Discharge Coordinator Intervention in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Overview

This is a single-centre randomized controlled clinical trial which will enroll COPD patients in Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV, hospitalized due to acute exacerbation. Patients will be randomised in a 1:1 fashion to intervention group, which will have care organized by discharge coordinator, and control group which will receive care as usual. The primary endpoint of this study is time to hospitalization due to COPD worsening. Data will be collected at baseline, at the time of hospital discharge, and at following time-points after the hospital discharge: 48 hours, 7-10 days, 30 days, 90 days, and 180 days.

Full Title of Study: “Effects of Discharge Coordinator Intervention on Hospitalizations and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

Detailed Description

This is a single-centre randomized controlled clinical trial to assess the effectiveness of discharge coordinator intervention compared to care as usual in patients with COPD.

The study is being conducted at University Clinic of Pulmonary and Allergic Diseases Golnik, Slovenia. Patients with suspicion of acute exacerbation of COPD will be screened at admission when they will be informed about study details. After explanations of concerns and questions that they might have, a signed informed consent will be collected. During 48 hours, patients will be included according to their eligibility. Main inclusion criteria are COPD stage II-IV according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, ability to perform phone contacts and availability for home visits. Patients will be excluded if in unstable or terminal stage of disease other than COPD, if they will die during hospitalization, or if unable to follow the study protocol.

Interventions

  • Other: Coordinated discharge
    • In intervention group, a discharge coordinator contacts hospitalized patients the day after randomization. During hospitalization, discharge coordinator visits are scheduled according to patients’ problems and home-care needs. At 48 hours after hospital discharge, a discharge coordinator calls patients by phone to check the process of adjustment to home environment and to inquire about additional needs patients might have. Thereafter, phone contacts are scheduled according to the patients’ needs and 7-10 days after the hospital discharge a home visit is performed by discharge coordinator, respectively.
  • Other: Control
    • Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.

Arms, Groups and Cohorts

  • Experimental: Coordinated discharge
    • Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care.
  • Placebo Comparator: Control
    • Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients hospitalized due to COPD worsening
    • Time Frame: 180 days
    • A hospitalization is defined as an unplanned overnight stay in hospital (different date for admission and discharge) due to acute worsening of COPD. Endpoint will be adjudicated by Endpoint committee.

Secondary Measures

  • All-cause mortality
    • Time Frame: 180 days
    • Mortality will be ascertained at the Central Population Registry.
  • Acute exacerbations of COPD
    • Time Frame: 180 days
    • Endpoint will be adjudicated by Endpoint committee.
  • Time to hospitalization due to COPD worsening
    • Time Frame: 180 days
    • A hospitalization is defined as an unplanned overnight stay in hospital (different date for admission and discharge) due to acute worsening of COPD. Endpoint will be adjudicated by Endpoint committee.
  • Days alive and out of hospital
    • Time Frame: 180 days
    • Endpoint will be adjudicated by Endpoint committee.
  • Health-related quality of life
    • Time Frame: 180 days
    • Endpoint will be adjudicated by Endpoint committee.
  • Health care costs
    • Time Frame: 180 days
    • Endpoint will be adjudicated by Endpoint committee.

Participating in This Clinical Trial

Inclusion Criteria

  • age >35 years
  • acute exacerbation of COPD stage II-IV
  • residence in the geographical area linked to the study hospital
  • ability to communicate
  • give written informed consent

Exclusion Criteria

  • diagnosis of cognitive impairment
  • unstable or terminal disease other than COPD
  • withdrawal of written informed consent before discharge
  • inability of phone contact
  • death during hospitalisation

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University Clinic of Pulmonary and Allergic Diseases Golnik
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mitja Lainščak, Professor – The University Clinic of Pulmonary and Allergic Diseases Golnik
  • Overall Official(s)
    • Mitja Lainscak, MD, PhD, Study Chair, University Clinic Golnik
    • Jerneja Farkas, MD, PhD, Principal Investigator, University of Ljubljana

References

Farkas J, Kadivec S, Kosnik M, Lainscak M. Effectiveness of discharge-coordinator intervention in patients with chronic obstructive pulmonary disease: study protocol of a randomized controlled clinical trial. Respir Med. 2011 Oct;105 Suppl 1:S26-30. doi: 10.1016/S0954-6111(11)70007-5.

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