NCT04796961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

March 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 24, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

March 10, 2021

Results QC Date

August 6, 2025

Last Update Submit

August 22, 2025

Conditions

Tobacco Smoking

Outcome Measures

Primary Outcomes (2)

  • Provider (Staff) 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 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

    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 Outcomes (10)

  • Number of Clients Recieved Smoking Status Assessment

    Baseline through 12 months

  • Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment

    Baseline through 12 months

  • Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling

    Baseline through 12 months

  • Number of Clients Interested in Quitting Smoking That Received Smoking Cessation Pharmacotherapy

    Baseline through 12 months

  • Acceptability of Evidence-based Practices Based on Adaptation of Acceptability of Intervention Measure

    Post Training (up to 2 weeks), 12 months

  • +5 more secondary outcomes

Other Outcomes (1)

  • Change in Tobacco Smoking Abstinence

    Baseline, 12 Months

Study Arms (1)

Implementation Intervention

OTHER

All participants will receive the implementation intervention.

Other: Implementation Intervention

Interventions

Implementation InterventionOTHER

The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.

Implementation Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • study population: community mental health clinic staff and providers

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • Dickerson F, Goldsholl S, Yuan CT, Dalcin A, Eidman B, Minahan E, Gennusa Rd JV, Mace E, Cullen B, Evins AE, Cather C, Wang NY, McGinty EM, Daumit GL. Promoting Evidence-Based Tobacco Cessation Treatment in Community Mental Health Clinics: Protocol for a Prepost Intervention Study. JMIR Res Protoc. 2023 May 12;12:e44787. doi: 10.2196/44787.

    PMID: 37171851DERIVED

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Results Point of Contact

Title
Gail Daumit MD, MHS
Organization
Johns Hopkins University School of Medicine
gdaumit@jhmi.edu
410-614-6460

Study Officials

  • Gail Daumit, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 15, 2021

Study Start

March 12, 2021

Primary Completion

July 18, 2023

Study Completion

July 31, 2023

Last Updated

September 3, 2025

Results First Posted

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)