Implementation of SGLT-2 Inhibitors in Patients With Heart Failure Through a New Digital Strategy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Implementation of Sodium-Glucose Cotransporter (SGLT)-2 Inhibitors in Patients With Heart Failure Through a New Digital Strategy

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Digital letter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered diagnosis of heart failure within the last 10 years Living in the Capital Region of Denmark or Roskilde Age ≥20 years Exclusion Criteria: 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 Dementia Cancer diagnosis within the last year (except prostate cancer and non-melanoma skin cancer) Exemption from the public digital mailbox system

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital letter<br>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. | Other: Digital letter<br>* A digital letter with 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.<br>|
| No Intervention: Control<br>The control group will not be sent the digital letter and will therefore receive usual follow-up and care in the public healthcare system. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients initiating therapy with a SGLT-2 inhibitor |  | from randomisation up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, SGLT-2 inhibitors, Digital implementation, Cardiorenal disease