Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics

Tobacco Smoking Clinical Trial

— IMPACT  

Official title:

Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796961
• Other study ID #: IRB00231836
• Secondary ID: 1P50MH115842-01
• Status: Completed
• Phase: N/A
• Start date: March 12, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study will examine whether an implementation intervention will improve delivery of evidence-based treatment for tobacco smoking cessation for patients in community mental health clinics.

Description:

In this pilot study, the investigators will work with community mental health clinical and pilot test an implementation intervention to improve mental health providers' delivery of evidence-based tobacco smoking cessation treatment in community mental health clinics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 31, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• study population: community mental health clinic staff and providers

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

Other:
• Implementation Intervention
The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in tobacco smoking abstinence	7-day patient abstinence reported in medical record	Baseline, 12 months
Primary	Change in provider knowledge of smoking cessation treatment as assessed by a 16-item scale	Knowledge of evidence-based smoking cessation treatment: 16-item scale developed by our team. Items are true/false. A higher score signifies an increased knowledge of smoking cessation treatment.	Baseline, 12 months
Primary	Change in provider self-efficacy to deliver evidence-based smoking cessation treatment as assessed by a 32-item instrument	36 item instrument on a likert scale of 1-10, adapted version of Compeau and Higgins' task-focused self-efficacy scale. Higher scores signify greater self-efficacy.	Baseline, 12 months
Secondary	Change in delivery of evidence-based smoking cessation treatment: assessment of smoking status	Measured by clinic documentation during patient visits.	Baseline, 12 months
Secondary	Change in delivery of evidence-based smoking cessation treatment: assessment of willingness to quit	Measured by clinic documentation during patient visits.	Baseline, 12 months
Secondary	Change in delivery of evidence-based smoking cessation treatment: receipt of behavioral counseling	Measured by clinic documentation during patient visits.	Baseline, 12 months
Secondary	Change in delivery of evidence-based smoking cessation treatment: receipt of pharmacotherapy	Measured by clinic documentation during patient visits.	Baseline, 12 months
Secondary	Change in acceptability of evidence-based practices based on adaptation of Acceptability of Intervention Measure	We will use an instrument measuring acceptability, using an adaptation of the Acceptability of Intervention Measure. Each of the 16 items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater acceptability.	Baseline, 12 months
Secondary	Change in appropriateness of evidence-based practices based on adaptation of the Intervention Appropriateness Measure	We will use an instrument measuring appropriateness, using an adaptation of the Intervention Appropriateness Measure. Each of the 16 items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness.	Baseline, 12 months
Secondary	Change in feasibility of evidence-based practices based on adaptation of the Feasibility of Intervention Measure	We will use an instrument measuring feasibility, using an adaptation of the Feasibility of Intervention Measure. Each of the 16 items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness.	Baseline, 12 months
Secondary	Change in acceptability of implementation intervention based on adaptation of Acceptability of Intervention Measure	We will use an instrument measuring acceptability, using an adaptation of the Acceptability of Intervention Measure. Each of the 24 items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater acceptability.	Baseline, 12 months
Secondary	Change in appropriateness of implementation intervention based on adaptation of the Intervention Appropriateness Measure	We will use an instrument measuring appropriateness, using an adaptation of the Intervention Appropriateness Measure. Each of the 24 items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness.	Baseline, 12 months
Secondary	Change in feasibility of implementation intervention based on adaptation of the Feasibility of Intervention Measure	We will use an instrument measuring feasibility, using an adaptation of the Feasibility of Intervention Measure. Each of the 24 items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness.	Baseline, 12 months