An interventional study of Implementation Intervention in Tobacco Smoking, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research
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.
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.
68 studies on the registry are indexed under Tobacco Smoking; 26 are open to participants now.
This study's enrollment of 91 is below the median of 111 across 60 interventional studies indexed under Tobacco Smoking.
Browse Tobacco Smoking studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will receive the implementation intervention.
Other: Implementation Intervention
The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.
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.
Time frame: 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.
Time frame: Baseline, 12 months
Number of Clients Recieved Smoking Status Assessment
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.
Time frame: Baseline through 12 months
Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment
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.
Time frame: Baseline through 12 months
Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling
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.
Time frame: Baseline through 12 months
Number of Clients Interested in Quitting Smoking That Received Smoking Cessation Pharmacotherapy
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.
Time frame: Baseline through 12 months
Acceptability of Evidence-based Practices Based on Adaptation of Acceptability of Intervention Measure
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.
Time frame: Post Training (up to 2 weeks), 12 months
Appropriateness of Evidence-based Practices Based on Adaptation of the Intervention Appropriateness Measure
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.
Time frame: Post Training (up to 2 weeks), 12 Months
Feasibility of Evidence-based Practices Based on Adaptation of the Feasibility of Intervention Measure
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.
Time frame: Post Training (up to 2 weeks), 12 Months
Acceptability of Implementation Intervention Based on Adaptation of Acceptability of Intervention Measure
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.
Time frame: Post Training (up to 2 weeks), 12 Months
Appropriateness of Implementation Intervention Based on Adaptation of the Intervention Appropriateness Measure
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.
Time frame: Post Training (up to 2 weeks), 12 Months
Feasibility of Implementation Intervention Based on Adaptation of the Feasibility of Intervention Measure
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.
Time frame: Post Training (up to 2 weeks), 12 Months
Change in Tobacco Smoking Abstinence
7-day patient abstinence reported in medical record
Time frame: Baseline, 12 Months
Mental health clinic staff (providers and prescribers) were recruited from 5 mental health clinics.
| Milestone | Implementation Intervention |
|---|---|
| Started | 91 |
| Mental health clinic clients (not enrolled) | 6011 |
| Completed | 68 |
| Not completed | 23 |
| Withdrew: Lost to follow-up | 10 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Left organization | 10 |
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.
| score on a scale | Implementation Intervention |
|---|---|
| Baseline | 13.8 ± 1.4 |
| 12 months | 14.2 ± 1.2 |
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.
| score on a scale | Counseling Providers | Prescribers |
|---|---|---|
| Smoking Screening - Baseline | 7.1 ± 2 | 6.6 ± 2.9 |
| Smoking Screening - 12 Months | 7.2 ± 2.2 | 7.2 ± 2.6 |
| Readiness to Quit Assessment - Baseline | 6.7 ± 2.1 | 6.1 ± 3.2 |
| Readiness to Quit Assessment - 12 Months | 7.3 ± 2.1 | 6.6 ± 3.2 |
| Smoking Cessation Counseling - Baseline | 5.5 ± 2.8 | — |
| Smoking Cessation Counseling - 12 Months | 7.0 ± 2.1 | — |
| Smoking Cessation Pharmacotherapy - Baseline | — | 6.2 ± 2.8 |
| Smoking Cessation Pharmacotherapy - 12 Months | — | 7.0 ± 2.9 |
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.
| Participants | Implementation Intervention |
|---|---|
| Number of Clients Recieved Smoking Status Assessment | 3406 |
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.
| Participants | Implementation Intervention |
|---|---|
| Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment | 1192 |
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.
| Participants | Implementation Intervention |
|---|---|
| Client Smokers Reported Interest in Quitting | 529 |
| Clients Not Reported Interest In Quitting Smoking | 759 |
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.
| Participants | Implementation Intervention |
|---|---|
| Client Smokers Reported Interest in Quitting | 232 |
| Client Smokers Not Reported Interest in Quitting | 173 |
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.
| score on a scale | Implementation Intervention |
|---|---|
| Post Training | 4.1 ± 0.5 |
| 12 Months | 4.0 ± 0.7 |
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.
| score on a scale | Implementation Intervention |
|---|---|
| Post Training | 4.2 ± 0.5 |
| 12 Months | 4.1 ± 0.7 |
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.
| score on a scale | Implementation Intervention |
|---|---|
| Post Training | 4.1 ± 0.5 |
| 12 Months | 4.0 ± 0.7 |
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.
| score on a scale | Implementation Intervention |
|---|---|
| Post Training | 4.1 ± 0.6 |
| 12 Months | 3.9 ± 0.7 |
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.
| score on a scale | Implementation Intervention |
|---|---|
| Post Training | 4.1 ± 0.6 |
| 12 Months | 3.9 ± 0.7 |
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.
| score on a scale | Implementation Intervention |
|---|---|
| Post Training | 4.0 ± 0.7 |
| 12 Months | 3.9 ± 0.7 |
7-day patient abstinence reported in medical record
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Implementation Intervention | — | — | — |
| Age, Categorical(Participants) | Implementation Intervention |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 81 |
| >=65 years | 10 |
| Age, Continuous(Years) | Implementation Intervention |
|---|---|
| Mean | 46.0 ± 13.0 |
| Sex: Female, Male(Participants) | Implementation Intervention |
|---|---|
| Female | 65 |
| Male | 26 |
| Ethnicity (NIH/OMB)(Participants) | Implementation Intervention |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 80 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Implementation Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 13 |
| White | 65 |
| More than one race | 6 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Implementation Intervention |
|---|---|
| United States | 91 |
| Staff Role(Participants) | Implementation Intervention |
|---|---|
| Counseling Provider | 54 |
| Prescriber | 37 |
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