Patient and Caregiver Psychological Functioning Following Neuro-ICU Admission: A Prospective Investigation

A Prospective Study to Investigate Relationships Between Patient and Family Caregiver Distress Following Neuroscience ICU Admission

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Neurological Disorder
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Neuro-ICU and their family caregivers

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

ICU Questionnaires; After enrollment, all subjects (patients and their primary caregiver) will be given baseline measures assessing: sociodemographics, depression, anxiety, distress, stress, PTSD, coping, mindfulness, quality of life, satisfaction with life, resiliency/self efficacy (patient only), patient caregiver interaction, caregiver preparedness (caregiver only), caregiver self efficacy (caregiver only), quality of adherence measure, and health care satisfaction. Subjects will complete the same measures again at time 2 (3 months) and time 3 (6 months). The study endpoint is time 3 follow up (6 months).

Other: Questionnaires; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale (HADS)	Measures symptoms of anxiety and depression.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Posttraumatic Stress (PCL-S)	Measures symptoms of posttraumatic stress disorder	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Satisfaction with Life Questionnaire (SWL)	Measures global cognitive judgements of satisfaction with one's life	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
World Health Organization QOL Questionnaire (WHOQOL-BREF)	Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Self-Efficacy Scale	Measures optimistic self-beliefs to cope with a variety of difficult demands in life. (Completed by the patient only).	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Caregiver Self-Efficacy Scale	Measures 3 domains of caregiving self-efficacy: Obtaining Respite, Responding to Disruptive Patient Behaviors, and Controlling Upsetting Thoughts. (Completed by the caregiver only).	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Distress Thermometer Scale	Measures one's distress, anxiety, depression, anger, and need for help over the past week on a scale from 0 to 10.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Visual Analog Stress Scale	Measures one's distress, stress, and ability to cope with that stress over the past week on a scale from 0 to 10.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Healthcare satisfaction (CSQ-8)	Measures one's satisfaction with health, human service, governmental, and public benefit programs and services.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Cognitive and Affective Mindfulness Scale (CAMS)	Measures the degree to which individuals experience their thoughts and feelings.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Patient-caregiver interaction (Intimate Bond Measure)	Measures the dimensions of care and control between partners in an intimate relationship.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Measure of Current Status (MOCS-A)	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.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Qualitative Adherence Measure	Measures medication and instruction adherence amongst patients and caregivers.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Caregiving Preparedness (Preparedness for Caregiving Scale)	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).	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients/Caregivers in the ICU	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.	Baseline (week 0)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: April 29, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 2014P002793