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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34DA046078 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Brown University | OTHER |
| University of Minnesota | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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Tobacco use disorder is a chronic disease. This is particularly true for people living with mental illness, who are more likely to smoke and make more unsuccessful quit attempts than those without. The current study is designed to test a package of two chronic disease management strategies to treatment tobacco in community mental health centers: regular provider interventions during routine mental healthcare visits, and proactive outreach by community mental health center staff to offer connections to tobacco cessation treatment. In study 1 we will interview patients, providers and leaders across wo community healthcare systems, in study 2 we will pilot test the package of interventions in 25 patients at a community mental health center for feasibility and acceptability. in Study 3, 50 patients at a community mental health center will receive provider intervention at their regular visits as well as 3 outreach calls over 9 months from trained staff to offer to connect them with stop smoking treatment. The investigators will measure the effect of these interventions on tobacco use over the next year.
BACKGROUND: The US Public Health Service (USPHS) designated tobacco dependence as a chronic disease. This is especially true for smokers with serious mental illness (SMI) who make more cessation attempts and are less successful sustaining long-term abstinence than the general population. There is a significant health disparity wherein individuals with SMI have a higher tobacco use prevalence and a greater risk for tobacco-related mortality than the general population. Chronic care models suggest chronic disease management requires a multidisciplinary care team to assess tobacco use, administer treatment, support patient self-management, and monitor progress. Proactive telephone outreach to smokers and brief provider interventions are two effective chronic disease management strategies. Community based mental health centers (CMHCs) are a primary treatment access point for many smokers with SMI. However, rates of intervention with smoking by CMHC providers are low. In order to implement the chronic care model for tobacco dependence for CMHCs, comprehensive implementation strategies are needed. OBJECTIVE: to conduct a feasibility pilot trial to adapt an implementation strategy developed by the SAMHSA-funded network of Addiction Technology Transfer Centers (ATTCs) to integrate a proactive, chronic care model of tobacco cessation treatment into CMHCs. AIM: To conduct a pilot trial to assess the feasibility, acceptability and initial effectiveness of the implementation strategy. DESIGN: The investigators will conduct 3 studies. The first study will include qualitative interviews of 29 individuals including patients, providers and leaders. Study 2 will be a pilot test of the study intervention. 25 patients will receive the intervention for 3 months the primary outcome is feasibility and acceptability as measured 3 months post intervention. Study 3 is a pilot hybrid type 2 implementation-effectiveness trial in 3 CMHCs (N=50 patients; 96-130 providers). The investigators will conduct 2 baseline assessments (3 months apart) and outcomes will be assessed at 3, 6, and 12-months post implementation.
Outcomes include feasibility, acceptability, effectiveness of the implementation strategy on tobacco cessation treatment utilization (counseling and medication) and patient effectiveness on tobacco cessation (CO confirmed 7-day point prevalence abstinence). SIGNIFICANCE: An effective implementation strategy for tobacco cessation treatment in CMHCs, a widespread model of care delivery, would have enormous public health impact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study 3 | Experimental | Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication. |
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| Study 2 | Experimental | In this study, participants received brief provider interventions about tobacco and a single outreach call to connect them to telephone cessation counseling and facilitate obtaining cessation medication. |
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| Study 1 | No Intervention | Patients, providers and leaders at community mental health centers were interviewed about intervention feasibility and acceptability |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study 3: Chronic care management | Behavioral | Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 9 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Study 3: Smoking Abstinence | number of participants who reported 7-day point prevalence smoking abstinence (no smoking past 7 days) and a expired air CO value of <6ppm in study 3 only | 1 year post baseline |
| Study 1: Perceived Feasibility of Intervention | Number of participants who reported the proposed intervention was feasible | interview (up to 30 minutes at study visit) |
| Study 1: Perceived Acceptability of Intervention | number of participants who agreed the proposed intervention was acceptable. | interview (up to 30 minutes at study visit) |
| Studies 2 & 3: Feasibility of Recruitment | Number of participants recruited (goal for study 2=25; goal for study 3=50) | baseline |
| Studies 2 & 3: Feasibility of Retention | % of participants completing follow-up in studies 2 & 3 | 3 months post enrollment |
| Study 2: Perceived Acceptability of Intervention | Number of participants who perceived that the intervention was acceptable drawn from qualitative reports of intervention acceptability from selected patients (N=5) and providers and leaders (N=4) | 3 months post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Study 3: Smoking Abstinence | 30 day prolonged abstinence (no smoking past 30 days prior to 1 year follow-up) | 1 year post baseline |
| Study 3: Quit Attempts | Number of 24 hour intentional quit attempts |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin Healthcare Research Institute | Minneapolis | Minnesota | 55415 | United States |
Within 18 months of study completion, we will make completely de-identified data (i.e., data that has been cleaned of all 18 types of HIPAA identifiers) datasets available to interested investigators who submit a written request to the PI. The only contingency on the use of the data will be that ethical guidelines be followed (e.g., only individuals who have completed a research ethics training course will have access to the data, the data will be stored securely).
18 months after collection of primary outcome data for 5 years post data collection.
research ethics training
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| ID | Title | Description |
|---|---|---|
| FG000 | Study 3 | This is a single arm pre-post trial. Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication. Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months. |
| FG001 | Study 1 | Single Interview regarding feasibility and acceptability of delivering chronic care management for smoking cessation in community mental health centers |
| FG002 | Study 2 | Quarterly brief provider interventions and a single proactive outreach call to connect patients to telephone cessation counseling and facilitate obtaining cessation medication. Chronic care management: brief provider intervention (the 5As) quarterly over 3 months and one outreach call over 3 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This is a single arm, pre-post study. Thus, we report the data for the full sample.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study 3 | Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication. Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographics were not collected in Study 1; age only collected for 48 patients in study 3 |
| 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 | Study 3: Smoking Abstinence | number of participants who reported 7-day point prevalence smoking abstinence (no smoking past 7 days) and a expired air CO value of <6ppm in study 3 only | Participants who completed baseline data and were alive at follow-up (1 participant died and so data was not analyzed) | Posted | Count of Participants | Participants | 1 year post baseline |
|
15 months
Adverse events were not systematically collected. However, if participants reported an adverse event or serious adverse event during follow-up phone calls it was documented. Additionally, if a participant was not available for follow-up due to a serious adverse event or death, that was recorded.
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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 | Study 3: Chronic care for tobacco use | Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication. Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 9 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Hospitalization | Injury, poisoning and procedural complications | Non-systematic Assessment | Complications following a hernia repair |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sandra Japuntich | Hennepin Healthcare Research Institute | 6128736856 | sandra.japuntich@hcmed.org |
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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 | Jun 23, 2021 | Jul 23, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2021 | Jul 23, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D001523 | Mental Disorders |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D064424 | Tobacco Use |
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Study 1 is a key informant interview study. Study 2 is a pre-post study. Study 3: is a pre-post study with multiple baselines to account for change over time.
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| Study 2: Pilot trial | Behavioral | Providers trained in brief provider intervention and 1 outreach call over 3 months. |
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| 1 year post-baseline |
| Study 3: Cigarettes Per Day | number of cigarettes smoked per day in study 3 | 12 months post baseline |
| Withdrawal by Subject |
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| Study 2 |
Quarterly brief provider interventions and a single proactive outreach call to connect patients to telephone cessation counseling and facilitate obtaining cessation medication. Chronic care management: brief provider intervention (the 5As) quarterly over 3 months and one outreach call over 3 months. |
| BG002 | Study 1 | Single interview regarding feasibility and acceptability of delivering chronic care management for smoking cessation in community mental health centers. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Demographics were not collected in study 1 | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Demographics were not collected in Study 1 | Count of Participants | Participants |
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| Race (NIH/OMB) | demographics were not collected in Study 1 | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| cigarettes per day | Cigarettes per day was not collected in Study 1 | Cigarettes per day was not collected in Study 1 | Mean | Standard Deviation | cigarettes per day |
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| Units | Counts |
|---|
| Participants |
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| Primary | Study 1: Perceived Feasibility of Intervention | Number of participants who reported the proposed intervention was feasible | Interview participants including patients, providers, and leaders at community mental health centers | Posted | Count of Participants | Participants | interview (up to 30 minutes at study visit) |
|
|
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| Primary | Study 1: Perceived Acceptability of Intervention | number of participants who agreed the proposed intervention was acceptable. | patients, providers, and leaders at a community mental healthcare center | Posted | Count of Participants | Participants | interview (up to 30 minutes at study visit) |
|
|
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| Primary | Studies 2 & 3: Feasibility of Recruitment | Number of participants recruited (goal for study 2=25; goal for study 3=50) | patients in a community mental healthcare center who smoke cigarettes | Posted | Count of Participants | Participants | baseline |
|
|
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| Primary | Studies 2 & 3: Feasibility of Retention | % of participants completing follow-up in studies 2 & 3 | This measure was the primary outcome of the chronic care for tobacco use (study 3) and the pilot trial (study 2) only. The recruitment target for study 2 was 25, the recruitment target for study 3 was 50. | Posted | Count of Participants | Participants | 3 months post enrollment |
|
|
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| Primary | Study 2: Perceived Acceptability of Intervention | Number of participants who perceived that the intervention was acceptable drawn from qualitative reports of intervention acceptability from selected patients (N=5) and providers and leaders (N=4) | Patients and providers from a community mental health center who participated in the study | Posted | Count of Participants | Participants | 3 months post enrollment |
|
|
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| Secondary | Study 3: Smoking Abstinence | 30 day prolonged abstinence (no smoking past 30 days prior to 1 year follow-up) | Participants who completed baseline and were alive at the 12 month follow-up (1 participant died during the follow up period and so the did not contribute outcome data). | Posted | Count of Participants | Participants | 1 year post baseline |
|
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| Secondary | Study 3: Quit Attempts | Number of 24 hour intentional quit attempts | Participants who completed baseline assessment. | Posted | Mean | Standard Deviation | quit attempts | 1 year post-baseline |
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| Secondary | Study 3: Cigarettes Per Day | number of cigarettes smoked per day in study 3 | participants who were alive at the 12 month follow-up (1 person died and so their data was not used) | Posted | Mean | Standard Deviation | cigarettes per day | 12 months post baseline |
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| 1 |
| 49 |
| 1 |
| 49 |
| 0 |
| 49 |
| EG001 | Study 2: Pilot trial | Provider brief provider interventions about tobacco and 1 proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Study 1: Interview study | patients, providers, and leaders were interviewed about study feasibility/acceptability | 0 | 20 | 0 | 20 | 0 | 20 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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