DYNAMIC-ROSE clinical trial
3-Month Interim Results Report
The DYNAMIC-ROSE study evaluated the impact of the Lenus COPD Support Service on clinical outcomes and health care resource utilisation when patients are onboarded onto the service immediately after a severe COPD exacerbation. The study was run by Hull University Teaching Hospitals NHS Trust and patients were recruited between 1st of March and September 2023, with further monitoring and evidence generation ongoing.
The study assessed the reproducibility of the positive outcomes observed in the RECEIVER study in a different population and health system. Data from this study inform the development of an early health economic model to understand the consequences of implementation of the service within the NHS.
The interim results report on the clinical outcomes of participants in the DYNAMIC-ROSE study compared to a historical control cohort of individuals discharged from hospital following an acute exacerbation of COPD in the same geography a year prior to the study enrolment period. Both cohorts outcomes were measured from the point of discharge from point of ward discharge from the acute exacerbation event.
Results
This interim report showed very encouraging results giving an early positive indication that the results of the RECEIVER trial, which showed improved clinical outcomes for patients with COPD who have access to the Lenus COPD support service, can be replicated in a different population and health system. This also provided encouraging indications that the service can be used to improve outcomes immediately following acute exacerbation events.
Key findings
- A significantly lower percentage of the cases than the historical controls had at least one all-cause hospital admission of in the three months following their index date (30% vs 55%).
- A significantly lower percentage of the cases than the historical controls had at least one all-cause hospital admission of in the three months following their index date (31% vs 50%).
- There were no deaths in the cases over the entire 3-month period of follow up, for comparison there were 12 deaths (8% of the cohort) in the historic controls.
Early Economic Model
Yorkshire Health Economic Consortium (YHEC) independently created an economic model to consider the incremental costs and consequences of using the Lenus COPD Support Service from an NHS perspective that identified that:
- The service was both less costly and more effective than standard care over the evaluated window (first year of service implementation).
- +0.03 additional quality adjusted life years (QALY) per patient.
- It is cost effective with more than 40 patients onboarded to the service
- The service was £1,749 per patient per annum cheaper than standard care.
Cohort
Cases- The individuals included in the intervention cohort were all enrolled onto the Lenus COPD Support Service in HUTH between 1st March and 1st September 2023 following a severe COPD exacerbation (defined here as an increase in COPD symptoms consistent with an exacerbation that resulted in ED attendance and/or hospital admission). The date of ward (including virtual ward) discharge for the severe COPD exacerbation was considered the index date for the intervention cohort.
Historical Control Cohort -The individuals included in the control cohort were all admitted to HUTH with a code of "COPD Exacerbation" between 1st March 2022 and 1st September 2022. The date of the ward discharge for the COPD exacerbation was considered the index date for the control cohort.
Intervention Arm Participants
The entry criteria for the cases cohort and the historical control cohort are shown below:
- To be included in the cases, individuals must have met the following criteria:
- Had clinician confirmed COPD.
- Enrolled in the Lenus COPD Support Service provided by HUTH between 1st March and 1st September 2023 following a Severe COPD exacerbation
- Had access to a web-enabled device (either personally or through carer support) and an email address
- Had at least 1 interaction with the Lenus web-app platform.
Control Arm Participants
To be included in the historical control cohort individuals must have met the following criteria:
- Clinician confirmed COPD.
- Discharged from HUTH following am acute exacerbation of COPD between 1st March 2022 and 1st September 2022