NCT03380910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 26, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

December 15, 2017

Last Update Submit

February 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in smoking abstinence

    Smoking abstinence will be measured by breath carbon monoxide level

    Baseline to 6 months

Secondary Outcomes (4)

  • Change in Readiness to Quit Smoking

    Baseline to 6 months

  • Change in Nicotine Dependence

    Baseline to 6 months

  • Change in Number of Cigarettes Smoked

    Baseline to 6 months

  • Change Carbon Monoxide Levels

    Baseline to 6 months

Study Arms (2)

Ready to Quit

EXPERIMENTAL

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

Not Ready to Quit

OTHER

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

Interventions

An interdisciplinary approach using medications through pharmacy support and counseling through behavioral health team members will be used to improve smoking cessation rates.

Ready to Quit

Patients not ready to quit will be offered motivational interviewing to increase readiness to quit.

Not Ready to Quit

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spanish-speaking
  • Uninsured
  • Current cigarette smoker

You may not qualify if:

  • Pregnant or breastfeeding
  • Heart attack or stroke in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CrossOver Healthcare Ministry

Henrico, Virginia, 23229, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Dosage FormsMotivational Interviewing

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative TechniquesDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2017

First Posted

December 21, 2017

Study Start

January 26, 2018

Primary Completion

January 20, 2020

Study Completion

January 20, 2020

Last Updated

February 15, 2021

Record last verified: 2021-02

Locations