Patient Reported Outcomes From Patients Seen in Virtual Phone Visits Compared to In-Person Physical Visits for Post-Operative Follow-Up at a Sports Medicine Clinic: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- PROMIS Physical and Mental Scores
研究概览
简要总结
This study will compare patient reported outcomes (PROs) of patients seen at virtual phone visits compared to in-person visits for 6 weeks, 12 weeks, and 6 months post-operative follow up at a sports medicine clinic. This study will determine if there is a difference in PROs between these two groups of patients. The investigators hypothesize patients who are seen during a virtual phone visit will report different PRO compared to patients who are seen during an in-person visit for post-operative follow-up at 6-months.
详细描述
In this prospective study, the investigators will enroll patients undergoing operative intervention at a Sports Medicine clinic.
The patient will arrive at a pre-operative clinic appointment, surgery, or 2 week post-operative appointment to sign the consent form in the presence of study team member and a witness in order to be eligible to participate in the study.
After consent is obtained, the Participant will be randomized to either in-person follow up or virtual phone follow up to take place after the 2-week post-op visit.
The randomization process will utilize block randomization and be conducted by an online program called http://www.randomization.com. The Participant will be assigned a number based on the order the Participant is enrolled in the study and that number will be randomly assigned to a follow-up group based on that number.
The Participant will be notified at the 2-week post-op or after if they will receive will in-person follow up or virtual phone follow-up. If the Participant in the virtual phone group feel they need an in-person visit, the Participant will be free to make an in-person follow-up. After each follow up visit (6-week, 12-week, and 6-month), the Participant will be asked to fill out 30-minute surveys.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are at least 18 years of age.
- •Participants who are seen at Harbor-UCLA Medical Center sports medicine clinic.
- •Participants have agreed to have operative intervention.
- •Participants must own a phone with reliable calling capabilities.
- •The Participants must have access to reliable internet to fill out the online survey.
- •The Participants must be able to provide consent.
- •Participants may include pregnant patients.
排除标准
- •Patients that are under the age of 18
- •any cognitive impaired adult
- •any adult unable to provide consent.
结局指标
主要结局
PROMIS Physical and Mental Scores
时间窗: 6 month post-operative visit
Patient-Reported Outcomes Measurement Information System (PROMIS) GLOBAL Survey is divided into PROMIS Physical and PROMIS Mental. Minimum score 16.2, Maximum Score 67.2 for PROMIS Physical. Minimum score 21.2, Maximum score 67.6 for PROMIS Mental. Higher score means better outcome.
次要结局
- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement(6 month post-operative visit)
- Oxford Shoulder Score(6 month post-operative visit)
- Patient Satisfaction Scores(6 month post-operative visit)
研究者
Jonathan Wu
Researcher
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center