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

NCT03130998 | Completed

• 1 other identifier: 065-2016
• Study Type: interventional
• Target: 2,765
• Locations: 1 country
• Sites: 1

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?

Conditions

Depression

Keywords

smoking cessation; depression; mental health; mood management; primary care; screening; brief intervention; referral to treatment

Outcome Measures

Primary Outcomes (1)

• 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."

  : Approximately 2-5 minutes as part of a brief intervention between the practitioner and patient

Secondary Outcomes (3)

• Smoking Abstinence

  Approximately 10 minutes during 1-hour appointment between practitioner and patient

• Cost-effectiveness

  6-month follow-up

• Decrease in depression scores

  6-month follow-up

Study Arms (2)

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).

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.

Behavioral: Remote Knowledge Broker (rKB)

Interventions

Remote Knowledge Broker (rKB) BEHAVIORAL

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.

Intervention - Group B

Emails BEHAVIORAL

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).

Control - Group A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T1P7, Canada

Location

Related Publications (2)

• 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.

  PMID: 29703714 BACKGROUND

• Minian 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.

  PMID: 33743777 DERIVED

MeSH Terms

Conditions

Depression; Smoking Cessation; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Health Behavior; Personal Satisfaction

Study Officials

• Peter Selby, MBBS CCFP FCFP MHSc DipABAM

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Medical Education

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 27, 2017
• Study Start: February 27, 2018
• Primary Completion: January 31, 2019
• Study Completion: March 4, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)