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Hip Fracture SurgeriesNCT07909876

A Decision Support Tool for Common Surgical Fixations of Hip Fractures

A study testing IDeA for Hip Fracture and Non-IDeA for hip fracture in people with Hip Fracture Surgeries and High Risk Population of Hip Fractures, run by Taipei Medical University WanFang Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
What is being tested?
IDeA for Hip Fracture and Non-IDeA for hip fracture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
No sites listed yet
Study dates
1 Dec 2026to 30 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults (age 20 and over) with a confirmed history of hip fracture.
  • Individuals who have a family member with a history of hip fracture (potential proxy decision-makers for hip fracture treatment).
  • Individuals in a high-risk group (age 60 and over and receiving anti-osteoporosis medication).

Who cannot join

  • Individuals with no capacity for or restricted capacity for independent action.
  • Individuals with a cognitive impairment.
  • Individuals with a history of mental illness, such as depression.

About this study

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

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.

Read more

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

Read the detailed description

This study draws upon multiple systematic reviews and meta-analyses to affirm that Patient Decision Aids (PDAs) play a critical role in shared decision making (SDM). PDAs have been shown to enhance medical knowledge, decision self-efficacy, and decision satisfaction while reducing decisional conflict, with particularly notable benefits in geriatric care and joint surgery. However, there remains a lack of decision aids specifically addressing hip fracture-related decisions, and this study aims to fill that gap. The objective of this study is to evaluate the usability of a PDA developed for surgical decision-making in hip fracture cases. This PDA integrates patient preferences with clinical evidence and presents the information through visual formats to support patients, families, and healthcare professionals in making value-congruent medical decisions. As the study involves tool testing, it is conducted through simulated scenarios without actual clinical intervention or risk. The research design is an online randomized parallel-group pre-post controlled trial. Participants include individuals aged 20 and above who have either experienced a hip fracture, are family members of such patients, or belong to high-risk populations. The target sample size is 450 participants. Participation is entirely voluntary, with full autonomy to join or withdraw at any time, and participation does not impact clinical care. After completing the pre-test questionnaire, participants will be randomly assigned to either the intervention group or the control group, undergoing a 30-60 minute simulated decision-making scenario, followed by a post-test questionnaire. Data collection and analysis will be fully digital and de-identified. Depending on the data characteristics, appropriate statistical tests will be prioritized to analyze differences in outcomes such as knowledge, self-efficacy, decisional conflict, and satisfaction. The ultimate goal of this study is to optimize the decision aid tool, promote patient-centered medical practice, and lay the groundwork for its future application in real-world clinical decision-making.

Being tested
IDeA for Hip Fracture, Non-IDeA for hip fracture
Keywords
Shared decision making, Geriatric surgical decision-making, Patient decision aid, Integrated decision aid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDeA for Hip FractureOther

    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.

  • Non-IDeA for hip fractureOther

    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.

Study groups in NCT07909876
Study groupRoleWhat they receive
Non-IDeAOtherThe Non-IDeA group serves control group with online health education materials regarding hip fracture interventions without interactive weighted decision support.
Receives: Other: Non-IDeA for hip fracture
IDeAExperimentalThe IDeA group serves experimental group with online health education materials regarding hip fracture interventions and an interactive weighted decision tool.
Receives: Other: IDeA for Hip Fracture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knowledge of hip fracture surgery

    Five self-developed true and false questions regarding hip fracture surgeries. The minimum and maximum values are 0 and 5. Higher scores mean a better knowledge on hip fracture surgery.

    Measured: From enrollment at baseline to one hour after treatment.

  2. Decision self-efficacy

    Decision self-efficacy will be measured using the Decision Self-Efficacy Scale (DSES) by Bunn H. and O'Connor A. (1996). The minimum and maximum values of the DSES are 0 and 44. Higher scores mean a stronger self-efficacy in making decision.

    Measured: From enrollment at baseline to one hour after treatment.

  3. Decisional conflict

    Decisional conflict will be measured using the SURE scale that consists of four yes/no questions based on the Decisional Conflict Scale (DCS) by Ferron Parayre, A., Labrecque, M., Rousseau, M., Turcotte, S., \& Légaré, F. (2014). The minimum and maximum values of SURE are 0 and 4. Higher scores mean a lower decisional conflict.

    Measured: From enrollment at baseline to one hour after treatment.

  4. Decisional satisfaction

    Decisional satisfaction will be measured using the Satisfaction with Decision (SWD) scale by Holmes-Rovner et al. (1996) and Wills \& Holmes-Rovner (2003). The minimum and maximum values of the SWD are 6 and 30. Higher scores mean a higher satisfaction in decision making.

    Measured: From enrollment at baseline to one hour after treatment.

Secondary outcomes (3)
  1. Style of decisional control

    Style of decisional control will be measured using the Control Preferences Scale (CPS) by Degner, L. F., Sloan, J. A., \& Venkatesh, P. (1997). The CPS is a categorical scale for different style of control preference without minimum or maximum values.

    Measured: From enrollment at baseline to one hour after treatment.

  2. Perceives in AI

    Perceives in AI will be measured using the tool that has been introduced in the AMAILED model by Kang, E., Chen, D., \& Chen, Y. (2022). This tool consists of two parts: trust and perceived usefulness of AI. The minimum and maximum values of perceives in AI are 7 and 35. Higher scores mean a higher trust or perceived usefulness of AI.

    Measured: One hour after treatment.

  3. Intention to use AI

    Intention to use AI will be measured using the tool that has been introduced in the AMAILED model by Kang, E., Chen, D., \& Chen, Y. (2022). The minimum and maximum values are 3 and 15. Higher scores mean a higher intention to use AI.

    Measured: One hour after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07909876
Sponsor's protocol ID
N202510053
Status last verified
Oct 2026
First submitted
18 Oct 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ferron Parayre A, Labrecque M, Rousseau M, Turcotte S, Legare F. Validation of SURE, a four-item clinical checklist for detecting decisional conflict in patients. Med Decis Making. 2014 Jan;34(1):54-62. doi: 10.1177/0272989X13491463. Epub 2013 Jun 17.

    PubMed 23776141
  • Bunn H, O'Connor A. Validation of client decision-making instruments in the context of psychiatry. Can J Nurs Res. 1996 Fall;28(3):13-27.

    PubMed 8997937
  • Wills CE, Holmes-Rovner M. Preliminary validation of the Satisfaction With Decision scale with depressed primary care patients. Health Expect. 2003 Jun;6(2):149-59. doi: 10.1046/j.1369-6513.2003.00220.x.

    PubMed 12752743
  • Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114.

    PubMed 8717600
  • Kang, E., Chen, D., & Chen, Y. (2022). Associations between literacy and attitudes toward artificial intelligence-assisted medical consultations: The mediating role of perceived distrust and efficiency of artificial intelligence. Comput. Hum. Behav., 139, 107529.

  • Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.

    PubMed 9505581

Questions about this trial

What is this clinical trial studying?

A study testing IDeA for Hip Fracture and Non-IDeA for hip fracture in people with Hip Fracture Surgeries and High Risk Population of Hip Fractures, run by Taipei Medical University WanFang Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge of hip fracture surgery (time frame: From enrollment at baseline to one hour after treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07909876, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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