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Proactive Outreach for Smoking Treatment

Implementation of Cessation Treatment in Community Based Mental Health Centers

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04988477
Acronym
POST
Enrollment
94
Registered
2021-08-03
Start date
2021-07-14
Completion date
2023-01-27
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Illness, Smoking, Tobacco

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

BEHAVIORALStudy 3: Chronic care management

Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 9 months.

BEHAVIORALStudy 2: Pilot trial

Providers trained in brief provider intervention and 1 outreach call over 3 months.

Sponsors

Brown University
CollaboratorOTHER
University of Minnesota
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Sandra Japuntich
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Study 2: Perceived Acceptability of Intervention3 months post enrollmentNumber 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 Interventioninterview (up to 30 minutes at study visit)number of participants who agreed the proposed intervention was acceptable.
Studies 2 & 3: Feasibility of RecruitmentbaselineNumber of participants recruited (goal for study 2=25; goal for study 3=50)
Studies 2 & 3: Feasibility of Retention3 months post enrollment% of participants completing follow-up in studies 2 & 3
Study 3: Smoking Abstinence1 year post baselinenumber 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 Interventioninterview (up to 30 minutes at study visit)Number of participants who reported the proposed intervention was feasible

Secondary

MeasureTime frameDescription
Study 3: Quit Attempts1 year post-baselineNumber of 24 hour intentional quit attempts
Study 3: Cigarettes Per Day12 months post baselinenumber of cigarettes smoked per day in study 3
Study 3: Smoking Abstinence1 year post baseline30 day prolonged abstinence (no smoking past 30 days prior to 1 year follow-up)

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total94

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath100
Overall StudyLost to Follow-up520
Overall StudyWithdrawal by Subject200

Baseline characteristics

CharacteristicStudy 3Study 2TotalStudy 1
Age, Continuous41.23 years
STANDARD_DEVIATION 11.88
48.64 years
STANDARD_DEVIATION 12.14
43.93 years
STANDARD_DEVIATION 12.37
cigarettes per day15.35 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 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
49 Participants25 Participants74 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants1 Participants4 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
44 Participants22 Participants66 Participants
Region of Enrollment
United States
49 Participants25 Participants94 Participants20 Participants
Sex: Female, Male
Female
32 Participants17 Participants49 Participants
Sex: Female, Male
Male
17 Participants8 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
1 / 490 / 250 / 20
other
Total, other adverse events
0 / 490 / 250 / 20
serious
Total, serious adverse events
1 / 490 / 250 / 20

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Study 3Studies 2 & 3: Feasibility of Recruitment25 Participants
Study 3Studies 2 & 3: Feasibility of Recruitment49 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Study 3Studies 2 & 3: Feasibility of Retention41 Participants
Study 3Studies 2 & 3: Feasibility of Retention23 Participants
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Study 3Study 1: Perceived Acceptability of Intervention18 Participants
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Study 3Study 1: Perceived Feasibility of Intervention17 Participants
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)

Time frame: 3 months post enrollment

Population: Patients and providers from a community mental health center who participated in the study

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Study 3Study 2: Perceived Acceptability of Intervention8 Participants
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

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Study 3Study 3: Smoking Abstinence3 Participants
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Study 3Study 3: Cigarettes Per Day10.56 cigarettes per dayStandard Deviation 12.02
Secondary

Study 3: Quit Attempts

Number of 24 hour intentional quit attempts

Time frame: 1 year post-baseline

Population: Participants who completed baseline assessment.

ArmMeasureValue (MEAN)Dispersion
Study 3Study 3: Quit Attempts3.07 quit attemptsStandard Deviation 4.46
Secondary

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).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Study 3Study 3: Smoking Abstinence3 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026