ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 34 of 36 for:    smoking [CONDITION] AND child [AGE-GROUP] | Recruiting, Not yet recruiting, Available Studies

Cluster Randomized Trial of Knowledge Brokering to Integrate Mood and Smoking Cessation in Ontario Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03130998
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Peter Selby, Centre for Addiction and Mental Health

Brief 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 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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
Allocation: Randomized
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.
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-FHTs participating in STOP program
  • Clinics who conduct STOP questionnaires exclusively on paper, or in French, or not in real-time with patient

Information from the National Library of Medicine

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


Contacts
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

Locations
Canada, Ontario
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         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Peter Selby, MBBS CCFP FCFP MHSc DipABAM Centre for Addiction and Mental Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Peter Selby, Director, Medical Education, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03130998     History of Changes
Other Study ID Numbers: 065-2016
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Peter Selby, Centre for Addiction and Mental Health:
smoking cessation
depression
mental health
mood management
primary care
screening
brief intervention
referral to treatment

Additional relevant MeSH terms:
Depression
Behavioral Symptoms