跳至主要内容
临床试验/NCT06752031
NCT06752031招募中不适用

Optimization of Care and Recovery in Older Colorectal Surgery Patients: A Hybrid Effectiveness-Implementation Pilot Study Protocol

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Postdischarge 30-day readmission or death

研究概览

简要总结

The goal of this study to test if a care transition intervention designed for older colorectal surgery patients would improve outcomes after discharge. It will assess the feasibility of the intervention.

详细描述

The period following discharge poses particularly high risks for older colorectal surgery patients. Nearly a quarter of these patients are readmitted within a month of discharge due to a variety of issues including medication errors, surgical complications, imbalance in fluid or nutrition, or worsening of pre-existing chronic diseases.Recognizing the complex interplay of these factors, it isa more comprehensive approach is imperative to improve post- operative patient care. Geriatrics co-management programs incorporate interdisciplinary patient management approaches and geriatric principles to improve outcomes in older surgical patients.The OSCAR program is an integrated care model developed by geriatricians in collaboration with colorectal surgeons that combines geriatrics co-management with postoperative surgical care for older colorectal surgery patients. The care transition intervention (CTI) is a well-established care transition model that focuses on four domains at discharge: 1) medication self-management, 2) the personal health record, 3) timely primary care/specialty care follow-up, and 4) knowledge of red flags that indicate a worsening in condition. CTI involves interactions with a trained transition coach, both in-person visits and phone calls over four weeks. In this study, the goal is to bridge the gap between inpatient and post-discharge phases and mitigate the risk of hospital readmissions through adaptation and combination of the core components of a geriatric surgery core co-management (OSCAR) program with the core components of a care transition (CTI) program by applying an implementation research approach. By customizing OSCAR co-management model with the CTI intervention model, the investigators will leverage their strengths and, efficiently address the unique requirements of both patients and the healthcare environment. The investigators will conduct a pilot feasibility hybrid type I implementation effectiveness trial of OSCAR-S.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients (>65 years old)
  • •Scheduled to undergo an elective colorectal surgery procedure
  • •Ability to provide informed consent

排除标准

  • •Emergent, non-elective colorectal procedures
  • •Non-English Speaking

研究组 & 干预措施

OSCAR-S Care Transition Model

Experimental

The surgery nurse coach within the OSCAR-S model will provide touch points to patients and families to support their transition from hospital to home after surgery.

干预措施: OSCAR-S Care Transition Model (Behavioral)

结局指标

主要结局

Postdischarge 30-day readmission or death

时间窗: 30 days

Composite incidence of all-cause hospital readmission or death within 30 days of discharge, measured by medical record review and hospital administrative data.

次要结局

  • Reach(12 months)
  • Fidelity(12 months)
  • Adoption(12 months)
  • Effectiveness - Postoperative Complications(30 days)
  • Effectiveness - Patient Satisfaction(30 days)

研究者

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

Sevdenur Cizginer Konuk, MD, MPH

Principal Investigator

Massachusetts General Hospital

研究点 (1)

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