Enhancing Quadruple Health Outcomes after Thoracic Surgery: A Feasibility Pilot Randomized Controlled Trial Utilizing Digital Home Monitoring. (Preprint)

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. CLINICALTRIAL This study was registered with ClinicalTrials.gov (NCT04340960)