Clinical trial NCT06247371: Impact of a Novel Heart Failure Medication Decision Aid
Official title: Randomised Controlled Trial of a Heart Failure Medication Decision Aid in Singapore
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Randomised controlled trial
Decision aid
Heart failure
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Ng Teng Fong General Hospital
First posted: 2024-02-07
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study incorporates a prospective single centre, two arms parallel randomised controlled trial with 1:1 patient allocation.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Medication cost discussion
timeFrame: Day 1 (Clinic session)
Secondary outcomes:
measure: Decisional conflict
timeFrame: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
measure: Decision satisfaction
timeFrame: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
measure: Decision regret
timeFrame: Day 180 (Follow-up appointment)
measure: Prescribed medication agreement with preferred medication
timeFrame: Day 1 (Immediately after clinic session)
measure: Health-related quality of life
timeFrame: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
measure: Financial toxicity
timeFrame: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
measure: Readmission rate
timeFrame: Day 180 (Follow-up appointment)
measure: Heart Failure symptoms and Adverse drug reactions
timeFrame: Day 180 (Follow-up appointment)
measure: Medication Adherence
timeFrame: Day 180 (Follow-up appointment)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Ng Teng Fong General Hospital
Study officials:
affiliation: National University of Singapore
name: Hwee Lin Wee, PhD
role: PRINCIPAL_INVESTIGATOR
References: