Impact of a Novel Heart Failure Medication Decision Aid

NCT06247371 | Completed

• 1 other identifier: 2023/00772
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Randomised controlled trial; Decision aid; Heart failure

Outcome Measures

Primary Outcomes (1)

• Frequency of Medication cost discussion

  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.

  Day 1 (Clinic session)

Secondary Outcomes (9)

• Decisional conflict

  Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)

• Decision satisfaction

  Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)

• Decision regret

  Day 180 (Follow-up appointment)

• Prescribed medication agreement with preferred medication

  Day 1 (Immediately after clinic session)

• Health-related quality of life

  Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)

Study Arms (2)

Decision aid

EXPERIMENTAL

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.

Behavioral: Decision aid

Usual care

NO INTERVENTION

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

Interventions

Decision aid BEHAVIORAL

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.

Decision aid

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead
• Ng Teng Fong General Hospital: collaborator

Study Sites (1)

Ng Teng Fong General Hospital

Singapore, 609606, Singapore

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Hwee Lin Wee, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participants are masked to the randomization allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: This study incorporates a prospective single centre, two arms parallel randomised controlled trial with 1:1 patient allocation.

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 7, 2024
• Study Start: April 9, 2024
• Primary Completion: July 25, 2024
• Study Completion: February 10, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Supporting information and IPD will be made available after publication of trial results
• Access Criteria: Data will be made available for sharing upon request, after execution of a data sharing agreement.

Locations

SG (1)