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NOT YET RECRUITING
NCT07909876
NA

A Decision Support Tool for Common Surgical Fixations of Hip Fractures

Sponsor: Taipei Medical University WanFang Hospital

View on ClinicalTrials.gov

Summary

This study aims to improve how patients, families, and healthcare professionals work together to make important medical decisions, especially in cases involving hip fractures. Making treatment decisions after a hip fracture can be challenging, as it often involves weighing different options, risks, and expected outcomes. These decisions are particularly important for older adults, who may have other health conditions or personal priorities that influence their choices. The study builds on previous research showing that Patient Decision Aids (PDAs) are valuable tools in supporting shared decision making (SDM). Shared decision making is a collaborative process in which healthcare providers and patients make decisions together, using both the best available medical evidence and the patient's personal values, preferences, and life circumstances. Rather than simply following a doctor's recommendation, patients are supported in understanding their options and actively participating in decisions about their care. Patient Decision Aids are designed to make complex medical information easier to understand. They present clear, balanced, and structured information about available treatment options, including potential benefits, risks, and uncertainties. Many PDAs also use visual elements such as charts, diagrams, or icons to help users better grasp the information. Research has shown that these tools can improve patients' knowledge about their condition, increase their confidence in making decisions (known as decision self-efficacy), and lead to greater satisfaction with the decisions made. At the same time, PDAs can reduce decisional conflict, which refers to feelings of uncertainty, confusion, or stress when choosing between options. These benefits have been particularly evident in older populations and in decisions related to surgeries, such as joint replacement. Despite these advantages, there is currently a lack of decision aids specifically designed for hip fracture-related decisions. Hip fractures are a common and serious health issue, especially among older adults, and they often require timely decisions about whether to undergo surgery, what type of surgery to choose, and how to manage recovery. This study seeks to address this gap by developing and evaluating a PDA tailored specifically for hip fracture treatment decisions. The main objective of this study is to assess the usability of this newly developed decision aid. Usability refers to how easy the tool is to use, how clear and understandable the information is, and how helpful it is in supporting decision making. The PDA developed in this study combines clinical evidence with individual patient preferences and presents the information in a visual and user-friendly format. Its goal is to help patients, their families, and healthcare professionals make decisions that are consistent with what matters most to the patient. Importantly, this study does not involve real medical treatment or interventions. Instead, it uses simulated scenarios in which participants are asked to imagine themselves or a loved one facing a hip fracture and needing to make treatment decisions. Because the study is based on simulation, there are no physical or medical risks involved. The research is designed as an online randomized controlled trial with a parallel-group and pre-test/post-test structure. A total of 450 participants will be recruited. Eligible participants include individuals aged 20 and above who have experienced a hip fracture, have a family member who has experienced one, or belong to a group at higher risk of hip fractures. Participation in the study is entirely voluntary. Participants have full freedom to decide whether to join and can withdraw from the study at any time without any consequences. Their participation or non-participation will not affect their medical care in any way. At the beginning of the study, participants will complete a pre-test questionnaire to assess their baseline knowledge, confidence, and perceptions related to decision making. They will then be randomly assigned to one of two groups: an intervention group that uses the hip fracture decision aid, or a control group that does not use the tool. Participants will then take part in a simulated decision-making activity, which is expected to take about 30 to 60 minutes. After completing the scenario, they will fill out a post-test questionnaire. All data collected during the study will be handled digitally and securely. Personal information will be removed so that participants cannot be identified, ensuring privacy and confidentiality. The researchers will analyze the data using appropriate statistical methods, depending on the type and distribution of the data collected. They will compare the two groups to evaluate differences in key outcomes, including knowledge about hip fracture treatment, confidence in decision making, level of decisional conflict, and satisfaction

Official title: A Randomized Controlled Trial on A Decision Support Tool for Common Surgical Fixations of Hip Fractures

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2026-12-01

Completion Date

2027-11-30

Last Updated

2026-11-02

Healthy Volunteers

Yes

Interventions

OTHER

IDeA for Hip Fracture

In the IDeA group, participants are provided with the Integrated Decision Aid (IDeA), featuring digital educational materials and an interactive decision tool presented across two panel pages. The educational content encompasses fundamental information, benefits, risks, and costs of two fixation options, ensuring uniformity between the two groups. The decision tool in the IDeA group employs Multiple-criteria decision-making method, enabling participants to select relevant considerations and assign weights to aid in decision making.

OTHER

Non-IDeA for hip fracture

In the Non-IDeA group, participants will receive digital educational materials and straightforward decision questions within two panel pages. The educational content encompasses fundamental information, benefits, risks, and costs of two fixation options, ensuring uniformity between the two groups. The Non-IDeA group is presented with simple decision questions on the second panel page, utilizing a 10-point Likert scale for responses.