COPD Care Pathway for Chronic Obstructive Pulmonary Disease
Recruiting in Palo Alto (17 mi)
Overseen byThomas Lycan, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Severe psychiatric symptoms, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study gathers information for the development of a COPD care pathway for patients with cancer that reduces the treatment burden of patients, implements critical components of COPD care, and overcomes common barriers to COPD care in the community oncology clinic.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the COPD Care Pathway treatment for Chronic Obstructive Pulmonary Disease?
Research shows that using care pathways for managing COPD in hospitals can improve how well treatment guidelines are followed and may reduce hospital readmissions. This suggests that the COPD Care Pathway treatment could help improve patient outcomes by ensuring more consistent and effective care.
12345Is the COPD Care Pathway safe for humans?
The research articles do not provide specific safety data for the COPD Care Pathway treatment, but they focus on improving care and reducing errors in managing COPD exacerbations.
34567How does the COPD Care Pathway treatment differ from other treatments for COPD?
The COPD Care Pathway is unique because it focuses on a structured approach to care, aiming to improve adherence to evidence-based guidelines and reduce hospital readmissions. Unlike traditional treatments that may not consistently follow guidelines, this pathway provides a simplified, task-oriented method to manage COPD exacerbations effectively.
12348Eligibility Criteria
This trial is for people who may have COPD and are undergoing or have had immunotherapy for any cancer, or healthcare providers working in oncology or with COPD patients. Participants must understand and consent to the study.Inclusion Criteria
The participant meets one of the following criteria: (a) a patient known or suspected to have COPD and currently or have ever previously received immunotherapy for any type of cancer (b) a provider who currently works at least part time in a medical oncology clinic, or (c) a provider who currently works at least part time providing care for patients with known or suspected COPD. In the context of this study, a provider is defined as a physician, advanced practice provider, nurse, or respiratory therapist.
Ability to understand and be willing to sign an IRB-approved informed consent document directly.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Observational Phase 1
Participants complete surveys to gather information on COPD care pathway development
4 weeks
1 visit (in-person or virtual)
Observational Phase 2
Participants complete interviews and participate in focus groups or guided tours
8 weeks
2-3 visits (in-person)
Observational Phase 3
A subset of participants participate in a workshop to develop a final draft of the COPD care pathway
4 weeks
1 visit (in-person)
Follow-up
Participants are monitored for feedback on the feasibility and effectiveness of the COPD care pathway
12 months
Participant Groups
The study aims to create a care pathway for managing COPD in community oncology clinics. It involves surveys and interviews (Arm A) to develop this pathway, setting up for a future randomized controlled trial.
4Treatment groups
Experimental Treatment
Group I: Observational Phase 3Experimental Treatment1 Intervention
A subset of interested participants from Phase 2 participate in a workshop on study to develop a final draft of the COPD care pathway.
Group II: Observational Phase 2, Group IIExperimental Treatment1 Intervention
Participants complete an interview and participate in guided tours of the oncology clinic on study.
Group III: Observational Phase 2, Group IExperimental Treatment1 Intervention
Participants complete an interview and participate in a focus group on study.
Group IV: Observational Phase 1Experimental Treatment1 Intervention
Participants complete surveys
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Impact of care pathways for in-hospital management of COPD exacerbation: a systematic review. [2018]In-hospital management of COPD exacerbation is suboptimal, and outcomes are poor. Care pathways are a possible strategy for optimizing care processes and outcomes.
Impact of a care pathway for COPD on adherence to guidelines and hospital readmission: a cluster randomized trial. [2022]Current in-hospital management of exacerbations of COPD is suboptimal, and patient outcomes are poor. The primary aim of this study was to evaluate whether implementation of a care pathway (CP) for COPD improves the 6 months readmission rate. Secondary outcomes were the 30 days readmission rate, mortality, length of stay and adherence to guidelines.
The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial. [2021]Hospital treatment of chronic obstructive pulmonary disease (COPD) frequently does not follow published evidences. This lack of adherence can contribute to the high morbidity, mortality and readmissions rates. The European Quality of Care Pathway (EQCP) study on acute exacerbations of COPD (NTC00962468) is undertaken to determine how care pathways (CP) as complex intervention for hospital treatment of COPD affects care variability, adherence to evidence based key interventions and clinical outcomes.
Impact of clinical pathway on clinical outcomes in the management of COPD exacerbation. [2021]Exacerbations, a leading cause of hospitalization in patients with chronic obstructive pulmonary disease (COPD), affect the quality of life and prognosis. Treatment recommendations as provided in the evidence-based guidelines are not consistently followed, partly due to absence of simplified task-oriented approach to care. In this study, we describe the development and implementation of a clinical pathway (CP) and evaluate its effectiveness in the management of COPD exacerbation.
Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation. [2021]Optimization of the clinical care process by integration of evidence-based knowledge is one of the active components in care pathways. When studying the impact of a care pathway by using a cluster-randomized design, standardization of the care pathway intervention is crucial. This methodology paper describes the development of the clinical content of an evidence-based care pathway for in-hospital management of chronic obstructive pulmonary disease (COPD) exacerbation in the context of a cluster-randomized controlled trial (cRCT) on care pathway effectiveness.
Gaps in the care of patients admitted to hospital with an exacerbation of chronic obstructive pulmonary disease. [2019]Patients admitted to hospital because of an exacerbation of chronic obstructive pulmonary disease (COPD) are at high risk of adverse events. We evaluated the association between gaps in care and adverse events during the hospital stay and after discharge.
Inhaled Medication Errors During Hospitalization or on Hospital Discharge in Patients Living With Chronic Obstructive Pulmonary Disease: A Literature Review. [2023]Inhaled medications, including beta-agonists, muscarinic antagonists, and corticosteroids, are the backbone of chronic obstructive pulmonary disease (COPD) treatment, and pharmacotherapy plans are frequently optimized during and following hospitalization. Clinical practice guidelines acknowledge that patients living with COPD may experience medication errors from inadequate inhaler technique or device faults, but inhaled medication errors within COPD pharmacotherapy plans remain unreported. This literature review aimed to collect and present studies describing medication errors occurring with inhaled medications in patients living with COPD during and following hospitalization. The databases searched included Ovid MEDLINE, Embase, and International Pharmaceutical Abstracts. One hundred forty-five unique studies were collected, and 10 studies were included. The rate of inhaled medication errors reported across the 10 studies ranged between 2.5% and 66% of patients living with COPD and who were hospitalized or discharged. The incidence and types of medication errors reported across the studies varied significantly. Standardization in categorizing and reporting inhaled medication errors is necessary for future studies to determine the true incidence of inhaled medication errors occurring in patients living with COPD who are hospitalized or discharged.
Qualitative Validation of COPD Evidenced Care Pathways in Japan, Canada, England, and Germany: Common Barriers to Optimal COPD Care. [2022]Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. A comprehensive and detailed understanding of COPD care pathways from pre-diagnosis to acute care is required to understand the common barriers to optimal COPD care across diverse health systems.