Case Study: Engaging and Retaining Patients in a Complex Hybrid Study
Maximising patient participation and ensuring a remarkable patient experience during screening, initial treatment and follow-up visits.
Our client, a biopharmaceutical company focused on creating novel precision medicines for the treatment of rare muscle disorders, needed to recruit and manage patients for a clinical trial – many of whom lived in remote, rural locations across the US.
Due to the nature of the disease, participant mobility was a challenge – yet treatment had to be delivered at one centralised specialist clinic.
Patients were required to spend 24 days at the clinic during the treatment phase of the clinical trial, a significant commitment which required considered support and careful management.
mdgroup was contracted to deliver the highest level and quality of support to patients and their carers during this important trial, easing the burden of participation and ensuring the highest possible retention and engagement rate.
First, we facilitated in-depth mobile screening visits in patients’ homes, removing the need for patients to travel up to thousands of miles just to determine eligibility.
This decentralised, mobile approach eliminated the risk of participants making wasted trips. Instead, nurses visited patients’ homes at a time which was convenient for them and conducted initial screenings.
Training & Communication
As we were dealing with such a rare disease, healthcare practitioners involved in these home visits required specific training on the condition, study protocol and specialist equipment to be used during home visits.
Clear, regular communication and feedback between our team, site, sponsor, patients and nurses allowed us to successfully complete all screening visits within the required time frame.
Distribution & Logistics
Horreum, our medical distribution centres, supplied us with the specialist medical equipment needed for screening, and our in-house team was on hand to provide any additional support required during nurses’ visits.
Additionally, the study protocol demanded complex lab sampling and transportation logistics. In order to ensure the viability of samples collected during screening visits, we delivered dedicated training on lab requirements to couriers and ensured we kept in close communication with them throughout.
Tailored 24/7 Support
When home screening was complete, we worked with each of the eligible participants and their caregivers to identify their specific travel needs, ensuring every person was able to attend the on-site clinic for treatment.
The client provided funding for caregivers and/or family members to travel with patients, making participation easier and less daunting.
Throughout the study, our in-house travel team provided personalised, 24/7 support for patients using their in-depth knowledge of the study protocol and individuals’ needs.
Anticipating Patients’ Needs
We arranged for a Registered Nurse who was familiar with the patient population and study requirements to travel to the study site before patients visited.
Our nurse conducted an inspection of the airport and visited hotels near the clinic, identifying which were suitable and could accommodate participants’ and caregivers’ needs.
Following this inspection, we created a detailed travel guide for patients about their stay, including:
- Airport accessibility – specific information about the airport that was relevant to their mobility challenges
- Transport contacts – details of car services for airport transfers
- Accommodation information – everything patients and caregivers needed to know about their hotel stay and facilities
- Site visit information – including how to get there, what to expect during the visit and pre- and post-visit guidance
- Food & leisure – lists of nearby restaurants, amenities and attractions for the study participants and their caregivers/families so they could make the most of their stay outside of site visits and treatment
Participants remained at the clinic and hotel for 3-4 weeks, during which time they completed their initial treatment and first follow-up visits.
During this time, we provided prepaid credit cards to ensure participants and caregivers/families were not out of pocket due to additional travel and subsistence expenses.
We made all arrangements for patients to travel back home and scheduled home visits for follow-up appointments.
In most cases, we were able to ensure these visits were conducted by the same healthcare practitioner who completed their screening visit, with the site joining via a secure video calling platform.
Despite the unique and complex challenges presented by hybrid studies such as this one, we were able to deliver a remarkable patient experience which meant every participant successfully completed this phase of the clinical trial.
Our ability to deliver an integrated approach to mobile health, travel, accommodation and expenses provided patients with comprehensive, tailored and reliable support throughout their participation.
Every patient who attended the clinic reported a positive experience and said they were happy they had participated. We were delighted to hear that all patients cited our team as having a particularly positive impact on their experience.
Key Learnings For Hybrid Studies
- Listen to patients’ and caregivers’ needs and work to accommodate these from the beginning of the study
- Ensure the study protocol design gives patients options for their participation
- Replace site visits with home visits wherever possible to minimise travel and disruption to patients
- Where site visits are needed, ensure you provide dedicated travel, accommodation and expenses support
- Where possible, minimise the number of assessments needed while ensuring you collect the required data
- Ensure any technology used in the study is easy to use, integrates with patients’ lives and enhances rather than replaces the human touch
- Clear, regular communication between sites, sponsors, participants and all involved parties is crucial for a successful study outcome
Want to find out more about our complex hybrid clinical trial services?
We’re on a mission to truly put patients first in clinical research. Through our personalised patient-focused services and technologies, we support patients at every stage of the clinical journey regardless of where visits take place.
Our approach to patient health drastically reduces patient drop-out rates, and prevents disruption to your clinical trial, getting products to market faster.