Alcohol; Harmful UseSWYW2NCT04594304
Screening While You Wait 2: Alcohol and Tobacco Use
A study of Alcohol; Harmful Use and Tobacco Use, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol; Harmful Use, Tobacco Use, Tobacco Use Cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2020to 2 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B2
Natasha Kithulegoda, MPH, 416-323-6400 ext. 8356, natasha.kithulegoda@wchospital.ca
Payal Agarwal, MD
About this study
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.
Read the 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.
- Being tested
- Behavioral: Usual care plus eToolkit
- Medical subject headings
- Tobacco Use, Tobacco Use Cessation, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Usual care plus eToolkitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized eToolkit | Experimental | 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. Receives: Behavioral: Behavioral: Usual care plus eToolkit |
| Usual care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Updated Cumulative Patient Profile (CPP) Status
Updated CPP statuses for Alcohol and Smoking
Measured: Baseline
Updated Cumulative Patient Profile (CPP) Status
Updated CPP statuses for Alcohol and Smoking
Measured: 3 months post appointment
Discussion around risky substance use in clinic visit
Patient reported discussion (Y/N) around risky substance use in clinic visit
Measured: 3 days post appointment
Secondary outcomes (17)
Level of satisfaction with intervention
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
Measured: 3 days post appointment
PCP administration of treatment resources/programs
Patient reported receival of treatment resources, referrals and programs
Measured: 3 days post appointment
PCP administration of treatment resources/programs
Patient reported receival of treatment resources, referrals and programs
Measured: 3 months post appointment
PCP provisioning of pharmacotherapy
Patient reported receival of prescriptions related to alcohol or tobacco use
Measured: 3 days post appointment
PCP provisioning of pharmacotherapy
Patient reported receival of prescriptions related to alcohol or tobacco use
Measured: 3 months post appointment
Patient engagement with personalized toolkit
Patient reported engagement with toolkit
Measured: 3 months post appointment
Patient motivation and self-efficacy to change
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.
Measured: Baseline
Patient motivation and self-efficacy to change
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.
Measured: 3 months post appointment
Patient use of alcohol
Patient reported number of drinks per week. A higher score is likely to indicate harmful drinking or alcohol dependence.
Measured: Baseline
Patient use of alcohol
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.
Measured: Baseline
Patient use of alcohol
Patient reported number of drinks per week. A higher score is likely to indicate harmful drinking or alcohol dependence.
Measured: 3 months post appointment
Patient use of alcohol
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.
Measured: 3 months post appointment
Patient use of tobacco
Patient reported number of cigarettes per week. A higher number is likely to indicate increased risk for negative health outcomes.
Measured: Baseline
Patient use of tobacco
Patient reported number of cigarettes per week. A higher number is likely to indicate increased risk for negative health outcomes.
Measured: 3 months post appointment
Proportion of consent
Proportion of patients that consented, completed the surveys at each time interval, and at follow-up (with reasons for refusal if applicable)
Measured: Baseline
Proportion of consent
Proportion of patients that consented, completed the surveys at each time interval, and at follow-up (with reasons for refusal if applicable)
Measured: 3 days post appointment
Proportion of consent
Proportion of patients that consented, completed the surveys at each time interval, and at follow-up (with reasons for refusal if applicable)
Measured: 3 months post appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start2 Jan 2020
- Primary completion2 Apr 2021 (estimated)
- Study completion2 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alcohol; Harmful UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Payal Agarwal, Women's College Hospital
- Investigators
- Payal Agarwal, MD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594304
- Sponsor's protocol ID
- 2019-0002-E
- Acronym
- SWYW2
- Status last verified
- Feb 2021
- First submitted
- 23 Jun 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28521782Papadakis 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.
PubMed 27184994Carey 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.
PubMed 26001983Kumar 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.
PubMed 27344194Rogausch 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.
PubMed 19493355Hess 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.
PubMed 18373148
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening While You Wait 2: Alcohol and Tobacco Use
- ClinicalTrials.gov ID
- NCT04594304
- Acronym / sponsor ID
- SWYW2 / 2019-0002-E
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 2 Apr 2021 (estimated)
- Study completion
- 2 Aug 2021 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Personalized eToolkit | Experimental | Behavioral: Behavioral: Usual care plus eToolkitThe 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. |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Usual care plus eToolkitA 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. | Behavioural | Personalized eToolkit |
Primary outcome
Updated Cumulative Patient Profile (CPP) Status
Time frame: Baseline
Updated CPP statuses for Alcohol and Smoking
Updated Cumulative Patient Profile (CPP) Status
Time frame: 3 months post appointment
Updated CPP statuses for Alcohol and Smoking
Discussion around risky substance use in clinic visit
Time frame: 3 days post appointment
Patient reported discussion (Y/N) around risky substance use in clinic visit
17 secondary outcomes
Level of satisfaction with intervention
Time frame: 3 days post appointment
PCP administration of treatment resources/programs
Time frame: 3 days post appointment
PCP administration of treatment resources/programs
Time frame: 3 months post appointment
PCP provisioning of pharmacotherapy
Time frame: 3 days post appointment
PCP provisioning of pharmacotherapy
Time frame: 3 months post appointment
Patient engagement with personalized toolkit
Time frame: 3 months post appointment
Patient motivation and self-efficacy to change
Time frame: Baseline
Patient motivation and self-efficacy to change
Time frame: 3 months post appointment
Patient use of alcohol
Time frame: Baseline
Patient use of alcohol
Time frame: Baseline
Patient use of alcohol
Time frame: 3 months post appointment
Patient use of alcohol
Time frame: 3 months post appointment
Patient use of tobacco
Time frame: Baseline
Patient use of tobacco
Time frame: 3 months post appointment
Proportion of consent
Time frame: Baseline
Proportion of consent
Time frame: 3 days post appointment
Proportion of consent
Time frame: 3 months post appointment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Background: PubMed 28521782Minian 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.
- Background: PubMed 27184994Papadakis 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.
- Background: PubMed 26001983Carey 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.
- Background: PubMed 27344194Kumar 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.
- Background: PubMed 19493355Rogausch 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.
- Background: PubMed 18373148Hess 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Payal Agarwal, MD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Alcohol; Harmful Use and Tobacco Use, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natasha Kithulegoda, MPH (416-323-6400 ext. 8356, natasha.kithulegoda@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Updated Cumulative Patient Profile (CPP) Status (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04594304, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.