214575
Research type
Research Study
Full title
Time and Motion (T&M) study to quantify time and resources associated with the management and administration of injectable biologics to treat patients with Severe Asthma (SA) and/or Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
IRAS ID
340292
Contact name
Rafael Alfonso
Contact email
Sponsor organisation
GlaxoSmithKline
Duration of Study in the UK
0 years, 3 months, days
Research summary
In recent years, biologics have become a key component of Severe Asthma (SA) and/or Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) treatment as add-on maintenance therapies.
The purpose of this Time and Motion (T&M) study is to better understand the time taken by Healthcare Professionals (HCPs) and associated costs related to the routine use of injectable biologics to treat SA and/or CRSwNP patients in both clinic and home settings. This study will also aim to capture patient’s perspectives on the burden related to biologic administrations administered in-clinic or at their homes.
The data that is being collected as part of this T&M study includes the time HCPs dedicate to tasks involved in the management and administration of injectable biologics, e.g., the time spent by the HCP in administering the injectable biologic in-clinic or training the patient for home administration.The study will focus on measuring the time taken by HCPs in performing pre-specified tasks related to the administration of injectable biologics. As this is an observational study design, the decision to treat a patient with an injectable biologic to manage their SA and/or CRSwNP will be taken as part of routine clinical practice and is independent of this study.
As part of this study, participants will be asked to complete a one-time survey about their experience and burden on their caregiver (if applicable) about the management and administration of injectable biologics. The duration of the survey will be approximately 20 minutes.
This study will be conducted in up to sixteen sites across up to eight countries (China, France, Germany, Italy, Japan, Spain, the UK, and the US) to capture potential geographic differences. The study will be overseen by Syneos Health, the SCC.
Lay summary of study results: The study looked at how much time and resources are needed to give injectable medicines to treat severe asthma (SA) and chronic sinus issues with nasal polyps (CRSwNP). It focused on two ways these medicines are given: at clinics and at home.
Key Findings:
1. Clinic Visits:
o Healthcare professionals (HCPs) spend about 15 minutes on average for each injection. Most of this time is spent preparing the medicine, giving the injection, and doing paperwork.
o Patients spend more time at the clinic, including traveling, waiting, and post-injection monitoring. On average, patients spend 113 minutes per visit.
o Over a year, patients receiving injections at the clinic spend between 24 and 70 hours, depending on the medicine and how often it needs to be given.
o The cost per visit for healthcare professionals and supplies is around $13 for severe asthma and $9 for chronic sinus issues.
2. At-Home Administration:
o Healthcare professionals spend less time managing at-home injections, about 3.6 hours per patient per year. Most of this time is spent on doctor consultations and training patients to self-administer the medicine.
o Patients spend less time overall with at-home injections, ranging from 15 to 21 hours per year, depending on the medicine.
o The cost per injection visit for healthcare professionals and supplies is higher for at-home administration, ranging from $152 to $180 per visit.
Key Takeaways:
• Medicines that require fewer injections (like benralizumab) save time and money for both healthcare professionals and patients compared to medicines that need frequent injections (like dupilumab).
• Patients generally find the treatment manageable, with travel time and waiting being the biggest challenges.
• Giving injections at home reduces the time spent at clinics and can make treatment more convenient for patients and caregivers.
Conclusion:
Medicines that need fewer injections can make life easier for patients and healthcare professionals, saving time and resources while still providing effective care.REC name
London - London Bridge Research Ethics Committee
REC reference
24/PR/0607
Date of REC Opinion
25 Jun 2024
REC opinion
Further Information Favourable Opinion