Cluster Randomized Trial of Knowledge Brokering to Integrate Mood and Smoking Cessation in Ontario Primary Care
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|ClinicalTrials.gov Identifier: NCT03130998|
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : April 11, 2018
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?
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: eKnowledge Broker||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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.|
|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|
|Actual Study Start Date :||February 27, 2018|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||September 2019|
No Intervention: Control - Group A
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).
Experimental: Intervention - Group B
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 knowledge broker communicating via interactive technology (eKB). The eKB 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 eKB 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.
Behavioral: eKnowledge Broker
The intervention is the tailored support received by a knowledge broker via technology in Group B. The eKB 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 eKB, learn new evidence, and work with the eKB on how to best implement the evidence.
- Intervention offer by practitioner [ Time Frame: Approximately 10 minutes during 1-hour appointment between practitioner and patient ]The primary outcome, measured at the site level, is the proportion of eligible baseline visits which result in practitioners offering the mood management intervention to patients as measured by the STOP Portal system.
- Intervention delivery by practitioner [ Time Frame: Approximately 10 minutes during 1-hour appointment between practitioner and patient ]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).
- Smoking cessation [ Time Frame: 6-month follow-up ]Part one of the tertiary outcome is the proportion of eligible patients reporting smoking abstinence at 6-month follow-up, measured by self-report of having abstained from smoking for at least 7 previous days.
- Decrease in depression scores [ Time Frame: 6-month follow-up ]Part two of the tertiary outcome is proportion of eligible patients reporting a decrease in depression scores at 6-month follow-up, as measured by self-report on the PHQ-9 mood questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130998
|Contact: Peter Selby, MBBS CCFP FCFP MHSc DipABAM||416-535-8501 ext 77432||Peter.Selby@camh.ca|
|Contact: Nadia Minian, PhD||416-535-8501 ext 77420||Nadia.Minian2@camh.ca|
|Centre for Addiction and Mental Health||Recruiting|
|Toronto, Ontario, Canada, M5T1P7|
|Contact: Peter Selby, MBBS CCFP FCFP MHSc DipABAM 416-535-8501 ext 77432 Peter.Selby@camh.ca|
|Contact: Sarwar Hussain, MHSc 416-535-8501 ext 77417 Sarwar.Hussain@camh.ca|
|Principal Investigator: Peter Selby, MBBS CCFP FCFP MHSc DipABAM|
|Principal Investigator: Angie Heydon, MBA|
|Sub-Investigator: Nadia Minian, PhD|
|Sub-Investigator: Dolly Baliunas, PhD|
|Sub-Investigator: Laurie Zawertailo, PhD|
|Sub-Investigator: Arun Ravindran, MD MSc PhD|
|Principal Investigator:||Peter Selby, MBBS CCFP FCFP MHSc DipABAM||Centre for Addiction and Mental Health|