eligible Family Health Teams (FHTs) in Ontario and has treated 47,888 smokers with free nicotine replacement and counselling since July 2011. Based on data already collected in the STOP Program, the STOP portal (an online data management and collection tool used by all STOP practitioners to complete participant enrollment and record smoking status at each visit), will flag smokers with current or past depressive symptoms. FHTs will be randomly allocated 1:1 to receive messages regarding depression and smoking exclusively via email (Group A) or via an eKB who will develop a one-on-one relationship with clinicians through frequent phone calls, web conferencing, and emails (Group B). The investigators will compare which method is more effective in changing clinician behavior by recording the number of times resources are provided to eligible patients. Investigators will also compare the smoking quit rates of patients from the two groups at 6-month follow-up and ask clinicians and patients what they liked and disliked about the program.
- Conditions
- Depression
- Being tested
- Remote Knowledge Broker (rKB), Emails
- Keywords
- smoking cessation, depression, mental health, mood management, primary care, screening, brief intervention, referral to treatment
- Medical subject headings
- Depression, Smoking Cessation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Knowledge Broker (rKB)Behavioural
The intervention is the tailored support received by a knowledge broker via technology in Group B. The rKB will: ensure relevant research evidence related to depression and smoking is transferred to the FHTs in ways that are most useful to them; develop capacity for evidence-informed decision-making at each site; and assist sites in translating evidence into local practice. These tasks will be accomplished by an initial 2-hour, virtual visit with each site and regular phone- and email-based check-ins. The specific tasks will be dictated by the needs of each site, and will create opportunity for practitioners to share their experiences with the rKB, learn new evidence, and work with the rKB on how to best implement the evidence.
EmailsBehavioural
When a patient is screened as showing depressive symptoms, the practitioner will be prompted to intervene and refer that patient to treatment. The practitioner will receive knowledge broker support to carry out these actions in the form of one email per month for one year. The first email will provide an electronic copy of a Cochrane review (describing the link between smoking and mood) and a short description of the integration of a depression ICP in the STOP portal. The STOP YouTube channel with detailed instructions on how to use the revised portal will be made available. Subsequent communications will be based on general needs identified at baseline and content discussed in the STOP Community of Practice (teleconferences, online forum between STOP practitioners).
| Study group | Role | What they receive |
|---|---|---|
| Control - Group A | Active comparator | When a patient is screened as showing depressive symptoms, the practitioner will be prompted to intervene and refer that patient to treatment. The practitioner will receive knowledge broker support to carry out these actions in the form of one email per month for one year. The first email will provide an electronic copy of a Cochrane review (describing the link between smoking and mood) and a short description of the integration of a depression ICP in the STOP portal. The STOP YouTube channel with detailed instructions on how to use the revised portal will be made available. Subsequent communications will be based on general needs identified at baseline and content discussed in the STOP Community of Practice (teleconferences, online forum between STOP practitioners). Receives: Behavioral: Emails |
| Intervention - Group B | Experimental | When a patient is screened as showing depressive symptoms, the practitioner will be prompted to intervene and refer that patient to treatment. The practitioner will receive individualized support through a remote knowledge broker (rKB) communicating via interactive technology. The rKB will be certified in tobacco cessation counseling through CAMH's TEACH program and will have completed a specialty course on tobacco addiction treatment in those with mental illness. The rKB will have access to the CAMH network of KBs (e.g. Evidence Exchange Network ) for guidance and support, as this has been shown to be important for KB success. Receives: Behavioral: Remote Knowledge Broker (rKB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resource accepted by patient
The primary outcome will be the provision of the mood management intervention to eligible patients upon completion of the STOP smoking cessation program enrollment. This dichotomous outcome will be measured as positive by a response of "Patient accepted the resource" to the practitioner question "Did the patient accept or decline the resource?". In contrast, the outcome will be measured as negative if given a response of "Patient declined the resource" to the practitioner question "Did the patient accept or decline the resource?" or a response of "no" to the practitioner directive "Provide this patient with resources on mood management."
Measured: : Approximately 2-5 minutes as part of a brief intervention between the practitioner and patient
Secondary outcomes (3)
Smoking Abstinence
The secondary outcome, measured at the site level, is the proportion of eligible baseline visits which result in practitioners delivering the mood management intervention to patients as measured by the STOP Portal system (patient accepts practitioner's offer of intervention).
Measured: Approximately 10 minutes during 1-hour appointment between practitioner and patient
Cost-effectiveness
The tertiary outcome will be a cost-effectiveness analysis (CEA), evaluating the delivery of each intervention from the health care system, and societal perspectives. The CEA will include the costs of developing, maintaining, and running each intervention in addition to costs associated with personnel, training, supplies, and services. The incremental cost-effectiveness ratio (ICER) will be the primary outcome of the CEA. An additional measure of interest will be the 95% confidence interval for the ICER
Measured: 6-month follow-up
Decrease in depression scores
Other outcomes measured in this study will include change in The Patient Health Questionnaire (PHQ)-9 score between the baseline and 6-month follow-up surveys. Scores in the PHQ-9 range from 0-27; the higher the score the more likely the person has more severe depression.
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 posted27 Apr 2017
- Study start27 Feb 2018
- Primary completion31 Jan 2019
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a cluster (cluster = clinical practice) randomized trial of FHTs participating in the STOP program. FHTs in the STOP program will be randomly allocated 1:1 to receive either generalized messages (related to depression and smoking) exclusively via email (Group A) or be assigned an eKB who provides personalized support through phone- and email-based check-ins (Group B). Academic affiliation and cluster size will be treated as balancing factors in a stratified allocation or as covariates in the statistical analyses.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, 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
- NCT03130998
- Sponsor's protocol ID
- 065-2016
- Status last verified
- Oct 2020
- First submitted
- 18 Apr 2017
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Minian N, Noormohamed A, Baliunas D, Zawertailo L, Mulder C, Ravindran A, de Oliveira C, Selby P. Tailored Versus Generic Knowledge Brokering to Integrate Mood Management Into Smoking Cessation Interventions in Primary Care Settings: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 27;7(4):e111. doi: 10.2196/resprot.9715.
PubMed 29703714Minian N, Ahad S, Ivanova A, Veldhuizen S, Zawertailo L, Ravindran A, de Oliveira C, Baliunas D, Mulder C, Bolbocean C, Selby P. The effectiveness of generic emails versus a remote knowledge broker to integrate mood management into a smoking cessation programme in team-based primary care: a cluster randomised trial. Implement Sci. 2021 Mar 20;16(1):30. doi: 10.1186/s13012-021-01091-6.
PubMed 33743777
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial of Tailored vs Generic Knowledge Brokering to Integrate Mood Management Into Smoking Cessation Interventions in Primary Care Settings in Ontario, Canada
- ClinicalTrials.gov ID
- NCT03130998
- Acronym / sponsor ID
- 065-2016
- Conditions
- Depression
- Keywords
- smoking cessation, depression, mental health, mood management, primary care, screening, brief intervention, referral to treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,765 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 27 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.
Compared to smokers who are not depressed, smokers with depression who try to quit smoking are 10% less likely to succeed when given standard treatment. A simple program with a detailed handout on relaxation exercises and a journal to record mood and urges to smoke when trying to quit has been shown to increase quit success in depressed smokers by 12 to 20%. However, it remains unclear how to best implement this knowledge into primary care settings.
Through this study, the investigators will seek to answer the following questions:
- Does a knowledge broker communicating via generic email reminders engage clinicians to provide patients resources for mood management more or less frequently than via interactive technology (eKB)?
- Which Knowledge Translation (KT) strategy used to change clinicians' behavior (emails vs. eKB) has the greatest effect on smoking quit rates in depressed smokers?
- What is the incremental cost effectiveness of the two KT strategies?
Detailed description
Given the cost-effectiveness of smoking cessation programs, the Centre for Addiction and Mental Health implemented the STOP program in 147 Family Health Teams (FHTs) treating 47,888 smokers with nicotine replacement therapy and counselling. Following the knowledge to action framework every FHT in STOP uses a web portal with an integrated decision aid, data collection, and feedback tool. Though STOP data finds lower quit rates among smokers with depression, it currently does not offer specialized clinical pathways for depressed smokers.
Both smoking and depression are major public health problems with high morbidity and mortality. Individuals with depression are almost twice as likely to be smokers, have lower long-term smoking abstinence (OR=0.81, 95% CI=0.67-0.97), and experience greater addiction severity and negative mood when quitting smoking. In the STOP Program, 38% of smokers have current or past depression; their 6-month quit rates are significantly lower than participants without depression (33% vs. 40%, p<0.001). This has led FHT-STOP practitioners to express the need for specialized clinical pathways for depressed smokers.
Self-help mood management (relaxation exercises and mood monitoring) integrated with smoking cessation treatment increases long-term quit rates by 12 to 20%. More research is needed to test the effectiveness of an integrated care pathway (ICP) for depression as part of cessation treatment. It is unclear which KT strategy would be more effective in engaging clinicians and driving behavior change. A randomized controlled trial in Public Health Units (PHUs) found no difference in health care provider behavior when prompted by a knowledge broker, emails or websites. However , similar to other studies, it showed the need to match organizational research culture to KT strategy; emails worked better in PHUs with a strong research culture, while KBs seemed more suitable in PHUs where research culture was low. Given that FHTs range anywhere from academic- to community-based research cultures, it is unclear which KT strategy will be most effective.
CAMH's existing Smoking Treatment for Ontario Patients (STOP) program works in partnership with 80% of eligible Family Health Teams (FHTs) in Ontario and has treated 47,888 smokers with free nicotine replacement and counselling since July 2011. Based on data already collected in the STOP Program, the STOP portal (an online data management and collection tool used by all STOP practitioners to complete participant enrollment and record smoking status at each visit), will flag smokers with current or past depressive symptoms. FHTs will be randomly allocated 1:1 to receive messages regarding depression and smoking exclusively via email (Group A) or via an eKB who will develop a one-on-one relationship with clinicians through frequent phone calls, web conferencing, and emails (Group B). The investigators will compare which method is more effective in changing clinician behavior by recording the number of times resources are provided to eligible patients. Investigators will also compare the smoking quit rates of patients from the two groups at 6-month follow-up and ask clinicians and patients what they liked and disliked about the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study design is a cluster (cluster = clinical practice) randomized trial of FHTs participating in the STOP program. FHTs in the STOP program will be randomly allocated 1:1 to receive either generalized messages (related to depression and smoking) exclusively via email (Group A) or be assigned an eKB who provides personalized support through phone- and email-based check-ins (Group B). Academic affiliation and cluster size will be treated as balancing factors in a stratified allocation or as covariates in the statistical analyses.
| Arm | Type | Receives |
|---|---|---|
| Control - Group A | Active comparator | Behavioral: EmailsWhen a patient is screened as showing depressive symptoms, the practitioner will be prompted to intervene and refer that patient to treatment. The practitioner will receive knowledge broker support to carry out these actions in the form of one email per month for one year. The first email will provide an electronic copy of a Cochrane review (describing the link between smoking and mood) and a short description of the integration of a depression ICP in the STOP portal. The STOP YouTube channel with detailed instructions on how to use the revised portal will be made available. Subsequent communications will be based on general needs identified at baseline and content discussed in the STOP Community of Practice (teleconferences, online forum between STOP practitioners). |
| Intervention - Group B | Experimental | Behavioral: Remote Knowledge Broker (rKB)When a patient is screened as showing depressive symptoms, the practitioner will be prompted to intervene and refer that patient to treatment. The practitioner will receive individualized support through a remote knowledge broker (rKB) communicating via interactive technology. The rKB will be certified in tobacco cessation counseling through CAMH's TEACH program and will have completed a specialty course on tobacco addiction treatment in those with mental illness. The rKB will have access to the CAMH network of KBs (e.g. Evidence Exchange Network ) for guidance and support, as this has been shown to be important for KB success. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must be Family Health Team (FHT) participating in the Smoking Treatment for Ontario Patients (STOP) program
- FHT must use online portal to complete STOP questionnaires, in English, in real-time with patient
Key exclusion criteria (2 listed)
- Non-FHTs 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 |
|---|---|---|
| Remote Knowledge Broker (rKB)The intervention is the tailored support received by a knowledge broker via technology in Group B. The rKB will: ensure relevant research evidence related to depression and smoking is transferred to the FHTs in ways that are most useful to them; develop capacity for evidence-informed decision-making at each site; and assist sites in translating evidence into local practice. These tasks will be accomplished by an initial 2-hour, virtual visit with each site and regular phone- and email-based check-ins. The specific tasks will be dictated by the needs of each site, and will create opportunity for practitioners to share their experiences with the rKB, learn new evidence, and work with the rKB on how to best implement the evidence. | Behavioural | Intervention - Group B |
| EmailsWhen a patient is screened as showing depressive symptoms, the practitioner will be prompted to intervene and refer that patient to treatment. The practitioner will receive knowledge broker support to carry out these actions in the form of one email per month for one year. The first email will provide an electronic copy of a Cochrane review (describing the link between smoking and mood) and a short description of the integration of a depression ICP in the STOP portal. The STOP YouTube channel with detailed instructions on how to use the revised portal will be made available. Subsequent communications will be based on general needs identified at baseline and content discussed in the STOP Community of Practice (teleconferences, online forum between STOP practitioners). | Behavioural | Control - Group A |
Primary outcome
Resource accepted by patient
Time frame: : Approximately 2-5 minutes as part of a brief intervention between the practitioner and patient
The primary outcome will be the provision of the mood management intervention to eligible patients upon completion of the STOP smoking cessation program enrollment. This dichotomous outcome will be measured as positive by a response of "Patient accepted the resource" to the practitioner question "Did the patient accept or decline the resource?". In contrast, the outcome will be measured as negative if given a response of "Patient declined the resource" to the practitioner question "Did the patient accept or decline the resource?" or a response of "no" to the practitioner directive "Provide this patient with resources on mood management."
3 secondary outcomes
Smoking Abstinence
Time frame: Approximately 10 minutes during 1-hour appointment between practitioner and patient
Cost-effectiveness
Time frame: 6-month follow-up
Decrease in depression scores
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 23 Oct 2020.
- Background: PubMed 29703714Minian N, Noormohamed A, Baliunas D, Zawertailo L, Mulder C, Ravindran A, de Oliveira C, Selby P. Tailored Versus Generic Knowledge Brokering to Integrate Mood Management Into Smoking Cessation Interventions in Primary Care Settings: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 27;7(4):e111. doi: 10.2196/resprot.9715.
- Derived from this study: PubMed 33743777Minian N, Ahad S, Ivanova A, Veldhuizen S, Zawertailo L, Ravindran A, de Oliveira C, Baliunas D, Mulder C, Bolbocean C, Selby P. The effectiveness of generic emails versus a remote knowledge broker to integrate mood management into a smoking cessation programme in team-based primary care: a cluster randomised trial. Implement Sci. 2021 Mar 20;16(1):30. doi: 10.1186/s13012-021-01091-6.
- 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 Remote Knowledge Broker (rKB) and Emails in people with Depression, 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 23 Oct 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 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?
Resource accepted by patient (time frame: : Approximately 2-5 minutes as part of a brief intervention between the 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 NCT03130998, which also lists 2 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 23 Oct 2020.