Preferred Method of Postoperative Follow Up After Pelvic Reconstructive Surgery. (Phone Call Versus Clinic Visit): A Non-Inferiority Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Patient Satisfaction (questionnaire)
研究概览
简要总结
A randomized controlled trial that will evaluate whether telephone two-week postoperative follow up visits are an acceptable and safe alternative to traditional face-to-face-clinic two-week postoperative visits.
详细描述
This is a two group, parallel randomized non-inferiority clinical trial at one institution evaluating telephone postoperative visits as non-inferior in patient satisfaction, patient preference, and patient safety, when compared with clinic postoperative visits. This protocol was written in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines 2011.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women >18 desiring surgical management of prolapse or incontinence
- •English speaking
- •Willing and able to provide written and informed consent without assistance from medical surrogate or interpreter
- •Immediate access to telephone services (landline, mobile phone, office phone)
排除标准
- •Women <18
- •Non-English speaking
- •Unwilling and unable to provide written and informed consent without assistance from surrogate or interpreter
- •Hearing impairment
- •No access to telephone services (landline, mobile phone, office phone)
- •Grade 3 complication- a complication requiring surgical, endoscopic, or radiological intervention. [3]
- •Patient who did not attend any postoperative follow up visit
研究组 & 干预措施
Telephone Group
The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits.
Vital signs and physical examination will be deferred for the patients in the telephone follow up group.
Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes.
干预措施: Telehealth 2 week postoperative visit (Other)
In Person Clinic Visit Group
For the patient randomized into the clinic group, the clinic visit will entail questions about common postoperative complications (including fever, nausea/vomiting, pain, urinary symptoms, constipation, etc.). As per usual, vital signs and a focused physical examination will be completed at the clinic visit. All clinic visits will be performed by an FPRMS fellow and/or attending physician
结局指标
主要结局
Patient Satisfaction (questionnaire)
时间窗: Survey will be provided at the six-week follow up visit.
Comparison of patient satisfaction as determined by completion of a non-validated, treatment non-specific satisfaction questionnaire between the two groups.
次要结局
- Patient safety (adverse events)(Postoperative period up to 6 weeks)
- Time Spent (post op telephone follow up compared to clinic follow up [minutes])(Calculated from time spent at the two week follow up visit)
研究者
Elisha Jackson
Physician-Fellow
Jackson, Elisha