A Prospective, Mixed-Methods Feasibility Study to Evaluate the Agreement, Safety, and Acceptability of 'Dora Care', an Automated AI Voice Assistant, for Supporting Clinical Pathways in a Fracture Liaison Service.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 217
- 主要终点
- Agreement (concordance) between Dora Care and clinician-collected data (Intake and Follow-up)
研究概览
简要总结
What is the study about? This study is testing "Dora", an AI-powered assistant that can make phone calls to patients, for use in the Fracture Liaison Service (FLS). The FLS is a clinic that helps prevent more bone fractures after an initial "fragility fracture" (a break that happens easily, usually due to osteoporosis).
Why is this being done? FLS clinicians often have to spend a lot of time on routine phone calls for assessments and follow-ups. If Dora can safely and accurately collect patient information, it might save time for staff and still give patients a good experience.
What will happen to patients in the study? Invitation and consent - Patients with a new fragility fracture who are eligible will be invited to take part after informed consent.
Dora call - Patients will receive an automated phone call from Dora, at the start of their FLS pathway and at follow-up.
At intake, Dora will ask about risk factors for bone problems (e.g., smoking, alcohol use, family fracture history).
At follow-up, Dora will ask about medication use, side effects, falls, or new fractures.
Clinician call - Soon after, patients will have their usual phone appointment with an FLS clinician, who asks similar questions.
Surveys/interviews - Patients will be asked to complete a short questionnaire and take part in an optional interview to say how they felt about talking to Dora.
What about clinicians? Clinicians involved in the FLS pathway will be asked to complete a short survey and to take part in an optional interview to understand how useful Dora's reports might be in their work.
Who can take part? Patients - Age 50+, English-speaking, with a new fragility fracture, and able to use the phone.
Clinicians - Those working in FLS or similar bone health services. How long will it take? Each patient might be involved for up to about 7 months. The whole study will take about a year.
详细描述
Fragility fractures are common and are associated with substantial morbidity, mortality, and healthcare costs. Fracture Liaison Services (FLS) are internationally recognised as an effective model for secondary fracture prevention; however, FLS pathways can be resource-intensive and place a significant burden on clinical staff, particularly for standardised intake risk assessment and longer-term follow-up conversations related to medication adherence, side effects, and interval clinical events.
Dora Care is a cloud-based, standalone software product that delivers automated natural-language telephone calls to patients using an AI voice assistant. Dora Care can be configured to conduct structured clinical or administrative conversations where a validated protocol exists and returns a structured summary of the interaction for healthcare teams to review. Dora Care is not intended for clinical diagnosis and, in this study, is used as an adjunct to standard Fracture Liaison Service care rather than a replacement for clinician review.
This prospective, mixed-methods feasibility study evaluates whether Dora Care can support elements of the FLS pathway by assessing agreement between patient-reported information collected by Dora Care and information collected by an FLS clinician during routine care, evaluating safety when Dora Care is deployed in this context, and exploring acceptability and usability for both patients and clinicians.
Study design and setting This is a prospective, single-arm feasibility study conducted in NHS hospital-based Fracture Liaison Services, initially at University College London Hospitals NHS Foundation Trust, with additional potential recruitment sites. All patient participants receive a Dora Care telephone call in addition to their routine FLS telephone consultation.
The study includes two linked components:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Access to and ability to use a telephone for automated conversations as part of a routine, FLS phone pathway. This includes patients who are:
- •Adults aged ≥50 years.
- •Presenting with a new fragility fracture requiring FLS assessment.
- •Able to provide informed consent.
- •English speaking.
- •Reside in the UK.
排除标准
- •Severe cognitive impairment precluding meaningful telephone interaction or informed consent.
- •Patients already established on long-term osteoporosis treatment.
- •Terminal illness with a life expectancy <12 months.
- •Current participation in another clinical trial altering standard of care thus altering the care schedule.
研究组 & 干预措施
Patient population receiving Dora call
Patient participant will receive a Dora call in addition to their standard care clinical appointment call
干预措施: Dora call (Device)
结局指标
主要结局
Agreement (concordance) between Dora Care and clinician-collected data (Intake and Follow-up)
时间窗: Intake assessment and Follow-up assessment (planned at 16 weeks)
Concordance for predefined variables collected by Dora Care versus those routinely collected by an FLS clinician during baseline care consultation (slot-level agreement; categorical variables via % agreement and Cohen's kappa; continuous variables via ICC and/or Bland-Altman).
次要结局
- Medication adherence rate(16 week follow up where available)
- Incidence of patient-reported medication side effects(16 weeks and 24 weeks)
- Incidence of new fragility fractures(16 weeks and 24 weeks)
- Incidence of patient-reported falls(16 weeks and 24 weeks)
- Patient satisfaction scores with Dora Care (adapted Client Satisfaction Questionnaire)(Baseline (intake assessment), 16 weeks, and 24 weeks)
- Patient usability scores (System Usability Scale)(Baseline (intake assessment), 16 weeks and 24 weeks)
- Qualitative themes from patient interviews on experience and acceptability of Dora Care(Through study completion, an average of 12 months)
- Clinician usability scores (System Usability Scale)(Through study completion, an average of 12 months)
- Clinician experience themes (qualitative interviews)(Through study completion, an average of 12 months)