COPD Discharge Bundle Delivered Alone or Enhanced Through a Care Coordinator (PRIHS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03358771 |
Recruitment Status :
Completed
First Posted : December 2, 2017
Last Update Posted : May 5, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3710 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 |
Actual Primary Completion Date : | December 30, 2019 |
Actual Study Completion Date : | December 30, 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:
|
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 |
- ED revisits [ Time Frame: 30 days after discharge ]Number of revisits
- Hospital readmissions [ Time Frame: 30 days after discharge ]Number of readmissions
- ED revisits [ Time Frame: 7 days after discharge ]Number of revisits
- ED revisits [ Time Frame: 90 days after discharge ]Number of revisits
- ED revisits [ Time Frame: 1 year after discharge ]Number of revisits
- Hospital readmission [ Time Frame: 7 days after discharge ]Number of readmissions
- Hospital readmission [ Time Frame: 90 days after discharge ]Number of readmissions
- Hospital readmission [ Time Frame: 1 year after discharge ]Number of readmissions
- Time to first physician visit and total visits [ Time Frame: in the first 30 days after discharge ]Number of days
- Time to first physician visit and total visits [ Time Frame: in the first 90 days after discharge ]Number of days
- Mortality [ Time Frame: 7 days after discharge ]Number of cases
- Mortality [ Time Frame: 30 days after discharge ]Number of cases
- Mortality [ Time Frame: 90 days after discharge ]Number of cases
- Mortality [ Time Frame: 1 year after discharge ]Number of cases
- Patient Experience - Inpatient [ Time Frame: 45-60 days after discharge ]For a randomly selected sample of patients, Patient Experience Survey - Inpatient Care
- Patient Experience - ED [ Time Frame: 45-60 days after discharge ]For a randomly selected sample of patients, Patient Experience Survey - Emergency Department
- Economic Evaluation [ Time Frame: 1 year after termination of the trial ]Cost per readmission prevented; cost of intervention; cost of healthcare use (MD visits, ED visits, medication use, hospitalizations)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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.

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
Canada, Alberta | |
Foothills Medical Centre | |
Calgary, Alberta, Canada | |
Rockyview General Hospital | |
Calgary, Alberta, Canada | |
Royal Alexandra Hospital | |
Edmonton, Alberta, Canada | |
University of Alberta Hospital | |
Edmonton, Alberta, Canada | |
Red Deer Regional Hospital Centre | |
Red Deer, Alberta, Canada, T4N 4E7 |
Principal Investigator: | Michael K Stickland, PhD | University of Alberta |
Responsible Party: | Michael Stickland, Professor, University of Alberta |
ClinicalTrials.gov Identifier: | NCT03358771 |
Other Study ID Numbers: |
Pro00065003 |
First Posted: | December 2, 2017 Key Record Dates |
Last Update Posted: | May 5, 2021 |
Last Verified: | May 2021 |
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 |
COPD AECOPD Discharge care bundle Patient Care Bundles |
Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |