Impact of a Novel Heart Failure Medication Decision Aid

National University of Singapore

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Decision aid

Study type: Interventional

Funder types: Other

Identifiers

NCT06247371

2023/00772

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with heart failure with reduced ejection fraction (HFrEF)
• Singaporean nationality

Exclusion criteria

• Patient is currently on Medifund OR have Medical Claims Pro-ration System (MCPS)
• Pregnant
• Age 21 years and below
• Incapable of personally giving consent
• Unable to speak and read English or Chinese

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Decision aid

Experimental group

Description:

Patients will be presented with a decision aid featuring personalized cost information, as well as other information about angiotensin receptor neprilysin inhibitor (ARNI) and angiotensin-converting enzyme inhibitor (ACEI) 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.

Treatment:

Behavioral: Decision aid

Usual care

No Intervention group

Description:

Patients are managed as per usual clinical routine without the decision aid.