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

URN to cite this document:

urn:nbn:de:bvb:355-epub-463783 Copy

DOI to cite this document:

10.5283/epub.46378 Copy

Rohr, M. ; Brandstetter, S. ; Bernardi, C. ; Fisser, C. ; Drewitz, K. P. ; Brunnthaler, V. ; Schmidt, K. ; Malfertheiner, M. V. ; Apfelbacher, C. J.

Preview

License: Creative Commons Attribution 4.0 PDF - Published Version (2MB)

Date of publication of this fulltext: 15 Jul 2021 16:50

---

Alternative links to fulltext:DOIPublisher

---

---

Details

Item type:	Article
Open Access Type:	DEAL (Springer Gold)
Höhe Gebühr (aus OpenAPC):	1704.08
Institution der Zahlung:	Regensburg U
Journal or Publication Title:	Pilot and Feasibility Studies
Publisher:	BMC
Volume:	7
Number of Issue or Book Chapter:	1
Page Range:	pp. 1-13
Date:	30 March 2021
Institutions:	Medicine > Institut für Epidemiologie und Präventivmedizin
Identification Number:	Value Type 10.1186/s40814-021-00796-1 DOI
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	46378

Preview

Export bibliographical data

ASCII CitationAtomBibTeXData Cite XMLDataCite XML OAIDublin CoreDublin Core (LZV)EndNoteHTML CitationJSONJSON LDMETSMODSOPENAIREOpenAPCRDF+N-TriplesRDF+N3RDF+XMLReferReference ManagerSimple MetadataXMLopenCostxMetaDissPlus

---

Abstract

Background Intensive care unit (ICU) survivors often suffer from cognitive, physical and mental impairments, known as post-intensive care syndrome (PICS). ICU follow-up clinics may improve aftercare of these patients. There is a lack of evidence whether or which concept of an ICU follow-up clinic is effective. Within the PINA study, a concept for an ICU follow-up clinic was developed and will be ...

Abstract

Background
Intensive care unit (ICU) survivors often suffer from cognitive, physical and mental impairments, known as post-intensive care syndrome (PICS). ICU follow-up clinics may improve aftercare of these patients. There is a lack of evidence whether or which concept of an ICU follow-up clinic is effective. Within the PINA study, a concept for an ICU follow-up clinic was developed and will be tested in a pilot randomised controlled trial (RCT), primarily to evaluate the feasibility and additionally the potential efficacy.

Methods/design
Design: Pilot RCT with intervention and control (usual care) arms plus mixed-methods process evaluation. Participants: 100 ICU patients (50 per arm) of three ICUs in a university hospital (Regensburg, Germany), ≥ 18 years with an ICU stay of > 5 days, a sequential organ failure assessment (SOFA) score > 5 during the ICU stay and a life expectancy of more than 6 months.

Intervention: The intervention will contain three components: information, consultation and networking. Information will be available in form of an intensive care guide for patients and next of kin at the ICU and phone support during follow-up. For consultation, patients will visit the ICU follow-up clinic at least once during the first 6 months after discharge from ICU. During these visits, patients will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The networking part (e.g. special referral letter from the ICU follow-up clinic) aims to provide a network of outpatient care providers for former ICU patients. Feasibility Outcomes: Qualitative and quantitative evaluation will be used to explore reasons for non-participation and the intervention´s acceptability to patients and caregivers. Efficacy Outcomes: Health-related quality of life (HRQOL) will be assessed as primary outcome by the physical component score (PCS) of the Short-Form 12 Questionnaire (SF-12). Secondary outcomes encompass further patient-reported outcomes. All outcomes are assessed at 6 months after discharge from ICU.

Discussion
The PINA study will determine feasibility and potential 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 multi-centre RCT.

---

---

Metadata last modified: 01 Feb 2023 08:21

Owner only: item control page

Download Statistics

Download Statistics

Download Statistics

Download Statistics

Downloads

Downloads per month over past year

Altmetric

Altmetric

Altmetric

Alternative Statistics (altmetrics)

More literature (via CORE)

More literature (via CORE)

More literature (via CORE)

More literature (via CORE)