Pilot randomized trial of an electronic symptom monitoring intervention for hospitalized patients with cancer

Abstract

Background: Hospitalized patients with cancer experience a high symptom burden, which is associated with poor health outcomes and increased health care utilization. However, studies investigating symptom monitoring interventions in this population are lacking. We conducted a pilot randomized trial to assess the feasibility and preliminary efficacy of a symptom monitoring intervention to improve symptom management in hospitalized patients with advanced cancer. Patients and methods: We randomly assigned patients with advanced cancer who were admitted to the inpatient oncology service to a symptom monitoring intervention or usual care. Patients in both arms self-reported their symptoms daily (Edmonton Symptom Assessment System and Patient Health Questionnaire-4). Patients assigned to the intervention had their symptom reports presented graphically with alerts for moderate/severe symptoms during daily team rounds. The primary end point of the study was feasibility. We defined the intervention as feasible if >75% of participants hospitalized >2 days completed >2 symptom reports. We observed daily rounds to determine whether clinicians discussed and developed a plan to address patients' symptoms. We used regression models to assess intervention effects on patients' symptoms throughout their hospitalization, readmission risk, and hospital length of stay (LOS). Results: Among 150 enrolled patients (81.1% enrollment), 94.2% completed >2 symptom reports. Clinicians discussed 60.4% of the symptom reports and developed a plan to address the symptoms highlighted by the symptom reports 20.8% of the time. Compared with usual care, intervention patients had a greater proportion of days with lower psychological distress (B ¼ 0.12, P ¼ 0.008), but no significant difference in the proportion of days with improved Edmonton Symptom Assessment Systemphysical symptoms (B ¼ 0.07, P ¼ 0.138). Intervention patients had lower readmission risk (hazard ratio ¼ 0.68, P ¼ 0.224), although this difference was not significant. We found no significant intervention effects on hospital LOS (B ¼ 0.16, P ¼ 0.862). Conclusions: This symptom monitoring intervention is feasible and demonstrates encouraging preliminary efficacy for improving patients' symptoms and readmission risk. ClinicalTrials.gov identifier NCT02891993

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“…We also included diarrhea and constipation because these symptoms are highly prevalent among patients with cancer. [23][24][25] Each individual symptom is scored on a scale of 0 to 10 (with 0 reflecting absence of the symptom and 10 reflecting the worst possible severity). We categorized the severity of ESAS-r scores as none (0), mild (1-3), moderate (4-6), and severe (7-10), consistent with prior research.…”

“…[24][25][26] Also consistent with prior work, we computed composite ESAS-r physical and ESAS-r total symptom variables, which included summed scores of patients' physical and total symptoms. [22][23][24][25][26] We used the Geriatric Depression Scale (GDS-15) to assess depression symptoms. The 15-item GDS (scored 0-15) measures depression symptoms in older adults, with higher scores indicating greater depression symptoms.…”

“…Consistent with prior work, we investigated time to first unplanned hospitalization within 90 days and time to first unplanned emergency department (ED) visit within 90 days. [23][24][25] We used the 90-day time frame to account for mortality, because patients who die may have less time at risk for hospitalizations and ED visits. We defined time to first unplanned hospitalization as the number of days from study enrollment to first unplanned hospitalization within 90 days.…”

Strategies to improve patient-reported outcome completion rates in longitudinal studies

“…The patients' experience of symptoms and HRQoL can be validly and reliably captured with patient-reported outcome (PRO) questionnaires [24]. Integration of PROs into routine care management of patients with advanced cancer is associated with increased overall survival and reduction of the symptom burden [25,26]. Typically, PRO assessments are scheduled at key time points and when a questionnaire is not completed at a scheduled time, it is referred to as a non-response (NR).…”

Multiprofessional Medication Management (MuMM) Intervention Aiming at Enhancing the Tolerability of Cancer Chemotherapy: A Randomized Feasibility Trial

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