D-Med Study
Research type
Research Study
Full title
Evaluation of an electronic decision-support system, plus training with follow-up support and performance review, for the deintensification of potentially inappropriate medications (D-Med) to prevent overtreatment in the management of older frail people with type 2 diabetes: a 12-month follow-up cluster randomised trial
IRAS ID
280971
Contact name
Samuel Seidu
Contact email
ISRCTN Number
ISRCTN53221378
Duration of Study in the UK
1 years, 5 months, 28 days
Research summary
Evaluation of an electronic-based decision support system, plus training and support, for the deintensification of potentially inappropriate medications (D-Med) to prevent overtreatment in the management of older frail people with type 2 diabetes: a 12-month follow-up cluster randomised trial.
Many older people suffer from frailty with progressive age, characterised by a decline in both their physical and mental health and a number of health conditions requiring treatment. In type 2 diabetes, managing frailty means striking a balance to prevent over treatment with some diabetes medications which increase the risk of low blood sugars and lead to more falls, fractures and deaths. Guidelines are now in place detailing when to deintensify (stop, change or reduce) some diabetes medications in frail older people; however, these have not been well implemented in primary care. Pragmatic interventions are needed to address this problem.
Our study aims to address this problem by developing and evaluating an enhanced care intervention involving an electronic decision-support system, with training and follow-up support, to help primary care providers identify and manage their frail older type 2 diabetes patients more effectively. The study is funded by the NIHR Applied Research Collaboration East Midlands.
The primary objective will be to evaluate the effectiveness of the intervention on reducing the number of potentially inappropriate diabetes medications prescribed whilst secondary objectives will evaluate the effect on clinical outcomes and associated adverse events. As a cluster trial, practices (from different regions) and not patients will be recruited and randomised to either the control or intervention group. Database searches will find frail type 2 diabetes patients, aged 65 years and over, with blood sugar levels below the recommended targets. Then, relevant demographic, clinical and prescription pseudonymised data will be extracted for these patients at baseline, 6- and 12-months, and the two groups will be compared.
Lay summary of study results: Thank you to everyone who took part in this study. Your involvement has helped us understand how GP practices can safely review medicines for older adults who take many treatments.Study title
D-MED Study: Understanding whether a general practice intervention can safely reduce the number of medicines taken by older adults with multiple long-term conditions.Who carried out the research?
The research was carried out by the NIHR ARC EM team based at the Leicester Diabetes Centre and sponsored by the University of Leicester.Public involvement
People with experience of living with multiple long-term conditions advised the research team. They shared views on medication burden and helped ensure the study focused on issues that matter to patients.Where and when the study took place
The study took place in 40 GP practices across England. We used routinely collected medical records to identify participants and assess outcomes.Why the research was needed
Many older adults take multiple medicines, known as polypharmacy. While medicines can be beneficial, taking too many can increase the risk of side effects, falls and hospital admissions. The study explored whether a structured medication review, supported by an electronic decision tool, could help GP practices safely reduce medicines that may no longer be needed.Main questions studied
• Does the intervention lead to a reduction in medicines?
• Is this approach safe?
• How does it compare with usual GP care?Who took part
The study included 3,310 adults with an average age of 75 years. Around half were women. Most were White British, with a substantial number from South Asian backgrounds. Participants commonly lived with multiple long-term conditions such as high blood pressure, heart disease, kidney disease, arthritis, depression and dementia.What treatments participants received
All participants continued with usual NHS care. In intervention practices, clinicians used an electronic tool that flagged patients who might benefit from reducing diabetes medicines. The tool guided safe decision-making. No experimental medicines were given.Medical problems (adverse reactions)
The study used existing medical records, so short-term side effects were not collected as they would be in a clinical trial. We maintained regular contact with participating practices during the study, and no concerns about adverse effects were raised.What happened during the study
We compared the number of medicines taken before and after the start of the study. We looked at results at 6 and 12 months. We also examined diabetes medicines and measures such as blood pressure and HbA1c (a blood test that reflects long-term blood sugar levels). Statistical analyses were used to compare groups fairly.Results
Across both groups, the average number of medicines reduced slightly over time. This may be due to increased focus on medication review during the study. At 6 months, patients in intervention practices were slightly more likely to have a reduction in medicines than those in usual-care practices. By 12 months, the difference between groups was smaller.How this study has helped
The study shows that structured medication reviews supported by electronic tools are safe and may help reduce unnecessary medicines in the short term. The findings will support future NHS work on safety and polypharmacy.Further research
A follow-on qualitative study is underway to explore clinicians’ experiences of using the electronic tool and to inform future improvements.
URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F38220558%252F%2FNBTI%2FYHvBAQ%2FAQ%2Fac6923df-66f1-4bef-9f76-35d737bd3966%2F1%2FWkpoaHFAjn&data=05%7C02%7Cleicestercentral.rec%40hra.nhs.uk%7C2256a11c154845b87d0208de2753724c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638991436537292900%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=C96%2BJq8x0UdG%2FEL2VC6RemgSbT7WnYmg1NGkfn8da%2FE%3D&reserved=0REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
21/EM/0163
Date of REC Opinion
12 Jul 2021
REC opinion
Favourable Opinion