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Personalized Alerts and Care Pathways to Prompt Prevention Interventions for Alcohol and Tobacco Users in Primary Care (COMBAT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Dr. Peter Selby, Centre for Addiction and Mental Health
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Dr. Peter Selby, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT03108144
First received: April 5, 2017
Last updated: April 11, 2017
Last verified: April 2017
  Purpose

Tobacco and alcohol use present multiplicative risk for aerodigestive cancers. Reducing alcohol consumption improves smoking cessation outcomes and reduces cancer risk. Risky alcohol consumption and smoking are often treated separately despite concurrent treatment potentially leading to better outcomes for each. However, no rapidly scalable program exists for combined interventions in primary care clinics spread across wide geographic areas. This cluster randomized trial aims to report on the effects of a novel clinical decision support system (CDSS) on intervention rates by primary care practitioners addressing risky alcohol use in a smoking cessation program.

The investigators will be implementing a clinical decision support system (CDSS) in 221 primary care sites participating in the Smoking Treatment for Ontario Patients (STOP) program across Ontario, Canada. Sites will be blindly allocated to one of two clinical decision support systems guiding practitioners to provide a risky alcohol use intervention to smokers attempting to quit using nicotine replacement therapy (NRT). Risky alcohol use is defined as drinking above the Canadian Cancer Society's low-risk drinking guidelines. Primary analysis will measure the proportion of risky drinkers offered an alcohol intervention in each CDSS arm at baseline. Patients will be contacted by phone or email to track smoking cessation and alcohol consumption rates at 6- and 12-month follow up.

Upon completion of the trial, the effect of different clinical decision support systems on practitioner behavior, and on client tobacco and alcohol use, will be discussed. If the CDSS successfully promotes SBIRT for risky alcohol use in a primary care setting and/or improves patient-level outcomes, including smoking cessation rates and alcohol use reduction, this tool can be used as a model for other web-based behavior change interventions integrated into primary care practice.


Condition Intervention
Cancer
Behavioral: Brief alcohol intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Organizations will be randomly allocated in a 1:1 allocation ratio to Group A (Test) or Group B (Control) accounting for rurality, organization type, practice size and academic affiliation.
Masking: Investigator
Primary Purpose: Prevention
Official Title: Personalized Patient Alerts and Care Pathways to Prompt Prevention Interventions for Combined Alcohol and Tobacco Users in Primary Care

Further study details as provided by Dr. Peter Selby, Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Intervention offer by practitioner [ Time Frame: Approximately 10 minutes during 1-hour appointment between practitioner and patient ]
    The study's primary outcome is the proportion of health practitioners who offer the brief alcohol intervention (with educational resource) to eligible patients.


Secondary Outcome Measures:
  • Intervention delivery by practitioner [ Time Frame: Approximately 10 minutes during 1-hour appointment between practitioner and patient ]
    The study's secondary outcome is the proportion of health practitioners who deliver the brief alcohol intervention (with educational resource) to eligible patients (patient accepts practitioner's offer of intervention).

  • Smoking cessation and non-risky drinking [ Time Frame: 6-month follow-up ]
    The study's tertiary outcome is the proportion of eligible participants who report being abstinent from smoking and meet CCS alcohol guidelines at follow-up.


Estimated Enrollment: 15000
Actual Study Start Date: April 11, 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control - Group A
When a patient is identified as consuming alcohol above CCS guidelines (based on mandatory baseline questionnaire) the practitioner in Group A will not receive computer alerts but will still have access to the alcohol consumption data as part of the baseline assessment (Screening). Healthcare providers will have access to all the same resources available as the intervention clinic (Treatment as usual).
Experimental: Intervention - Group B
When a patient is identified as consuming alcohol above CCS guidelines (based on mandatory baseline questionnaire) the practitioner in Group B will receive computer alerts (Screening). The alert will provide a 5 minute script (Brief Intervention) for the health care providers to relay to patients and the ability to print or email a self-help resource to the patient each time the patient visits (Referral to Treatment).
Behavioral: Brief alcohol intervention
The intervention is a clinical decision support system (CDSS) that provides a computerized prompt in the clinic's online portal. The CDSS prompts a practitioner to intervene when a patient is screening above recommended drinking guidelines. The prompt appears as an alert message, recommending intervention. The portal suggests scripted brief intervention language, designed based on the College of Family Physicians of Canada and Canadian Centre on Substance Abuse's resource on conducting evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) guidelines.

Detailed Description:

Background: Primary care providers work in busy settings responding to a variety of acute and chronic problems. Implementing even brief evidence-based interventions for cancer risk behaviors, such as tobacco smoking and excess alcohol consumption, is sub-optimal due to time and knowledge constraints. These behaviors cluster in the same person and confer a multiplicative, positively associated risk for aero-digestive cancers but are often addressed separately, if at all, despite alcohol consumption undermining smoking cessation. Processes that reduce time and effort and yet increase practitioner effectiveness show promise to increase adoption of such practices. Computerized clinical decision support systems (CDSS) within practices allow for prompt procedural knowledge for practitioners, simplifies the decision-making process, and provides recommendations for patient care.

The initiation of the STOP Program (Smoking Treatment for Ontario Patients - an Ontario-wide initiative providing smoking cessation to eligible smokers who wish to quit), has demonstrated that such a system allows for rapid adoption of smoking cessation interventions in primary care with 189 sites (80% of eligible sites) in Ontario treating 40,000 smokers in 2 years. Approximately 36% consume alcohol above Canadian Cancer Society (CCS) guidelines (less than one drink per day for women; less then two drinks per day for men; no engagement in binge drinking) and those that do have a lower quit rate.

A combined alcohol and tobacco intervention delivered systematically using such a platform has never been studied before, which constitutes a missed opportunity to simultaneously address two closely related risk factors for cancer. Thus, implementation of a CDSS within the daily clinical workflow is a novel concept for cancer prevention with high potential to address the lack of brief interventions by health care providers.

Objective: Assess the effectiveness of a CDSS to increase the rates of brief alcohol intervention by healthcare providers and to reduce alcohol consumption in adult smokers making a quit attempt.

Methodology: Organizations from the STOP Program will be randomly allocated (1:1) to Group A or Group B.

Patient Population: Adult consenting smokers of the STOP Program identified as drinking above the sex-specific cut off at baseline will be eligible for the intervention.

Intervention: Half the sites will have a computer prompt built into STOP's data collection system, which will appear for any participant identified as drinking above the sex-specific cut off at baseline (Group A). The reminder will provide the practitioners with a five minute script advising their patient to reduce alcohol consumption to increase their chances of quitting smoking, and will be prompted to provide a self-help booklet to reduce alcohol intake. Sites without the prompt (Group B) will not receive reminders but will have access to the same resources.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participating clinics must be Family Health Team, Community Health Centre, or Nurse Practitioner-Led Clinic (primary care clinics) participating in the Smoking Treatment for Ontario Patients (STOP) program
  • Clinic must use online portal to complete STOP questionnaires, in English, in real-time with patient

Exclusion Criteria:

  • Non-primary care clinics participating in STOP program
  • Clinics who conduct STOP questionnaires exclusively on paper, or in French, or not in real-time with patient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03108144

Contacts
Contact: Peter Selby, MBBS CCFP FCFP MHSc DipABAM 416-535-8501 ext 77432 Peter.Selby@camh.ca
Contact: Nadia Minian, PhD 416-535-8501 ext 77420 Nadia.Minian2@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5T1P7
Contact: Peter Selby, MBBS CCFP FCFP MHSc DipABAM    416-535-8501 ext 77432    Peter.Selby@camh.ca   
Contact: Sarwar Hussain, MHSc    416-535-8501 ext 77417    Sarwar.Hussain@camh.ca   
Principal Investigator: Peter Selby, MBBS CCFP FCFP MHSc DipABAM         
Sub-Investigator: Nadia Minian, PhD         
Sub-Investigator: Laurie Zawertailo, PhD         
Sub-Investigator: Dolly Baliunas, PhD         
Sub-Investigator: Christian Hendershot, PhD, CPsych         
Sub-Investigator: Andriy Samokhvalov, MD, PhD         
Sub-Investigator: Norman Giesbrecht, PhD         
Sub-Investigator: Jurgen Rehm, PhD         
Sub-Investigator: Bernard Le Foll, MD, PhD, CCFP         
Sub-Investigator: John Cunningham, PhD         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: Peter Selby, MBBS CCFP FCFP MHSc DipABAM Centre for Addiction and Mental Health
  More Information

Responsible Party: Dr. Peter Selby, Director, Medical Education, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03108144     History of Changes
Other Study ID Numbers: 035-2015
Study First Received: April 5, 2017
Last Updated: April 11, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Peter Selby, Centre for Addiction and Mental Health:
smoking cessation
alcohol
primary care
screening
brief intervention
referral to treatment
cancer risk

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017