MONITOR-IC Post ICU Care Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2027-07-01

Brief Summary

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* OBJECTIVE To evaluate the clinical effectiveness and cost effectiveness of structured, multidisciplinary and personalized post-ICU care versus usual care on physical and psychological functioning, and quality of life (QoL) of ICU survivors one and two years post-ICU.
* RESEARCH QUESTION What is the clinical- and cost effectiveness of structured, personalized post-ICU care versus usual care on physical and psychological functioning, and QoL of ICU survivors?
* HYPOTHESIS Structured, multidisciplinary, and personalized post-ICU care results in improved QoL of ICU survivors and is more cost effective compared to usual care.

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Detailed Description

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* OBJECTIVE To evaluate the clinical effectiveness and cost effectiveness of structured, multidisciplinary and personalized post-ICU care versus usual care on physical and psychological functioning, and quality of life (QoL) of ICU survivors one and two years post-ICU.
* RESEARCH QUESTION What is the clinical- and cost effectiveness of structured, personalized post-ICU care versus usual care on physical and psychological functioning, and QoL of ICU survivors?
* HYPOTHESIS Structured, multidisciplinary, and personalized post-ICU care results in improved QoL of ICU survivors and is more cost effective compared to usual care.
* STUDY POPULATION Adult patients at high risk of critical illness-associated morbidity post-ICU.
* INTERVENTION Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.
* USUAL CARE / COMPARISON No or unstructured post-ICU care.
* OUTCOMES Primary: QoL and mental functioning 1-year post-ICU. Secondary: physical and cognitive functioning 1- and 2-year post-ICU, cost effectiveness and cost utility.
* FOLLOW-UP TIME One and two years post-ICU.
* STUDY DESIGN Stepped wedge cluster RCT in 5 hospitals.
* SAMPLE SIZE \& DATA ANALYSIS 5 ICUs (11 patients/ICU/month, in total 770 intervention patients, and 1480 (active and historical) controls gives power of 87% to detect effect of 0.074 in EQ-5D (ICC 0.035; SD 0.26). Data will be analysed according to intention to treat principles, also per-protocol analyses will be performed.
* COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS Comparison of 'cost per QALY' gained between patients in the intervention and control group. Decision analytical modelling will be used to calculate the average savings per patient; extrapolated to population level using a budget-holders perspective.

Conditions

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Post ICU Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter stepped-wedge cluster randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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structured, multidisciplinary and personalized post-ICU care

Group Type EXPERIMENTAL

structured, multidisciplinary and personalized post-ICU care

Intervention Type OTHER

Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.

Ususal care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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structured, multidisciplinary and personalized post-ICU care

Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ICU patients at high risk of critical illness-associated morbidity post-ICU
* 18 years or older
* Patient or legal representative understands the Dutch language

Exclusion Criteria

* Patients discharged from ICU/hospital direct to a nursing home
* Patients discharged from ICU/hospital direct to a medical or geriatric rehabilitation clinic
* Patients discharged for palliative care

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes