Mental Illness, Smoking, Tobacco
Conditions
Keywords
smoking, Chronic care model, Serious mental illness, implementation science
Brief summary
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.
Detailed description
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.
Interventions
Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 9 months.
Providers trained in brief provider intervention and 1 outreach call over 3 months.
Sponsors
Study design
Intervention model description
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.
Eligibility
Inclusion criteria
* daily cigarettes smokers (smoking \>25 days/month) * English speaking * patient in one of the two community mental health center study sites.
Exclusion criteria
* cognitive impairment * judged by community mental health center staff as unable to participate in research * no access to a telephone * no mailing address.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study 2: Perceived Acceptability of Intervention | 3 months post enrollment | 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) |
| Study 1: Perceived Acceptability of Intervention | interview (up to 30 minutes at study visit) | number of participants who agreed the proposed intervention was acceptable. |
| Studies 2 & 3: Feasibility of Recruitment | baseline | Number of participants recruited (goal for study 2=25; goal for study 3=50) |
| Studies 2 & 3: Feasibility of Retention | 3 months post enrollment | % of participants completing follow-up in studies 2 & 3 |
| Study 3: Smoking Abstinence | 1 year post baseline | 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 |
| Study 1: Perceived Feasibility of Intervention | interview (up to 30 minutes at study visit) | Number of participants who reported the proposed intervention was feasible |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study 3: Quit Attempts | 1 year post-baseline | Number of 24 hour intentional quit attempts |
| Study 3: Cigarettes Per Day | 12 months post baseline | number of cigarettes smoked per day in study 3 |
| Study 3: Smoking Abstinence | 1 year post baseline | 30 day prolonged abstinence (no smoking past 30 days prior to 1 year follow-up) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| 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. | 25 |
| Study 1 Single interview regarding feasibility and acceptability of delivering chronic care management for smoking cessation in community mental health centers. | 20 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 5 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Study 3 | Study 2 | Total | Study 1 |
|---|---|---|---|---|
| Age, Continuous | 41.23 years STANDARD_DEVIATION 11.88 | 48.64 years STANDARD_DEVIATION 12.14 | 43.93 years STANDARD_DEVIATION 12.37 | — |
| cigarettes per day | 15.35 cigarettes per day STANDARD_DEVIATION 8.97 | 16.67 cigarettes per day STANDARD_DEVIATION 10.07 | 15.92 cigarettes per day STANDARD_DEVIATION 9.3 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 25 Participants | 74 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants | — |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) White | 44 Participants | 22 Participants | 66 Participants | — |
| Region of Enrollment United States | 49 Participants | 25 Participants | 94 Participants | 20 Participants |
| Sex: Female, Male Female | 32 Participants | 17 Participants | 49 Participants | — |
| Sex: Female, Male Male | 17 Participants | 8 Participants | 25 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 49 | 0 / 25 | 0 / 20 |
| other Total, other adverse events | 0 / 49 | 0 / 25 | 0 / 20 |
| serious Total, serious adverse events | 1 / 49 | 0 / 25 | 0 / 20 |
Outcome results
Studies 2 & 3: Feasibility of Recruitment
Number of participants recruited (goal for study 2=25; goal for study 3=50)
Time frame: baseline
Population: patients in a community mental healthcare center who smoke cigarettes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 3 | Studies 2 & 3: Feasibility of Recruitment | 25 Participants |
| Study 3 | Studies 2 & 3: Feasibility of Recruitment | 49 Participants |
Studies 2 & 3: Feasibility of Retention
% of participants completing follow-up in studies 2 & 3
Time frame: 3 months post enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 3 | Studies 2 & 3: Feasibility of Retention | 41 Participants |
| Study 3 | Studies 2 & 3: Feasibility of Retention | 23 Participants |
Study 1: Perceived Acceptability of Intervention
number of participants who agreed the proposed intervention was acceptable.
Time frame: interview (up to 30 minutes at study visit)
Population: patients, providers, and leaders at a community mental healthcare center
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 3 | Study 1: Perceived Acceptability of Intervention | 18 Participants |
Study 1: Perceived Feasibility of Intervention
Number of participants who reported the proposed intervention was feasible
Time frame: interview (up to 30 minutes at study visit)
Population: Interview participants including patients, providers, and leaders at community mental health centers
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 3 | Study 1: Perceived Feasibility of Intervention | 17 Participants |
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)
Time frame: 3 months post enrollment
Population: Patients and providers from a community mental health center who participated in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 3 | Study 2: Perceived Acceptability of Intervention | 8 Participants |
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
Time frame: 1 year post baseline
Population: Participants who completed baseline data and were alive at follow-up (1 participant died and so data was not analyzed)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 3 | Study 3: Smoking Abstinence | 3 Participants |
Study 3: Cigarettes Per Day
number of cigarettes smoked per day in study 3
Time frame: 12 months post baseline
Population: participants who were alive at the 12 month follow-up (1 person died and so their data was not used)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study 3 | Study 3: Cigarettes Per Day | 10.56 cigarettes per day | Standard Deviation 12.02 |
Study 3: Quit Attempts
Number of 24 hour intentional quit attempts
Time frame: 1 year post-baseline
Population: Participants who completed baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study 3 | Study 3: Quit Attempts | 3.07 quit attempts | Standard Deviation 4.46 |
Study 3: Smoking Abstinence
30 day prolonged abstinence (no smoking past 30 days prior to 1 year follow-up)
Time frame: 1 year post baseline
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 3 | Study 3: Smoking Abstinence | 3 Participants |