Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-04-24 @ 5:52 AM
Study NCT ID:
NCT03332394
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2017-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COPD Care Model on Clinical and Patient-Reported Outcomes
Sponsor:
Ottawa Hospital Research Institute
Organization:
Study Overview
Official Title:
Impact of Goal-Directed COPD Care Model on Clinical and Patient-Reported Outcomes : A Pilot Feasibility Study
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: