Intensive Care Neurological Disorder
Conditions
Brief summary
The current study has the following objectives: 1. To determine predictors of time 2 and 3 (3 and 6 months post-ICU admission) depression, PTSD, satisfaction with life and quality of life in both patients and caregivers, after controlling for injury severity and impairment. 2. To determine factors associated with patient and caregiver satisfaction with medical care at time 2 and time 3. The investigators would thus be able to identify the best time point for intervention delivery, intervention targets, and risk factors for chronic psychological distress.
Interventions
OTHERQuestionnaires
All subjects (patients and caregivers) will complete a battery of psychological questionnaires at baseline (ICU admission), 3 months post-baseline, and 6 months post-baseline.
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for patients: 1. 18 years of age and older 2. English fluency and literacy 3. Admitted to the Neuro-ICU Inclusion criteria for family caregivers: 1. 18 years of age and older 2. English fluency and literacy 3. Family member of patient who is identified by patient as the primary caregiver
Exclusion criteria
1. Patients who cannot complete questionnaires due to their medical condition, and are anticipated to not be able to complete questionnaires at any of the future time points, due to permanent impairment. 2. Patients who lack decision-making capacity as determined by their clinical team 3. Patients who are comfort measures only (CMO)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization QOL Questionnaire (WHOQOL-BREF) | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns. |
| Hospital Anxiety and Depression Scale (HADS) | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures symptoms of anxiety and depression. |
| Posttraumatic Stress (PCL-S) | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures symptoms of posttraumatic stress disorder |
| Satisfaction with Life Questionnaire (SWL) | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures global cognitive judgements of satisfaction with one's life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Stress Scale | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures one's distress, stress, and ability to cope with that stress over the past week on a scale from 0 to 10. |
| Healthcare satisfaction (CSQ-8) | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures one's satisfaction with health, human service, governmental, and public benefit programs and services. |
| Cognitive and Affective Mindfulness Scale (CAMS) | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures the degree to which individuals experience their thoughts and feelings. |
| Measure of Current Status (MOCS-A) | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. |
| Qualitative Adherence Measure | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures medication and instruction adherence amongst patients and caregivers. |
| Caregiving Preparedness (Preparedness for Caregiving Scale) | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | A caregiver self-rated instrument that consists of eight items that asks caregivers how well prepared they believe they are for multiple domains of caregiving. Preparedness is defined as perceived readiness for multiple domains of the caregiving role such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of caregiving. (Completed by the caregiver only). |
| Patient-caregiver interaction (Intimate Bond Measure) | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures the dimensions of care and control between partners in an intimate relationship. |
| General Self-Efficacy Scale | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures optimistic self-beliefs to cope with a variety of difficult demands in life. (Completed by the patient only). |
| Caregiver Self-Efficacy Scale | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures 3 domains of caregiving self-efficacy: Obtaining Respite, Responding to Disruptive Patient Behaviors, and Controlling Upsetting Thoughts. (Completed by the caregiver only). |
| Distress Thermometer Scale | Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) | Measures one's distress, anxiety, depression, anger, and need for help over the past week on a scale from 0 to 10. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients/Caregivers in the ICU | Baseline (week 0) | This questionnaire asks ICU patients/caregivers to report their age, gender, race, ethnicity, marital status, highest level of education, and primary employment status over the last 12 months. |
Countries
United States
Outcome results
None listed