Trial Outcomes & Findings for Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics (NCT NCT04796961)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

91 participants

Primary outcome timeframe

Baseline, 12 months

Results posted on

2025-09-03

Participant Flow

Mental health clinic staff (providers and prescribers) were recruited from 5 mental health clinics.

Ninety-one mental health clinic staff (providers and prescribers) were enrolled in the study. The mental health clinics had 6,011 clients with data that were included in the analysis.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	Implementation Intervention All participants will receive the implementation intervention. Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.
Overall Study STARTED	91 5
Overall Study Mental Health Clinic Clients (Not Enrolled)	6011 5
Overall Study COMPLETED	68 5
Overall Study NOT COMPLETED	23 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Implementation Intervention All participants will receive the implementation intervention. Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.
Overall Study Lost to Follow-up	10
Overall Study Withdrawal by Subject	3
Overall Study Left Organization	10

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implementation Intervention n=91 Participants All participants will receive the implementation intervention. Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	46.0 Years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	91 Participants n=5 Participants
Staff Role Counseling Provider	54 Participants n=5 Participants
Staff Role Prescriber	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Outcome measures
Measure	Implementation Intervention n=90 Participants All participants will receive the implementation intervention. Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.	Prescribers Consented and enrolled staff participants at mental health organizations who prescribe medications
Provider (Staff) Knowledge of Smoking Cessation Treatment as Assessed by a 16-item Scale Baseline	13.8 score on a scale Standard Deviation 1.4	—
Provider (Staff) Knowledge of Smoking Cessation Treatment as Assessed by a 16-item Scale 12 months	14.2 score on a scale Standard Deviation 1.2	—

PRIMARY outcome

Timeframe: Baseline, 12 months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Outcome measures
Measure	Implementation Intervention n=53 Participants All participants will receive the implementation intervention. Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.	Prescribers n=37 Participants Consented and enrolled staff participants at mental health organizations who prescribe medications
Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment Smoking Screening - Baseline	7.1 score on a scale Standard Deviation 2	6.6 score on a scale Standard Deviation 2.9
Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment Smoking Screening - 12 Months	7.2 score on a scale Standard Deviation 2.2	7.2 score on a scale Standard Deviation 2.6
Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment Readiness to Quit Assessment - Baseline	6.7 score on a scale Standard Deviation 2.1	6.1 score on a scale Standard Deviation 3.2
Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment Readiness to Quit Assessment - 12 Months	7.3 score on a scale Standard Deviation 2.1	6.6 score on a scale Standard Deviation 3.2
Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment Smoking Cessation Counseling - Baseline	5.5 score on a scale Standard Deviation 2.8	—
Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment Smoking Cessation Counseling - 12 Months	7.0 score on a scale Standard Deviation 2.1	—
Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment Smoking Cessation Pharmacotherapy - Baseline	—	6.2 score on a scale Standard Deviation 2.8
Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment Smoking Cessation Pharmacotherapy - 12 Months	—	7.0 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: Mental health clinic clients

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.

Outcome measures

Outcome measures
Measure	Implementation Intervention n=6011 Participants All participants will receive the implementation intervention. Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.	Prescribers Consented and enrolled staff participants at mental health organizations who prescribe medications
Number of Clients Recieved Smoking Status Assessment	3406 Participants	—

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: Clients who had a smoking status assessment collected where they reported smoking during the study period were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Implementation Intervention n=1469 Participants All participants will receive the implementation intervention. Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.	Prescribers Consented and enrolled staff participants at mental health organizations who prescribe medications
Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment	1192 Participants	—

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: Clients who had a smoking status assessment collected where they reported smoking during the study period were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Implementation Intervention n=1469 Participants All participants will receive the implementation intervention. Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.	Prescribers Consented and enrolled staff participants at mental health organizations who prescribe medications
Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling Client Smokers Reported Interest in Quitting	529 Participants	—
Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling Clients Not Reported Interest In Quitting Smoking	759 Participants	—

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: Clients who had a smoking status assessment collected where they reported smoking during the study period were included in this analysis

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.