COPD ExacerbationNCT03332394
COPD Care Model on Clinical and Patient-Reported Outcomes
An observational study of COPD Exacerbation, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This study is the first to evaluate a unique integrated care model for COPD which uses a validated clinical frailty indicator to set care goals and guide health care in hospital and in the community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2017to 30 May 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult COPD patients hospitalized with a COPD exacerbations on the Respirology or Medicine wards of the Ottawa Hospital, General campus and Healthcare professionals working on the Respiratory and Medicine wards of the Ottawa Hospital, General campus who used the COPD care pathway
Who may be able to join
- Adult
- COPD
- Hospitalized with a COPD exacerbations between November 2017 to May 2019 on the Respiratory ward of the Ottawa Hospital, General campus
- OR
- Healthcare professional working on the Respiratory and Medicine wards of the Ottawa Hospital, General campus who used the COPD care pathway
Who cannot join
- Patients not appropriate for inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Goal-Directed COPD Care Model on Clinical and Patient-Reported Outcomes : A Pilot Feasibility Study
This study is the first to evaluate a unique integrated care model for COPD which uses a validated clinical frailty indicator to set care goals and guide health care in hospital and in the community. The impact of this care model on patient reported outcomes, costs, and health care utilization will inform further health system re-design for patients with COPD and other chronic diseases.
Read the detailed description
Background: Chronic obstructive pulmonary disease (COPD) is an incurable and progressive lung disease associated with poor quality of life, increased mortality, and high health system costs. Health system care for COPD patients is often fragmented, and patients report feeling isolated and lack the confidence in health services to address their needs.
Integrated COPD care programs attempt to address the many physical, psychosocial, and medical needs of COPD patients by bridging the gaps in care between hospital and community settings. These programs are tailored to patients with severe disease and involve self-management education sessions and sustained contact with a health care provider in the community. Evidence for the efficacy of integrated care programs is conflicting and there is limited information on which COPD patients would benefit from these programs. Prior integrated care programs have used a 'one size fits all' approach to care, where all patients receive the same interventions and treatments. There is a need for a more personalized approach to COPD care, as comorbidity burden, socioeconomic factors, and functional status also have a significant influence on health outcomes in this patient population.
Hypothesis: The investigators hypothesize that care-delivery tailored to a patient's goals and functional health status will improve patient engagement, and translate into both short and long-term improved health service outcomes.
Objectives: The objectives of this study are to: 1) Determine the feasibility of implementing a unique goal-directed COPD care model in the hospital setting, and 2) Determine the process measures and personnel required for successful replication of this care model intervention in other sites
Methods: This prospective cohort study will include 50 adult patients hospitalized for COPD exacerbation between November 2017 and May 2019. The investigators will determine the clinical frailty rating for each enrolled patient. The frailty rating will be matched with pre-specified care goals, and subsequent health care consultations and services will be arranged based upon these goals. COPD burden and 'health confidence' will be measured prior to the intervention and at 3 months following discharge, and also determine cost of hospitalization, length of stay, 30-day readmission rate, and mortality. The Wilcoxon's signed-rank test will be used to compare patient reported outcomes before and after the care intervention in the study cohort. An interrupted time series analysis will be used to determine the differences in health service outcomes between the study cohort and a random sample of hospitalized COPD patients from a contemporary period one year-prior to the care intervention.
This study will also include 26 healthcare professionals (HCPs) who work on the Respirology ward of the Ottawa Hospital, General campus during the study period. HCP's, once consented, are asked to participate in a focus group and complete a questionnaire on the COPD care Pathway.
Consent Process: Patients eligible for the study will be approached by the study respiratory nurse educator (RT), who is already part of the patients circle of care. The RT will ensure the potential participant understands the study and what it would require of them (two questionnaires: one in hospital and one during a 3-month post-discharge visit). If the patient accepts, the RT will ask them to review the Informed Consent Form and sign if they agree to participate in the study.
The clinical manager of the Respiratory ward at TOH will approach Healthcare professionals (HCPs) who work on the Respiratory ward (6NW) of TOH, General campus and have used the COPD care pathway to participate in the study. Consent forms and questionnaires will be available at the nurse's station of the Respiratory ward, of TOH General campus. The consent form requests a consent to complete a questionnaire and participate in the focus group with other HCPs. If the HCP chooses to participate, the signed informed consent is placed in one box, while the completed questionnaire is placed in another. This is to conserve anonymity of the questionnaire responses. Once focus group times and location are set, an email will be sent out by a member of the study team to inform those who consented to participate of the focus group time and location.
- Conditions
- COPD Exacerbation
- Keywords
- Care Model, COPD, Exacerbations, Health Confidence Score
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare Professionals | Includes nurses, physicians, and allied health professionals who care for patients on the 6NW (Respirology ward) of the General campus at TOH who have implemented and worked with the COPD care pathway during the study duration. | |
| COPD Patients | Adult patients admitted to the 6NW (Respirology ward) of the General campus at TOH with a primary diagnosis of acute exacerbation of COPD (AECOPD). The diagnosis is based on the admitting physician's assessment of the patient in the emergency room. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the COPD Care Pathway on a hospital ward
In this practical experiment, feasibility will be defined by recruitment of 50 patients (3-4 per month x 18 months) to the care pathway, with an 85% completion rate. This will be calculated using the number of completed pathway documents divided by the total number of care pathways initiated at the time of admission. Each document will be critically reviewed for completion.
Measured: 6 months from patient enrollment
Secondary outcomes (10)
Qualitative Implementation Metrics - Identification of Barriers to the Care Pathway
Implementation of the care pathway will be evaluated by focus groups composed of health care workers (nurses, allied health professionals, and physicians) who have used the pathway. The number of focus groups planned will depend upon when data saturation is achieved. During focus groups, common themes for barriers to implementation will be identified using a-priori selected questions. Success of implementation will be considered if no significant barriers are identified through group consensus in the focus groups.
Measured: March 2018
Qualitative Implementation Metrics - Healthcare Worker assessment of the Care Pathway
Implementation of the care pathway will also be evaluated by 2 rounds of written user survey responses from healthcare workers who used the pathway. Exit surveys have been designed to assess three domains; appropriateness of care, safety of care, and user satisfaction. Success of implementation will be considered if no significant barriers are identified through group consensus in the focus groups, and if 80% of survey responses in each domain fall into the "agree" or "strongly agree" responses.
Measured: March 2018
Knowledge Translation Metrics
Knowledge translation with achievement of 80% adherence to basic COPD care guideline standards including use of appropriate antibiotics, systemic steroids, bronchodilators, venous thromboembolism prophylaxis, and advanced directives documentation. Adherence will be calculated from direct review of the order set and care pathway documents after completion.
Measured: November 2017 to May 2019
Patient Reported 'Health Confidence'
Health confidence will be measured using a four-item scaled survey: 1) I know enough about my health, 2) I can look after my health, 3) I can get the right help if I need it, and 4) I am involved in decisions about me. Participants answer each of the statements with the following scale: strongly agree, agree, not sure, or disagree. Patients who report 'strongly agree' for each of the above mentioned statements are considered to have a higher level of health confidence than participants who report 'disagree'. These statements have demonstrated adequate psychometric properties and construct validity in preliminary testing (19). The health confidence survey will be administered at the start of the education session in hospital, and repeated at 3 months, during a follow-up visit.
Measured: Hospital admission to 3 months post-discharge
Patient Reported 'Quality of Life'
Patients quality of life can be measured with the Health Related Quality of Life Score, or 'howRu' tool which has been validated against other quality of life tools. This tool is a four-item scaled survey: 1) Pain or discomfort, 2) feeling low or worried, 3) Limited in what I can do, and 4) require help from others. Participants answer each of the statements with the following scale: none, a little, quite a lot, or extreme. Those who report 'none' for each of the above mentioned statements are considered to have a better quality of life than those who respond 'extreme'. These statements have demonstrated adequate psychometric properties and construct validity in preliminary testing (19). This survey will be administered at the start of the education session in hospital, and repeated at 3 months, during a follow-up visit.
Measured: Admission to 3 months post-discharge
Health Service Metrics - Length of stay in hospital
Data on length of stay in hospital will be obtained from the Ottawa Hospital Data Warehouse (TOHDW). TOHDW is a relational database that captures clinical and administrative data for each unique hospital encounter.
Measured: 3 months post-discharge
Health Service Metrics - Cost per weighted case
Data on cost per weighted case will be obtained from the Ottawa Hospital Data Warehouse (TOHDW). TOHDW is a relational database that captures clinical and administrative data for each unique hospital encounter.
Measured: 3 months post-discharge
Health Service Metrics - 30-day readmission
Data on 30 day readmission to hospital will be obtained from the Ottawa Hospital Data Warehouse (TOHDW). TOHDW is a relational database that captures clinical and administrative data for each unique hospital encounter.
Measured: 3 months post-discharge
Health Service Metrics - Mortality
Data on mortality in hospital will be obtained from the Ottawa Hospital Data Warehouse (TOHDW). TOHDW is a relational database that captures clinical and administrative data for each unique hospital encounter.
Measured: 6 months post-discharge
Health Service Metrics - Intensive Care Unit Admission
Data on intensive care unit admissions will be obtained from the Ottawa Hospital Data Warehouse (TOHDW). TOHDW is a relational database that captures clinical and administrative data for each unique hospital encounter.
Measured: 3 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start15 Nov 2017
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunita Mulpuru, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332394
- Sponsor's protocol ID
- 20170676-01H
- Status last verified
- Dec 2020
- First submitted
- 10 Oct 2017
- Last updated
- 4 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Goal-Directed COPD Care Model on Clinical and Patient-Reported Outcomes : A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT03332394
- Acronym / sponsor ID
- 20170676-01H
- Conditions
- COPD Exacerbation
- Keywords
- Care Model, COPD, Exacerbations, Health Confidence Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 6 Nov 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.
This study is the first to evaluate a unique integrated care model for COPD which uses a validated clinical frailty indicator to set care goals and guide health care in hospital and in the community. The impact of this care model on patient reported outcomes, costs, and health care utilization will inform further health system re-design for patients with COPD and other chronic diseases.
Detailed description
Background: Chronic obstructive pulmonary disease (COPD) is an incurable and progressive lung disease associated with poor quality of life, increased mortality, and high health system costs. Health system care for COPD patients is often fragmented, and patients report feeling isolated and lack the confidence in health services to address their needs.
Integrated COPD care programs attempt to address the many physical, psychosocial, and medical needs of COPD patients by bridging the gaps in care between hospital and community settings. These programs are tailored to patients with severe disease and involve self-management education sessions and sustained contact with a health care provider in the community. Evidence for the efficacy of integrated care programs is conflicting and there is limited information on which COPD patients would benefit from these programs. Prior integrated care programs have used a 'one size fits all' approach to care, where all patients receive the same interventions and treatments. There is a need for a more personalized approach to COPD care, as comorbidity burden, socioeconomic factors, and functional status also have a significant influence on health outcomes in this patient population.
Hypothesis: The investigators hypothesize that care-delivery tailored to a patient's goals and functional health status will improve patient engagement, and translate into both short and long-term improved health service outcomes.
Objectives: The objectives of this study are to: 1) Determine the feasibility of implementing a unique goal-directed COPD care model in the hospital setting, and 2) Determine the process measures and personnel required for successful replication of this care model intervention in other sites
Methods: This prospective cohort study will include 50 adult patients hospitalized for COPD exacerbation between November 2017 and May 2019. The investigators will determine the clinical frailty rating for each enrolled patient. The frailty rating will be matched with pre-specified care goals, and subsequent health care consultations and services will be arranged based upon these goals. COPD burden and 'health confidence' will be measured prior to the intervention and at 3 months following discharge, and also determine cost of hospitalization, length of stay, 30-day readmission rate, and mortality. The Wilcoxon's signed-rank test will be used to compare patient reported outcomes before and after the care intervention in the study cohort. An interrupted time series analysis will be used to determine the differences in health service outcomes between the study cohort and a random sample of hospitalized COPD patients from a contemporary period one year-prior to the care intervention.
This study will also include 26 healthcare professionals (HCPs) who work on the Respirology ward of the Ottawa Hospital, General campus during the study period. HCP's, once consented, are asked to participate in a focus group and complete a questionnaire on the COPD care Pathway.
Consent Process: Patients eligible for the study will be approached by the study respiratory nurse educator (RT), who is already part of the patients circle of care. The RT will ensure the potential participant understands the study and what it would require of them (two questionnaires: one in hospital and one during a 3-month post-discharge visit). If the patient accepts, the RT will ask them to review the Informed Consent Form and sign if they agree to participate in the study.
The clinical manager of the Respiratory ward at TOH will approach Healthcare professionals (HCPs) who work on the Respiratory ward (6NW) of TOH, General campus and have used the COPD care pathway to participate in the study. Consent forms and questionnaires will be available at the nurse's station of the Respiratory ward, of TOH General campus. The consent form requests a consent to complete a questionnaire and participate in the focus group with other HCPs. If the HCP chooses to participate, the signed informed consent is placed in one box, while the completed questionnaire is placed in another. This is to conserve anonymity of the questionnaire responses. Once focus group times and location are set, an email will be sent out by a member of the study team to inform those who consented to participate of the focus group time and location.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare Professionals | – | –Includes nurses, physicians, and allied health professionals who care for patients on the 6NW (Respirology ward) of the General campus at TOH who have implemented and worked with the COPD care pathway during the study duration. |
| COPD Patients | – | –Adult patients admitted to the 6NW (Respirology ward) of the General campus at TOH with a primary diagnosis of acute exacerbation of COPD (AECOPD). The diagnosis is based on the admitting physician's assessment of the patient in the emergency room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult COPD patients hospitalized with a COPD exacerbations on the Respirology or Medicine wards of the Ottawa Hospital, General campus and Healthcare professionals working on the Respiratory and Medicine wards of the Ottawa Hospital, General campus who used the COPD care pathway
Key inclusion criteria (5 listed)
- Adult
- COPD
- Hospitalized with a COPD exacerbations between November 2017 to May 2019 on the Respiratory ward of the Ottawa Hospital, General campus
- OR
- Healthcare professional working on the Respiratory and Medicine wards of the Ottawa Hospital, General campus who used the COPD care pathway
Key exclusion criteria (1 listed)
- Patients not appropriate for inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of the COPD Care Pathway on a hospital ward
Time frame: 6 months from patient enrollment
In this practical experiment, feasibility will be defined by recruitment of 50 patients (3-4 per month x 18 months) to the care pathway, with an 85% completion rate. This will be calculated using the number of completed pathway documents divided by the total number of care pathways initiated at the time of admission. Each document will be critically reviewed for completion.
10 secondary outcomes
Qualitative Implementation Metrics - Identification of Barriers to the Care Pathway
Time frame: March 2018
Qualitative Implementation Metrics - Healthcare Worker assessment of the Care Pathway
Time frame: March 2018
Knowledge Translation Metrics
Time frame: November 2017 to May 2019
Patient Reported 'Health Confidence'
Time frame: Hospital admission to 3 months post-discharge
Patient Reported 'Quality of Life'
Time frame: Admission to 3 months post-discharge
Health Service Metrics - Length of stay in hospital
Time frame: 3 months post-discharge
Health Service Metrics - Cost per weighted case
Time frame: 3 months post-discharge
Health Service Metrics - 30-day readmission
Time frame: 3 months post-discharge
Health Service Metrics - Mortality
Time frame: 6 months post-discharge
Health Service Metrics - Intensive Care Unit Admission
Time frame: 3 months post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: Undecided
Related trials for COPD Exacerbation
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Active, not recruiting
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Oxygen Deficiency, COPD Exacerbation
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
Chronic Obstructive Pulmonary Disease, COPD Exacerbation
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.
Sunita Mulpuru, MD principal investigator
Ottawa Hospital Research Institute
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 COPD Exacerbation, run by Ottawa Hospital Research Institute 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 5 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: finished, as of the sponsor's last update on 4 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of the COPD Care Pathway on a hospital ward (time frame: 6 months from patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2020.