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临床试验/NCT03707392
NCT03707392Unknown3 期

Quality Outcomes of Ostomy Teaching: A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching

University of Southern California1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2018年7月17日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
74
试验地点
1
主要终点
Delay in hospital discharge

研究概览

简要总结

Adult patients without prior history of ostomy, undergoing elective surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative and postoperative stoma care teaching video. Post operative outcomes including delay in discharge and stoma-related complications will be tracked.

详细描述

Adult patients without prior history of ostomy, undergoing surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative and postoperative stoma care teaching video. Patients will be consented and randomized at the time of preoperative clinic visit. All patients will receive standard preoperative ostomy teaching materials and education from the surgeon and clinic nurse. Patients randomized to the treatment arm will receive additional take-home teaching materials based on the American College of Surgeons Ostomy Teaching videos.

After post-operative inpatient ostomy-nurse teaching, and prior to discharge from the hospital, patients will fill out a survey detailing their level of comfort with various aspects of ostomy home care. Patients in the treatment arm will be be asked to review the ostomy teaching videos and fill out the survey prior to discharge. Primary outcome will be delay in discharge from hospital due to stoma-teaching related issues. Secondary outcomes will include rate of calls to the clinic for stoma-related questions, stoma-related clinic/urgent care/emergency department visits, and stoma-related complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
是

入选标准

  • •adults over 18 yrs of age
  • •undergoing elective surgery including plan for ileostomy or colostomy

排除标准

  • •patients unable or unwilling to provide informed consent for any reason, including patients with inadequate capacity for decision making.
  • •Patients undergoing emergent surgery
  • •Vulnerable populations such as prison and psychiatric ward patients
  • •Patients who for any reason do not undergo construction of pre-operatively planned stoma
  • •Patients with history of previous stoma creation
  • •Patients who are not their own primary caregivers will also be excluded, including those patients who are planned to be discharged to care facility or nursing facility

研究组 & 干预措施

Control

Active Comparator

Standard preoperative and postoperative stoma teaching including ostomy nurse teaching and educational materials

干预措施: Control - Standard ostomy education (Other)

Treatment

Experimental

Ostomy care educational video combined with standard preoperative and postoperative stoma teaching including ostomy nurse teaching and educational materials

干预措施: Ostomy Education Video (Other)

结局指标

主要结局

Delay in hospital discharge

时间窗: through initial inpatient hospital stay: an average of 5 days

Delay in hospital discharge due to need for additional ostomy teaching

次要结局

  • Phone Calls(within 60 days of discharge)
  • Length of stay(through initial inpatient hospital stay: an average of 5 days)
  • Clinic/Urgent Care/Emergency Department visits(within 60 days of discharge)
  • Hospital Readmission(within 30 days, and within 30-60 days postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sang Won Lee

Professor of Clinical Surgery, Chief, Division of Colorectal Surgery

University of Southern California

研究点 (1)

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