Implementation of Sodium-Glucose Cotransporter (SGLT)-2 Inhibitors in Patients With Heart Failure Through a New Digital Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,996
- 试验地点
- 5
- 主要终点
- Proportion of patients initiating therapy with a SGLT-2 inhibitor
研究概览
简要总结
The implementation of new medical therapies and guidelines, is a long and complex process that takes up to 10 years on average. This prolonged process is a global challenge and is mainly due to the complexity of cross-institutional patient care, involving primary care, out-patient clinics, nursing homes and patient associations.
The main objective of this clinical trial is to determine whether a new digital strategy that employs official digital letters to inform and invite patients to evaluate their eligibility for new therapies, specifically the sodium-glucose co-transporter-2 (SGLT-2) inhibitor for heart failure patients, can facilitate and optimise the implementation. The aim is to increase the number of eligible patients with heart failure who start taking SGLT-2 inhibitors and reduce the time it takes to initiate treatment compared to the current process. Ultimately, this approach may improve patient outcomes.
详细描述
The study is a prospective, multicenter, two-armed, randomised clinical trial that will be coordinated from the Department of Cardiology, Herlev-Gentofte Hospital. The primary objective of the study is to determine whether a new digital strategy can be implemented to introduce novel medical therapies, specifically sodium-glucose co-transporter-2 (SGLT-2) inhibitors to heart failure patients. The aim is to increase the number of eligible patients who initiate therapy and to reduce the time taken to initiate therapy compared to the current process. The study will recruit patients with a registered diagnosis of heart failure residing in The Capital Region of Denmark and Roskilde, who have not yet been started on SGLT-2 inhibitor therapy. Patient identification and recruitment will be carried out through Danish nationwide registries, using their personal identification number (CPR-number), which is also linked to a secure digital mailbox where all official letters from public authorities are sent to Danish citizens. Patients will be randomly assigned (1:1) to receive a digital letter containing evidence-based information about the newly approved heart failure therapy option, SGLT-2 inhibitors. The letter will also invite recipients to be evaluated by a heart failure specialist for potential initiation of the therapy. Outcome measures will be obtained from Danish nationwide registers at pre-specified time points and in collaboration with the Danish Health Data Authority.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the trial design, blinding the patients who received the digital letters is not possible. However, the letters do not disclose that they were sent as part of a randomized trial, which enhances the generalizability of the study intervention. Additionally, patients in the control group, who did not receive a letter, remain unaware that they are part of the control group in a randomized trial. Also, the HF specialists who prescribed the SGLT2 inhibitors are blinded to the primary endpoint, as they do not receive information on whether patients actually redeemed their prescriptions and commenced the medication.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered diagnosis of heart failure within the last 10 years
- •Living in the Capital Region of Denmark or Roskilde
- •Age ≥20 years
排除标准
- •Redeemed prescription of a SGLT-2 inhibitor after 2015
- •Type 1 diabetes
- •History of diabetic ketoacidosis
- •Chronic kidney disease in long term dialysis
- •Living in a nursing home
- •Cancer diagnosis within the last year (except prostate cancer and non-melanoma skin cancer)
- •Exemption from the public digital mailbox system
研究组 & 干预措施
Digital letter
The experimental group will receive a digital letter with information on the newly approved heart failure therapy option, SGLT-2 inhibitors. The letter will also invite recipients to be evaluated by a heart failure specialist for potential initiation of the therapy.
干预措施: Digital letter (Other)
Control
The control group will not be sent the digital letter and will therefore receive usual follow-up and care in the public healthcare system.
结局指标
主要结局
Proportion of patients initiating therapy with a SGLT-2 inhibitor
时间窗: from randomisation up to 6 months
次要结局
- Time to first occurrence of a composite heart failure endpoint consisting of all-cause death or heart failure hospitalisation.(from randomisation up to 2 years)
研究者
Morten Schou
MD, PhD, Professor
Herlev and Gentofte Hospital