Diagnosis-related Outcomes in NeurocriTical Care: Prognostic Estimate by Health-care Providers Versus Risk Scores in Intracerebral and Subarachnoid Hemorrhage

University of Leipzig1,085 enrolled

Overview

The aim of the observational multicenter trial encompasses the comparison of estimation of the long-term prognosis (functional and cognitive outcomes, quality of life) after intracerebral and subarachnoid hemorrhages assessed by clinical scores, treating physicians and nurses. The scores and the assessment of the treating physicians and nurses are recorded on admission, at 7 and 14 days after symptom onset.

The physicians and nurses responsible for the individual patient's care will be given a questionaire. They are asked to estimate the functional and cognitive status as well as quality of life of their patient. The patient with intracerebral hemorrhage and subarachnoid hemorrhage is examined and assessed with respective established and validated prognostic scores and models at the same time points. The actual prognosis is assessed by telephone interview and questionaires at 3 and 6 months, either from the patient or his/her caretaker.

Study Type

OBSERVATIONAL

Enrollment

1,085

Conditions

Intracerebral Hemorrhage Subarachnoid Hemorrhage

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Spontaneous intracerebral hemorrhage or nontraumatic subarachnoid hemorrhage * Treatment in Centers with neurocritical care expertise Exclusion Criteria: * Language other than German and English * Restriction of diagnostic and therapeutic measures during acute hospitalization according to advanced directives * Admission \> 48 hours after symptom onset * Hemorrhage due to trauma

Locations (10)

Charité University Hospital

Berlin, Germany

University Hospital of Duesseldorf

Düsseldorf, Germany

University of Frankfurt

Frankfurt, Germany

Wolf-Dirk Niesen

Freiburg im Breisgau, Germany

University of Leipzig

Leipzig, Germany

University of Mainz

Mainz, Germany

Minden Hospital

Minden, Germany

LMU University of Munich

Munich, Germany

Osnabrueck Hospital

Osnabrück, Germany

University Hospital of Regensburg

Regensburg, Germany

Outcomes

Primary Outcomes

Modified Rankin Scale dichotomized 0-2 versus 3-6 at 6 months

Modified Rankin Scale dichotomized 0-2 (good functional outcome) versus 3-6 (poor functional outcome)

Time frame: 6 months

Secondary Outcomes

Modified Rankin Scale dichotomized 0-2 versus 3-6 at 3 months

Modified Rankin Scale dichotomized 0-2 (good functional outcome) versus 3-6 (poor functional outcome)

Time frame: 3 months

Modified Rankin Scale dichotomized 0-3 versus 4-6 at 6 months

Modified Rankin Scale dichotomized 0-3 (good functional outcome) versus 4-6 (poor functional outcome)

Time frame: 6 months

Modified Rankin Scale dichotomized 0-3 versus 4-6 at 3 months

Modified Rankin Scale dichotomized 0-3 (good functional outcome) versus 4-6 (poor functional outcome)

Time frame: 3 months

Quality of life measured by Short Form Health Survey Short Form (SF)-36

Short Form Health Survey Short Form (SF)-36: Out of the 36 items, the following 8 subscales/dimensions are assessed and compared to the values of the normal Population: physical function (10 items), physical role function (4 items), physical pain (2 items), general perception of health status (5 items), vitality (4 items), social function and Integration (2 items), emotional role functioning (3 items), psychological well-being (5 items), Change of health status, compared to one year ago (1 item). The first 4 dimensions can be summarized to the physical sum scale, the second 4 items comprise the psychological sum scale.

Time frame: 3 and 6 months

Quality of life measured by Sickness Impact Profile

Sickness Impact Profile: 189 items in 14 topic categories. The physical dimension score is obtained by adding the scale values for each item checked within categories body care and movement, mobility, and ambulation, dividing by the maximum possible dysfunction score for these categories, and then multiplying by 100; the psychosocial dimension score is obtained by adding the scale values for each item checked within categories emotional behavior, social interaction, alterness behavior, and communication, dividing by the maximum possible dysfunction score for these categories, and then multiplying by 100. The scores for the remaining categories are always calculated individually. The overall score for the SIP is calculated by adding the scale values for each item checked across all categories and dividing by the maximum possible dysfunction score for the SIP. This figure is then multiplied by 100 to obtain the SIP overall score.

Time frame: 3 and 6 months

Cognitive outcome Telephone Interview for Cognitive Status

Telephone Interview for Cognitive Status: During the telephone interview scores for 22 questions are obtained and added to a total score. The qualitative interpretive ranges are 33-41: cognitive impairment unlikely; 26-32 cognitive impairment may be or may not be present dependent on patients's age, education, history, etc.; 21-25: mild cognitive impairment; \</=20: moderate to severe cognitive impairment.

Time frame: 3 and 6 months