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Clinical Trials/NCT03358771
NCT03358771CompletedNot Applicable

Effectiveness and Cost-effectiveness of a COPD Discharge Bundle Delivered Alone or Enhanced Through a Care Coordinator

University of Alberta5 sites in 1 country3,710 target enrollmentStarted: March 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3,710
Locations
5
Primary Endpoint
ED revisits

Study Overview

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a common, chronic progressive lung disease that is characterized by shortness of breath, activity limitation, and a predisposition to flare-ups resulting in frequent emergency department (ED) visits and hospitalizations. COPD flare-ups increase risks of disease progression and mortality and account for the greatest proportion of preventable hospitalizations among major chronic diseases.

Evidence show that timely integrated disease management can prevent future COPD flare-ups and readmissions, but recent data indicate that appropriate follow-up after a COPD hospitalization is limited. To reduce this care gap, the investigators developed a discharge care bundle to help a patient that are being discharged from hospital or ED after COPD flare-up transition to community care.

The aim of this study is to assess how effective and cost-effective is such bundle delivered alone or supported by the dedicated care manager. The investigators will be assessing reduction of ED and hospital readmission.

Detailed Description

Introduction/Significance

Chronic obstructive pulmonary disease (COPD) is a common, chronic progressive lung disease that is characterized by shortness of breath, activity limitation, and a predisposition to acute exacerbations resulting in frequent emergency department (ED) visits and hospitalizations. COPD exacerbations account for the greatest proportion of preventable hospitalizations among major chronic diseases. In Alberta, a recent report from the COPD Working Group of the Respiratory Health Strategic Clinical Network (RHSCN) found that, with an average length of stay of 12.9 days, COPD hospitalizations result in an estimated total inpatient cost of $112 million annually. In addition to increasing the risk of disease progression and mortality, COPD exacerbations are a major risk factor for subsequent COPD exacerbations, resulting in additional ED visits and hospitalizations. Approximately 35% of COPD patients who are discharged from the ED have a subsequent revisit within 30 days of initial ED discharge. National data indicate that 18% of hospitalized COPD patients are readmitted within one year after the index hospitalization while 14% are admitted twice within the year. Analysis of Alberta Health Services (AHS) administrative data shows that the 30-day hospital readmission rates for COPD in Alberta during 2012 (18.8%) and 2013 (19.5%) were well above the national 30-day readmission rate for all hospital admissions (8.4%).

The Canadian Thoracic Society (CTS) has developed evidence-based management guidelines for optimizing COPD care and preventing exacerbations and has recommended that COPD patients should be seen by their primary care provider within 14 days following an exacerbation. Further, the Global Initiative for Obstructive Lung Disease has proposed a list of items to review with the patient at discharge and recommends follow-up at 4-6 weeks after discharge. Despite evidence from systematic reviews that timely integrated disease management can prevent future COPD exacerbations and readmissions, recent Alberta data indicate that appropriate follow-up after a COPD hospitalization is limited. An audit at the University of Alberta hospital found that only 43% of COPD patients received appropriate medication prescriptions at discharge; only 10% of eligible patients were referred to a rehabilitation program while only 58% of smokers received instructions on smoking cessation interventions. To overcome these care gaps in COPD, previously published work has supported the introduction of clinical bundles and case management for follow-up after discharge, suggesting promising results to reduce readmissions and minimize health care utilization costs. Clinical bundles support the translation of clinical guidelines into local protocols and their subsequent standardization and application to clinical practice, enhance integrated care, and optimize patient outcomes while maximizing clinical efficiency and containing costs.

A recently completed systematic review of the scientific literature on the effectiveness of COPD discharge care bundles showed that COPD discharge care bundles reduced hospital readmission rates (Risk Ratio [RR]=0.8; 95% Confidence Interval [CI] [0.65, 0.99]); they did not, however, significantly reduce long-term mortality (RR=0.74; CI [0.43; 1.28]) nor improved quality of life after acute care discharge (Mean Difference=1.84; CI [-5.23, 5.80])

COPD discharge care bundle

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Medical diagnosis of COPD;
  • •Male or female, 50 years of age and over, admitted to ED or hospital for an exacerbation of COPD. The age limit is imposed to reduce the chances of enrolling patients with asthma.
  • •Any stage of severity;
  • •Not being treated previously under the COPD care bundle

Exclusion Criteria

  • •Patients with a diagnosis other than COPD will be excluded.

Arms & Interventions

Usual Care

No Intervention

During the initial stepped wedge phase, all sites will receive usual care. There is currently no standardized discharge care bundle for COPD in Alberta. Some electronic patient information sheets do exist; however, their content is general and use is limited. It is expected that a vast majority of patients will transition to the community on a sub-optimal medication regimen, with limited referral to additional outpatient programs and no formal follow-up organized with a primary care provider (e.g., "F/U prn" or "F/U with Fam MD").

COPD discharge care bundle

Active Comparator

COPD discharge care bundle:

  1. Ensure patient has demonstrated adequate inhaler technique
  2. Send discharge summary to family physician office and arrange follow-up
  3. Optimize and reconcile prescription of respiratory medications
  4. Provide a written discharge management plan, and assess patient's and care giver's comprehension of discharge instructions
  5. Refer to pulmonary rehabilitation
  6. Screen for frailty and comorbid condition(s)
  7. Assess smoking status, provide counseling and refer to smoking cessation program, where appropriate

Intervention: COPD discharge care bundle (Other)

COPD discharge care bundle & coordinator

Experimental

COPD discharge care bundle as listed for active comparator arm enhanced with care coordinator support.

Intervention: COPD discharge care bundle & coordinator (Other)

Outcomes

Primary Outcomes

ED revisits

Time Frame: 30 days after discharge

Number of revisits

Hospital readmissions

Time Frame: 30 days after discharge

Number of readmissions

Secondary Outcomes

  • ED revisits(1 year after discharge)
  • Hospital readmission(1 year after discharge)
  • Time to first physician visit and total visits(in the first 90 days after discharge)
  • Mortality(1 year after discharge)
  • Patient Experience - Inpatient(45-60 days after discharge)
  • Patient Experience - ED(45-60 days after discharge)
  • Economic Evaluation(1 year after termination of the trial)
  • ED revisits(7 days after discharge)
  • ED revisits(90 days after discharge)
  • Hospital readmission(7 days after discharge)
  • Hospital readmission(90 days after discharge)
  • Time to first physician visit and total visits(in the first 30 days after discharge)
  • Mortality(7 days after discharge)
  • Mortality(30 days after discharge)
  • Mortality(90 days after discharge)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Stickland

Professor

University of Alberta

Study Sites (5)

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