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NCT Number: NCT06118606

Pilot Study of a Multidisciplinary Intervention in ICU Survivors At Risk for Psychological or Physical Morbidity

Pilot study of the feasibility and utility of an early, in-hospital multidisciplinary intervention in ICU survivors at risk for psychological and physical problems post-ICU stay

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICU Karolinska University Hospital, Stockholm, Sweden

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About this study

60 adult patients at two hospitals in Region Stockholm (Karolinska University Hospital and Södersjukhuset) with an ICU stay ≥12 hours with increased risk for psychological/physical sequelae will be invited to participate.

Intervention: Early re-assessment and multidisciplinary follow-up, led by an ICU follow-up staff (Case Manager, CM). The CM will support the patient and coordinate the rehabilitation efforts from ICU discharge to primary care with a secondary, deepened assessment of symptoms in the ward, recapitulation and information about the time spent in the ICU, followed by a multidisciplinary discussion with concerned specialists and the set-up of an individual rehabilitation plan communicated to the patient and the informal caregivers. The CM will keep track of the patient during hospital stay and ensure that there is a plan for further primary care rehabilitation after hospital discharge. The CM will contact the patient weekly to follow up on wellbeing and planned primary care activities until 12 weeks. At twelve weeks, patients will be assessed with regards to psychological symptoms (HADS, PTSS-14) and physical disability (BI).

Outcome: The primary outcome is the feasibility of the intervention. Patients and informal caregivers will be invited to participate in semi-structured interviews that will deepen the knowledge about their views upon the intervention, needs and suggested measures to improve the patients' recovery. Resource utilisation will be documented by the CM and feedback collected from involved ICU staff and hospital clinicians. Secondary outcomes are patients' level of psychological and physical problems and health-related quality of life. The results from the pilot study will inform a subsequent randomized controlled trial of an early follow-up intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted ≥12 hours to the ICU with an increased risk for physical or psychological sequelae (assessed with the PROGRESS-ICU/PREPICS instruments)

Exclusion criteria

  • Dementia or other major cognitive problems
  • Structural brain or spinal cord injury
  • Multiple limitations of medical treatment
  • Insufficient language skills (Swedish)

Treatment and study plan

Case-manager led multidisciplinary follow-up after intensive care

Other

Early in-hospital follow-up in survivors of intensive care with an increased risk of psychological/physical sequelae. The follow-up is led by a case-manager reassessing the patient after ICU discharge for psychological/physical rehabilitation needs. The CM will discuss patient needs with concerned specialists in a multidisciplinary team, leading to the establishment of a personal rehabilitation plan, communicated to the patient and next-of-kin. The CM will keep track of the patient during hospital stay and ensure primary care rehabilitation (if needed) is established once the patient is discharged from the hospital. The CM will contact the patient weekly to follow up on well-being and primary care activities until 12 weeks after discharge.

Primary outcomes

  1. Feasibility of the intervention

    Time frame: Outcome measured during and after termination of data collection and end of intervention

    Evaluation of the method including resource utilization with involved ICU follow-up staff/case managers and patients and their informal caregivers.

  2. Utility of the intervention

    Time frame: Outcome measured three-four months after ICU discharge

    Patient and caregiver views on the intervention's utility. Views on the intervention from hospital ward staff.

Secondary outcomes

  1. Depressive symptoms post-ICU

    Time frame: Outcome measured three months after ICU discharge

    Assessment of patients' symptoms of depression post-intervention

  2. Anxiety symptoms post-ICU

    Time frame: Outcome measured three months after ICU discharge

    Assessment of patients' symptoms of anxiety post-intervention

  3. Symptoms of post-traumatic stress post-ICU

    Time frame: Outcome measured three months after ICU discharge

    Assessment of patients' symptoms of post-traumatic stress post-intervention

  4. Physical disability post-ICU

    Time frame: Outcome measured three months after ICU discharge

    Assessment of physical performance post-intervention

  5. Health-related quality of life post-ICU

    Time frame: Outcome measured three months after ICU discharge

    Health-related quality of life (HRQL) assessed with the RAND-36 questionnaire, scoring 0-100 where a higher score indicates greater HRQL.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Milton, PhD

CONTACT

[email protected]

+46812370000

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Registry information

Official study title

Interventional Multidisciplinary Rehabilitation and Special Support; a Pilot Study of a Case Manager-led Multidisciplinary Intervention in ICU Survivors At Risk for Psychological or Physical Morbidity -IMPRESS-ICU Pilot Study

Acronym: IMPRESS

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 7, 2023
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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