Smoking Reduction: Testing a Novel Approach to Cessation in Primary Care Practice Settings

NCT03128554 | Terminated

• 1 other identifier: 20170061-01H
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Traditional models of smoking cessation focus on delivering advice and counseling to quit and providing assistance to patients ready to quit smoking, but do not actively intervene with patients who are not ready to quit (NRTQ). This abrupt cessation approach is often not an appealing option to those not ready to quit, however, a reduction approach can seem more attainable and engaging. In response to this need, this smoking cessation intervention has been developed. This research is part of a pilot study to assess the feasibility of introducing a NRTQ intervention in a primary care setting. This study will also assess the effectiveness of increasing the number of smoking reduction interventions delivered, provider confidence and satisfaction, relative to control practice. Outcomes will be assessed by a pre-survey and a three-month follow-up survey, administered to all study participants. All study participants will also be asked to fill out brief NRTQ consult forms for each NRTQ patient they encounter for a two-week period. Additionally, participants randomized to the intervention arm will receive training, and access to tools and resources.

Conditions

Smoking Cessation

Keywords

Not Ready to Quit; Primary Care; Tobacco; Reduce to Quit; Smoking Reduction

Outcome Measures

Primary Outcomes (2)

• Feasibility of Providing the Intervention Measured by the Participation Rate

  The feasibility of introducing a not ready to quit (NRTQ) intervention in a primary care setting by measuring the participation rate (i.e. Practitioner recruitment). The study will evaluate the number of providers who agree to participate divided by the total number of providers who are sent an invitation letter.

  1 year

• Feasibility of Providing the Intervention Measured by the Consult Completion Rate

  The feasibility of introducing a not ready to quit (NRTQ) intervention in a primary care setting by measuring the NRTQ consult completion rate. The number of NRTQ consults completed per physician in the intervention group and the control group will be evaluated and compared.

  1 year

Secondary Outcomes (3)

• Increasing the number of reduction interventions provided by providers

  3 months

• Increasing provider confidence in addressing tobacco use among patients NRTQ

  3 months

• Assessing provider satisfaction with the smoking reduction intervention program: post-intervention survey

  3 months

Study Arms (2)

Intervention with Training and Materials

EXPERIMENTAL

Clinics randomized to the intervention group will receive a one time, 2-hour Continuing Medical Education/Group Learning training session on the smoking reduction intervention model, along with provider and patient handouts.

Other: Intervention with Training and Materials

Usual Care

NO INTERVENTION

Clinics randomized to the control group will not be exposed to the intervention program.

Interventions

Intervention with Training and Materials OTHER

Peer-Led Continuing Medical Education Session and Provider/Patient Handouts

Intervention with Training and Materials

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care practice from the existing OMSC network
• Primary care practice is staffed by ≥ 4 MDs/NPs/RNs/Pharmacists
• A minimum of four clinicians within the practice are willing to participate

You may not qualify if:

• Actively using a Reduce to Quit protocol in practice

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• University of Ottawa: collaborator
• The Ottawa Hospital: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 1J7, Canada

Location

Related Links

• Website for the Ottawa Model for Smoking Cessation

MeSH Terms

Conditions

Smoking Cessation; Smoking Reduction

Interventions

Methods

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Vanessa Murley, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 25, 2017
• Study Start: March 25, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)