JMIR Publications

ABSTRACT

Background:

The alarming prevalence of psychological distress among surrogate decision-makers (surrogates) for critically ill patients is well documented. Existing interventions for supporting surrogates in their role often target surrogates’ informational needs without directly addressing surrogates’ acute emotional burden. Therefore, we developed the Family Emotion Regulation Application for the intensive care unit (FAMERA-ICU), a tablet-based application that empowers surrogates to manage their psychological distress with cognitive reappraisal.

Objective:

We sought to: 1) determine the feasibility, acceptability, and appropriateness of implementing FAMERA-ICU and 2) examine its preliminary effects on surrogates’ psychological distress.

Methods:

We conducted a pilot, non-randomized trial at a tertiary medical center in northeast Ohio. We recruited adult surrogates for incapacitated ICU patients (≥ 48 hours). The first 20 participants received usual care (UC); the next 28 received UC and FAMERA-ICU, consisting of three sequential 10- to 15-minute modules administered every 24 to 48 hours (T1-T3) post-enrollment (T0). We evaluated implementation outcomes both quantitatively and qualitatively by describing enrollment and completion rates, surrogates’ scores on the Acceptability of Intervention Measure and the Intervention Appropriateness Measure, and thematically analyzing feedback from each interventional module. We measured psychological distress with the PROMIS Anxiety and Depression short forms at enrollment (T0) and approximately one-week post-enrollment (T3). We used linear mixed-effect models to assess changes in anxiety and depression severity between groups from T0 to T3, adjusting for the surrogate’s gender, patient relation, prior decision-making experience, and perceived stress.

Results:

Our analytic sample included forty-eight surrogates (UC = 20; FAMERA-ICU = 28). Two-thirds (67.9%) of those assigned to FAMERA-ICU completed all three modules, with over 70% finding it acceptable and appropriate. Qualitative feedback indicated that surrogates appreciated the intervention’s normalization of their emotions and provision of practical reappraisal strategies. Both groups showed significant reductions in anxiety and depressive symptom severity from T0 to T3, which were not different between groups for anxiety. However, the FAMERA-ICU group reported greater improvement in their depressive symptoms than those in UC. Perceived stress was the strongest predictor of psychological distress severity in both models.

Conclusions:

FAMERA-ICU was feasible to implement, well-received by users, and deemed relevant for the ICU context. We provide preliminary evidence indicating it may effectively reduce surrogates’ depressive symptoms within the first seven to ten days of a patient’s ICU stay. However, we were underpowered to determine its effects on anxiety symptoms. These findings highlight the potential of integrating cognitive-reappraisal tools into routine ICU practice to support surrogates’ psychological well-being, which may lead to more effective shared decision-making. Larger, more diverse trials with extended follow-up periods are necessary to confirm and broaden our findings. Clinical Trial: NCT05408468