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

Study Description

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

  Show Detailed Description

Study Design

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: Ensure patient has demonstrated adequate inhaler technique; Send discharge summary to family physician office and arrange follow-up; Optimize and reconcile prescription of respiratory medications; Provide a written discharge management plan, and assess patient's and care giver's comprehension of discharge instructions; Refer to pulmonary rehabilitation; Screen for frailty and comorbid condition(s); 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

Outcome Measures

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)

Eligibility Criteria

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Contacts and Locations

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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