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A Web-enabled Integrated Care Pathway (ICP) for Addressing Multiple Modifiable Risk Factors as a Part of Smoking Cessation Treatment in Primary Care Settings.

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04223336
Recruitment Status : Completed
First Posted : January 10, 2020
Last Update Posted : August 4, 2021
Sponsor:
Collaborators:
Public Health Agency of Canada (PHAC)
Medical Psychiatry Alliance
Information provided by (Responsible Party):
Peter Selby, Centre for Addiction and Mental Health

Brief Summary:

Compared to non-smokers, smokers are significantly more likely to also engage in other chronic disease-related risk behaviours; which can be a barrier to quitting successfully. Therefore a holistic approach is needed for smoking cessation treatment. The Smoking Treatment for Ontario Patients (STOP) program currently offers an online integrated care pathway (ICP) for addressing alcohol and mood as a part of smoking cessation treatment. Evidence also shows that smokers are also more likely to be physical inactive and not consume enough fruits/vegetables. These risk behaviours can further compound the negative health effects for smokers. However, it is remains unclear which and how many behaviours should be addressed simultaneously in smoking cessation treatment and what the impact on smoking cessation and care for STOP participants will be.

Through this study, the investigators will seek to:

  1. Determine whether the addition of an integrated care pathway for physical activity and fruits/vegetable consumption to the STOP program is associated with participants' quit prevalence at 6 month follow-up among STOP participants who are physically inactive and/or have low levels of fruits/vegetable consumption.
  2. Understand how the integrated care pathway for physical activity and fruits/vegetable consumption is implemented in primary care settings. In the process, we hope to generate insights on how this ICP can be most helpful to organizations, staff and patients.

Condition or disease Intervention/treatment Phase
Physical Activity Fruits and Vegetable Consumption Smoking Cessation Behavioral: Brief physical activity and diet intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5331 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Individuals enrolling into the STOP program at a primary care organization (Family Health Team, Community Health Centre, or Nurse Practitioner-led Clinic) will be randomly allocated in a 1:1 allocation ratio to control or intervention group.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Web-enabled Integrated Care Pathway (ICP) for Addressing Multiple Modifiable Risk Factors as a Part of Smoking Cessation Treatment in Primary Care Settings.
Actual Study Start Date : November 30, 2019
Actual Primary Completion Date : May 2, 2021
Actual Study Completion Date : May 2, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
When a participant in the control group is identified via a mandatory baseline questionnaire as having low levels of physical activity and/or low levels of fruits/vegetable consumption, the practitioner seeing this participant during their visit will not receive any computer alerts for physical activity and fruits/vegetable consumption. However, practitioners will still have access to the physical activity and diet data as part of the baseline assessment (Screening). Practitioners will also continue to have access to all the same resources as they currently do (treatment as usual).
Experimental: Intervention Group
When a participant in the intervention group is identified via mandatory baseline questionnaire as having low levels of physical activity and/or low levels of fruits/vegetable consumption, the practitioner seeing this participant during their visit will receive computer alerts (screening), prompting to provide participant with a brief intervention (risk communication) and a self-monitoring resource for physical activity and/or fruits/vegetable consumption.
Behavioral: Brief physical activity and diet intervention
The intervention is an integrated care pathway that provides a computerized prompts for practitioners in the STOP program via their online portal. For a participant who is in the intervention group, the online portal will screen the participant for their physical activity and fruit/vegetable consumption and provide the practitioner (who is seeing this participant for their visit) with computerized alerts for physical activity and fruits/vegetable consumption. Specifically, the portal will prompt practitioners to provide a brief intervention for these two behaviours using risk communication and will also suggest brief intervention language designed based on the Elicit-Provide-Elicit framework. The portal will also have available a self-monitoring resource for physical activity and fruits/vegetable consumption and will prompt practitioners to provide this self-monitoring resource to the participant during their visit.




Primary Outcome Measures :
  1. Smoking cessation - self-report questionnaire [ Time Frame: 6-month follow-up ]
    The primary outcome of the study, measured at the patient level, is 7 day point prevalence of abstinence at 6 month follow-up. We will compare the proportion of intervention vs control group participants who report being quit at follow-up.


Secondary Outcome Measures :
  1. Physical activity - self-report questionnaire [ Time Frame: 6-month follow-up ]
    The secondary outcome, also measured at the patient level, is change in physical activity levels from baseline to 6 months follow-up. We will compare the change in physical activity from baseline to 6 month follow-up in intervention vs control group participants.

  2. Fruits/vegetable consumption - self-report questionnaire [ Time Frame: 6-month follow-up ]
    The secondary outcome, also measured at the patient level, is change in fruits/vegetable consumption levels from baseline to 6 months follow-up. We will compare the change in fruits/vegetable consumption levels from baseline to 6 month follow-up in intervention vs control group participants.



Information from the National Library of Medicine

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

Inclusion Criteria:

The sample of patients for the study will be recruited from 153 Family Health Teams (FHTs), 61 Community Health Centres (CHCs) and 18 Nurse Practitioner-Led Clinics (NPLCs) currently participating in the STOP program. The inclusion criteria are as follows:

  • An individual enrolling in the STOP program at a participating FHT, CHC, or NPLC.
  • Must have at least one of the following two modifiable risk factors: low levels of physical activity and/or low levels of fruits/vegetable consumption.
  • Enrollment into STOP program must be completed online on the STOP Portal, in real-time with the participant present.
  • Must have at least one piece of contact information (e.g. phone number or email address).

Exclusion Criteria:

  • An individual enrolling in the STOP program at a participating Addictions Agencies (AAs)
  • STOP enrollment conducted on paper, no contact information.

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): NCT04223336


Locations
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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T1P7
Sponsors and Collaborators
Centre for Addiction and Mental Health
Public Health Agency of Canada (PHAC)
Medical Psychiatry Alliance
Investigators
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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):
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Responsible Party: Peter Selby, Director, Medical Education, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT04223336    
Other Study ID Numbers: 119-2018
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Selby, Centre for Addiction and Mental Health:
smoking cessation
physical activity
diet
primary care
screening
brief intervention
integrated care pathway