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

August 22, 2025 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • study population: community mental health clinic staff and providers

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Implementation Intervention
All participants will receive the implementation intervention.
The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider (Staff) Knowledge of Smoking Cessation Treatment as Assessed by a 16-item Scale
Time Frame: Baseline, 12 months
Knowledge of evidence-based smoking cessation treatment: 16-item scale developed by our team. Items are true/false and score reflects number answered correctly. Average score range 0-16 with a higher score signifies an increased knowledge of smoking cessation treatment.
Baseline, 12 months
Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment
Time Frame: Baseline, 12 months
Self-efficacy for a four components of the smoking cessation intervention were evaluated using an instrument adapted from Compeau and Higgins' task-focused self-efficacy scale. Responses for items are on a Likert scale of 1-10. Average score range 1-10 and higher scores signify greater self-efficacy for the smoking cessation task.
Baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Clients Recieved Smoking Status Assessment
Time Frame: Baseline through 12 months
Assessment of smoking status measured by clinic documentation during client visits with the number below indicating the number of clients who had a smoking status assessment during the 12 month study period.
Baseline through 12 months
Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment
Time Frame: Baseline through 12 months
Assessment of willingness to quit measured by clinic documentation during client visits, with the number below indicating the number of clients who reported smoking during a smoking status assessment who had a willingness to quit assessment during the 12 month study period.
Baseline through 12 months
Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling
Time Frame: Baseline through 12 months

Receipt of behavioral counseling measured by clinic documentation during client visits, with the number below indicating the number of clients interested in quitting smoking that reported smoking during a smoking status assessment who staff reported as receiving behavioral counseling during the 12 months study period.

Data is reported in two groups based upon whether the client had a recorded interest in quitting smoking or not, and only includes clients who reported smoking at some point during the study period. Clients can be reported in both groups if they responded differently to this question at two points over the course of the 12 months.

Baseline through 12 months
Number of Clients Interested in Quitting Smoking That Received Smoking Cessation Pharmacotherapy
Time Frame: Baseline through 12 months

Measured by clinic documentation during client visits with the number below indicating the number of clients interested in quitting smoking, that reported smoking during a smoking status assessment who staff reported as receiving smoking cessation pharmacotherapy during the 12 months study period.

Clients can be reported in both groups (Interested in quitting, not interested in quitting) if they responded differently to this question at two points over the course of the 12 months.

Baseline through 12 months
Acceptability of Evidence-based Practices Based on Adaptation of Acceptability of Intervention Measure
Time Frame: Post Training (up to 2 weeks), 12 months
An adaptation of the Acceptability of Intervention Measure was used. Each of the 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.
Post Training (up to 2 weeks), 12 months
Appropriateness of Evidence-based Practices Based on Adaptation of the Intervention Appropriateness Measure
Time Frame: Post Training (up to 2 weeks), 12 Months
An adaptation of the Intervention Appropriateness Measure was used. Each of the 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.
Post Training (up to 2 weeks), 12 Months
Acceptability of Implementation Intervention Based on Adaptation of Acceptability of Intervention Measure
Time Frame: Post Training (up to 2 weeks), 12 Months
An adaptation of the Acceptability of Intervention Measure was used. Each of the 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.
Post Training (up to 2 weeks), 12 Months
Appropriateness of Implementation Intervention Based on Adaptation of the Intervention Appropriateness Measure
Time Frame: Post Training (up to 2 weeks), 12 Months
An adaptation of the Intervention Appropriateness Measure was used. Each of the 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.
Post Training (up to 2 weeks), 12 Months
Feasibility of Evidence-based Practices Based on Adaptation of the Feasibility of Intervention Measure
Time Frame: Post Training (up to 2 weeks), 12 Months
An adaptation of the Feasibility of Intervention Measure was used. Each of the 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 feasibility.
Post Training (up to 2 weeks), 12 Months
Feasibility of Implementation Intervention Based on Adaptation of the Feasibility of Intervention Measure
Time Frame: Post Training (up to 2 weeks), 12 Months
An adaptation of the Feasibility of Intervention Measure was used. Each of the 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 feasibility.
Post Training (up to 2 weeks), 12 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tobacco Smoking Abstinence
Time Frame: Baseline, 12 Months
7-day patient abstinence reported in medical record
Baseline, 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gail Daumit, MD, MHS, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2021

Primary Completion (Actual)

July 18, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00231836
  • 1P50MH115842-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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