At Home Spirometry and Video Module Education for COPD Patients (BREATHES)

The University of Chicago

Status: Completed

Conditions: COPD

Treatments: Device: BREATHES SpiroPD or Propeller Health; Other: BREATHES Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03834350

IRB18-1210

R03HL144883 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The central hypothesis is that patients hospitalized for COPD who subsequently complete the at-home BREATHES Program with V-TTG skill training and SpiroPD adherence support will retain increased medication knowledge, skill, self-efficacy, and adherence that otherwise decays substantially by 30 days post-discharge. To test this hypothesis, this study proposes the following specific aims:

Aim 1: Determine the feasibility of, adherence to, and efficacy of at-home V-TTG for ongoing inhaler skill training.

Hypothesis: Participants who complete both in-hospital and at-home V-TTG will have a significantly increased likelihood of demonstrating effective respiratory inhaler technique within 30 days after hospital discharge compared to in-hospital technique

Aim 2. Determine the feasibility of, adherence to, and efficacy of at-home SpiroPD for COPD medication adherence support.

Hypothesis: Participants' use of SpiroPD (PMD Healthcare) will significantly improve their COPD medication adherence.

Full description

Chronic obstructive pulmonary disease (COPD) results in nearly 750,000 hospitalizations annually and is the third leading cause of 30-day hospital readmissions in the United States.Improving the quality of care for hospitalized COPD patients has recently become a national priority through the Centers for Medicare and Medicaid Services' Hospital Readmissions Reduction Program. A key element of improving care quality is translating existing evidence into improved practice. Extensive evidence exists to support the efficacy of inhaled medications to control and reduce COPD symptoms and to improve patient outcomes. However, the real-world effectiveness of these medications is often limited due both to poor inhaler technique and to insufficient adherence to treatment plans. Most interventions for hospitalized patients with COPD focus on medication reconciliation, treatment optimization, and inhaler technique education prior to being discharged home. However, after discharge home, patients quickly lose inhaler technique skills, have difficulty adhering to complex regimens, and lack tools to aid adherence, such as lung function response to their treatment regimen. Interventions to reinforce skills and support adherence are needed across care transitions to reduce the risk of deleterious health outcomes.

Simple and feasible at-home interventions to provide skills training and adherence support are needed. This novel idea is to pair at-home inhaler skill training with at-home spirometry measurements to comprehensively support both medication skill and adherence. The investigator proposes testing a novel at-home self-management support program called "BREATHES" (Bringing Respiratory Education for improved Adherence and Technique Home through E-interventions for Self-management) Program. BREATHES will include two main components: first, self-directed inhaler skill training sessions through the virtual Teach-To-Goal (V-TTG) intervention the investigator developed and tested during a K23 grant and, second, a handheld lung function device to provide physiologic feedback and capture medication adherence called SpiroPD. TTG is a patient-centered strategy that uses cycles of assessment and demonstration tailored to patients' self-management needs; the investigator's research shows in-person TTG is effective for teaching inhaler technique and reduces acute care utilization. Virtual-TTG delivers the key features of TTG using virtual patient-directed lessons through novel adaptive technology that provides tailored self-assessment and training. The investigator's studies demonstrate participants' willingness to use V-TTG at-home for post-discharge booster education and show that V-TTG is effective and may be non-inferior to in-person TTG in significantly reducing inhaler misuse among hospitalized patients. However, it remains unknown whether at-home V-TTG sessions will maintain self-management skills over the longer term and how direct physiologic lung monitoring support can impact medication adherence. The proposed studies will determine whether combining at-home skill training with objective measurements of lung function and adherence monitoring through the BREATHES Program improves self-management skills and medication adherence in the first 30 days after hospitalization for COPD.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years and older
2. Physician-diagnosed COPD (prior to or during hospitalization)
3. Owns a wifi-enabled device (desktop, laptop, tablet, smart phone, etc.)
4. Discharged with a rescue and/or controller MDI (metered dose inhaler).

Exclusion criteria

1. Currently in an intensive care unit
2. Physician declines to provide consent
3. Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

At-Home Breathes Program

Other group

Description:

Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.

Treatment:

Other: BREATHES Program

Device: BREATHES SpiroPD or Propeller Health