PINA: ICU Follow-up After Prolonged Intensive Care Stay

Sponsor

Otto-von-Guericke University Magdeburg (Other)

Overall Status

Unknown status

CT.gov ID

NCT04186468

Collaborator

University of Regensburg (Other), University Hospital Regensburg (Other)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

33.3

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness PICS Post Intensive Care Syndrome	Other: ICU follow-up clinic	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The treatment group will supported by activities of an ICU follow-up clinic. The control group will receive usual care.The treatment group will supported by activities of an ICU follow-up clinic. The control group will receive usual care.

Masking:

Single (Outcomes Assessor)

Masking Description:

Group allocation will be masked during analysis of the primary outcome. Masking and unmasking will be done by a Trust Center by coding both groups.

Primary Purpose:

Health Services Research

Official Title:

Piloting an ICU Follow-up Clinic to Improve Health Related Quality of Life After a Prolonged Intensive Care Stay

Actual Study Start Date :

Dec 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICU follow-up clinic Participants will be invited to visit the ICU follow-up clinic.	Other: ICU follow-up clinic The intervention aims at improving health-related quality of life and will contain three components: information, consultation and networking. More information 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 outpatient 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, 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.
No Intervention: Usual care Participants will solely receive usual care.

Arm

Intervention/Treatment

Experimental: ICU follow-up clinic

Participants will be invited to visit the ICU follow-up clinic.

Other: ICU follow-up clinic

The intervention aims at improving health-related quality of life and will contain three components: information, consultation and networking. More information 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 outpatient 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, 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.

No Intervention: Usual care

Participants will solely receive usual care.

Outcome Measures

Primary Outcome Measures

Health related quality of life, physical component summary score (HRQOL-PCS) [Six months after ICU discharge]
HRQOL will be assessed six months after discharge from the intensive care unit (ICU) by the Short Form-12 self-report questionnaire (SF-12) physical component summary score (PCS) (Ware, 1996). The German translation (Bullinger, 1998) will be used. Scores can range between zero and one hundred, with higher values indicating higher HRQOL.

Secondary Outcome Measures

Health related quality of life, mental component summary score (HRQOL-MCS) [Six months after ICU discharge]
HRQOL will be assessed six months after discharge from the intensive care unit (ICU) by the Short Form-12 self-report questionnaire (SF-12) mental component summary score (MCS) (Ware, 1996). The German translation (Bullinger, 1998) will be used. Scores can range between zero and one hundred, with higher values indicating higher HRQOL.
Activities of Daily Living (ADL) [Six months after ICU discharge]
ADL will be assessed by the Barthel-Index (Mahoney, 1965) in German translation (Lübke, 2004), which evaluates ten everyday functions. The degree of independence or care dependence can be assessed on a score ranging between zero (complete need for care) and one hundred points (independence).
Chair Rise Test [Six months after ICU discharge]
The Chair Rise Test (Cooper, 2010 and Fuchs, 2013) will be used to assess participants' physical functioning. Anyone who cannot get up from a chair at normal height five times in a row in eleven seconds or less without supporting himself with his arms is considered to be at risk of falling.
Hand Grip Strength [Six months after ICU discharge]
As an indicator for the general muscular strength (Beaton, 1995, Bobos, 2019), we will measure the hand grip strength with a dynamometer (Jamar Plus+ Digital Hand Dynamometer). Values can range fron zero to ninety kilogram, whereby higher values indicate a higher gripping force.
Post-Traumatic Stress Syndrome 10-Questions Inventory (PTSS-10) [Six months after ICU discharge]
The PTSS-10 (Weisæth, 1989) will be used in the German translation (Maercker, 1998) to assess participants' risk of post traumatic stress disorders. Each symptom is rated from one (never) to seven (always). A total score of more than thirty-five predicts a likely diagnosis of post-traumatic stress disorder (PTSD).
Short Form German Patient Health Questionnaire (PHQ-D) [Six months after ICU discharge]
The PRIME MD Brief Patient Health Questionnaire, PHQ (Spitzer, 1999) will be used in the German short form translation PHQ-D (Loewe, 2002) to assess psychopathological symptoms (anxiety, panic disorder or depression). Score values can range from zero to twenty-seven, with higher values being a good indicator for psychiatric diagnoses.
Inpatient and outpatient health care utilization. [Six months after ICU discharge]
The extent of ambulatory and stationary health care use among the former ICU patients will be assessed by self-reported contacts with health services using a questionnaire as a proxy for morbidity. These contacts can range from zero to unlimited. A higher level of contacts indicates a weaker state of health.
Health related quality of life (HRQOL) of next of kin [Six months after ICU discharge of the participant]
HRQOL of next of kin will be assessed also six months after discharge of the participant by the Short Form-12 self-report questionnaire (SF-12) PCS and MCS (Ware, 1996) after informed consent was obtained from the the respective relative. The German translation (Bullinger, 1998) will be used. Scores of both component scales can range between zero and one hundred, with higher values indicating higher HRQOL.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institute of Social Medicine and Health Systems Research	Magdeburg	Germany	39120
2	Department for Epidemiology and Preventive Medicine	Regensburg	Germany	93051
3	University Hospital	Regensburg	Germany	93053