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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50MH115842-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implementation Intervention | Other | All participants will receive the implementation intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation Intervention | Other | The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through 12 months |
| Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tobacco Smoking Abstinence | 7-day patient abstinence reported in medical record | Baseline, 12 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Daumit, MD, MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37171851 | Derived | 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. |
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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.
Mental health clinic staff (providers and prescribers) were recruited from 5 mental health clinics.
| ID | Title | Description |
|---|---|---|
| FG000 | Implementation Intervention | All participants will receive the implementation intervention. Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Implementation Intervention | All participants will receive the implementation intervention. Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Staff with data collected analyzed under modeling approach. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 months |
|
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Adverse Events Not Collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implementation Intervention | All participants will receive the implementation intervention. Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gail Daumit MD, MHS | Johns Hopkins University School of Medicine | 410-614-6460 | gdaumit@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2022 | Aug 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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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 | 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 | 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 | 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 | 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 | 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 |
| 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. | 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. | 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. | Post Training (up to 2 weeks), 12 Months |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Staff Role | Role of the staff member as it relates to delivery of the evidence-based practice intervention. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
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|
|
| Primary | 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. | Staff with data collected analyzed under modeling approach. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 months |
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| Secondary | 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. | Mental health clinic clients | Posted | Count of Participants | Participants | Baseline through 12 months |
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| Secondary | 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. | Clients who had a smoking status assessment collected where they reported smoking during the study period were included in this analysis. | Posted | Count of Participants | Participants | Baseline through 12 months |
|
|
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| Secondary | 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. | Clients who had a smoking status assessment collected where they reported smoking during the study period were included in this analysis. | Posted | Count of Participants | Participants | Baseline through 12 months |
|
|
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| Secondary | 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. | Clients who had a smoking status assessment collected where they reported smoking during the study period were included in this analysis | Posted | Count of Participants | Participants | Baseline through 12 months |
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| Secondary | 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. | Staff with data collected, analyzed under modeling approach. | Posted | Mean | Standard Deviation | score on a scale | Post Training (up to 2 weeks), 12 months |
|
|
|
| Secondary | 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. | Staff with data collected, analyzed under modeling approach. | Posted | Mean | Standard Deviation | score on a scale | Post Training (up to 2 weeks), 12 Months |
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| Secondary | 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. | Staff with data collected, analyzed under modeling approach. | Posted | Mean | Standard Deviation | score on a scale | Post Training (up to 2 weeks), 12 Months |
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| Secondary | 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. | Staff with data collected, analyzed under modeling approach. | Posted | Mean | Standard Deviation | score on a scale | Post Training (up to 2 weeks), 12 Months |
|
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| Secondary | 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. | Staff with data collected, analyzed under modeling approach. | Posted | Mean | Standard Deviation | score on a scale | Post Training (up to 2 weeks), 12 Months |
|
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| Secondary | 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. | Staff with data collected, analyzed under modeling approach. | Posted | Mean | Standard Deviation | score on a scale | Post Training (up to 2 weeks), 12 Months |
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| Other Pre-specified | Change in Tobacco Smoking Abstinence | 7-day patient abstinence reported in medical record | Information data source was the health record and this data was not present routinely. When available the data appeared not to be valid. | Posted | Baseline, 12 Months |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| Smoking Screening - 12 Months |
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| Readiness to Quit Assessment - Baseline |
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| Readiness to Quit Assessment - 12 Months |
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| Smoking Cessation Counseling - Baseline |
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| Smoking Cessation Counseling - 12 Months |
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| Smoking Cessation Pharmacotherapy - Baseline |
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| Smoking Cessation Pharmacotherapy - 12 Months |
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| Mean Difference (Net) |
| 0.6 |
| 2-Sided |
| 95 |
| -0.1 |
| 1.2 |
| Superiority |
| smoking cessation counseling | Mean Difference (Net) | 1.4 | 2-Sided | 95 | 0.8 | 2.0 | Superiority |
| smoking cessation pharmacotherapy | Mean Difference (Net) | 0.6 | 2-Sided | 95 | -0.5 | 1.7 | Superiority |
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