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

NCT03108144 | Completed

• 1 other identifier: 035-2015
• Study Type: interventional
• Target: 15,222
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

smoking cessation; alcohol; primary care; screening; brief intervention; referral to treatment; cancer risk

Outcome Measures

Primary Outcomes (1)

• Intervention offer by practitioner

  The study's primary outcome is the proportion of health practitioners who offer the brief alcohol intervention (with educational resource) to eligible patients.

  Approximately 10 minutes during 1-hour appointment between practitioner and patient

Secondary Outcomes (2)

• Intervention delivery by practitioner

  Approximately 10 minutes during 1-hour appointment between practitioner and patient

• Smoking cessation and non-risky drinking

  6-month follow-up

Study Arms (2)

Control - Group A

NO INTERVENTION

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).

Intervention - Group B

EXPERIMENTAL

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

Interventions

Brief alcohol intervention BEHAVIORAL

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.

Intervention - Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T1P7, Canada

Location

Related Publications (4)

• Minian N, Noormohamed A, Lingam M, Zawertailo L, Le Foll B, Rehm J, Giesbrecht N, Samokhvalov AV, Baliunas D, Selby P. Integrating a brief alcohol intervention with tobacco addiction treatment in primary care: qualitative study of health care practitioner perceptions. Addict Sci Clin Pract. 2021 Mar 16;16(1):17. doi: 10.1186/s13722-021-00225-x.

  PMID: 33726843 DERIVED

• Minian N, Baliunas D, Noormohamed A, Zawertailo L, Giesbrecht N, Hendershot CS, Le Foll B, Rehm J, Samokhvalov AV, Selby PL. The effect of a clinical decision support system on prompting an intervention for risky alcohol use in a primary care smoking cessation program: a cluster randomized trial. Implement Sci. 2019 Aug 23;14(1):85. doi: 10.1186/s13012-019-0935-x.

  PMID: 31443663 DERIVED

• Minian N, Noormohamed A, Zawertailo L, Baliunas D, Giesbrecht N, Le Foll B, Rehm J, Samokhvalov A, Selby PL. A method for co-creation of an evidence-based patient workbook to address alcohol use when quitting smoking in primary care: a case study. Res Involv Engagem. 2018 Feb 5;4:4. doi: 10.1186/s40900-018-0086-2. eCollection 2018.

  PMID: 29445521 DERIVED

• 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.

  PMID: 28521782 DERIVED

MeSH Terms

Conditions

Neoplasms; Smoking Cessation

Interventions

Ethanol; Methods

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Study Officials

• Peter Selby, MBBS CCFP FCFP MHSc DipABAM

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Medical Education

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: April 11, 2016
• Primary Completion: September 1, 2017
• Study Completion: April 1, 2018
• Last Updated: June 21, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)