N/A N=240 Randomized Single-blind Treatment

Improving Patient-Centered Care Delivery Among Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease

Bottom Line

View on ClinicalTrials.gov: NCT02036294 ↗

Enrolled (actual)

240

Serious AEs

60.4%

Results posted

Feb 2019

Primary outcome: Primary: Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm — 0.72; 1.40 COPD-related visits per participant

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BREATHE program (Other); Usual Care (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm	0.43; 0.78	—
PRIMARY Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm	-1.13; -0.85	—
SECONDARY Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm	0.43; 0.78	—
SECONDARY Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm	0.43; 0.78	—
SECONDARY Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm	-1.13; -0.85	—
SECONDARY Probability for Survival Without Death or a COPD- Related Acute Care Event at 6 Months Post Index-hospitalization, Estimated Using the Kaplan-Meier Method	0.58; 0.45	—

Summary

This study involves development and testing of a patient and family-centered transitional care program for patients who are hospitalized with Chronic Obstructive Pulmonary Disease (COPD) exacerbations. The study intervention includes tailored services to address individual patients' biopsychosocial needs, starting early during hospital stay and continuing for 3 months post hospital discharge. The study hypothesis is that compared to usual care, the study intervention will : a) Improve patient health- related quality of life and survival, and reduce use of hospital and emergency room visits; b) result in improved patient experience, self- confidence, and self-care behaviors; c) result in improved family caregivers coping skills, self-confidence, and problem solving skills to address patient barriers to care and treatment.

Eligibility Criteria

Inclusion criteria

Admitted to the hospital with a diagnosis of an acute COPD exacerbation; OR has a previous COPD diagnosis* AND receiving treatment to control COPD symptoms - (e.g. nebulizer treatment, prednisone course, …) in the current hospitalization
Age > 40 and >10 pack-yrs smoking
English speaking
Anticipated discharge back to home (rather than to Hospice or long term nursing home placement)

Exclusion criteria

Severe cognitive dysfunction
Terminal illness (less than 6 months life expectancy) that is non-COPD related
Homeless (no home address)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02036294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.