Case Study: C. difficile telephone diary support service
During a review meeting, an ESMS client raised with us a challenging and problematic issue regarding the implementation of an eDiary with a group of patients taking part in one of their trials. This was a Phase 3, randomised double blind trial, investigating treatment of Clostridium difficile infection, with a senior patient pool across 28 countries.
The study design required that participating patients were to make daily entries about the study medication and their bowel movements into an electronic diary. The patient population had an average age of 60 years. Our client had been encountering reluctance from patients to use the eDiary, with some patients choosing not to enrol if this was mandatory.
Our client was looking to implement a protocol amendment that would allow for an alternative support service for collection of this data to be recorded on a daily basis, by contacting patients directly over the telephone. An additional problem was language barriers, as the patient pool was spread across 28 countries.
Outcome and benefits for the client
Using our interpretation facility ensured that language barriers were neither an issue nor encountered. Benefits included:
- Recruitment of patients who would otherwise not be eligible for the study.
- A Direct to Patient, friendly, ‘Non-IVRS system’ outbound Telephone Diary Support Service.
- Rapid submission of patient data by ESMS into eCRF means power of timely entry into eDiary is not lost by using this service.
- Patients reassured that their valuable data would still be retained and eligible for the study without facing technical constraints.
- Potential to reduce study timelines and associated costs due to improved recruitment.
- The highly experienced team are trained to recognise adverse events and direct the caller to the most appropriate resources, if needed.
- A more cost-effective alternative to commissioning such a service at each site.
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