Clinical trial NCT04186468: ICU Follow-up After Prolonged Intensive Care Stay
Official title: Piloting an ICU Follow-up Clinic to Improve Health Related Quality of Life After a Prolonged Intensive Care Stay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
PICS
Post Intensive Care Syndrome
Keywords: PICS
ICU
Intensive Care Unit
Post Intensive Care Syndrome
Follow-up clinic
Intensive care unit-acquired weakness
Critical illness polyneuropathy
Health-related quality of life
Critical care
Muscle weakness
Lead sponsor: Otto-von-Guericke University Magdeburg
Sponsor class: OTHER
Collaborators: name: University of Regensburg
name: University Hospital Regensburg
First posted: 2019-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The treatment group will supported by activities of an ICU follow-up clinic. The control group will receive usual care.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* duration of ICU stay more than five days
* sequential organ failure assessment score (SOFA) greater than five
* expected survival time greater than six months
* written informed consent

Exclusion Criteria:

* minor participants under the age of eighteen
* no written informed consent (unable or unwilling)
* unable to complete questionnaires
* insufficient German language skills

Primary outcomes:
measure: Health related quality of life, physical component summary score (HRQOL-PCS)
timeFrame: Six months after ICU discharge
Secondary outcomes:
measure: Health related quality of life, mental component summary score (HRQOL-MCS)
timeFrame: Six months after ICU discharge
measure: Activities of Daily Living (ADL)
timeFrame: Six months after ICU discharge
measure: Chair Rise Test
timeFrame: Six months after ICU discharge
measure: Hand Grip Strength
timeFrame: Six months after ICU discharge
measure: Post-Traumatic Stress Syndrome 10-Questions Inventory (PTSS-10)
timeFrame: Six months after ICU discharge
measure: Short Form German Patient Health Questionnaire (PHQ-D)
timeFrame: Six months after ICU discharge
measure: Inpatient and outpatient health care utilization.
timeFrame: Six months after ICU discharge
measure: Health related quality of life (HRQOL) of next of kin
timeFrame: Six months after ICU discharge of the participant
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Institute of Social Medicine and Health Systems Research
city: Regensburg
country: Germany
facility: Department for Epidemiology and Preventive Medicine
city: Regensburg
country: Germany
facility: University Hospital
Study officials:
affiliation: Otto-von-Guericke University Magdeburg
name: Christian J Apfelbacher, Prof.Dr.PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Rohr M, Brandstetter S, Bernardi C, Fisser C, Drewitz KP, Brunnthaler V, Schmidt K, Malfertheiner MV, Apfelbacher CJ. Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2021 Mar 30;7(1):90. doi: 10.1186/s40814-021-00796-1.