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| Name | Class |
|---|---|
| Ng Teng Fong General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Usual care | No Intervention | Patients are managed as per usual clinical routine without the decision aid. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hwee Lin Wee, PhD | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ng Teng Fong General Hospital | Singapore | 609606 | Singapore |
De-identified data will be made available for sharing upon request.
Supporting information and IPD will be made available after publication of trial results
Data will be made available for sharing upon request, after execution of a data sharing agreement.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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This study incorporates a prospective single centre, two arms parallel randomised controlled trial with 1:1 patient allocation.
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Only participants are masked to the randomization allocation.
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| Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment) |
| 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) |
| 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) |
| 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) |
| 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 level sum score that ranges from 5 to 25 with 25 being the worst health and 5 being perfect health. | Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment) |
| 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) |
| 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) |
| 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) |
| 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) |