Post-Intensive Care Syndrome and Caregiver Burden: A Post Hoc Analysis of a Randomized Clinical Trial.

Importance: Understanding the reciprocal association between post-intensive care syndrome (PICS) and caregiver burden is crucial for optimal care of patients and caregivers following critical illness. Objective: To evaluate the associations between patient post-intensive care impairments and caregiver burden. Design, Setting, and Participants: This secondary analysis of the MIND-USA study, a multicenter randomized clinical trial, which enrolled patients admitted to intensive care units (ICU) from 16 academic medical centers across the US (December 2011 to August 2017), included 148 patient-caregiver dyads. Patients were adults aged 18 years or older with ICU delirium randomized to receive haloperidol, ziprasidone, or placebo. A caregiver who provided unpaid assistance to the patient was identified at enrollment. PICS and caregiver burden were assessed at 3 months and 12 months after randomization. Statistical analysis was performed from March 2023 to April 2024. Main Outcomes and Measures: ICU survivors were assessed for PICS domains, including physical and cognitive function, and posttraumatic stress disorder using the Katz Activities of Daily Living, the Functional Activities Questionnaire, the Telephone Interview for Cognitive Status, and the Posttraumatic Stress Disorder Checklist-Civilian version, respectively. Caregiver burden was assessed using the Zarit Burden Interview. The associations between patient PICS and caregiver burden at 3 and 12 months were examined using structural equation modeling. Results: Of 148 patients included in this study with a median (IQR) age of 58 (48-65) years, the majority identified as male (79 patients [53.4%]), and there were 16 (10.8%) Black, 139 (93.9%) non-Hispanic, and 127 (85.8%) White patients. PICS and caregiver burden at 3-month follow-up was positively associated with these outcomes at 12-month follow-up (PICS: β = 0.69; 95% CI, 0.50 to 0.88; P < .001; caregiver burden: β = 0.68; 95% CI, 0.53 to 0.82; P < .001). However, contrary to the study hypotheses, significant associations between 3-month PICS and 12-month caregiver burden and between 3-month caregiver burden and 12-month PICS were not observed (PICS→caregiver burden: β = 0.82; 95% CI, -0.02 to 1.66; P = .09; caregiver burden→PICS: β = 0.00; 95% CI, -0.03 to 0.03; P = .95). There was significant covariance between PICS and caregiver burden at each time point. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial of ICU survivors and their caregivers, patient PICS and caregiver burden were associated at concurrent time points but were not associated with each other longitudinally. Trial Registration: ClinicalTrials.gov Identifier: NCT01211522.