Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04223336 |
| Other study ID # |
119-2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2019 |
| Est. completion date |
May 2, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Centre for Addiction and Mental Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Tobacco use, in particular, continues to be the leading cause of preventable death, with a
recent review identifying strong associations between tobacco and other modifiable risk
behaviours. Tobacco users tend to consume more alcohol, eat less fruits and vegetables and
report less minutes of leisure physical activity as compared with non-tobacco users. The
clustering of these modifiable risk behaviours among tobacco users not only translates a
heightened risk for cardiovascular disease but may also negatively influence the likelihood
of successful smoking cessation. Alcohol consumed even in small amounts, has been shown to
increase cravings for smoking, thus increasing risk of relapse to smoking. Increasing
physical activity levels can help to reduce tobacco withdrawal and cravings, as well as
minimize the reward anticipation. Individuals also often misattribute the reversal of
withdrawal symptoms (i.e. irritability) from smoking as relief from stress. This can also
increase the risk of relapse when attempting to quit.
In addition to the more direct relationships between these health behaviours and smoking
cessation, successfully changing one or more behaviours may also help to increase
self-efficacy and self-confidence to change other health behaviours that individuals may be
less motivated to act on. As a result, targeting multiple risk behaviours in smokers may help
maximize health promotion efforts by augmenting smoking abstinence rates, improving overall
health, and reducing healthcare-related costs. In order to address this, the Smoking
Treatment for Ontario Patients (STOP) Program (REB#: 058-2011), a province-wide initiative
that uses the existing healthcare infrastructure to provide smoking cessation support to
smokers in Ontario, has been developed and is currently testing a web-enabled Integrated Care
Pathways (ICP) for some of these behaviours. In 2016, the STOP program started offering
specialized clinical pathways through the STOP Portal (a web-based platform and an online
data collection/management tool used by the STOP practitioners to complete participant
enrollment and record smoking status at each visit) for smokers who drink above Canadian
Cancer Society guidelines (REB# 035-2015). In 2018, it added a specialized ICP for those who
have mood disorders (REB#: 065-2016). However, there are currently no web-enabled tools in
the STOP program that also address some of the other well-known modifiable risk factors such
as: physical activity, and diet.
There is substantial high quality evidence that shows the effectiveness of screening for
these behaviors, providing a brief intervention, and referral to treatment when needed for
helping patients quit smoking as well as change other behaviours. Moreover, a recent
systematic review of behaviour change techniques practitioners can use to promote health
behaviour change in patients found that, relative to other techniques, 'risk communication'
and 'self-monitoring of behaviour' are the most effective techniques.
As a result, we designed the intervention - an integrated care pathway that facilitates
practitioners to deliver a brief intervention that includes risk communication, and provides
tools for patients to monitor their health behaviours to STOP patients who have at least one
of the following other modifiable risk factors at baseline: low levels of physical activity,
and low levels of fruits/vegetable consumption. Low levels of physical activity will be
defined as being below the Canadian national guidelines: less than 150 min per week of
moderate-to-vigorous activity. Low fruits and vegetable is defined as being below the 2007
Canada's Food Guide: less than 7 servings (female) or 8 servings (male) of fruits/vegetable
per day.
The specific components of the intervention are outlined below:
1. Systematic screening through the STOP portal for STOP participants with at least one of
the following risk factors: low levels of physical activity, and low fruits/vegetable
consumption.
2. Have computer prompts that advise the practitioner of patient's risk factors, and to
provide a brief intervention that includes how the identified risk factors affect the
patient's ability to quit successfully (Risk communication).
3. Provision of self-monitoring tool(s) for monitoring physical activity and/or
fruits/vegetable consumption levels.
This study aims to assess whether the addition of an ICP for physical activity and diet into
Family Health Teams (FHTs), Community Health Centres (CHCs), and Nurse Practitioner-led
Clinics (NPLCs) participating in the STOP program is associated with participants' quit rate
at 6 month follow-up. Individuals enrolling into the STOP program through one of these
organizations will be randomly allocated (1:1) to control vs intervention group. In addition,
we hope to gather insights on how this ICP can be most helpful to organizations, staff and
patients, thereby informing implementation processes in other primary care settings across
Canada/ Ontario. Our evaluation includes patient, clinician, and organization-level outcomes.
To organize this multifaceted evaluation, we use the Reach, Efficacy, Adoption,
Implementation, and Maintenance (RE-AIM) framework.
