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

Sponsor
Johns Hopkins University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04796961
Collaborator
National Institute of Mental Health (NIMH) (NIH)
6,220
1
1
22.7
274.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Implementation Intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
6220 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics
Actual Study Start Date :
Mar 12, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Implementation Intervention

All participants will receive the implementation intervention.

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

Outcome Measures

Primary Outcome Measures

  1. Change in provider knowledge of smoking cessation treatment as assessed by a 16-item scale [Baseline, 12 months]

    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.

  2. Change in provider self-efficacy to deliver evidence-based smoking cessation treatment as assessed by a 32-item instrument [Baseline, 12 months]

    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.

Secondary Outcome Measures

  1. Change in delivery of evidence-based smoking cessation treatment: assessment of smoking status [Baseline, 12 months]

    Measured by clinic documentation during patient visits.

  2. Change in delivery of evidence-based smoking cessation treatment: assessment of willingness to quit [Baseline, 12 months]

    Measured by clinic documentation during patient visits.

  3. Change in delivery of evidence-based smoking cessation treatment: receipt of behavioral counseling [Baseline, 12 months]

    Measured by clinic documentation during patient visits.

  4. Change in delivery of evidence-based smoking cessation treatment: receipt of pharmacotherapy [Baseline, 12 months]

    Measured by clinic documentation during patient visits.

  5. Change in acceptability of evidence-based practices based on adaptation of Acceptability of Intervention Measure [Baseline, 12 months]

    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.

  6. Change in appropriateness of evidence-based practices based on adaptation of the Intervention Appropriateness Measure [Baseline, 12 months]

    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.

  7. Change in feasibility of evidence-based practices based on adaptation of the Feasibility of Intervention Measure [Baseline, 12 months]

    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.

  8. Change in acceptability of implementation intervention based on adaptation of Acceptability of Intervention Measure [Baseline, 12 months]

    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.

  9. Change in appropriateness of implementation intervention based on adaptation of the Intervention Appropriateness Measure [Baseline, 12 months]

    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.

  10. Change in feasibility of implementation intervention based on adaptation of the Feasibility of Intervention Measure [Baseline, 12 months]

    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.

Other Outcome Measures

  1. Change in tobacco smoking abstinence [Baseline, 12 months]

    7-day patient abstinence reported in medical record

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • study population 1: community mental health clinic staff and providers

  • study population 2: patients in community mental health clinics

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Johns Hopkins University
  • National Institute of Mental Health (NIMH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04796961
Other Study ID Numbers:
  • IRB00231836
  • 1P50MH115842-01
First Posted:
Mar 15, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 31, 2022