Case study: Delivering a study via a Primary Care Network
The STATIC study - Crohn's Disease
STATIC - 38687 Stopping Aminosalicylate Therapy in Inactive Crohn's Disease
Study Overview:- Aminosalicylates (5-ASAs) are often used as first line agents for management of Crohn’s Disease (CD) and are thought to have an anti-inflammatory effect on the lining of the bowel. They are one of the most commonly prescribed classes of drugs for CD worldwide. Generally, they are considered to be safe and inexpensive agents, although rare but serious side effects can occur. Unlike with ulcerative colitis, there is little evidence that 5-ASAs are any more effective than dummy treatment (placebo) in maintaining remission for patients with CD, but many doctors still prescribe 5-ASAs in CD.
The STATIC study aims to definitively answer the question of whether 5-ASAs should be continued in patients with CD who are in remission. It will compare the safety and effectiveness of continuing existing 5-ASA medication versus stopping it. The results of the study may have implications for the management of CD worldwide and help to improve evidence-based treatment guidelines and the approach to patient care.
The study has been open in the Clinical Research Network West Midlands from 1 October 2020 and is due to close to recruitment on 28 February 2024.
How many sites?
We agreed on a target of 60 sites with the study team, from across the whole CRN WM footprint, with the expectation that each site would recruit one participant. We initially sent invitations out to 292 Practices, with 78 indicating an interest in participating.
How has it gone?
We are currently on target to reach 60 sites by the end of February 2024. This has been a challenging study and quite time consuming for the practice staff and research nurses alike, with little patient recruitment to reflect the hard work that has been done to get this far. One of the reasons the study has achieved little recruitment throughout the CRN nationally is that there is an overwhelming majority of patients that appear to be reluctant to stop their medications while they are in remission of their Crohn’s disease. To try and mitigate any concerns from GPs about altering medication prescribed by a consultant, the study team worked with the local secondary care GI consultants and produced a letter in support of the study.
The total recruitment for the West Midlands is 27 consented patients, and 19 patients have been randomised in the study to date.
We started targeting practices with more patients in order to achieve more recruitment, but quickly found out that the practice list size has no bearing on actual recruitment. For example, one of our practices with a patient list of 6,000 patients recruited two participants, and another with a list size of 49,000 patients only recruited one participant.
The STATIC study was also the first study to be delivered via a Primary Care Network (PCN). It meant that we had one Study Site Coordinator (PI) who oversaw the study at each surgery within her PCN. This worked well as it reduced the need for multiple site initiation visits, site files and time from practice staff, as well as efficiently communicating with one lead person for the PCN. This new way of working has been very successful and has proved that conducting research via a PCN can be done.
CRN WM remains the country’s highest recruiters and has recruited 31% of the total participants in Primary Care.