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An Interprofessional Intervention to Reduce Smoking Rates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03380910
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Brief Summary:
The purpose of this study is to test the effectiveness of an experimental process to aid Spanish-speaking patients in quitting smoking with the help of pharmacists and behavioral health psychologist trainees and clinicians.

Condition or disease Intervention/treatment Phase
Smoking, Cigarette Behavioral: Pharmacy and Behavioral Health Team Behavioral: Motivational Interviewing Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Interprofessional Intervention With Behavioral Health and Pharmacy Trainees to Reduce Smoking Rates at a Free Health Clinic in Richmond
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : January 20, 2020
Actual Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ready to Quit
Current patients who speak Spanish, smoke cigarettes, and are ready to quit will be included. The intervention includes an interdisciplinary team approach using pharmacy and behavioral health trainees to provide smoking cessation services.
 Behavioral: Pharmacy and Behavioral Health Team
An interdisciplinary approach using medications through pharmacy support and counseling through behavioral health team members will be used to improve smoking cessation rates.
Not Ready to Quit
Current patients who speak Spanish, smoke cigarettes, and are not ready to quit will be included. The intervention includes an interdisciplinary team approach using pharmacy and behavioral health trainees to provide smoking cessation services.
 Behavioral: Motivational Interviewing
Patients not ready to quit will be offered motivational interviewing to increase readiness to quit.


Outcome Measures
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Primary Outcome Measures :
  1. Change in smoking abstinence [ Time Frame: Baseline to 6 months ]
    Smoking abstinence will be measured by breath carbon monoxide level


Secondary Outcome Measures :
  1. Change in Readiness to Quit Smoking [ Time Frame: Baseline to 6 months ]
    Improvement in readiness to quit will be measured by the quit ladder

  2. Change in Nicotine Dependence [ Time Frame: Baseline to 6 months ]
    Nicotine dependence will be measured by the Fagerstrom scale

  3. Change in Number of Cigarettes Smoked [ Time Frame: Baseline to 6 months ]
    Change in the number of cigarettes smoked will be measured by patient reported values

  4. Change Carbon Monoxide Levels [ Time Frame: Baseline to 6 months ]
    Measured by Carbon Monoxide Meter


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spanish-speaking
  • Uninsured
  • Current cigarette smoker

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Heart attack or stroke in the last 3 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380910


Locations
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United States, Virginia
CrossOver Healthcare Ministry
Henrico, Virginia, United States, 23229
Sponsors and Collaborators
Virginia Commonwealth University
More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03380910    
Other Study ID Numbers: HM20010390
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021

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