ISRCTN53221378进行中（未招募）未知
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
niversity of Leicester0 个研究点目标入组 1,520 人开始时间: 2021年8月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,520
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38220558/ (added 15/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Practice inclusion criteria:
- •As this is a cluster randomised trial, individual patient consent will not be sought. Instead, consent will be obtained at the practice level from a GP, designated as the principal investigator (PI), for the practice to take part as the study participant. In addition, an Organisational Information Document (OID), which will include a data agreement, will be signed by the PI to confirm capability and capacity as an investigator site. Additionally, the PI will need to confirm acceptance of the Remote Access Agreement which will allow PRIMIS (University of Nottingham) to process the data on behalf of the University of Leicester. A Service-Level Agreement is in place for this activity. Therefore, practices will need to comply with the following conditions:
- •1. A list size between approximately 4000 and 12000 patients
- •2. A principal investigator (PI), on behalf of the practice, is willing and able to give informed consent to take part (as the research participant) in the cluster randomised trial
- •3. The PI, on behalf of the practice is willing and able to sign an OID, including a data agreement, with the University of Leicester to confirm capability and capacity to deliver the study
- •4. The PI is willing for PRIMIS to carry out a remote database search and data extractions (at 0, 6- and 12-months), on behalf of the lead study team at the University of Leicester and in line with the Remote Access Agreement
- •5. The PI is willing, if allocated to the intervention group, to have an electronic decision-support system remotely installed by PRIMIS and have clinical staff participate in the training and follow-up
- •6. The PI is able and willing (in the Chief Investigator’s opinion) to comply with all other study requirements
- •7. The GP practice is using either the EMIS Web or SystmOne clinical database systems
- •8. The GP practice has categorised moderate to severe frail patients with type 2 diabetes in line with the Quality Outcomes Framework (QOF)
- •Patient inclusion criteria:
- •At baseline, PRIMIS will run a remote database search to identify potential patients eligible for deintensification who fulfil the following inclusion criteria:
- •1. Confirmed diagnosis of type 2 diabetes
- •2. Issued diabetes medication in the last 3 months prior to the baseline search
- •3. Aged 65 years or older
- •4. Last HbA1c reading <53 mmol/mol (7.0%) in the previous 12 months prior to the baseline search
- •5. Categorised as moderate to severe frailty (i.e. an electronic frailty index (eFI) >0.24)
- •The patients identified at the baseline search will create the main study cohort and will have pseudonymised demographic, clinical and prescription data extracted at the 6- and 12-month timepoints.
- •Additionally, the initial search criteria will be rerun at the 6- and 12-month time points to track any practice-level changes in prescribing rates of inappropriate diabetes medications during the study.
排除标准
- •Practice exclusion criteria:
- •The researchers will exclude practices that meet any of the following criteria:
- •1. The PI is not willing and able to give informed consent
- •2. The PI is not willing and able to sign the OID and data agreement
- •3. The PI is not willing to let PRIMIS remotely install electronic software on their system to carry out the database search and data extractions
- •4. The PI is not willing to let PRIMIS remotely install the electronic decision-support system nor have clinical staff participate in the training and follow-up
- •5. The PI is not able and willing (in the chief investigator’s opinion) to comply with all other study requirements
- •6. The GP practice is not using either EMIS Web or SystmOne clinical database systems
- •7. The GP practice has not categorised moderate to severe frail patients with type 2 diabetes in line with QOF
- •Patient exclusion criteria:
- •At the baseline and subsequent 6- and 12-month searches, the researchers will exclude patients who fulfil any of the following criteria:
- •1. No confirmed diagnosis of type 2 diabetes
- •2. No diabetes medication issued in the last 3 months
- •3. Aged 64 years old and younger
- •4. Last Hb1AC reading =53 mmol/mol (7.0%) in the previous 12-months prior to the baseline search
- •5. Receiving palliative/end of life care
- •6. No frailty categorisation available or eFI =0.24
- •7. Patient has opted out of sharing their personal data as part of the national data opt-out policy
研究者
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