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COPD Discharge Bundle Delivered Alone or Enhanced Through a Care Coordinator (PRIHS)

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ClinicalTrials.gov Identifier: NCT03358771
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : December 4, 2017
Sponsor:
Collaborators:
University of Calgary
Alberta Health Services
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
Michael Stickland, University of Alberta

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Other: COPD discharge care bundle Other: COPD discharge care bundle & coordinator Not Applicable

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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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effectiveness and Cost-effectiveness of a COPD Discharge Bundle Delivered Alone or Enhanced Through a Care Coordinator
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Arm Intervention/treatment
No Intervention: Usual Care
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").
Active Comparator: COPD discharge care bundle

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
Other: COPD discharge care bundle
As a part of RHSCN quality improvement initiative, the elements of the COPD discharge bundle were integrated into a standardized COPD admission order set and are being implemented province-wide. The discharging physician/team will complete the COPD bundle (with reminders facilitated by clinical decision support tools) prior to patient discharge. A copy of the bundle is retained in the patient's medical record, and another copy is sent to the patient's primary care provider detailing the components of the bundle that were completed prior to discharge, and those still needing to be addressed. The patient will also receive a patient-focused discharge checklist detailing discharge bundle items

Experimental: COPD discharge care bundle & coordinator
COPD discharge care bundle as listed for active comparator arm enhanced with care coordinator support.
Other: COPD discharge care bundle & coordinator
The coordinator will be health professional associated with a Primary Care Network, ED or AHS with access to patient information. Patients will be informed that care coordinator may contact them for follow up after discharge. At 48-72 hours after hospital/ED discharge and then at intervals to be determined, the care coordinator will contact the patient by phone. The care coordinator will identify specific needs or problems that patient may have encountered after discharge, which could potentially affect the successful transition from acute to community care setting. Specifically, the care coordinator will seek information on any follow up with family doctor visit, pulmonary rehabilitation and smoking cessation referrals




Primary Outcome Measures :
  1. ED revisits [ Time Frame: 30 days after discharge ]
  2. Hospital readmissions [ Time Frame: 30 days after discharge ]

Secondary Outcome Measures :
  1. ED revisits [ Time Frame: 7 days after discharge ]
  2. ED revisits [ Time Frame: 6 months after discharge ]
  3. ED revisits [ Time Frame: 1 year after discharge ]
  4. Hospital readmission [ Time Frame: 7 days after discharge ]
  5. Hospital readmission [ Time Frame: 6 months after discharge ]
  6. Hospital readmission [ Time Frame: 1 year after discharge ]
  7. Mortality [ Time Frame: 7 days after discharge ]
  8. Mortality [ Time Frame: 30 days after discharge ]
  9. Mortality [ Time Frame: 6 months after discharge ]
  10. Mortality [ Time Frame: 1 year after discharge ]
  11. Time to first physician visit and total visits [ Time Frame: in the first 30 days after discharge ]
  12. Time to first physician visit and total visits [ Time Frame: in the first 6 months after discharge ]
  13. Patient Experience - inpatient [ Time Frame: 45-60 days after discharge ]
    For a randomly selected sample of patients, Patient Experience Survey - Inpatient Care

  14. Patient Experience - ED [ Time Frame: 45-60 days after discharge ]
    For a randomly selected sample of patients, Patient Experience Survey - Emergency Department

  15. Economic evaluation [ Time Frame: 1 year after termination of the trial (April 2020) ]
    E.g. cost per readmission prevented; Cost of intervention; Cost of healthcare use (MD visits, ED visits, medication use, hospitalizations)



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358771


Contacts
Contact: Marta Michas, PhD 780-248-1761 marta.michas@ualberta.ca
Contact: Michael K Stickland, PhD 780-492-3995 michael.stickland@ualberta.ca

Locations
Canada, Alberta
Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada
Rockyview General Hospital Not yet recruiting
Calgary, Alberta, Canada
Royal Alexandra Hospital Not yet recruiting
Edmonton, Alberta, Canada
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada
Red Deer Regional Hospital Centre Recruiting
Red Deer, Alberta, Canada, T4N 4E7
Contact: Michael K Stickland, PhD    780-492-3995    michael.stickland@ualberta.ca   
Sponsors and Collaborators
University of Alberta
University of Calgary
Alberta Health Services
Alberta Innovates Health Solutions
Investigators
Principal Investigator: Michael K Stickland, PhD University of Alberta

Responsible Party: Michael Stickland, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03358771     History of Changes
Other Study ID Numbers: Pro00065003
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Stickland, University of Alberta:
COPD
AECOPD
Discharge care bundle
Patient Care Bundles

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive