Real-world multicentre observational study protocol to assess the efficacy, safety and acceptability of a home monitoring programme for patients with interstitial lung disease (Preprint)

Abstract

Standard of care for patients with interstitial lung disease (ILD) typically involves 3 to 6 monthly outpatient attendance for investigations, monitoring disease course and assessing response to treatment. Home monitoring and remote review of spirometry, pulse oximetry and patient reported measures (PRMs) offers an alternative approach to in-person clinic review and/or laboratory-based physiological measurements. Clinical trials indicate home monitoring of patients with ILD is acceptable and results correlate with laboratory-based pulmonary function testing. The impact of implementing a home monitoring programme for patients with ILD in a real-world setting is not well understood.

We aim to evaluate the efficacy, safety and acceptability of integrating home monitoring with standard care in the clinical management of patients with ILD. We hypothesise home monitoring will be effective, safe and acceptable for patients with ILD and result in 50% reduction in routine laboratory-based pulmonary function testing and in-person clinic consultations.

Patients with multidisciplinary team (MDT) diagnosis of ILD will be recruited to the home monitoring programme and followed up for 12 months. All participants will be required to complete at least once-weekly home spirometry and oximetry readings. Patients will also be required to complete patient reported measures (PRMs), including symptom measures, health-related quality of life and experience questionnaires to characterise the impact of participation in a home monitoring programme. Patient recorded metrics will be available to the healthcare provider in real-time and used to monitor disease and/or assess response to treatment.

This study is registered as a quality improvement (QI) project on the QI project tracking with Guy’s and St Thomas’ NHS Foundation Trust (13660) and at the Royal Devon University Healthcare NHS Foundation Trust (ref 24-1378). QI programmes offer one approach that focuses on achieving clinical effectiveness and clinical collaboration in the NHS in England. The project oversight steering group of clinicians, representatives from the technology partner, patient advocacy charity and patients diagnosed with ILD are meeting fortnightly. Approximately 100 patients will be recruited from each site.

This study will contribute toward a better understanding of home monitoring and will inform the implementation of integrated digital pathways of care in interstitial lung diseases.