Table 3

Schedule of enrolment, interventions and assessments in the Enhanced Recovery after Intensive Care Trial from the patient’s perspective. Randomisation of all clusters to a transition step was done before the start of the trial

TimelineStudy period
Admission (or transfer from ward)Treatment periodPost-ICU follow-up*
To ICUICU stayICU discharge3 months after T06 months after T0
TimepointT-1†TxT0T1T2
Randomisation—institutional levelX
Enrolment
 Eligibility screenX
 Patient‘s informed consent‡X
 Patient demographicsX
 Medical history, comorbidities at admissionX
 Critical illness characteristics (eg, admission diagnosis, physiological and illness severity scores)(X)X(X)
Intervention 
 Intervention conditionEmbedded Image
 Control condition (usual care)Embedded Image
Assessments (in-person, by GP or site personnel)
 Quality measurements (QI-related performance parameters, QI adherence (see table 1))(X)X (daily)(X)
 Mental health (Patient Health Questionnaire-4, Impact of Event Scale—Revised)§XX
 Cognition (MiniCog test, Animal Naming Test)§XX
 Physical and muscle function and symptoms (Timed Up and Go Test, Hand Grip Strength Test)§XX
 Health-related quality of life (EuroQol—5 dimensions—5 level)XX
 Organ dysfunctionXX
 Pulmonary function (Modified British Medical Research Council)X
 Outpatient ventilationXX
 Functioning and disability (WHO Disability Assessment Schedule V.2.0)X
 All-cause mortalityXXXX
 Socioeconomic data (including educational background, current employment status/working ability)X
 Healthcare utilisation, including concomitant (drug and non-drug) therapies, readmission, outpatient careXX
  • (X) depicts an optional measurement.

  • *Follow-up visits (at the GP’s practice, or at the patient’s home, or at a rehabilitation or nursing facility with assessments performed by site personnel) scheduled 3 and 6 months after the first study-related ICU discharge (index ICU stay).

  • †Time of admission to the hospital and to the ICU can be identical (depending on the patient’s health condition). Otherwise, transferral from hospital’s general ward to the participating ICU and recruitment happens at a later date.

  • ‡If applicable, by authorised representative.

  • §Assessments are part of the outpatient post-intensive care syndrome screening.

  • GP, general practitioner; ICU, intensive care unit; QI, quality indicator.