Impact of a Novel Heart Failure Medication Decision Aid

Not Applicable

Active, not recruiting

• Conditions: Heart Failure
• Interventions: Behavioral: Decision aid

• Registration Number: NCT06247371
• Lead Sponsor: National University of Singapore

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.

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-07
• Study Start: 2024-04-09
• Primary Completion: 2024-07-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision aid	Decision aid	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.

Primary Outcome Measures

Name	Time	Method
Frequency of Medication cost discussion	Day 1 (Clinic session)	This outcome will be measured using an audio recording of the clinic session. Audio recording will be transcribed. The presence of cost discussion during the clinic session will coded based on Hunter et al. (2016) definition. Presence of cost discussion is coded as 1 and absence of cost discussion is coded as 0. Coding of cost discussion frequency will be done by 2 analysts who are blinded to the randomisation.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)	Patients will assess their HRQoL with EuroQol scale (EQ-5D-5L). The EQ-5D-5L score is calculated using a standardized algorithm that considers five dimensions (mobility, self-care, usual activities, pain, and anxiety/depression). Each dimension has five response levels (no problems, slight problems, moderate problems, severe problems or extreme problems). The algorithm produces a utility score that ranges from 0 to 1 with 0 being the worst health and 1 being perfect health.
Financial toxicity	Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)	Patient's financial well-being will be assessed with COST-FACIT questionnaire. The questionnaire contains twelve items with a total score of 0 to 44. The higher the score, the better the financial well-being. The threshold for financial toxicity is defined as a score \< 26.
Readmission rate	Day 180 (Follow-up appointment)	Electronic medical record will be used to evaluate this outcome measures. The frequency of readmission into hospital within 6 months of recruitment will be tallied and compared between arms.
Decision regret	Day 180 (Follow-up appointment)	The Decision Regret Scale (DRS) evaluates the degree of regret that an individual experiences after making a decision. DRS has demonstrated strong internal consistency and includes five items. A score of 0 suggests the absence of any regret, while a score of 100 indicates a high level of regret.
Decisional conflict	Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)	Decisional conflict is defined as uncertainty when faced with choosing among competing options that can impact patient's personal values or well-being. The Decisional Conflict Scale (DCS) contains 16 items with 5 responses. The level of decisional conflict is reported from 0 to 100, with 0 indicating a high degree of certainty about the best choice and 100 indicating a significant degree of uncertainty about the best choice.
Decision satisfaction	Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)	Patient's satisfaction with their decision will be measured with the Satisfaction with Decision Scale (SWD) developed by Holmes-Rovner. The SWD is a reliable tool consisting of 6 items. Respondents rate each item on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree." A higher score indicates greater decisional satisfaction.
Prescribed medication agreement with preferred medication	Day 1 (Immediately after clinic session)	Patient's prescribed medication record will be obtained from the electronic medical record. Their preferred medication choice will be documented after reading the decision aid. Presence of agreement is coded as 1 and presence of discrepancy is coded as 0.
Heart Failure symptoms and Adverse drug reactions	Day 180 (Follow-up appointment)	Clinician's notes will be used to evaluate these two outcome measures. The frequency of various heart failure symptoms and drug reactions will be tallied within 6 months of recruitment and compared between arms.
Medication Adherence	Day 180 (Follow-up appointment)	Medication adherence will be captured by generating the Medication Possession Ratio using the pharmacy database. The higher the ratio, the better the medication adherence. The ratio between the two arms will be compared.

Trial Locations

Locations (1)

Ng Teng Fong General Hospital; 🇸🇬 Singapore, Singapore