Effectiveness of a nurse-led digital care program for patients with external fixation: A randomized controlled trial

We aimed to determine whether a nurse-led digital care program improves postoperative outcomes compared to usual care in patients receiving external fixation. Specifically, we assessed its impact on complication rates, pain, function, psychological well-being, patient satisfaction, and adherence.

We conducted a single-center, parallel-group randomized controlled trial involving 100 adult patients (aged 18-75) undergoing external fixation for trauma or reconstructive procedures. Participants were randomized 1:1 to receive either a nurse-led digital care program or standard postoperative care. The digital intervention included daily symptom logging, structured educational modules, video consultations, and in-app nurse communication. The primary outcome was the occurrence of at least one postoperative complication by 24 weeks. Complication burden, defined as the number of postoperative complications per participant, was assessed as a supportive summary. Secondary outcomes included pain (VAS), function (LEFS), psychological status (HADS), and patient satisfaction. Data were collected at baseline, 4, 12, and 24 weeks. Analyses were performed using linear mixed-effects models.

At 24 weeks, complication rates were similar between the digital and control groups (difference: -0.02; 95% CI, -0.205 to 0.165; p=0.829). Improvements in pain, LEFS scores and HADS were also similar between groups at 24 weeks. Patient satisfaction, particularly regarding ease of use and communication with nurses, was significantly higher in the digital group. Per-protocol analysis confirmed these findings.

The nurse-led digital care program did not reduce postoperative complications by 24 weeks. It was associated with modest improvements in pain and function at 4 and 12 weeks, with no sustained differences at 24 weeks. Patient satisfaction favored the digital care program. As a single centre trial among smartphone users, these findings should be interpreted as preliminary evidence of acceptability in this specific clinical context. Multicenter evaluation across diverse settings and patient populations is needed before broader implementation can be considered.