Tobacco Smoking
Conditions
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.
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.
Interventions
The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.
Sponsors
National Institute of Mental Health (NIMH)
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* study population: community mental health clinic staff and providers
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment | Baseline, 12 months | 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. |
| Provider (Staff) 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 and score reflects number answered correctly. Average score range 0-16 with a higher score signifies an increased knowledge of smoking cessation treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment | Baseline through 12 months | 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. |
| Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling | Baseline through 12 months | 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. |
| Number of Clients Interested in Quitting Smoking That Received Smoking Cessation Pharmacotherapy | Baseline through 12 months | 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. |
| Acceptability of Evidence-based Practices Based on Adaptation of Acceptability of Intervention Measure | Post Training (up to 2 weeks), 12 months | 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. |
| Feasibility of Evidence-based Practices Based on Adaptation of the Feasibility of Intervention Measure | Post Training (up to 2 weeks), 12 Months | 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. |
| Acceptability of Implementation Intervention Based on Adaptation of Acceptability of Intervention Measure | Post Training (up to 2 weeks), 12 Months | 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. |
| Appropriateness of Implementation Intervention Based on Adaptation of the Intervention Appropriateness Measure | Post Training (up to 2 weeks), 12 Months | 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. |
| Feasibility of Implementation Intervention Based on Adaptation of the Feasibility of Intervention Measure | Post Training (up to 2 weeks), 12 Months | 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. |
| Appropriateness of Evidence-based Practices Based on Adaptation of the Intervention Appropriateness Measure | Post Training (up to 2 weeks), 12 Months | 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. |
| Number of Clients Recieved Smoking Status Assessment | Baseline through 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Tobacco Smoking Abstinence | Baseline, 12 Months | 7-day patient abstinence reported in medical record |
Countries
United States
Participant flow
Recruitment details
Mental health clinic staff (providers and prescribers) were recruited from 5 mental health clinics.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Implementation Intervention All participants will receive the implementation intervention.
Implementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings. | 91 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Left Organization | 10 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Implementation Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants |
| Age, Continuous | 46.0 Years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 65 Participants |
| Region of Enrollment United States | 91 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 26 Participants |
| Staff Role Counseling Provider | 54 Participants |
| Staff Role Prescriber | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Baseline, 12 months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implementation Intervention | Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment | Smoking Screening - Baseline | 7.1 score on a scale | Standard Deviation 2 |
| Implementation Intervention | Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment | Smoking Screening - 12 Months | 7.2 score on a scale | Standard Deviation 2.2 |
| Implementation Intervention | 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 |
| Implementation Intervention | 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 |
| Implementation Intervention | Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment | Smoking Cessation Counseling - Baseline | 5.5 score on a scale | Standard Deviation 2.8 |
| Implementation Intervention | 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 |
| Prescribers | 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 |
| Prescribers | Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment | Smoking Screening - Baseline | 6.6 score on a scale | Standard Deviation 2.9 |
| Prescribers | Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment | Readiness to Quit Assessment - 12 Months | 6.6 score on a scale | Standard Deviation 3.2 |
| Prescribers | Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment | Smoking Screening - 12 Months | 7.2 score on a scale | Standard Deviation 2.6 |
| Prescribers | Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment | Smoking Cessation Pharmacotherapy - Baseline | 6.2 score on a scale | Standard Deviation 2.8 |
| Prescribers | Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment | Readiness to Quit Assessment - Baseline | 6.1 score on a scale | Standard Deviation 3.2 |
Comparison: smoking screening95% CI: [-0.1, 1.1]
Comparison: readiness to quit assessments95% CI: [-0.1, 1.2]
Comparison: smoking cessation counseling95% CI: [0.8, 2]
Comparison: smoking cessation pharmacotherapy95% CI: [-0.5, 1.7]
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.
Time frame: Baseline, 12 months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implementation Intervention | 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 |
| Implementation Intervention | 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 |
95% CI: [0.1, 0.7]
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.
Time frame: Post Training (up to 2 weeks), 12 months
Population: Staff with data collected, analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implementation Intervention | Acceptability of Evidence-based Practices Based on Adaptation of Acceptability of Intervention Measure | Post Training | 4.1 score on a scale | Standard Deviation 0.5 |
| Implementation Intervention | Acceptability of Evidence-based Practices Based on Adaptation of Acceptability of Intervention Measure | 12 Months | 4.0 score on a scale | Standard Deviation 0.7 |
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.
Time frame: Post Training (up to 2 weeks), 12 Months
Population: Staff with data collected, analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implementation Intervention | Acceptability of Implementation Intervention Based on Adaptation of Acceptability of Intervention Measure | Post Training | 4.1 score on a scale | Standard Deviation 0.6 |
| Implementation Intervention | Acceptability of Implementation Intervention Based on Adaptation of Acceptability of Intervention Measure | 12 Months | 3.9 score on a scale | Standard Deviation 0.7 |
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.
Time frame: Post Training (up to 2 weeks), 12 Months
Population: Staff with data collected, analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implementation Intervention | Appropriateness of Evidence-based Practices Based on Adaptation of the Intervention Appropriateness Measure | Post Training | 4.2 score on a scale | Standard Deviation 0.5 |
| Implementation Intervention | Appropriateness of Evidence-based Practices Based on Adaptation of the Intervention Appropriateness Measure | 12 Months | 4.1 score on a scale | Standard Deviation 0.7 |
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.
Time frame: Post Training (up to 2 weeks), 12 Months
Population: Staff with data collected, analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implementation Intervention | Appropriateness of Implementation Intervention Based on Adaptation of the Intervention Appropriateness Measure | Post Training | 4.1 score on a scale | Standard Deviation 0.6 |
| Implementation Intervention | Appropriateness of Implementation Intervention Based on Adaptation of the Intervention Appropriateness Measure | 12 Months | 3.9 score on a scale | Standard Deviation 0.7 |
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.
Time frame: Post Training (up to 2 weeks), 12 Months
Population: Staff with data collected, analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implementation Intervention | Feasibility of Evidence-based Practices Based on Adaptation of the Feasibility of Intervention Measure | Post Training | 4.1 score on a scale | Standard Deviation 0.5 |
| Implementation Intervention | Feasibility of Evidence-based Practices Based on Adaptation of the Feasibility of Intervention Measure | 12 Months | 4.0 score on a scale | Standard Deviation 0.7 |
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.
Time frame: Post Training (up to 2 weeks), 12 Months
Population: Staff with data collected, analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implementation Intervention | Feasibility of Implementation Intervention Based on Adaptation of the Feasibility of Intervention Measure | Post Training | 4.0 score on a scale | Standard Deviation 0.7 |
| Implementation Intervention | Feasibility of Implementation Intervention Based on Adaptation of the Feasibility of Intervention Measure | 12 Months | 3.9 score on a scale | Standard Deviation 0.7 |
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.
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Implementation Intervention | Number of Clients Interested in Quitting Smoking That Received Smoking Cessation Pharmacotherapy | Client Smokers Reported Interest in Quitting | 232 Participants |
| Implementation Intervention | Number of Clients Interested in Quitting Smoking That Received Smoking Cessation Pharmacotherapy | Client Smokers Not Reported Interest in Quitting | 173 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Implementation Intervention | Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling | Client Smokers Reported Interest in Quitting | 529 Participants |
| Implementation Intervention | Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling | Clients Not Reported Interest In Quitting Smoking | 759 Participants |
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.
Time frame: Baseline through 12 months
Population: Mental health clinic clients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implementation Intervention | Number of Clients Recieved Smoking Status Assessment | 3406 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implementation Intervention | Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment | 1192 Participants |
Other Pre-specified
Change in Tobacco Smoking Abstinence
7-day patient abstinence reported in medical record
Time frame: Baseline, 12 Months
Population: Information data source was the health record and this data was not present routinely. When available the data appeared not to be valid.