Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
Study NCT ID:
NCT04186468
Status:
COMPLETED
Last Update Posted:
2022-11-21
First Post:
2019-12-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ICU Follow-up After Prolonged Intensive Care Stay
Sponsor:
Otto-von-Guericke University Magdeburg
Organization:
Study Overview
Official Title:
Piloting an ICU Follow-up Clinic to Improve Health Related Quality of Life After a Prolonged Intensive Care Stay
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PINA
Brief Summary:
Treatment in the intensive care unit (ICU) for more than five days often leads to chronic physical, cognitive and psychological complaints, such as post-traumatic stress disorders, muscle weakness, depression, anxiety and adjustment disorders. This is referred to as Post Intensive Care Syndrome (PICS). So far, there have been only a few studies investigating this syndrome.
The aim of this pilot study is to test the effectiveness and feasibility of an ICU follow-up clinic, which our study team developed in a participatory process involving patients, caregivers, health care providers and researcher.
For this purpose, the participants will be randomly assigned to a group with treatment in this follow-up clinic or to a group with usual care. Both groups will then be compared.
The aim of this pilot study is to test the effectiveness and feasibility of an ICU follow-up clinic, which our study team developed in a participatory process involving patients, caregivers, health care providers and researcher.
For this purpose, the participants will be randomly assigned to a group with treatment in this follow-up clinic or to a group with usual care. Both groups will then be compared.
Detailed Description:
Intensive care unit (ICU) survivors often suffer from cognitive, physical and psychological impairments, known as Post Intensive Care Syndrome (PICS). In order to improve healthcare of these patients in general and medical follow-up in particular, various aftercare models have been developed in different countries, including ICU follow-up clinics. So far, there is no uniform concept for an ICU follow-up clinic. Therefore, there is insufficient evidence whether or which concept of an ICU follow-up clinic is effective in addressing the health needs of ICU survivors. Within our study "Piloting an ICU Follow-up Clinic to Improve Health Related Quality of Life After a Prolonged Intensive Care Stay" (German abbreviation PINA), a concept for an ICU follow-up clinic was developed and will be tested in a pilot randomized controlled trial (RCT).
The study design comprises a pilot RCT with intervention and control (usual care) arms and an additional qualitative and quantitative process evaluation. One hundred ICU patients (fifty per arm) of three ICUs at University Hospital Regensburg will be enrolled as participants. Potential participants have to be older than eighteen years with an ICU stay of at least five days, a SOFA (sequential organ failure assessment) score greater than five and a life expectancy of more than six months.
The intervention aims at improving health-related quality of life and will contain three components: information, consultation and networking. More information (e.g. about sequelae after ICU, treatment options) will be available for the participants from the intensive care stay onwards, e.g. an information brochure, and during the entire follow-up period, e.g. by contacting the ICU follow-up clinic via telephone. Participants will be invited to visit the ICU follow-up clinic at least once during the first six months after discharge from ICU. During the visits, participants will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The aim of the networking part is to improve the exchange between the health sectors and disciplines involved in the treatment of the patients, e.g. through a special referral letter from the ICU follow-up clinic, and thus to provide a network of outpatient care providers for the former ICU patients.
Efficacy Outcomes: Health-related quality of life (HRQOL) will be assessed as primary outcome by the Short-Form-12 Questionnaire (SF-12). As secondary outcomes patient-reported outcomes regarding physical, psychological and social functioning are assessed. Additionally, HRQOL of next of kin is assessed. All outcomes are assessed at six months after discharge from ICU. Feasibility Outcomes: Qualitative and quantitative evaluation will be used for exploring reasons for non-participation and the intervention's acceptability to patients, caregivers and health care providers The PINA study will determine feasibility and efficacy of a complex intervention in a pilot RCT to enhance follow-up care of ICU survivors. The pilot study is an important step for further studies in the field of ICU aftercare and especially for the implementation of a pragmatic multicenter RCT.
The study design comprises a pilot RCT with intervention and control (usual care) arms and an additional qualitative and quantitative process evaluation. One hundred ICU patients (fifty per arm) of three ICUs at University Hospital Regensburg will be enrolled as participants. Potential participants have to be older than eighteen years with an ICU stay of at least five days, a SOFA (sequential organ failure assessment) score greater than five and a life expectancy of more than six months.
The intervention aims at improving health-related quality of life and will contain three components: information, consultation and networking. More information (e.g. about sequelae after ICU, treatment options) will be available for the participants from the intensive care stay onwards, e.g. an information brochure, and during the entire follow-up period, e.g. by contacting the ICU follow-up clinic via telephone. Participants will be invited to visit the ICU follow-up clinic at least once during the first six months after discharge from ICU. During the visits, participants will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The aim of the networking part is to improve the exchange between the health sectors and disciplines involved in the treatment of the patients, e.g. through a special referral letter from the ICU follow-up clinic, and thus to provide a network of outpatient care providers for the former ICU patients.
Efficacy Outcomes: Health-related quality of life (HRQOL) will be assessed as primary outcome by the Short-Form-12 Questionnaire (SF-12). As secondary outcomes patient-reported outcomes regarding physical, psychological and social functioning are assessed. Additionally, HRQOL of next of kin is assessed. All outcomes are assessed at six months after discharge from ICU. Feasibility Outcomes: Qualitative and quantitative evaluation will be used for exploring reasons for non-participation and the intervention's acceptability to patients, caregivers and health care providers The PINA study will determine feasibility and efficacy of a complex intervention in a pilot RCT to enhance follow-up care of ICU survivors. The pilot study is an important step for further studies in the field of ICU aftercare and especially for the implementation of a pragmatic multicenter RCT.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: