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Comparative Effectiveness of Two Tobacco Cessation Interventions for Employees of Partners HealthCare, Inc. (PiHQ)

Primary Purpose

Smoking Cessation, Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internal tobacco coach
External tobacco coach
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

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

Inclusion Criteria:

  • Current permanent employee of Partners Healthcare, Inc. or their adult dependent
  • Current tobacco smoker (smoked a cigarette, even a puff, in the past 30 days)

Exclusion Criteria:

  • Temporary, per diem or former employee of Partners Healthcare, Inc.
  • Plan to leave Partners employment in the next 12 months
  • Inability to give informed consent or participate in counseling due to serious psychiatric disorder or cognitive disorder

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internal coaching program

External coaching program

Arm Description

The internal coaching program uses a chronic disease management strategy to treat tobacco use and dependence. The program provides evidence-based treatment consisting of up to 12 months of services from a tobacco coach based at Partners HealthCare. The tobacco coach offers (1) repeated smoking cessation counseling delivered by proactive telephone calls, emails, and interactive voice response [automated phone calls] and (2) facilitated access to a new Partners HealthCare Inc., health insurance benefit that provides access to all FDA-approved smoking cessation medications without copay or prior approval.

The external coaching program consists of referral to the Massachusetts Tobacco Control Program's Smokers Helpline, a free program offering multi-session proactive telephone counseling for 3 months to individuals who are ready to quit smoking. Individuals in this arm also receive information about Partners HealthCare, Inc.'s new health insurance benefit that provides access to all FDA-approved smoking cessation medications without copay or prior approval.

Outcomes

Primary Outcome Measures

Tobacco abstinence for the past 30 days

Secondary Outcome Measures

Tobacco abstinence for the past 30 days
Tobacco abstinence for the past 30 days
Quit attempt

Full Information

First Posted
November 9, 2015
Last Updated
February 22, 2021
Sponsor
Massachusetts General Hospital
Collaborators
Partners HealthCare, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02601521
Brief Title
Comparative Effectiveness of Two Tobacco Cessation Interventions for Employees of Partners HealthCare, Inc.
Acronym
PiHQ
Official Title
Comparative Effectiveness of Two Tobacco Cessation Interventions for Employees of Partners HealthCare, Inc.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Partners HealthCare, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Specific Aim: To conduct a randomized controlled trial among permanent employees of Partners HealthCare, Inc., and their adult dependents, who are current tobacco smokers. The trial will compare two interventions designed to help smokers stop using tobacco: (1) External Coaching Program (Standard Care) and (2) Internal Coaching Program, a chronic disease management strategy for treating tobacco use and dependence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Tobacco Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internal coaching program
Arm Type
Experimental
Arm Description
The internal coaching program uses a chronic disease management strategy to treat tobacco use and dependence. The program provides evidence-based treatment consisting of up to 12 months of services from a tobacco coach based at Partners HealthCare. The tobacco coach offers (1) repeated smoking cessation counseling delivered by proactive telephone calls, emails, and interactive voice response [automated phone calls] and (2) facilitated access to a new Partners HealthCare Inc., health insurance benefit that provides access to all FDA-approved smoking cessation medications without copay or prior approval.
Arm Title
External coaching program
Arm Type
Active Comparator
Arm Description
The external coaching program consists of referral to the Massachusetts Tobacco Control Program's Smokers Helpline, a free program offering multi-session proactive telephone counseling for 3 months to individuals who are ready to quit smoking. Individuals in this arm also receive information about Partners HealthCare, Inc.'s new health insurance benefit that provides access to all FDA-approved smoking cessation medications without copay or prior approval.
Intervention Type
Behavioral
Intervention Name(s)
Internal tobacco coach
Intervention Description
The internal coaching program will provide cognitive-behavioral counseling and medication adherence support for smokers who are ready to quit in the next 3 months It consists of: Telephone counseling by the Tobacco Coach (8 calls over 12 weeks). supplemented by automated phone calls using interactive voice response. At each IVR contact, smokers can request a call back from the Tobacco Coach. Smokers who are not quit after 3 months can restart into the 12-week counseling program. The Tobacco Coach will assist smokers in choosing pharmacotherapy and in obtaining a prescription from the smoker's physician. Support and monitoring for 12 months using automated phone calls. If relapse occurs, the smoker will have the option to return to the active 12-week program.
Intervention Type
Behavioral
Intervention Name(s)
External tobacco coach
Intervention Description
Referral to Massachusetts Smokers Helpline (telephone quitline operated by the Massachusetts Tobacco Control Program) for proactive telephone counseling.
Primary Outcome Measure Information:
Title
Tobacco abstinence for the past 30 days
Time Frame
6 months after enrollment
Secondary Outcome Measure Information:
Title
Tobacco abstinence for the past 30 days
Time Frame
3 months after enrollment
Title
Tobacco abstinence for the past 30 days
Time Frame
12 months after enrollment
Title
Quit attempt
Time Frame
Intentional tobacco abstinence for at least 24 hours since enrollment
Other Pre-specified Outcome Measures:
Title
Duration of use of tobacco cessation pharmacotherapy
Description
Includes any FDA-approved product (nicotine patch, gum, lozenge, inhaler, nasal spray or bupropion or varenicline
Time Frame
at 3 months and at 6 months after enrollment
Title
Smoking cessation counseling contacts
Description
Number of telephone calls with an internal or external tobacco coach to address smoking cessation
Time Frame
at 3 months and at 6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current permanent employee of Partners Healthcare, Inc. or their adult dependent Current tobacco smoker (smoked a cigarette, even a puff, in the past 30 days) Exclusion Criteria: Temporary, per diem or former employee of Partners Healthcare, Inc. Plan to leave Partners employment in the next 12 months Inability to give informed consent or participate in counseling due to serious psychiatric disorder or cognitive disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A Rigotti, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparative Effectiveness of Two Tobacco Cessation Interventions for Employees of Partners HealthCare, Inc.

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