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N/A Completed N=240 Randomized Single-blind Treatment

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

Source: ClinicalTrials.gov NCT02036294 ↗
Enrolled (actual)
240
Serious AEs
60.4%
Results posted
Feb 2019
Primary outcomePrimary: 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

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.

Outcome Measures

OutcomeResultp-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 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

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. Informational only — not medical advice.

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