Background
Methods/Study design
Trial design
Participants and randomisation
Intervention
Control treatment
Feasibility outcomes
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Is a pragmatic RCT on the effects of the participatory developed ICU follow-up clinic feasible in terms of recruitment, randomisation, intervention delivery and follow-up?
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Is it feasible to care for patients in terms of improving physical functioning and mental health in a participatory developed ICU follow-up clinic?
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Acceptability
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◦ Number of study participants divided by number of possibly eligible patients (consent rate)
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◦ Proportion of study participants who accepted their random group allocation (acceptance of randomisation)
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Fidelity
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◦ Number of study participants to whom all components of the intervention were delivered divided by all included study participants
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Completeness
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◦ Number of study participants lost to follow-up divided by all included participants (attrition rate)
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◦ Mean completeness of baseline measurements (on instrument level)
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◦ Mean completeness of follow-up measurements (on instrument level)
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Practicality
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◦ Proportion of participants needing assistance with questionnaires.
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Effectiveness outcomes (targeted results of the intervention)
Primary outcome
Secondary outcomes
Primary Outcome (participants) | Measurement | Reference |
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HRQOL, physical health | SF-12 (PCS) | |
Secondary Outcomes (participants) | ||
HRQOL, mental health | SF-12 (MCS) | |
Activities of Daily Living (ADL) | Barthel-Index (self-report and by proxy report) | |
Physical functioning | Chair Rising Test | |
Overall muscle strength | Hand grip strength assessment | |
PTSD | Post-Traumatic Stress Syndrome 10-Questions Inventory (PTSS-10) | |
Symptoms of depression, panic attacks, psychosocial impairment | Short Form of the Patient Health Questionnaire (PHQ-9) | |
Health care use | 13 items on frequency of visits to physicians from different specialties | |
Outcomes (next of kin) | ||
HRQOL | SF-12 (MCS, PCS) |
Data collection and analysis
Deviations from the initial study protocol
Results
Patient flow and feasibility outcomes
Feasibility domain | measured by | % |
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Acceptability | Number of study participants divided by number of possibly eligible patients (consent rate) | 85 |
Proportion of study participants who accepted their random group allocation | 100 | |
Fidelity | Number of study participants to whom all components of the intervention were delivered divided by all included study participants in the intervention group | 62 |
Completeness | Attrition rate | 34 |
Mean completeness of baseline measurement instruments | 100 | |
Mean completeness of all outcome measurement instruments | 77 | |
Practicality | Proportion of participants needing assistance with questionnaires1 | Baseline: 27 Follow-up: 85 |
Participant characteristics
Characteristics | Usual care (N = 20) | Intervention (N = 21) | Both groups (N = 41) |
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Male participants, n (%) | 14 (70.0) | 12 (57.1) | 26 (63.4) |
Mean age (SD) | 58.1 (15.8) | 58.5 (12.3) | 58.3 (13.9) |
min–max, years | 23–83 | 35–84 | 23–84 |
Education, n (%) | |||
No high school degree | 1 (5.0) | 1 (4.8) | 2 (4.9) |
General secondary school | 16 (80.0) | 11 (52.4) | 27 (65.8) |
Secondary school (Realschule) | 2 (10.0) | 6 (28.6) | 8 (19.5) |
Grammar school (Gymnasium) | 1 (5.0) | 3 (14.2) | 4 (9.8) |
Vocational qualification, n (%) | |||
None | 4 (20.0) | 2 (9.5) | 6 (14.6) |
Vocational school (Berufssschule) | 4 (20.0) | 3 (14.3) | 7 (17.1) |
Apprenticeship (Lehre) | 11 (55.0) | 10 (47.7) | 21 (51.2) |
Technical college (Berufsfachschule) | - | 2 (9.5) | 2 (4.9) |
University | 1 (5.0) | 4 (19.0) | 5 (12.2) |
Employment before ICU stay, n (%) | |||
None | 8 (40.0) | 14 (66.7) | 22 (53.7) |
Part-time | 2 (10.0) | 2 (9.5) | 4 (9.8) |
Full-time | 10 (50.0) | 5 (23.8) | 15 (36.5) |
Inclusion criteria | |||
Median ICU stay (IQR), days | 12.5 (9.0–27.0) | 13.0 (8.0–18.5) | 13.0 (9.0–25.5) |
Median SOFA (IQR), highest score value during ICU stay | 8.5 (7.0–11.8) | 9.0 (8.0–12.5) | 9 (7.5–12.0) |
Median Barthel-index at transfer from ICU to normal ward (IQR), N* | 62.5 (12.5–81.25), 14 | 60 .0 (30.0–80.0), 18 | 60.0 (30.0–80.0), 32 |
Primary diagnosesa, n (%) | |||
Cardiovascular | 9 (45.0) | 8 (38.1) | 17 (41.5) |
Pulmonary/ respiratory | 6 (30.0) | 2 (9.5) | 8 (19.5) |
Gastrointestinal | 4 (20.0) | 1 (4.8) | 5 (12.2) |
Cancerous condition | 1 (5.0) | 2 (9.5) | 3 (7.3) |
Otherb | - | 8 (38.1) | 8 (19.5) |
Aggregated diagnostic categories, n (%) | |||
Surgical | 8 (40.0) | 9 (42.9) | 17 (41.5) |
Medical | 12 (60.0) | 11 (52.4) | 23 (56.1) |
Trauma | - | 1 (4.8) | 1 (2.4) |
Ventilated during ICU stay, n (%) | 17 (85) | 18 (85.7) | 35 (85.4) |
Median duration of mechanical ventilation (IQR), hours | 271 (121.0–551.5) | 184 (103.5–225.75) | 198.0 (109.0–403.0) |
Extracorporeal life therapyc, n (%) | 9 (45.0) | 7 (33.3) | 16 (39.0) |
ECMO | 3 (15.0) | 4 (19.0) | 12 (29.3) |
Dialysis | 7 (35.0) | 5 (23.8) | 7 (17.1) |
Mean EQ-5D-VAS at baseline, (SD), min–max, score value | 51.7 (25.7), 10–95 | 52.1 (22.9), 5–90 | 51.9 (24.0), 5–95 |
Effectiveness outcomes (targeted results of the intervention)
Primary outcome
Secondary outcomes
Outcome measure1 | Usual care (N = 15) | n | Intervention (N = 12) | n |
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SF-12, MCS score | 44.4 (12.4), 23.4–59.8 | 14 | 49.0 (11.1), 35.7–65.6 | 11 |
Barthel indexa, median (IQR) | 90.0 (70.0–100.0) | 5 | 95.0 (66.3–100.0) | 12 |
Chair rising test, median (IQR), secondsb | 16.0 (9.5–22.5) | 6 | 20 (12.0–32.5) | 6 |
Hand grip strength, kgc | 28.3 (13), 11–47 | 11 | 28.5 (15.7), 7–52 | 7 |
PTSS-10 score | 27.4 (13.3) | 15 | 25.8 (10.6) | 12 |
Indication & strong indication for PTSD according PTSS-10, n (%) | 9 (60.0) | 15 | 6 (50.0) | 12 |
PHQ-D (short form) | ||||
Minimal to moderateddepressive condition, n (%) | 12 (80.0) | 15 | 10 (83.3) | 12 |
Moderately severe to severe depressive condition, n (%) | 3 (20.0) | 2 (16.7) | ||
Strong and very strong mental symptom-related difficultyein daily and working life, n (%) | 4 (26.7) | 15 | 3 (25.0) | 12 |
Panic attack during last four weeks, n (%) | 4 (26.7) | 15 | 3 (25.0) | 12 |
HRQOL next of kin | ||||
SF-12, PCS score | 48.7 (7.4), 37.5–57.0 | 10 | 53.1 (4.9), 46.5–58.0 | 4 |
SF-12, MCS score | 38.5 (11.4), 12.5-50.3 | 10 | 47.3 (10.0), 34.0–57.8 | 4 |
Health care use (any visit to the following specialties), n (%)f | 15 | 12 | ||
General medicine | 14 (93.3) | 10 (83.3) | ||
Internal medicine | 9 (60.0) | 7 (58.3) | ||
Otolaryngology | 5 (33.3) | 9 (75.0) | ||
Neurology | 9 (60.0) | 2 (16.6) | ||
Dental medicine | 7 (46.7) | 3 (25.0) |
Discussion
Feasibility
Signals for effectiveness of the intervention
Deviations from the initial study protocol and its implications
Strengths and limitations
Comparison to other ICU follow-up services feasibility studies
Characteristics | Henderson et al. 2021 | Samuel et al. 2015 | Bloom et al. 2019 | PINA/our study |
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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 |