Clinical trial NCT04594304: Screening While You Wait 2: Alcohol and Tobacco Use
Official title: Screening While You Wait 2: Alcohol and Tobacco Use
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol; Harmful Use
Tobacco Use
Tobacco Use Cessation
Alcohol Use, Unspecified
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An independent statistician following a 2:1 ratio to increase opportunities to learn about the intervention processes during this pilot trial will randomly allocate consenting patients following the completion of their baseline survey to intervention or usual care using a computer-generated sequence.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Burden of Alcohol and Tobacco: According to the World Health Organization (WHO), approximately 5.9% of total global deaths are attributable to alcohol consumption. It is estimated that tobacco kills more than 7 million people each year globally. In Ontario alone, approximately 9,800 new cases of cancer diagnosed in a single year could be attributed to tobacco, while 1,000 cases a year could be attributed to alcohol consumption. Despite this evidence, 15.2% of Canadian adults reported drinking more alcohol than the low-risk guidelines, while 15% reported using a tobacco product in the last 30 days.

Addressing Alcohol and Tobacco Together: The health issues associated with tobacco and alcohol use are diverse and pervasive. Many of the health concerns associated with each substance are exacerbated by use of the other (i.e. smokers who also drink alcohol are at an increased risk for cancers of the oral cavity). Further, it has been found that Ontarians who drink alcohol above the recommended safe guidelines are more likely to be smokers. It thus follows that any widespread screening program should target identification of both behaviours. This is supported by recent work that found that alcohol and tobacco use are "often treated separately despite concurrent treatment potentially leading to better outcomes for each".

PCPs are uniquely positioned to impact health behaviours of their patients. Strong evidence and relevant guidelines encourage PCPs to consistently ask about tobacco and alcohol use as a crucial first step to identifying and treating risky behaviours. However, current clinical practice does not live up to these guidelines. A recent report showed that only 23% of patients in Canada had spoken with their providers about alcohol use in the past two years. Furthermore, screening is often limited to periodic health exam visits (i.e. 'complete physicals'), leading to missed opportunities to screen at visit types which may provide key teachable moments, as well as missing patients who may not be coming in for preventative health visits.

Digital, patient-initiated screening is increasingly being recognised as a promising method to improve screening rates by overcoming commonly identified screening barriers. Several small-scale studies have shown that digital, patient-initiated screening can be an efficient method of systematic screening in primary care with high acceptance and usability by patients. These methods may also empower patients to become more engaged in their own health care, particularly those who are both most likely to have risky behaviours and least likely to book preventative care visits.

Eligibility criteria: 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.

Primary outcomes:
measure: Updated Cumulative Patient Profile (CPP) Status
timeFrame: Baseline
measure: Updated Cumulative Patient Profile (CPP) Status
timeFrame: 3 months post appointment
measure: Discussion around risky substance use in clinic visit
timeFrame: 3 days post appointment
Secondary outcomes:
measure: Level of satisfaction with intervention
timeFrame: 3 days post appointment
measure: PCP administration of treatment resources/programs
timeFrame: 3 days post appointment
measure: PCP administration of treatment resources/programs
timeFrame: 3 months post appointment
measure: PCP provisioning of pharmacotherapy
timeFrame: 3 days post appointment
measure: PCP provisioning of pharmacotherapy
timeFrame: 3 months post appointment
measure: Patient engagement with personalized toolkit
timeFrame: 3 months post appointment
measure: Patient motivation and self-efficacy to change
timeFrame: Baseline
measure: Patient motivation and self-efficacy to change
timeFrame: 3 months post appointment
measure: Patient use of alcohol
timeFrame: Baseline
measure: Patient use of alcohol
timeFrame: Baseline
measure: Patient use of alcohol
timeFrame: 3 months post appointment
measure: Patient use of alcohol
timeFrame: 3 months post appointment
measure: Patient use of tobacco
timeFrame: Baseline
measure: Patient use of tobacco
timeFrame: 3 months post appointment
measure: Proportion of consent
timeFrame: Baseline
measure: Proportion of consent
timeFrame: 3 days post appointment
measure: Proportion of consent
timeFrame: 3 months post appointment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Payal Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Minian N, Baliunas D, Zawertailo L, Noormohamed A, Giesbrecht N, Hendershot CS, Le Foll B, Rehm J, Samokhvalov A, Selby PL. Combining alcohol interventions with tobacco addictions treatment in primary care-the COMBAT study: a pragmatic cluster randomized trial. Implement Sci. 2017 May 18;12(1):65. doi: 10.1186/s13012-017-0595-7.
citation: Papadakis S, Cole AG, Reid RD, Coja M, Aitken D, Mullen KA, Gharib M, Pipe AL. Increasing Rates of Tobacco Treatment Delivery in Primary Care Practice: Evaluation of the Ottawa Model for Smoking Cessation. Ann Fam Med. 2016 May;14(3):235-43. doi: 10.1370/afm.1909.
citation: Carey M, Noble N, Mansfield E, Waller A, Henskens F, Sanson-Fisher R. The Role of eHealth in Optimizing Preventive Care in the Primary Care Setting. J Med Internet Res. 2015 May 22;17(5):e126. doi: 10.2196/jmir.3817.
citation: Kumar PC, Cleland CM, Gourevitch MN, Rotrosen J, Strauss S, Russell L, McNeely J. Accuracy of the Audio Computer Assisted Self Interview version of the Alcohol, Smoking and Substance Involvement Screening Test (ACASI ASSIST) for identifying unhealthy substance use and substance use disorders in primary care patients. Drug Alcohol Depend. 2016 Aug 1;165:38-44. doi: 10.1016/j.drugalcdep.2016.05.030. Epub 2016 Jun 22.
citation: Rogausch A, Sigle J, Seibert A, Thuring S, Kochen MM, Himmel W. Feasibility and acceptance of electronic quality of life assessment in general practice: an implementation study. Health Qual Life Outcomes. 2009 Jun 3;7:51. doi: 10.1186/1477-7525-7-51.
citation: Hess R, Santucci A, McTigue K, Fischer G, Kapoor W. Patient difficulty using tablet computers to screen in primary care. J Gen Intern Med. 2008 Apr;23(4):476-80. doi: 10.1007/s11606-007-0500-1.