search
Back to results

Proactive Outreach for Smoking Treatment (POST)

Primary Purpose

Smoking, Tobacco, Mental Illness

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Chronic care management
Sponsored by
Hennepin Healthcare Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking, Tobacco focused on measuring smoking, Chronic care model, Serious mental illness, implementation science

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hennepin Healthcare Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic care for tobacco use

Arm Description

Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.

Outcomes

Primary Outcome Measures

Smoking abstinence
CO validated 7-day point prevalence smoking abstinence

Secondary Outcome Measures

Smoking abstinence
30 day prolonged abstinence
Quit attempts
Number of 24 hour intentional quit attempts
Cigarettes per day
number of cigarettes smoked per day

Full Information

First Posted
July 23, 2021
Last Updated
April 12, 2023
Sponsor
Hennepin Healthcare Research Institute
Collaborators
Brown University, University of Minnesota
search

1. Study Identification

Unique Protocol Identification Number
NCT04988477
Brief Title
Proactive Outreach for Smoking Treatment
Acronym
POST
Official Title
Implementation of Cessation Treatment in Community Based Mental Health Centers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
December 6, 2022 (Actual)
Study Completion Date
January 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hennepin Healthcare Research Institute
Collaborators
Brown University, University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Tobacco, Mental Illness
Keywords
smoking, Chronic care model, Serious mental illness, implementation science

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
This is a pre-post study with multiple baselines to account for change over time.
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic care for tobacco use
Arm Type
Experimental
Arm Description
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Intervention Type
Behavioral
Intervention Name(s)
Chronic care management
Intervention Description
Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
Primary Outcome Measure Information:
Title
Smoking abstinence
Description
CO validated 7-day point prevalence smoking abstinence
Time Frame
12-months post baseline
Secondary Outcome Measure Information:
Title
Smoking abstinence
Description
30 day prolonged abstinence
Time Frame
12 months post-baseline
Title
Quit attempts
Description
Number of 24 hour intentional quit attempts
Time Frame
12 months post-baseline
Title
Cigarettes per day
Description
number of cigarettes smoked per day
Time Frame
12 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hennepin Healthcare Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
IPD Sharing Time Frame
18 months after collection of primary outcome data for 5 years post data collection.
IPD Sharing Access Criteria
research ethics training

Learn more about this trial

Proactive Outreach for Smoking Treatment

We'll reach out to this number within 24 hrs