System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program (SWIFT)
研究概览
详细说明
At the start of the study, inpatient and outpatient nurses, physicians and physicians assistants will be oriented to the intervention in the study and will be suggested that the intervention is standard of care based on the following study:
Nagle D, Pare T, Keenen E, Marcet K, Tizio S, Poylin V*. Ileostomy Pathway Virtually Eliminates Readmissions for Dehydration in New Ostomates. Diseases of the Colon and Rectum 2012; 55: 1266-1272.
The intervention patients will be subject to a compliance surveillance and intervention strategy (CSIS) administered by study personnel to encourage the following and persist with telephone calls if the following have not been achieved.
- Prospective audits by study personnel to check and encourage teaching in the clinic, teaching on the wards, and telephone follow up occurred.
- A self-assessment tool for patients and families to confirm understanding of the education materials.
- Coaching of inpatient nurses taking care of ileostomy patients by WOCN and/or the inpatient nurse champion
- Call from the clinic nurse practitioner or physician's assistant within 7 days of discharge to review the educational materials and administer a screening questionnaire to identify patients at risk of dehydration. In patients randomized to CSIS, study personnel will ensure this phone call is made.
The usual care arm will include no such surveillance.
The randomized study will be powered to detect a decrease in hospital readmission rates (all-cause) from 25% to 5%. Secondary outcomes include readmission due to dehydration and patient satisfaction (Surgical-CAHPS survey)
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Minnesota
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Minneapolis、Minnesota、美国、55455
- University of Minnesota Medical Center -Fairview
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Saint Paul、Minnesota、美国、55114
- Colon and Rectal Surgery Associates
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients who are scheduled or who undergo ileostomy alone or as part of a multiple procedure operation
- patients who have had an ileostomy in the past are eligible
- patients who have an ileostomy to address a recent surgical complication are eligible
Exclusion Criteria:
- Patients who have an ileostomy already in place immediately prior to the procedure (ie. revision, transposition, or parastomal hernia procedures
- patients on dialysis
- patients who require chronic TPN, IVF, or have short gut
- non-English speaking patients who do not have easy access to an appropriate interpreter.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:compliance surveillance
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External monitor to ensure compliance with an educational protocol.
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无干预:Usual Care
educational session at the start of the study
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Readmission to the hospital
大体时间:30 days after hospital discharge
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30 days after hospital discharge
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Patient satisfaction
大体时间:3-6 months after surgery
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S-CAHPS
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3-6 months after surgery
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Index length-of-stay
大体时间:Index length-of-stay
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Time from surgical date to hospital discharge
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Index length-of-stay
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Emergency room visit
大体时间:30 days after hospital discharge
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Emergency room visits for any reason 30 days after surgery
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30 days after hospital discharge
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Total hospital-length-of-stay
大体时间:30 days after hospital discharge
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Total hospital length of stay for any reason after surgery
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30 days after hospital discharge
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Readmission due to dehydration or acute renal failure
大体时间:30 days after hospital discharge
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Dehydration by clinician assessment, acute renal failure defined as elevation in creatinine to >2 mg/dl, or oliguria/anuria
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30 days after hospital discharge
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Post-discharge follow up phone call
大体时间:30 days after hospital discharge
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Nurse, physician, or physician-assistant documentation of phone call to the patient that describes monitoring of ileostomy output volume
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30 days after hospital discharge
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合作者和调查者
调查人员
- 首席研究员:Mary R Kwaan, MD、University of Minnesota
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
compliance surveillance and improvement strategy的临床试验
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Second Affiliated Hospital, School of Medicine,...The First Affiliated Hospital of Nanchang University; Chinese PLA General Hospital; The Affiliated... 和其他合作者招聘中