Development and Evaluation of a Personalized Discharge Letter for Low-risk Skin Cancer Patients After Dermatological Screening.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Level of Reassurance Immediately Post-Consultation
研究概览
简要总结
Current clinical practices often provide general verbal advice to low-risk patients, which may not sufficiently address individual concerns or offer actionable steps. Generic information on the internet can be overwhelming or unreliable, leading to confusion and unnecessary follow-up visits.
This project introduces a tailored approach by combining evidence-based guidelines with personalized details about the patient's risk profile. The discharge letter bridges the gap between clinical expertise and patient understanding, offering clear, specific, and actionable advice that has been shown to improve health behaviors and outcomes in other contexts .
The personalized discharge letters are generated using an AI agent trained on validated letters from the hospital's electronic health record system (KWS). Each letter is reviewed and approved by a physician before being provided to the patient, ensuring both accuracy and clinical relevance.
详细描述
This study is a prospective, parallel-group, open-label, randomized controlled trial designed to evaluate the impact of a personalized discharge letter-with or without digital visual support -on reassurance, knowledge, and self-management in low-risk skin cancer patients following dermatological screening.
Study Arms: Participants will be randomly assigned to one of three groups:
- Group A - Standard of Care: Verbal information only.
- Group B - Personalized Discharge Letter: Tailored written information based on individual risk profile, skin type and consultation findings.
- Group C - Personalized Discharge Letter + digital visual support: Tailored written information plus digital visual support (e.g. annotated images, visual summaries).
Scientific Rationale Current discharge practices for low-risk skin cancer patients often rely on general verbal advice, which may not sufficiently address individual concerns or promote long-term self-care. Evidence from other medical domains suggests that personalized communication improves patient understanding, satisfaction, and adherence to follow-up recommendations.
This study introduces an AI agent trained on validated discharge letters from the hospital's electronic health record system (KWS). The AI helpt collect information from the electronic health record that is relevant for creating personalized letters that are reviewed by a physician before being provided to the patient. These letters aim to improve understanding of personal skin cancer risk, sun protection, and self-monitoring practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •Low-risk skin cancer patients:
- •Negative personal history for melanoma
- •Less than 100 naevi
- •Less than 5 clinically atypical naevi
- •Maximum 1 BCC in history
- •Maximum 1 SCC, and at least 5 years ago
- •AK: treated and controlled with clinical response
- •M Bowen: treated and controlled with clinical response
- •Adult subjects (between 18 years of age and 80 years) at time of enrolment
排除标准
- •Presence of dermatological lesions requiring immediate treatment at the time of consultation.
- •History of solid organ transplantation (Organ Transplant Recipient, OTR).
- •Known carriers or suspected carriers (based on family history) of germline mutations associated with increased skin cancer risk (e.g. CDKN2A, PTCH1, XP genes).
- •Failure to meet one or more of the inclusion criteria.
- •Any condition or comorbidity that, in the opinion of the investigator, may interfere with study participation or data interpretation (e.g. severe cognitive impairment, language barrier).
- •Participation in another interventional clinical trial that may interfere with the outcomes of this study.
研究组 & 干预措施
Group A: Standard of Care
Verbal information only.
干预措施: Verbal information only (Behavioral)
Group B: Personalized Discharge Letter
Tailored written information based on individual risk profile, skin type and consultation findings.
干预措施: Personalized Discharge Letter (Behavioral)
Group C: Personalized Discharge Letter + Digital Visual Support (IntelliStudio)
Tailored written information plus digital visual support (e.g. annotated images, visual summaries).
干预措施: Personalized Discharge Letter + IntelliStudio (Behavioral)
结局指标
主要结局
Level of Reassurance Immediately Post-Consultation
时间窗: Through study completion, an average of 1 year
Measured via a questionnaire. Hypothesis: Patients in the IntelliStudio group will report the highest levels of reassurance.
Knowledge of Personal Skin Cancer Risk
时间窗: Through study completion, an average of 1 year
Assessed through a pre- and post-intervention knowledge questionnaire. Hypothesis: Personalized information (Groups B and C) improves risk awareness compared to standard care.
Confidence in Performing Self-Skin Checks
时间窗: Through study completion, an average of 1 year
Measured via self-reported confidence and frequency of self-checks. Hypothesis: Groups B and C will report higher confidence than Group A.
次要结局
未报告次要终点