Impact of a Novel Heart Failure Medication Decision Aid

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247371
• Other study ID #: 2023/00772
• Status: Recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: National University of Singapore
• Contact: Qianyu Shen
• Phone: 65164988
• Email: shen_qianyu[@]u.nus.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Singapore	Ng Teng Fong General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University of Singapore	Ng Teng Fong General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shared decision making	This outcome will be measured using an audio recording of the clinic session. Audio recording will be transcribed and scored with Observer OPTION 5 to assess shared decision-making of medications in the clinic. The OPTION 5 measure contains 5 items that are scored by 2 independent raters to provide a score between 0 and 100. A higher score indicates a greater extent to which clinicians involve patients in shared decision making.	Day 1 (Clinic session)
Secondary	Decisional conflict	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.	Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Secondary	Decision satisfaction	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.	Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Secondary	Decision regret	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.	Day 180 (Follow-up appointment)
Secondary	Prescribed medication agreement with preferred medication	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.	Day 1 (Immediately after clinic session)
Secondary	Health-related quality of life	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.	Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Secondary	Financial toxicity	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.	Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Secondary	Readmission rate	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.	Day 180 (Follow-up appointment)
Secondary	Heart Failure symptoms and Adverse drug reactions	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.	Day 180 (Follow-up appointment)
Secondary	Medication Adherence	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.	Day 180 (Follow-up appointment)