Electronic Proactive Outreach for Smokers With COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04462289
• Other study ID #: CDX 20-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: July 15, 2025

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: July 15, 2025
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive
• Smoking

Intervention

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

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to outreach intervention	Proportion of participants who respond to the proactive offer, feasibility outcome	60 days
Secondary	Participation in tobacco cessation treatment	Any participation in tobacco cessation treatment (medication use, counseling)	6 months
Secondary	Rate of Smoking cessation	Self-reported and biochemically confirmed smoking cessation	6 months
Secondary	Number of Quit attempts	Self-reported attempts to quit smoking	6 months
Secondary	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