Table 5 Characteristics of other ICU follow-up pilot studies compared to our study

Year

2019–2020

12/2011–10/2012

05–10/2017

2021

Country

UK

UK

US

DE

Study Design

single centre cohort (5 sub-cohorts)

single centre RCT plus extra "low risk" control

single centre RCT

single centre RCT

Target Group

adult post-operative cardiac surgical patients and their caregivers

parents of paediatric ICU patients with at least 12 h ICU stay

adults admitted to the study ICU for at least 48 h with a predicted risk of 30-day same-hospital readmission of at least 15%

adult ICU (stay > 5 days) patients and their next of kin

Sample Size

113

78 + 131 (low risk controls)

302

41

recruiting time

not reported

not reported

not reported, most probably 6 months

12 weeks

Setting

Centre for heart and lung services

University teaching hospital

University hospital

University hospital; surgical and medical ICU

Aim of study

To describe long-term outcomes of cardiac intensive care unit (CICU) patients and their primary caregivers; and to explore the feasibility of implementing a complex intervention, designed to support problems associated with PICS and PICS-F,

To identify parents at risk for PTSD due to their children’s ICU stay

To increase the number of ICU recovery program intervention components received by patients due to the follow-up clinic (feasibility); and to decrease the frequency of 30-day hospital readmission

(efficacy)

To explore and evaluate feasibility of an ICU follow-up clinic

Intervention

InS:PIRE programme, McPeak et al. [81]

follow-up clinic appointment 2 months after ICU discharge

10 components from discharge to 30 days after

ICU follow-up clinic

Components

five-week multidisciplinary peer support rehabilitation programme

review of current health condition of the child, reflection on the emotional experience of parents, access to further support services

inpatient visits, brochure, medication review, phone calls, ICU f/up clinic visit, assessment, neuro evaluation, referrals

assessment, medication review, social support, peer group

Aim of intervention

To ameliorate the signs and symptoms associated with PICS and PICS-F

To reduce parents' levels of posttraumatic stress, anxiety, and depression

To increase of use of intervention components / decrease of 30-day readmission

To increase HRQOL, physical functioning and psychosocial wellbeing

Follow-up

12 weeks after discharge (initial visit) and 3 & 12 Months after initial visit

not reported, most probably 6 months

not reported

planned: 6 months; actual: mean 198 days ~ 7 months

Willingness to participate

24%

52%

not reported, could be 232/302

85%

Acceptance of randomisation

not applicable

not reported

not reported, most probably 100%

100%

Adherence to the intervention

Initial uptake rate: 14%; uptake rates improved to between 25 and 30% following some changes in procedures

37%

not reported, 2/10 components completed (median)

mean 62%

Loss to follow-up

4%

24%

13%

34%

Completeness of baseline measurement

100% for patients / unknown for caregivers

100%

not reported; patients lost to follow-up were excluded from baseline analysis

100%

Main measurement instruments

HADS, EQ-5D

PAS, IES-R, HADS

readmission rate, death rate, health care utilisation

SF-12, PHQ, PTSS-10

Completeness of outcome measurement

54%

75%

not reported, most probably 100%

77%

Signals for effectiveness

HRQOL increased from 70 to 78

only small effect sizes in favour of the intervention for anxiety scores

time to readmission decreased in intervention group

Scores for mental HRQOL, ADL and relatives' HRQOL were higher in the intervention group