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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04796961
Other study ID # IRB00231836
Secondary ID 1P50MH115842-01
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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