Primary care Primary care Hub-and-spoke rides to the rescue E ast of England Primary Care Local Research Network uses a hub-andspoke study set-up model to improve the research experience for patients with Chronic Fatigue Syndrome and improve recruitment to an under-performing study. Chronic Fatigue Syndrome or Myalgic Encephalopathy (ME) includes chronic, often severe mental and physical exhaustion, widespread muscle and joint pain and headaches. Originally, patients for a study exploring ME in the East of England were seen by occupational therapists at the central ME specialty service clinic in Great Yarmouth. This meant a 40 mile commute across Norfolk and Suffolk for some patients which was not only inconvenient, but onerous and challenging for anyone with the condition. In addition, only one set of equipment was available to make essential measurements for the study. Sponsored by London School of Hygiene & Tropical Medicine (LSHTM), the study was struggling to meet the recruitment target of 105 participants. A third of the recruited participants in the study were required to be healthy controls and further, the existing study method for recruiting healthy controls was not working. As all referred patients to the clinic already had the condition, friends and family of the patients were asked to get involved as controls, but the uptake was poor. With study recruitment well below the target of 105 at 69 participants during the four months (61 cases and eight healthy controls), and the research contract with the ME specialty service clinic about to expire, Primary Care Research Network coordinator, Heather Leishman, contacted the study team: “As coordinator for East of England, I contacted Dr Eliana Lacerda, the project lead, to discuss how the Network could further support the study and what resources were available to address the low recruitment numbers. I recommended a huband-spoke model as it was a low-cost way of maximising the recruitment potential from local practices as set-up was required in just one practice, “the hub”. Recruiting from hub-and-spoke practices meant patients could see a Network research nurse at a practice local to them.” Primary Care Research Network East of England was waiting for an opportunity to pilot a hub-and-spoke model and this was the first study where the circumstances were right: 12 • It was a relatively straight-forward academic study only requiring blood and physical measurements to be taken • There was a suitable research active practice with sufficient space and resources in Lowestoft who, from previous Hub and spoke rides to the rescue conversations with the Network, were willing to act as a “hub’ where the clinical assessments would take place • There were five local practices within a five mile radius of the hub to act as “spokes” • The Network was able to provide research nurses with relevant skills • The area would provide sufficient recruitment opportunity for the size of the study In just two months of using the hub and spoke model, 62 patients were recruited, almost doubling the recruitment rate. ethics and research governance committees to reflect the new hub-and-spoke practices. A database search and mailing to the appropriate patients was then undertaken, initially by the hub and then by the five spoke practices. Heather confirms: “Staggering the mailings in this way prevented the study team from being overwhelmed by responses and should we have hit a problem after the first mailing was issued it would have been restricted to one site.” the patients who in this instance have had the chance to contribute to a study where there is limited treatment or indeed understanding of their condition so far. At the time of writing, a further 40 patients have consented to participate. Pleased with the results Heather looks to the future: “With Network support the study received a funding extension as the recruitment rate had dramatically improved. Hopefully this success will strengthen the study team’s position for securing funding for the next phase.” Responses were returned directly from patients to the study sponsor who booked the patient into a clinic at the hub with a Network Study project lead at LSHTM, Dr Eliana Lacerda, says the collaboration with the research nurse. Network was a positive experience: In just two months of using the hub-and“The adoption of our research study by the spoke model, 62 participants were recruited Primary Care Research Network has been almost doubling the recruitment rate. By a rewarding experience for our research the recruitment deadline, October 2012, team. The use of a hub and spoke model although the target had not yet been met, a has improved our recruitment rate; and, not further funding extension of twelve months only have we achieved our target for enlisting was agreed on the basis that recruitment cases in the first year, but we have also greatly had been much improved. Network research improved the enrolment of healthy controls. nurse, Sue Allen said: “This experience has also proven to be “The hub-and-spoke model enabled us to see more patients. Patients could travel locally very efficient, as it allows the combination of resources from the research team with which was particularly beneficial to those those of the Network team to be used in an with conditions that affected their mobility. optimal way. Therefore, we consider this to There were benefits for the spoke practices be a reproducible model, which may help too because the study provided a gentle to improve similar studies being carried out introduction to working in a new way and within the Primary Care Research Network.” an opportunity for neighboring practices to Working with the study sponsor, Heather coordinated the set up of the hub-and-spoke sites. This meant the six practices would invite potential cases and healthy controls to take part in the study and the clinical assessments would be carried out by Network research nurses in one central practice “the hub”. Heather had a great working relationship with the Practice Manager at the hub and commends the Practice Manager for her efforts work together.” in helping the model get off the ground: For spoke practices this experience has “Lisa Andrews, the Practice Manager, was very opened the door to a research active supportive of the Network and helped to guide future. Being a spoke gives the practice the confidence to pursue other research projects. the spoke practices through the process.” This not only benefits the practice by giving Study information and the patient invitation staff the opportunity to up skill, but benefits letter were updated and approved by the Primary Care Research Network East of England is looking forward to using the hub-and-spoke model in future studies and plans to pilot the model with a more complex commercial study when the opportunity arises. www.pcrn.org.uk “This experience has...proven to be very efficient, as it allows the combination of the research team and those of the Network team to be used in an optimal way.” Hub and spoke rides to the rescue 13