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

22 lutego 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

360

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M5S 1B2
        • Rekrutacyjny
        • Women's College Hospital
        • Kontakt:
        • Główny śledczy:
          • Payal Agarwal, MD
        • Pod-śledczy:
          • Noah Ivers, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Updated Cumulative Patient Profile (CPP) Status
Ramy czasowe: Baseline
Updated CPP statuses for Alcohol and Smoking
Baseline
Updated Cumulative Patient Profile (CPP) Status
Ramy czasowe: 3 months post appointment
Updated CPP statuses for Alcohol and Smoking
3 months post appointment
Discussion around risky substance use in clinic visit
Ramy czasowe: 3 days post appointment
Patient reported discussion (Y/N) around risky substance use in clinic visit
3 days post appointment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Level of satisfaction with intervention
Ramy czasowe: 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
Ramy czasowe: 3 days post appointment
Patient reported receival of treatment resources, referrals and programs
3 days post appointment
PCP administration of treatment resources/programs
Ramy czasowe: 3 months post appointment
Patient reported receival of treatment resources, referrals and programs
3 months post appointment
PCP provisioning of pharmacotherapy
Ramy czasowe: 3 days post appointment
Patient reported receival of prescriptions related to alcohol or tobacco use
3 days post appointment
PCP provisioning of pharmacotherapy
Ramy czasowe: 3 months post appointment
Patient reported receival of prescriptions related to alcohol or tobacco use
3 months post appointment
Patient engagement with personalized toolkit
Ramy czasowe: 3 months post appointment
Patient reported engagement with toolkit
3 months post appointment
Patient motivation and self-efficacy to change
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Women's College Hospital

Śledczy

  • Główny śledczy: Payal Agarwal, MD, Women's College Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 stycznia 2020

Zakończenie podstawowe (Oczekiwany)

2 kwietnia 2021

Ukończenie studiów (Oczekiwany)

2 sierpnia 2021

Daty rejestracji na studia

Pierwszy przesłany

23 czerwca 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 października 2020

Pierwszy wysłany (Rzeczywisty)

20 października 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 lutego 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 lutego 2021

Ostatnia weryfikacja

1 lutego 2021

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2019-0002-E

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Nie

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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