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

NCT04223336 | Completed

• 1 other identifier: 119-2018
• Study Type: interventional
• Target: 5,331
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Physical Activity; Fruits and Vegetable Consumption; Smoking Cessation

Keywords

smoking cessation; physical activity; diet; primary care; screening; brief intervention; integrated care pathway

Outcome Measures

Primary Outcomes (1)

• Smoking cessation - self-report questionnaire

  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.

  6-month follow-up

Secondary Outcomes (2)

• Physical activity - self-report questionnaire

  6-month follow-up

• Fruits/vegetable consumption - self-report questionnaire

  6-month follow-up

Study Arms (2)

Control Group

NO INTERVENTION

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).

Intervention Group

EXPERIMENTAL

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

Interventions

Brief physical activity and diet intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Public Health Agency of Canada (PHAC): collaborator
• Medical Psychiatry Alliance: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T1P7, Canada

Location

Related Publications (3)

• Minian N, Mehra K, Lingam M, Dragonetti R, Veldhuizen S, Zawertailo L, deRuiter WK, Melamed OC, Moineddin R, Thorpe KE, Taylor VH, Hahn M, Selby P. Healthcare providers' perspectives on implementing a brief physical activity and diet intervention within a primary care smoking cessation program: a qualitative study. BMC Prim Care. 2024 Jan 6;25(1):16. doi: 10.1186/s12875-023-02259-3.

  PMID: 38184559 DERIVED

• Minian N, Lingam M, Moineddin R, Thorpe KE, Veldhuizen S, Dragonetti R, Zawertailo L, Taylor VH, Hahn M, deRuiter WK, Melamed OC, Selby P. The Impact of a Clinical Decision Support System for Addressing Physical Activity and Healthy Eating During Smoking Cessation Treatment: Hybrid Type I Randomized Controlled Trial. J Med Internet Res. 2022 Sep 30;24(9):e37900. doi: 10.2196/37900.

  PMID: 36178716 DERIVED

• Minian N, Lingam M, Moineddin R, Thorpe KE, Veldhuizen S, Dragonetti R, Zawertailo L, Taylor VH, Hahn M, deRuiter WK, Melamed O, Selby P. Impact of a Web-Based Clinical Decision Support System to Assist Practitioners in Addressing Physical Activity and/or Healthy Eating for Smoking Cessation Treatment: Protocol for a Hybrid Type I Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 29;9(9):e19157. doi: 10.2196/19157.

  PMID: 32990250 DERIVED

MeSH Terms

Conditions

Motor Activity; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

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: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Medical Education

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: November 30, 2019
• Primary Completion: May 2, 2021
• Study Completion: May 2, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)