Electronic Proactive Outreach for Smokers With COPD

Overview

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.

Full Title of Study: “Electronic Proactive Outreach for Smokers With COPD: Engaging Patients to Quit (CDA 19-081)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 15, 2024

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Response to outreach intervention
    • Time Frame: 60 days
    • Proportion of participants who respond to the proactive offer, feasibility outcome

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Office of Research and Development
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anne C. Melzer, MD MS, Principal Investigator, Minneapolis VA Health Care System, Minneapolis, MN

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