NCT06247371

Impact of a Novel Heart Failure Medication Decision Aid

Randomised Controlled Trial of a Heart Failure Medication Decision Aid in Singapore

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: National University of Singapore · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

A modified Zelen design randomised controlled trial over 6 months period is designed to investigate the influence of a heart failure medication decision aid prior to clinic session on shared decision making and its long term effect. Participants are randomised to either the decision aid arm or the usual care arm.

Detailed description

A novel heart failure (HF) medication decision aid (DA) has been constructed, taking into account the needs of both patients and clinicians. Developed with a focus on brevity, this single-page DA is designed to offer patients a quick and concise overview of the information they desire about their medication ahead of their clinic session. It encompasses personalised cost information, considering the subsidies available in Singapore. The aim of the DA is to improve the communication between clinicians and HF patients. The conduct of this randomized controlled trial (RCT) is to study the effectiveness of the HF DA in the real-world setting. Patients are randomized to either the DA arm or the usual care (UC) arm. In the DA group, patients will be provided with a DA featuring duration and frequency of use, benefits, side effect and cost information about angiotensin receptor neprilysin inhibitor and angiotensin-converting enzyme inhibitor medications. These patients will then be tasked to choose a preferred medication and reflect on which attribute holds the most significance for them. The preferred medication will be communicated to the clinicians during the clinic session. For the UC arm, clinicians will manage the encounter as per current usual routine.

Conditions

• Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	Decision aid	The Singapore developed HF DA is a A3 sized one-page poster designed to convey information about HF medications options (ACEI and ARNI only) and their pros and cons. The DA contains informative attributes of both medications that are presented side by side for comparison. These attributes include subsidized cost, frequency of use, duration of use, route of administration, low blood pressure side effect rate and benefits such as non-hospitalization rate and survival rate.

Timeline

• Start date: 2024-04-09
• Primary completion: 2024-07-25
• Completion: 2025-02-10
• First posted: 2024-02-07
• Last updated: 2025-02-11

Locations

1 site across 1 country: Singapore