Case Study: C. difficile telephone diary support service

Background

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.

Challenge

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.

Context

ESMS had been providing 24/7 emergency medical response services for this trial since it began. With existing telecoms and language support infrastructure already set up across the required 28 countries, coupled with experience in providing patient support services, the Telephone Diary Support Service was a straightforward and seamless addition to the services already provided to the client.

Developing a system

ESMS worked with the client to develop the scope of the service and created SOPs, scripts and documentation describing how data would be collected from the patient, captured and transferred to the client database.

ESMS Information Scientists (IS) all hold a minimum qualification of a life science degree to include toxicology or pharmacology. The IS would call patients daily to talk through and collect the information for the eDiary questionnaire and facilitate patients by inputting the relevant data onto the software on their behalf.

Calls to collect data

  1. ESMS arrange a daily schedule of telephone calls with the patient in their local language.
  2. ESMS call the patient at agreed times to check in and collect the required data.
  3. Data collection method is designed to avoid bias.
  4. Appropriate triage of patient queries unrelated to the Telephone Diary Support Service.
  5. ESMS submit patient data into the client database (eCRF) as required.
  6. Appointments made to suit all patients across all time zones as ESMS operates a 24/7 support service.
  7. All Serious Adverse Events fully captured by ESMS and reported to the client PV within the required time frame.

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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