ICU Follow-up After Prolonged Intensive Care Stay (PINA)

November 18, 2022 updated by: Christian J. Apfelbacher, Otto-von-Guericke University Magdeburg

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Magdeburg, Germany, 39120
        • Institute of Social Medicine and Health Systems Research
      • Regensburg, Germany, 93051
        • Department for Epidemiology and Preventive Medicine
      • Regensburg, Germany, 93053
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life, physical component summary score (HRQOL-PCS)
Time Frame: 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.
Six months after ICU discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life, mental component summary score (HRQOL-MCS)
Time Frame: 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.
Six months after ICU discharge
Activities of Daily Living (ADL)
Time Frame: 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).
Six months after ICU discharge
Chair Rise Test
Time Frame: 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.
Six months after ICU discharge
Hand Grip Strength
Time Frame: 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.
Six months after ICU discharge
Post-Traumatic Stress Syndrome 10-Questions Inventory (PTSS-10)
Time Frame: 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).
Six months after ICU discharge
Short Form German Patient Health Questionnaire (PHQ-D)
Time Frame: 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.
Six months after ICU discharge
Inpatient and outpatient health care utilization.
Time Frame: 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.
Six months after ICU discharge
Health related quality of life (HRQOL) of next of kin
Time Frame: 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.
Six months after ICU discharge of the participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otto-von-Guericke University Magdeburg

Collaborators

University Hospital Regensburg
University of Regensburg

Investigators

  • Principal Investigator: Christian J Apfelbacher, Prof.Dr.PhD, Otto-von-Guericke University Magdeburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINA-2019
  • VF_2016-076 (Other Identifier: Federal Joint Committee (G-BA) application)
  • 01VSF16056 (Other Grant/Funding Number: Innovation Fund of the Federal Joint Committee (G-BA))
  • 19-1522-101 (Other Identifier: Ethics Committee, University of Regensburg)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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