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Screening While You Wait 2: Alcohol and Tobacco Use (SWYW2)

2021年2月22日 更新者：Payal Agarwal、Women's College Hospital

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (予想される)

360

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • カナダ
    • Ontario
      • Toronto、Ontario、カナダ、M5S 1B2
        • 募集
        • Women's College Hospital
        • コンタクト：
        • 主任研究者：
          • Payal Agarwal, MD
        • 副調査官：
          • Noah Ivers, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：ヘルスサービス研究
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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.
介入なし：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Updated Cumulative Patient Profile (CPP) Status
時間枠：Baseline
Updated CPP statuses for Alcohol and Smoking
Baseline
Updated Cumulative Patient Profile (CPP) Status
時間枠：3 months post appointment
Updated CPP statuses for Alcohol and Smoking
3 months post appointment
Discussion around risky substance use in clinic visit
時間枠：3 days post appointment
Patient reported discussion (Y/N) around risky substance use in clinic visit
3 days post appointment

二次結果の測定

結果測定
メジャーの説明
時間枠
Level of satisfaction with intervention
時間枠：3 days post appointment
Patient's level of satisfaction (on a 5-point likert scale: Very satisfied, Somewhat satisfied, Neutral, Somewhat dissatisfied, Very dissatisfied) with intervention measured through a process evaluation questionnaire
3 days post appointment
PCP administration of treatment resources/programs
時間枠：3 days post appointment
Patient reported receival of treatment resources, referrals and programs
3 days post appointment
PCP administration of treatment resources/programs
時間枠：3 months post appointment
Patient reported receival of treatment resources, referrals and programs
3 months post appointment
PCP provisioning of pharmacotherapy
時間枠：3 days post appointment
Patient reported receival of prescriptions related to alcohol or tobacco use
3 days post appointment
PCP provisioning of pharmacotherapy
時間枠：3 months post appointment
Patient reported receival of prescriptions related to alcohol or tobacco use
3 months post appointment
Patient engagement with personalized toolkit
時間枠：3 months post appointment
Patient reported engagement with toolkit
3 months post appointment
Patient motivation and self-efficacy to change
時間枠：Baseline
Patient self-reported self-efficacy score is determined through 11 questions. Each question is scored from 1-4 (Not at all true, barely true, most true, exactly true). If the participant answers 'mostly true' or 'exactly true' to the majority of the statements (score of 30 or more) they have high self-efficacy. If participant answers 'barely true' or 'not at all true' to the majority of the statements (score of 29 or below), they have low self-efficacy.
Baseline
Patient motivation and self-efficacy to change
時間枠：3 months post appointment
Patient self-reported self-efficacy score is determined through 11 questions. Each question is scored from 1-4 (Not at all true, barely true, most true, exactly true). If the participant answers 'mostly true' or 'exactly true' to the majority of the statements (score of 30 or more) they have high self-efficacy. If participant answers 'barely true' or 'not at all true' to the majority of the statements (score of 29 or below), they have low self-efficacy.
3 months post appointment
Patient use of alcohol
時間枠：Baseline
Patient reported number of drinks per week. A higher score is likely to indicate harmful drinking or alcohol dependence.
Baseline
Patient use of alcohol
時間枠：Baseline
AUDIT score. A score of 8 or more is associated with harmful or hazardous drinking. A score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.
Baseline
Patient use of alcohol
時間枠：3 months post appointment
Patient reported number of drinks per week. A higher score is likely to indicate harmful drinking or alcohol dependence.
3 months post appointment
Patient use of alcohol
時間枠：3 months post appointment
AUDIT score. AUDIT score. A score of 8 or more is associated with harmful or hazardous drinking. A score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.
3 months post appointment
Patient use of tobacco
時間枠：Baseline
Patient reported number of cigarettes per week. A higher number is likely to indicate increased risk for negative health outcomes.
Baseline
Patient use of tobacco
時間枠：3 months post appointment
Patient reported number of cigarettes per week. A higher number is likely to indicate increased risk for negative health outcomes.
3 months post appointment
Proportion of consent
時間枠：Baseline
Proportion of patients that consented, completed the surveys at each time interval, and at follow-up (with reasons for refusal if applicable)
Baseline
Proportion of consent
時間枠：3 days post appointment
Proportion of patients that consented, completed the surveys at each time interval, and at follow-up (with reasons for refusal if applicable)
3 days post appointment
Proportion of consent
時間枠：3 months post appointment
Proportion of patients that consented, completed the surveys at each time interval, and at follow-up (with reasons for refusal if applicable)
3 months post appointment

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Women's College Hospital

捜査官

  • 主任研究者：Payal Agarwal, MD、Women's College Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年1月2日

一次修了 (予想される)

2021年4月2日

研究の完了 (予想される)

2021年8月2日

試験登録日

最初に提出

2020年6月23日

QC基準を満たした最初の提出物

2020年10月13日

最初の投稿 (実際)

2020年10月20日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月25日

QC基準を満たした最後の更新が送信されました

2021年2月22日

最終確認日

2021年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2019-0002-E

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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