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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Clinical Pathway (CPW)

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada
      • Regina Qu'Appelle Health Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Care	Operationalized as hospital readmission rates and and emergency department (ED) presentation rates	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Utilization	Operationalized as hospital admission rates and hospital length of stay	36 months
Guideline Adherence	Operationalized as scheduled primary care provider and specialist visits	36 months

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Novartis; Lung Association of Saskatchewan

Publications and helpful links

General Publications

• Rotter T, Plishka C, Hansia MR, Goodridge D, Penz E, Kinsman L, Lawal A, O'Quinn S, Buchan N, Comfort P, Patel P, Anderson S, Winkel T, Lang RL, Marciniuk DD. The development, implementation and evaluation of clinical pathways for chronic obstructive pulmonary disease (COPD) in Saskatchewan: protocol for an interrupted times series evaluation. BMC Health Serv Res. 2017 Nov 28;17(1):782. doi: 10.1186/s12913-017-2750-x.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2017
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Adherence; COPD; Chronic Obstructive Pulmonary Disease; Cost; Clinical Pathway; CPW; Protocol; Readmission; Length of Stay
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: BIO-15-286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No