Electronic Proactive Outreach for Smokers With COPD

Electronic Proactive Outreach for Smokers With COPD: Engaging Patients to Quit (CDA 19-081)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Smoking; Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Behavioral: Proactive Outreach

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417-2309
      • Minneapolis VA Health Care System, Minneapolis, MN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Randomly assigned sample who will receive usual care for tobacco cessation treatment
Experimental: Proactive Outreach; Randomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program.	Behavioral: Proactive Outreach; Motivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to outreach intervention	Proportion of participants who respond to the proactive offer, feasibility outcome	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation in tobacco cessation treatment	Any participation in tobacco cessation treatment (medication use, counseling)	6 months
Rate of Smoking cessation	Self-reported and biochemically confirmed smoking cessation	6 months
Number of Quit attempts	Self-reported attempts to quit smoking	6 months
Marginal Cost	Cost associated with the proactive program, encompassing both direct costs and indirect costs related to increased use of quit resources and medications	6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Anne C. Melzer, MD MS, Minneapolis VA Health Care System, Minneapolis, MN

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): July 15, 2024
• Study Completion (Anticipated): July 15, 2025

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: smoking cessation; Pulmonary Disease, Chronic Obstructive; implementation science
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease
• Other Study ID Numbers: CDX 20-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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