OBJECTIVES: Explore short-term effects of "The Caregiver Pathway," an intervention for family caregiver follow-up, on Post-Intensive Care Syndrome symptoms among families (PICS-F). DESIGN: A randomized controlled trial. SETTING: A medical ICU at a Norwegian University Hospital. PARTICIPANTS: One hundred ninety-six family caregivers of critically ill patients randomized to an intervention ( n = 101) or control group ( n = 95). INTERVENTIONS: "The Caregiver Pathway" four-step model offers individual and structured follow-up, including: 1) mapping family caregivers' needs and concerns with an assessment tool followed by a conversation with an ICU nurse within the first days at the ICU, 2) a supportive card when leaving the ICU, 3) offer for the family caregivers to receive a phone call after ICU patient discharge, and 4) a follow-up conversation within 3 months. MEASUREMENTS AND MAIN RESULTS: Data were collected at baseline and after 3 months and analyzed using linear regression. No significant effects were detected when comparing all participants completing 3-month outcome measurements ( n = 144). A subgroups analysis stratified on patient survival, however, showed statistically significant effect for family caregivers of patients surviving the ICU stay receiving the intervention compared with controls. Caregivers of surviving patients reported improved symptoms related to post-traumatic stress disorder, measured by Impact of Event Scale-Revised (B = -8.2 [95% CI, -14.2 to -2.2]
p = 0.008), anxiety (B = -2.2 [95% CI, -4.0 to -0.5]
p = 0.014), and depression (B = -1.5 [95% CI, -2.9 to -0.1]
p = 0.035)
measured by the Hospital Anxiety and Depression Scale, subscore physical functioning in health-related quality of life (B = 9.7 [95% CI, 0.3-19.0]
p = 0.043)
measured by Short Form 12-Item Health Survey
and hope (B = 2.4 [95% CI, 0.4-4.3]
p = 0.017) and measured by the Herth Hope Index. At 3-month, the model did not appear to improve the outcomes for family caregivers of nonsurviving patients. CONCLUSIONS: "The Caregiver Pathway" intervention was associated with reduced symptoms of PICS-F in family caregivers of surviving ICU patients compared with controls.