Family supplemented patient monitoring after surgery (SMARTER): a pilot stepped-wedge cluster-randomised trial

Abstract

Background

Mortality after surgery in Africa is twice that in high-income countries. Most deaths occur on wards after patients develop postoperative complications. Family members might contribute meaningfully and safely to early recognition of deteriorating patients.

Methods

This was a stepped-wedge cluster-randomised trial of an intervention training family members to support nursing staff to take and record patient vital signs every 4 h after surgery. Adult inpatients across four surgical wards (clusters) in a Ugandan hospital were included. Clusters crossed once from routine care to the SMARTER intervention at monthly intervals. The primary outcome was frequency of vital sign measurements from arrival on the postoperative ward to the end of the third postoperative day (3 days).

Results

We enrolled 1395 patients between April and October 2021. Mean age was 28.2 (range 5–89) yr; 85.7% were female. The most common surgical procedure was Caesarean delivery (74.8%). Median (interquartile range) number of sets of vital signs increased from 0 (0–1) in control wards to 3 (1–8) in intervention wards (incident rate ratio 12.4, 95% confidence interval [CI] 8.8–17.5, P<0.001). Mortality was 6/718 (0.84%) patients in the usual care group vs 12/677 (1.77%) in the intervention group (odds ratio 1.32, 95% CI 0.1–14.7, P=0.821). There was no difference in length of hospital stay between groups (usual care: 2 [2–3] days vs intervention: 2 [2–4] days; hazard ratio 1.11, 95% CI 0.84–1.47, P=0.44).

Conclusions

Family member supplemented vital signs monitoring substantially increased the frequency of vital signs after surgery. Care interventions involving family members have the potential to positively impact patient care.

Clinical trial registration

NCT04341558.