JMIR Publications

ABSTRACT

Background:

Surgical recovery after hospital discharge often presents challenges for patients and caregivers. Postoperative complications and poorly managed pain at home can lead to unexpected visits to the emergency department and/or readmission to the hospital. Digital home monitoring (DHM) may improve postoperative care compared to standard methods.

Objective:

We conducted a feasibility study for a randomized controlled trial (RCT) to assess DHM's effectiveness following thoracic surgical procedures compared to standard care.

Methods:

We conducted a two-arm parallel-group pilot RCT at a single tertiary care center. Adult patients undergoing thoracic surgical procedures were randomized 1:1 into two groups: the digital home monitoring (DHM group) and the standard of care (control group). We adhered to the intention-to-treat analysis principle. The primary outcome was predetermined RCT feasibility criteria. The trial would be feasible if more than 75% of trial recruitment, protocol adherence, and data collection were achieved. Secondary outcomes included 30-day emergency department visit rates, 30-day readmission rates, postoperative complications, length of stay, post-discharge 30-day opioid consumption, 30-day quality of recovery (QOR-40), patient/program satisfaction, caregiver satisfaction, healthcare provider satisfaction and cost-per-case.

Results:

All RCT feasibility criteria were met. The trial recruitment rate was 87.9% (95% CI: 79.4% – 93.8%). Protocol adherence and outcome data collection rates were 96.3% (95% CI: 89.4% - 99.2%) and 98.7% (95% CI: 92.9% - 99.9%), respectively. Eighty patients were randomized, with 40 (50%) in the DHM group and 40 (50%) in the control group. Baseline patient and clinical characteristics were comparable between the two groups. The DHM group had fewer unplanned ED visits (2.7% vs. 20.5%; p=.02), fewer unplanned admission rates (0% vs. 7.6%; p=.24), lower rates of postoperative complications (20% vs. 47.5%, p=.01) shorter hospital stays (4.0 vs. 6.9 days; p=.05), but more opioid consumption (111.6 ± 110.9 vs. 74.3 ± 71.9 mg morphine equivalents; p=.08) compared to the control group. DHM also resulted in shorter ED visit times (130 ± 0 vs. 1048 + 1093 minutes; p=.48) and lower cost per case ($12,145 ± 8,779 vs. $17,247 ± 15,313; p=.07). The quality of recovery scores was clinically significantly better than the controls (185.4 ± 2.6 vs. 178.3 ± 3.3; p<.0001). All 37 patients who completed the intervention answered the program satisfaction survey questionnaires (100%; 95% CI: 90.5% - 100%). Only 36 out of 80 caregivers responded to the caregiver satisfaction questionnaires at the end of the 4th week post-hospital discharge (47.7%; 95% CI: 35.7% to 59.1%). Healthcare providers reported a 100% satisfaction rate.

Conclusions:

This pilot RCT demonstrates the feasibility of conducting a full-scale trial to assess DHM's efficacy in improving postoperative care following thoracic surgery. DHM shows promise for enhancing continuity of care and warrants further investigation. Clinical Trial: This study was registered with ClinicalTrials.gov (NCT04340960)