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The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan

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ClinicalTrials.gov Identifier: NCT03075709
Recruitment Status : Enrolling by invitation
First Posted : March 9, 2017
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
Lung Association of Saskatchewan
Novartis
Information provided by (Responsible Party):
Thomas Rotter, University of Saskatchewan

Brief Summary:

Chronic obstructive pulmonary disease (COPD) has substantial economic and human costs. To minimize these costs high quality guidelines have been developed. However, development of guidelines alone rarely results in changes to practice. One method of integrating guidelines into professional practice is the use of clinical pathways (CPWs).

The investigators are working with local stakeholders to develop CPWs for COPD with the aims of improving quality of care and guideline adherence while reducing healthcare utilization. The CPWs will utilize several steps including: standardizing diagnostic training, implementing and unifying common components of chronic disease care, coordinating the provision of education and reconditioning programs, and ensuring disease specific care utilizes and delivers evidence-informed practices. In addition, the investigators have worked to identify evidence-informed strategies for the implementation of the CPWs. Efforts are underway to tailor these implementation strategies for the local context.

The investigators will conduct a three-year quantitative health services research project using an interrupted time series (ITS) design in the form of a multiple baseline approach with control groups. The CPW will be implemented in two Saskatchewan health regions (experimental groups) and two health regions will act as controls (control groups). The experimental and control groups will each contain one urban and one rural health region.

This project is expected to improve quality of life and reduce healthcare utilization. The project will also provide evidence on the effects of CPWs in both urban and rural settings. If the pathways are found effective the investigators will work with all stakeholders to implement similar CPWs for the remaining health regions in the province.


Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Other: Clinical Pathway (CPW)

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
Actual Study Start Date : September 30, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Experimental - CPW (Urban)
We are working with Regina Qu'Appelle Health Region (RQHR), a primarily urban health region, to develop and implement a clinical pathway (CPW). The CPW will improve care through the following steps: standardizing diagnostic, coordinating and unifying common components of chronic disease care, coordinating the provision of education and reconditioning programs, and ensuring disease specific care utilizes and delivers evidence-informed practices.
Other: Clinical Pathway (CPW)
CPWs bring the available evidence to a range of healthcare professionals by adapting guidelines to a local context and detailing the essential steps in the assessment and care of patients.

Experimental - CPW (Rural)
Following implementation in RQHR a rural health region will be chosen as an intervention site for a second CPW. The CPW will improve care through the following steps: standardizing diagnostic, coordinating and unifying common components of chronic disease care, coordinating the provision of education and reconditioning programs, and ensuring disease specific care utilizes and delivers evidence-informed practices.
Other: Clinical Pathway (CPW)
CPWs bring the available evidence to a range of healthcare professionals by adapting guidelines to a local context and detailing the essential steps in the assessment and care of patients.

Control - Standard Care (Urban)
Saskatoon Health Region (SHR) will act as the urban control site. No attempts will made to alter care in SHR and therefore patients will continue to receive the current standard of care.
Control - Standard Care (Rural)
Following implementation in RQHR a rural health region will be chosen to act as the rural control site. No attempts will made to alter care in this health region and therefore patients will continue to receive the current standard of care.



Primary Outcome Measures :
  1. Quality of Care [ Time Frame: 36 months ]
    Operationalized as hospital readmission rates and and emergency department (ED) presentation rates


Secondary Outcome Measures :
  1. Healthcare Utilization [ Time Frame: 36 months ]
    Operationalized as hospital admission rates and hospital length of stay

  2. Guideline Adherence [ Time Frame: 36 months ]
    Operationalized as scheduled primary care provider and specialist visits



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The intervention will be implemented at the health region level and will therefore include all individuals diagnosed with chronic obstructive pulmonary disease (COPD) residing within a control or intervention health region.
Criteria

Inclusion Criteria:

  • All individuals with diagnosed chronic obstructive pulmonary disease (COPD)

Exclusion Criteria:

  • N/A

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): NCT03075709


Locations
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Canada, Saskatchewan
Regina Qu'Appelle Health Region
Regina, Saskatchewan, Canada
Sponsors and Collaborators
University of Saskatchewan
Lung Association of Saskatchewan
Novartis

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Rotter, Research Chair in Health Quality Improvement Science, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03075709     History of Changes
Other Study ID Numbers: BIO-15-286
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Thomas Rotter, University of Saskatchewan:
Clinical Pathway
CPW
Chronic Obstructive Pulmonary Disease
COPD
Protocol
Adherence
Readmission
Length of Stay
Cost

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