Pulmonary Disease, Chronic ObstructiveNCT03075709
The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
An observational study of Pulmonary Disease, Chronic Obstructive, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Clinical Pathway (CPW)
- How many people
- 800 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2017to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- All individuals with diagnosed chronic obstructive pulmonary disease (COPD)
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Clinical Pathway (CPW)
- Keywords
- Clinical Pathway, CPW, Chronic Obstructive Pulmonary Disease, COPD, Protocol, Adherence, Readmission, Length of Stay, Cost
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pathway (CPW)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical Pathway (CPW) | |
| 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. Receives: Other: Clinical Pathway (CPW) | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Quality of Care
Operationalized as hospital readmission rates and and emergency department (ED) presentation rates
Measured: 36 months
Secondary outcomes (2)
Healthcare Utilization
Operationalized as hospital admission rates and hospital length of stay
Measured: 36 months
Guideline Adherence
Operationalized as scheduled primary care provider and specialist visits
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start30 Sep 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Lung Association of Saskatchewan, Novartis
- Responsible party
- Principal investigator, Thomas Rotter, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075709
- Sponsor's protocol ID
- BIO-15-286
- Status last verified
- Oct 2018
- First submitted
- 3 Mar 2017
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29183318
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
- ClinicalTrials.gov ID
- NCT03075709
- Acronym / sponsor ID
- BIO-15-286
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Clinical Pathway, CPW, Chronic Obstructive Pulmonary Disease, COPD, Protocol, Adherence, Readmission, Length of Stay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Lung Association of Saskatchewan, Novartis
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental - CPW (Urban) | – | Other: Clinical Pathway (CPW)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. |
| Experimental - CPW (Rural) | – | Other: Clinical Pathway (CPW)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All individuals with diagnosed chronic obstructive pulmonary disease (COPD)
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental - CPW (Rural), Experimental - CPW (Urban) |
Primary outcome
Quality of Care
Time frame: 36 months
Operationalized as hospital readmission rates and and emergency department (ED) presentation rates
2 secondary outcomes
Healthcare Utilization
Time frame: 36 months
Guideline Adherence
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Derived from this study: PubMed 29183318Rotter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Care (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.