Clinical trial NCT04462289: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Smoking
Keywords: smoking cessation
Pulmonary Disease, Chronic Obstructive
implementation science
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-07-08
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient-level randomized pilot
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Response to outreach intervention
timeFrame: 60 days
Secondary outcomes:
measure: Participation in tobacco cessation treatment
timeFrame: 6 months
measure: Rate of Smoking cessation
timeFrame: 6 months
measure: Number of Quit attempts
timeFrame: 6 months
measure: Marginal Cost
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Anne C. Melzer, MD MS
role: PRINCIPAL_INVESTIGATOR
References: