A deprescribing programme aimed to optimise blood glucose-lowering medication in older people with type 2 diabetes mellitus, the OMED2-study:the study protocol for a randomised controlled trial

BACKGROUND: Older patients with type 2 diabetes mellitus (T2D) have an increased risk of hypoglycaemic episodes when using sulphonylureas or insulin. In the Netherlands, guidelines exist for reducing glucose-lowering medication in older patients. However, evidence is lacking that a medication reduction in older patients can be safely pursued. Here, we will examine if promoting the deprescribing of insulin/sulphonylureas with a deprescribing programme (DPP) in general practice affects T2D-complications in older overtreated patients. METHODS: We will perform a 1:1 cluster randomised controlled t... Mehr ...

Verfasser: Andriessen, Charlotte
Blom, Marieke T
van Hoek, Beryl A C E
de Boer, Anna W
Denig, Petra
de Wit, G Ardine
Swart, Karin
de Rooij-Peek, Angela
van Marum, Rob J
Hugtenburg, Jacqueline G
Slottje, Pauline
van Raalte, Daniël
van Bloemendaal, Liselotte
Herings, Ron
Nijpels, Giel
Vos, Rimke C
Elders, Petra J M
Dokumenttyp: Artikel
Erscheinungsdatum: 2024
Reihe/Periodikum: Andriessen , C , Blom , M T , van Hoek , B A C E , de Boer , A W , Denig , P , de Wit , G A , Swart , K , de Rooij-Peek , A , van Marum , R J , Hugtenburg , J G , Slottje , P , van Raalte , D , van Bloemendaal , L , Herings , R , Nijpels , G , Vos , R C & Elders , P J M 2024 , ' A deprescribing programme aimed to optimise blood glucose-lowering medication in older people with type 2 diabetes mellitus, the OMED2-study : the study protocol for a randomised controlled trial ' , Trials , vol. 25 , 505 . https://doi.org/10.1186/s13063-024-08249-9
Schlagwörter: Humans / Diabetes Mellitus / Type 2/drug therapy / Deprescriptions / Hypoglycemic Agents/therapeutic use / Aged / Sulfonylurea Compounds/therapeutic use / Netherlands / Blood Glucose/drug effects / Randomized Controlled Trials as Topic / Glycemic Control / Treatment Outcome / Insulin/therapeutic use / Age Factors / Biomarkers/blood / Time Factors / Multicenter Studies as Topic / Glycated Hemoglobin/metabolism / Patient Education as Topic/methods / Hypoglycemia/chemically induced
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-29191827
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://hdl.handle.net/11370/a142adcd-f445-4e58-a093-2acd775d9fa3

BACKGROUND: Older patients with type 2 diabetes mellitus (T2D) have an increased risk of hypoglycaemic episodes when using sulphonylureas or insulin. In the Netherlands, guidelines exist for reducing glucose-lowering medication in older patients. However, evidence is lacking that a medication reduction in older patients can be safely pursued. Here, we will examine if promoting the deprescribing of insulin/sulphonylureas with a deprescribing programme (DPP) in general practice affects T2D-complications in older overtreated patients. METHODS: We will perform a 1:1 cluster randomised controlled trial in 86 general practices in the Netherlands. The DPP will consist of education sessions with general practitioners and practice nurses about reducing glucose-lowering medication in older patients (≥ 70 years). Topics of the sessions include the necessity of deprescribing, tools to initiate deprescribing and strategies to discuss deprescribing with patients (shared decision making). The DPP further includes a support programme with practice visits. The study will employ a selection tool to identify possibly overtreated older patients from the electronic medical records of the general practitioner. Eligibility for enrolment in the study will be based on HbA1c targets indicated by the Dutch guidelines, which depend on age, diabetes duration, presence of frailty, and life expectancy. The control group will provide usual care. We aim to include 406 patients. The follow-up period will be 2 years. For the primary outcome, the effect of the DPP on T2D-complications will be assessed by counting the cumulative incidence of events related to under- and overtreatment in T2D as registered in the electronic medical records. We shall perform an intention-to-treat analysis and an analysis including only patients for whom deprescribing was initiated. The implementation of the DPP in general practice will be evaluated quantitatively and qualitatively using the Extended Normalisation Process Theory (ENPT) and the Reach, Efficacy - ...