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临床试验/CTRI/2024/02/062519
CTRI/2024/02/062519进行中(未招募)不适用

ICU Survivors Follow up: Post Intensive Care Syndrome (PICS) Burden on Critical Care Unit and Family.

未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月17日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
To assess the psychological and physical burden of PICS on family.

研究概览

简要总结

Intensive care unit (ICU) survivors often face a myriad of physical, psychological, and cognitive challenges, collectively known as post-intensive care syndrome (PICS). This complex condition not only impacts the individual patient but also extends to their families, known as PICS-F and exerts a significant burden on the critical care unit during post-discharge care, which plays a crucial role in managing the long-term consequences of critical illness and improving patient outcomes. Understanding the burden of PICS on both the ICU and the family is essential for developing effective interventions and optimizing post-ICU follow-up strategies.

Family members of the consecutive patients who are discharged from the ICU, are to be studied on, after considering the following inclusion and exclusion criteria:

Inclusion criteria:

Family members of:

a.      a. Patients who are discharged from ICU with Cerebral Performance Category Scale Score (CPCSS) less than or equals to 4.

b.     b. Patients who are 18-65 years old.

Exclusion criteria: (any of the following)

Family members:

a. Of terminally ill patients discharged for home comfort care.

b.     b. Of patients who are not capable of following up due to socioeconomic or manpower related issues.

c.      c. Of patients with ICU stay less than 7 days.

d.     d. Of patients with pre-illness CPCSS more than or equals to 3.

e.      e. Who are unable to comprehend the ‘Expenditure chart’.

f.      f. Of patients who are Discharged Against Medical Advice or transferred to another institution.

g.     g. Of patients with more than 1 time readmission in CCM during the same course of illness.

Duration of study: 1 year 6 months.

Work plan:

After discharge from hospital, the ICU survivors will be asked to follow up in the CCM department at least once after 1 month and once after 2-3 months. The family members will be counselled regarding the possible post hospital course as well as they will be explained about the purpose of the study. They will be provided with an ‘expenditure chart’, a specially made chart exclusive for this study, to keep track of their expenses during the follow up period. The most important family member will also be interviewed during the final follow up visit for assessment of physical and psychological impact of PICS-F by Health Related Quality of Life (HRQoL-14) Questionnaire originally formulated by Centre of Disease Control (CDC). Thus, the physical, psychological and economical burden of PICS on family (PICS-F) will be holistically viewed. The PICS-F, thus understood, will be stacked against the disability of the ICU survivors in terms of CPCSS and Clinical Frailty Score (CFS) and compared. During the follow up, the patients will be attended to their proper needs and the time and manpower utilisation from CCM department, SGPGIMS during individual follow up visit will be documented as a novel index specially formulated for this study, named the ‘man-time index’, which should reflect the burden of ICU survivors on the critical care unit.

Ethical issues:

This is an observational study which involves the follow up visits of the ICU survivors after discharge. This will not affect the routine post discharge care of the patient. The logistic problems faced by the families of following up to a particular critical care unit are unavoidable, mostly because of the distances between their residence and the critical care unit are significant. This is nullified by encouraging the family to synchronise the multi-disciplinary follow up visits to a single day as ICU survivors often has multi-disciplinary issues for which follow up visits to respective disciplines are required. There are no obvious ethical issues and interventions are planned based on this data. Informed consent is taken for each inclusion.

Statistical Analysis:

As there is no adequate literature available to guide this study, this study can be considered to be a pilot study. Statistical analysis to be performed using software “Statistical package for social sciences version 23 (SPSS-23) and MedCalc.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Family members of: a.
  • Patients who are discharged from ICU with Cerebral Performance Category Scale Score (CPCSS) less than or equals to
  • Patients who are 18-65 years old.

排除标准

  • (any of the following) Family members: a.
  • Of terminally ill patients discharged for home comfort care.
  • Of patients who are not capable of following up due to socioeconomic or manpower related issues.
  • Of patients with ICU stay less than 7 days.
  • Of patients with pre-illness CPCSS more than or equals to
  • Who are unable to comprehend the ‘Expenditure chart’.
  • Of patients who are Discharged Against Medical Advice or transferred to another institution.
  • Of patients with more than 1 time readmission in CCM during the same course of illness.

结局指标

主要结局

To assess the psychological and physical burden of PICS on family.

时间窗: 2-3 months after discharge from hospital.

次要结局

  • 1. To assess the financial burden of PICS on the family.(2. To assess the burden of ICU survivors on department of Critical Care Medicine, SGPGIMS, Lucknow.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Banani Poddar

Sanjay Gandhi Post Graduate Institute Of Medical Sciences

研究点 (1)

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