COPD Flare-Up Clinic After Severe Exacerbations

Official title

The Role of COPD Flare-up Clinic Service After Severe Exacerbations to Reduce Recurrent Exacerbations

Overview

This prospective randomized controlled trial evaluates whether a specialized "COPD flare-up clinic service" improves outcomes in patients following an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Patients presenting to the emergency department with AECOPD and discharged or hospitalized will be randomized 1:1 to either structured follow-up in a dedicated flare-up clinic or standard follow-up by scheduled telephone interviews. The researches hypothesize that structured follow-up in a specialized clinic will reduce recurrent exacerbations, optimize long-term COPD management, and improve patients' quality of life compared to standard care.

Detailed description

The primary outcome is to determine whether the flare-up clinic intervention reduces the annualized rate of moderate and severe COPD exacerbations over 12 months. Secondary outcomes include effect of the intervention on the long-term management of COPD and related comorbidities, patients' quality of life, and mortality.

* Randomization // A total of 240 participants with established COPD presenting to the emergency department with an acute exacerbation (AECOPD) will be randomized in a 1:1 ratio to either the intervention or control group. To ensure balance across key clinical pathways, randomization will be stratified by the disposition of the index visit: Emergency Department (ED) discharge versus acute hospitalization. Within each stratum, treatment assignments will be determined using a computer-generated random allocation sequence utilizing variable block sizes of two or four. To prevent selection bias and maintain strict allocation concealment, the randomization schedule will be generated and housed within a secure, centralized electronic system managed exclusively by an independent study coordinator. The clinical research team, including investigators responsible for patient enrollment and clinical care, will remain entirely removed from sequence generation and block determination. Allocation will be revealed sequentially on a patient-by-patient basis only after a participant's eligibility is confirmed and the index visit disposition is finalized. * Sample size calculation // Based on prior studies, the researchers anticipate that the intervention will reduce the rate of moderate or severe COPD exacerbations by approximately 33% over 12 months, with a clinically meaningful effect considered at 20-25%. Assuming that 60% of patients in the control group will experience at least one exacerbation during this period, a sample size of 95 patients per group is required to achieve 80% power with a two-sided alpha of 0.05. To account for a potential 15-20% loss to follow-up, the study will enroll 120 patients per group, for a total of 240 participants.

Interventions

• Other Follow-up in a flare-up clinic
  Participants in the intervention arm will attend a specialized "COPD flare-up clinic" for structured follow-up after hospitalization or ED visit due to acute COPD exacerbation. The program includes three in-person clinic visits at 1, 4, and 10 months after the first visit, and two additional structured telephone follow-up at 10 and 18 months. To assess cardiovascular outcomes, a follow-up phone call will be conducted 24 months after Visit 1.

Primary outcome measures

• Rate of Moderate and Severe COPD Exacerbations [Time frame: From baseline to 12 months]

Secondary outcome measures (12)

• Severe COPD exacerbation rate [Time frame: During study follow-up (12 months from inclusion)]
• Percentage with any COPD exacerbation [Time frame: During study follow-up (12 months from inclusion).]
• Time to First COPD Exacerbation [Time frame: During study follow-up (12 months from inclusion).]
• Time to First Hospital Arrival [Time frame: During study follow-up (12 months from inclusion)]
• Number of Moderate and Severe COPD Exacerbations (per-protocol) [Time frame: 12 months from the first follow-up visit]
• Change in Forced Expiratory Volume in 1 second (FEV1) [Time frame: Spirometry will be performed according to ATS/ERS guidelines, under supervision of trained personnel at baseline and after 12 months.]
• Oscillometric changes in respiratory resistance at 5 Hz, 20 Hz and the difference between 5 and 20 Hz [Time frame: During study follow-up (12 months from inclusion)]
• Oscillometric changes in area of reactance [Time frame: During study follow-up (12 months from inclusion)]
• Respiratory Symptoms Burden Assessed by CAT [Time frame: Assessed from enrollment to 12 months following study initiation.]
• Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale [Time frame: Assessed by a physician at baseline, and subsequent 12 months following study initiation.]
• Differences In New Diagnoses of Cardiovascular Comorbidities (12 months) [Time frame: From baseline and to 12 months.]
• Composite of Major Cardiovascular Events [Time frame: During study follow-up (12 months from inclusion).]

Eligibility criteria

Inclusion criteria

• Prior COPD diagnosis based on clinical and spirometry accepted criteria.
• Acute exacerbation of COPD as the main reason for ED arrival.
• Ability to perform in-person and telephone follow-up.
• Agree to participate, with a signed informed consent.

Exclusion criteria

• Symptomatic heart failure as the main reason for emergency department visit in the last 6 months.
• Uncontrolled comorbidity.
• Vulnerable Populations: To ensure ethical compliance and participant safety, the study will exclude vulnerable populations. This includes pregnant women, and any person lacking the mental or legal capacity to provide independent informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Israel · 1 center

• Tel Aviv Sourasky Medical Center, Tel Aviv, 6423906 — Tel Aviv

Publications

• Lindenauer PK, Pekow P, Gao S, Crawford AS, Gutierrez B, Benjamin EM. Quality of care for patients hospitalized for acute exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 2006 Jun 20;144(12):894-903. doi: 10.7326/0003-4819-144-12-200606200-00006. PMID 16785478
• Parums DV. Editorial: Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023 Guidelines for COPD, Including COVID-19, Climate Change, and Air Pollution. Med Sci Monit. 2023 Oct 1;29:e942672. doi: 10.12659/MSM.942672. PMID 37777859
• Agusti A, Celli BR, Criner GJ, Halpin D, Anzueto A, Barnes P, Bourbeau J, Han MK, Martinez FJ, Montes de Oca M, Mortimer K, Papi A, Pavord I, Roche N, Salvi S, Sin DD, Singh D, Stockley R, Lopez Varela MV, Wedzicha JA, Vogelmeier CF. Global Initiative for Chronic Obstructive Lung Disease 2023 Report: GOLD Executive Summary. Eur Respir J. 2023 Apr 1;61(4):2300239. doi: 10.1183/13993003.00239-2023. PMID 36858443
• Nici L, Mammen MJ, Charbek E, Alexander PE, Au DH, Boyd CM, Criner GJ, Donaldson GC, Dreher M, Fan VS, Gershon AS, Han MK, Krishnan JA, Martinez FJ, Meek PM, Morgan M, Polkey MI, Puhan MA, Sadatsafavi M, Sin DD, Washko GR, Wedzicha JA, Aaron SD. Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Car PMID 32283960
• Bar-Shai A, Freund O, Ovdat T, Segel MJ, Klempfner R, Elis A. Management of acute COPD exacerbations in the internal medicine departments in Israel-a national survey. Front Med (Lausanne). 2023 Aug 24;10:1174148. doi: 10.3389/fmed.2023.1174148. eCollection 2023. PMID 37692773
• Kitchlu A, Abdelshaheed T, Tullis E, Gupta S. Gaps in the inpatient management of chronic obstructive pulmonary disease exacerbation and impact of an evidence-based order set. Can Respir J. 2015 May-Jun;22(3):157-62. doi: 10.1155/2015/587026. Epub 2015 Apr 17. PMID 25886627
• Choi PP, Day A, Etchells E. Gaps in the care of patients admitted to hospital with an exacerbation of chronic obstructive pulmonary disease. CMAJ. 2004 Apr 27;170(9):1409-13. doi: 10.1503/cmaj.1030713. PMID 15111474
• Chapman KR, Bourbeau J, Rance L. The burden of COPD in Canada: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S23-31. doi: 10.1016/s0954-6111(03)80022-7. PMID 12647940

Identifiers

NCT: NCT07629869 · 0690-25-TLV

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗