- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04796961
Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics (IMPACT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- study population: community mental health clinic staff and providers
Exclusion Criteria:
- None
Study Plan
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Gail Daumit, MD, MHS, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.