COPD Care Pathway for Chronic Obstructive Pulmonary Disease

Overseen By Sandra Norona

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Severe psychiatric symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

100 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{3 4 5 6 7}

How 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. ^{1 2 3 4 8}

Research Team

Thomas Lycan, MD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Eligibility 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.

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

Treatment Details

Interventions

• COPD Care Pathway
• Surveys and Interviews - Arm A

Trial Overview 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.

Participant Groups

Group I: Observational Phase 3 Experimental Treatment 1 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 II Experimental Treatment 1 Intervention

Participants complete an interview and participate in guided tours of the oncology clinic on study.

Group III: Observational Phase 2, Group I Experimental Treatment 1 Intervention

Participants complete an interview and participate in a focus group on study.

Group IV: Observational Phase 1 Experimental Treatment 1 Intervention

Participants complete surveys

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The review identified four studies on care pathways for managing COPD exacerbations, which showed some positive effects on clinical processes like blood sampling and patient anxiety, but the overall evidence is limited due to weak study designs and lack of robust statistical analysis.

Despite some reported benefits, the impact of these care pathways on clinical outcomes such as length of hospital stay and readmission rates remains inconclusive, highlighting the need for more rigorous research to better evaluate their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of care pathways for in-hospital management of COPD exacerbation: a systematic review. Lodewijckx, C., Sermeus, W., Panella, M., et al.[2018]

The implementation of a care pathway for managing COPD exacerbations did not significantly affect the 6-month readmission rate, indicating that long-term outcomes may not improve with this intervention.

However, the care pathway did lead to a significant reduction in the 30-day readmission rate, with a decrease from 15.3% in the control group to 9.7% in the intervention group, suggesting short-term benefits in patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a care pathway for COPD on adherence to guidelines and hospital readmission: a cluster randomized trial. Vanhaecht, K., Lodewijckx, C., Sermeus, W., et al.[2022]

The EQCP study is an international cluster randomized controlled trial involving 40 hospital teams and 398 patients across Belgium, Italy, Ireland, and Portugal, aimed at improving the treatment of chronic obstructive pulmonary disease (COPD) through structured care pathways.

The study will assess the impact of these care pathways on adherence to evidence-based interventions and clinical outcomes, specifically focusing on the six-month readmission rate as the primary outcome, which could help reduce morbidity and mortality associated with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial. Vanhaecht, K., Sermeus, W., Peers, J., et al.[2021]

The implementation of a clinical pathway (CP) for managing COPD exacerbations significantly reduced the length of hospital stay, with patients in the CP group staying a median of 5 days compared to 7 days in the non-CP group.

Patients in the CP group experienced 24.1% fewer complications than those in the non-CP group, indicating that the CP approach may enhance patient safety and care quality during hospitalizations for COPD exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of clinical pathway on clinical outcomes in the management of COPD exacerbation. Ban, A., Ismail, A., Harun, R., et al.[2021]

A comprehensive care pathway for managing COPD exacerbations was developed, consisting of 38 evidence-based interventions and 39 indicators (24 process and 15 outcome), validated by nine multidisciplinary teams in Belgium.

The eight-step method used to create this care pathway can serve as a model for other healthcare teams to standardize clinical content for various patient populations, ensuring effective and evidence-based care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation. Lodewijckx, C., Decramer, M., Sermeus, W., et al.[2021]

In a study of 105 patients hospitalized for COPD exacerbation, 84% experienced at least one gap in inpatient care, which was linked to a higher incidence of adverse events during their hospital stay, including longer hospital stays and increased risk of serious outcomes like death.

While nearly all patients had gaps in discharge-related care, these gaps did not correlate with adverse events within 30 days after discharge, suggesting that while inpatient care quality is critical, discharge processes may need different evaluation for their impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaps in the care of patients admitted to hospital with an exacerbation of chronic obstructive pulmonary disease. Choi, PP., Day, A., Etchells, E.[2019]

A literature review identified that inhaled medication errors in patients with chronic obstructive pulmonary disease (COPD) during and after hospitalization can range from 2.5% to 66%, highlighting a significant issue in treatment adherence.

The review emphasizes the need for standardized reporting of these errors to better understand their incidence and improve inhaler technique and device reliability in COPD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled Medication Errors During Hospitalization or on Hospital Discharge in Patients Living With Chronic Obstructive Pulmonary Disease: A Literature Review. Boylan, PM., Gibbs, MJ., Helwig, KN.[2023]

A study involving 24 healthcare professionals across four high-income countries identified common barriers to optimal COPD management, including late presentation to healthcare, low consideration of COPD in diagnoses, and inadequate management of both acute and chronic phases of the disease.

The COVID-19 pandemic has worsened COPD management but also highlighted the potential for virtual consultations, suggesting that adapting care pathways could improve patient outcomes and reduce healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Validation of COPD Evidenced Care Pathways in Japan, Canada, England, and Germany: Common Barriers to Optimal COPD Care. Meiwald, A., Gara-Adams, R., Rowlandson, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Impact of care pathways for in-hospital management of COPD exacerbation: a systematic review. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Impact of a care pathway for COPD on adherence to guidelines and hospital readmission: a cluster randomized trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Impact of clinical pathway on clinical outcomes in the management of COPD exacerbation. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Gaps in the care of patients admitted to hospital with an exacerbation of chronic obstructive pulmonary disease. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Inhaled Medication Errors During Hospitalization or on Hospital Discharge in Patients Living With Chronic Obstructive Pulmonary Disease: A Literature Review. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Qualitative Validation of COPD Evidenced Care Pathways in Japan, Canada, England, and Germany: Common Barriers to Optimal COPD Care. [2022]