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Electronic Proactive Outreach for Smokers With COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Smoking

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proactive Outreach
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pulmonary Disease, Chronic Obstructive focused on measuring smoking cessation, Pulmonary Disease, Chronic Obstructive, implementation science

Eligibility Criteria

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

Inclusion Criteria:

  • Veterans active in clinical care (at least one primary care or pulmonary visit within the past year)
  • Past-year smoking status in the electronic health record indicating current smoking
  • Diagnosed with COPD (2 ICD-10 diagnoses of COPD within the past 2 years)
  • Currently enrolled in MyHealtheVet secure messaging

Exclusion Criteria:

  • Already enrolled in behavioral VA tobacco treatment
  • Enrolled in hospice
  • Undergoing active cancer treatment
  • Advanced dementia
  • Unable to communicate in English

Sites / Locations

  • Minneapolis VA Health Care System, Minneapolis, MN

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Proactive Outreach

Arm Description

Randomly assigned sample who will receive usual care for tobacco cessation treatment

Randomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program.

Outcomes

Primary Outcome Measures

Response to outreach intervention
Proportion of participants who respond to the proactive offer, feasibility outcome

Secondary Outcome Measures

Participation in tobacco cessation treatment
Any participation in tobacco cessation treatment (medication use, counseling)
Rate of Smoking cessation
Self-reported and biochemically confirmed smoking cessation
Number of Quit attempts
Self-reported attempts to quit smoking
Marginal Cost
Cost associated with the proactive program, encompassing both direct costs and indirect costs related to increased use of quit resources and medications

Full Information

First Posted
July 2, 2020
Last Updated
May 16, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04462289
Brief Title
Electronic Proactive Outreach for Smokers With COPD
Official Title
Electronic Proactive Outreach for Smokers With COPD: Engaging Patients to Quit (CDA 19-081)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory diseases, with 90% of cases directly attributable to smoking. Unfortunately, many patients continue to smoke and have an urgent need to quit. Proactive tobacco treatment programs identify patients outside of a routine clinical appointment and engage them in making a supported quit attempt. Most previous research of proactive tobacco treatment has used telephone outreach, which can be resource intensive. Electronic methods (texting, secure messaging) may be effective while requiring fewer resources. In this study, a previously tested telephone outreach intervention will be adapted for electronic delivery, with content tailored to smokers with COPD. First, information will be gathered from smokers with COPD and the medical staff who care for them to adapt the program for electronic delivery. Then, the program will be pilot-tested. Smokers with COPD will be randomly assigned to either usual medical care or the outreach intervention, with goals to increase participation in smoking cessation programs, quit attempts, and successful cessation.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory conditions and the 4th leading cause of death in the US. 90% of cases are directly attributable to smoking. Quitting smoking is the most important intervention for these patients, who continue to smoke at rates double the national average. Smokers with COPD remain undertreated for tobacco use. Proactive tobacco treatment programs identify patients outside of a routine clinic visit, engage them in making a quit attempt and connect them with treatment. These programs may be particularly beneficial for smokers with COPD. Previous phone-based programs are resource intensive to deliver. Electronic methods for delivering proactive outreach for tobacco cessation may be effective and cost-effective, and can be tailored to the target population. Hypothesis: A proactive tobacco treatment program adapted to electronic delivery and tailored to smokers with COPD will be effective and cost effective for increasing quit engagement among smokers with COPD. Study design: Multi-aim implementation study with randomized pilot. Aim 1: Mixed methods (survey and interview) assessment of current use of health information technology among smokers with COPD with a focus on the impact of the chronic disease state on tobacco cessation. Aim 2: Qualitative assessment of barriers and facilitators to implementation of proactive tobacco treatment programs for patients with COPD among staff and leadership. Aim 3: Randomized pilot of a proactive tobacco treatment program for smokers with COPD delivered through phone and text messaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Smoking
Keywords
smoking cessation, Pulmonary Disease, Chronic Obstructive, implementation science

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patient-level randomized pilot
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Randomly assigned sample who will receive usual care for tobacco cessation treatment
Arm Title
Proactive Outreach
Arm Type
Experimental
Arm Description
Randomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program.
Intervention Type
Behavioral
Intervention Name(s)
Proactive Outreach
Intervention Description
Motivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs
Primary Outcome Measure Information:
Title
Response to outreach intervention
Description
Proportion of participants who respond to the proactive offer, feasibility outcome
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Participation in tobacco cessation treatment
Description
Any participation in tobacco cessation treatment (medication use, counseling)
Time Frame
6 months
Title
Rate of Smoking cessation
Description
Self-reported and biochemically confirmed smoking cessation
Time Frame
6 months
Title
Number of Quit attempts
Description
Self-reported attempts to quit smoking
Time Frame
6 months
Title
Marginal Cost
Description
Cost associated with the proactive program, encompassing both direct costs and indirect costs related to increased use of quit resources and medications
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans active in clinical care (at least one primary care or pulmonary visit within the past year) Past-year smoking status in the electronic health record indicating current smoking, confirmed on enrollment call Diagnosed with COPD (2 ICD-10 diagnoses of COPD within the past 2 years) Currently enrolled in MyHealtheVet secure messaging Exclusion Criteria: Already enrolled in behavioral VA tobacco treatment Enrolled in hospice Undergoing active cancer treatment Advanced dementia Unable to communicate in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne C. Melzer, MD MS
Organizational Affiliation
Minneapolis VA Health Care System, Minneapolis, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417-2309
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Electronic Proactive Outreach for Smokers With COPD

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