Recruiting

Observational Study

Sponsor:

Women's College Hospital

Code:

NCT04594304

Conditions

Alcohol; Harmful Use

Tobacco Use

Tobacco Use Cessation

Alcohol Use, Unspecified

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Behavioral: Usual care plus eToolkit

Study Details

Brief summary:

This project aims to help patients improve their health through screening and treatment of risky alcohol and tobacco use. Previous studies show the best approach to reduce substance use includes routine screening, short discussions with a clinician, and tailored resources. Unfortunately, primary care providers (PCPs) do not often screen or provide evidence-based interventions. PCPs report lack of confidence, lack of awareness, and competing priorities as barriers to screening and providing evidence-based care. However, digital solutions can enable patient-initiated screening and overcome barriers in a manner that has the potential to be both efficient and effective.

The proposed project will test the feasibility of digital patient-initiated screening at the WCH Family Practice (WCH FP) for alcohol and tobacco use, building on work from the first iteration of Screen While You Wait (SWYW). The research team will email patients a secure link to a survey with screening questions assessing substance use and important contextual factors. The results will be summarized in the patient's chart with an automatic notification to the PCP. If the survey reveals risky behaviours, both the PCP and patient will receive a package of tailored resources for further care delivered through a customized website.

Conditions

Alcohol; Harmful Use

Tobacco Use

Tobacco Use Cessation

Alcohol Use, Unspecified

Study ID

NCT04594304

Start date

Jan 2, 2020

Status verified date

Feb, 2021

Completion date

Aug 2, 2021

Anticipated

Primary completion date

Apr 2, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult patients aged >18 who are rostered at WCH FP and have a clinical appointment booked with their PCP in the next 2 weeks
  • Have an email address in their EMR chart, and
  • Are under-screened for alcohol or tobacco use defined as either a) missing a tobacco or alcohol use status documented in the appropriate section of the cumulative patient profile (CPP) in their EMR or b) having an alcohol or tobacco use status that is positive (defined as any status but: ex-smoker, non-smoker, "rare"-drinker or non-drinker) and no CPX in the last year.

Exclusion Criteria:

  • Patients booked for an urgent care appointment (noted in the EMR), as it would not be appropriate to ask patients with acute issues (i.e., short-term severe injury or illness requiring relatively urgent medical attention) to spend extended time receiving alcohol and tobacco use counselling.
  • Patients with active risky alcohol or tobacco use who are already undergoing pharmacologic treatment
  • Currently pregnant patients will be excluded as pathways for diagnosing, counselling and treating substance use is different among this population. They will be identified through a question before the informed consent form appears asking for the patient's gender. If the patient identifies as a woman, a second question will appear that asks if they are currently pregnant. If yes, the survey will end and the participant will not be asked to complete the consent and survey.

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Personalized eToolkit

The intervention arm will receive a personalized eToolkit with community and electronic supports upon survey completion, and their PCP will receive automatic supports in the EMR to assess and treat the patient's alcohol and/or tobacco use. In cases where a patient does not have risky alcohol and tobacco use, a personalized eToolkit based on their physical activity levels will be administered, and their PCP will receive automatic supports in the EMR to facilitate physical activity discussions. Intervention arm patient participants will be asked to complete a baseline e-survey before their scheduled appointment, a process evaluation e-survey 3 days following their appointment, and a 3 months follow-up e-survey following their appointment. Resources will be automatically produced for the patient and PCP following completion of the baseline e-survey.

no intervention: Usual care

The control arm will not receive intervention materials. Control arm patient participants will be asked to complete a baseline e-survey before their scheduled appointment, a process evaluation e-survey 3 days following their appointment, and 3 months follow-up e-survey following their appointment.

Interventions

Behavioral: Usual care plus eToolkit

A baseline e-survey will be sent to participants prior to their scheduled appointment to collect baseline alcohol/tobacco use levels as well as a series of questions evaluating precursors to behaviour change. If randomized into the intervention group, patients will be sent a link to a tailored toolkit based on their behaviours, motivation to change and other pertinent factors. Patients who identify as non-smokers and meet the low-risk drinking guideline, will complete a third screening survey for physical activity. The cumulative patient profile (CPP) status for the patient for alcohol/smoking will be automatically updated post-baseline survey, and the PCP will receive a notification via EMR about the status update. For patients identifying with risky behaviours, the PCP will receive a prompt to update the CPP for the patient and will receive a link, embedded in the EMR, to a PCP-facing toolkit that facilitates evidence-based intervention.

Primary outcome measure

  • Updated Cumulative Patient Profile (CPP) Status [ Time Frame: Baseline ]
  • Updated Cumulative Patient Profile (CPP) Status [ Time Frame: 3 months post appointment ]
  • Discussion around risky substance use in clinic visit [ Time Frame: 3 days post appointment ]

Central Contacts and Locations

Central contacts

Natasha Kithulegoda, MPH

416-323-6400natasha.kithulegoda@wchospital.ca

Locations

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Contacts

Natasha Kithulegoda, MPH

416-323-6400natasha.kithulegoda@wchospital.ca

Principal Investigator:

Payal Agarwal, MD

More Information

Sponsor

Women's College Hospital

Last update posted

Feb 25, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women's College Hospital on 2021-02-25.