Clinical trial NCT03358771: COPD Discharge Bundle Delivered Alone or Enhanced Through a Care Coordinator
Official title: Effectiveness and Cost-effectiveness of a COPD Discharge Bundle Delivered Alone or Enhanced Through a Care Coordinator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
AECOPD
Discharge care bundle
Patient Care Bundles
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: Alberta Health services
name: Alberta Innovates Health Solutions
First posted: 2017-12-02
Enrollment: 3710
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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

In view of the promising results from systematic reviews that indicate that integrated care bundles can be effective for conditions with relatively predictable trajectories of care such as COPD, the investigators want to assess whether a COPD discharge bundle adapted to local ED and hospital settings is a relevant, feasible and cost-effective alternative within the Alberta health care system, and whether the addition of a care coordinator to the bundle further reduces ED and hospital readmissions while containing health care costs.

To assure that the care bundle is relevant to the local practice and applicable in the Alberta health system, the research team developed a COPD discharge care bundle through an evidence-based consultation-driven process. During this process, the researchers consulted patients and expert clinicians from Alberta and Canada. The development of the bundle has been a part of 3-year PRIHS project titled "Developing and assessing the effectiveness of a post-discharge care pathway to reduce emergency department revisits and hospital re-admission rates for patients with COPD". The process of bundle development involved several steps:

* Systematic review - to identify evidence-based components incorporated in COPD discharge care bundles in the scientific literature;
* 2-step Delphi technique with field experts and patients to reach consensus on the evidence-based individual components of discharge care bundles;
* A face-to-face Consensus Meeting with practitioners and experts from Alberta and to finalize components of the bundle and identify practical issues for bundle implementation;
* Targeted focus groups with patients and health professionals who work within hospitals, emergency units and/or primary care settings to recognize barriers and facilitators for care bundle implementation.

As a result, the investigators developed the COPD discharge care bundle that includes 7 action items (see Table 2). The list constitutes a single intervention (COPD discharge care bundle). The bundle has subsequently been integrated into the new provincial AHS COPD Order Set by the AHS pathway development team. The current study will specifically examine the efficacy of this new discharge care bundle, and whether the addition of a case manager will improve care. Currently, the research team is conducting the needs and readiness assessments within the five hospitals that are part of the project to determine the best implementation strategies.

Study objectives

This study aims to assess the effectiveness and cost-effectiveness of an evidence-based COPD discharge care bundle, delivered alone or facilitated by a dedicated care coordinator, to reduce ED and hospital readmissions, and improve patient-centered and economic outcomes.

Eligibility criteria: 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.

Primary outcomes:
measure: ED revisits
timeFrame: 30 days after discharge
measure: Hospital readmissions
timeFrame: 30 days after discharge
Secondary outcomes:
measure: ED revisits
timeFrame: 7 days after discharge
measure: ED revisits
timeFrame: 90 days after discharge
measure: ED revisits
timeFrame: 1 year after discharge
measure: Hospital readmission
timeFrame: 7 days after discharge
measure: Hospital readmission
timeFrame: 90 days after discharge
measure: Hospital readmission
timeFrame: 1 year after discharge
measure: Time to first physician visit and total visits
timeFrame: in the first 30 days after discharge
measure: Time to first physician visit and total visits
timeFrame: in the first 90 days after discharge
measure: Mortality
timeFrame: 7 days after discharge
measure: Mortality
timeFrame: 30 days after discharge
measure: Mortality
timeFrame: 90 days after discharge
measure: Mortality
timeFrame: 1 year after discharge
measure: Patient Experience - Inpatient
timeFrame: 45-60 days after discharge
measure: Patient Experience - ED
timeFrame: 45-60 days after discharge
measure: Economic Evaluation
timeFrame: 1 year after termination of the trial
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Rockyview General Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Red Deer
country: Canada
facility: Red Deer Regional Hospital Centre
state: Alberta
Study officials:
affiliation: University of Alberta
name: Michael K Stickland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atwood CE, Bhutani M, Ospina MB, Rowe BH, Leigh R, Deuchar L, Faris P, Michas M, Mrklas KJ, Graham J, Aceron R, Damant R, Green L, Hirani N, Longard K, Meyer V, Mitchell P, Tsai W, Walker B, Stickland MK. Optimizing COPD Acute Care Patient Outcomes Using a Standardized Transition Bundle and Care Coordinator: A Randomized Clinical Trial. Chest. 2022 Aug;162(2):321-330. doi: 10.1016/j.chest.2022.03.047. Epub 2022 Apr 9.