Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118606
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-11-01
Brief Title:
Pilot Study of a Multidisciplinary Intervention in ICU Survivors At Risk for Psychological or Physical Morbidity
Sponsor:
Region Stockholm
Organization:
Region Stockholm
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPRESS
Brief Summary:
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
Detailed Description:
60 adult patients at two hospitals in Region Stockholm Karolinska University Hospital and Södersjukhuset with an ICU stay 12 hours with increased risk for psychologicalphysical 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None