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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03075709
Other study ID # BIO-15-286
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 30, 2017
Est. completion date September 30, 2021

Study information

Verified date October 2018
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 800
Est. completion date September 30, 2021
Est. primary completion date September 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Regina Qu'Appelle Health Region Regina Saskatchewan

Sponsors (3)

Lead Sponsor Collaborator
University of Saskatchewan Lung Association of Saskatchewan, Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Care Operationalized as hospital readmission rates and and emergency department (ED) presentation rates 36 months
Secondary Healthcare Utilization Operationalized as hospital admission rates and hospital length of stay 36 months
Secondary Guideline Adherence Operationalized as scheduled primary care provider and specialist visits 36 months
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