A Digital Outpatient Service With a Mobile App for Tailored Care and Health Literacy in Adults With Long-Term Health Service Needs: Multicenter Nonrandomized Controlled Trial.

backgroundPatients with long-term health needs are often expected to actively participate in outpatient care, assuming that they have appropriate health literacy and digital health literacy. However, the association between participation in a digital outpatient service and health literacy remain unclear.

objectiveThis study aims to evaluate whether digital outpatient care for 6 months improved health literacy, health-related quality of life (HRQoL), digital/eHealth literacy, and the use of health care services compared with usual care.

methodsWe conducted a multicenter nonrandomized trial with 1 intervention arm and 1 control arm. Patients aged ≥18 years receiving outpatient care in the pain, lung, neurology, or cancer departments at 2 Norwegian university hospitals were allocated in a 1:2 ratio, favoring the intervention arm. The intervention arm received digital outpatient care using tailored patient-reported outcome measures, self-monitoring, and chats for timely contact with the outpatient clinic. Patient responses were assessed by health care workers via a dashboard with a traffic light system to draw attention to the most urgent reports. The control arm received usual care. The data were collected at baseline and after 3 and 6 months. The primary outcome was the change in health literacy according to the Health Literacy Questionnaire domain understanding health information well enough to know what to do from baseline to 6 months. The mean difference in change between the 2 treatment arms was the effect measure. The secondary outcomes were additional domains from the Health Literacy Questionnaire, digital/eHealth literacy, HRQoL, acceptability of the digital intervention, and health service use.

resultsOverall, 162 patients were recruited, 55 (34%) in the control arm and 107 (66%) in the intervention arm, with a 17.3% attrition rate after 6 months. There was no statistically significant difference in the primary outcome, "understanding health information well enough to know what to do," between the arms at 6 months (mean difference -0.05, 95% CI -0.20 to 0.10; P=.53). After 3 months, the health literacy domains actively managing my own health (-0.15, 95% CI -0.30 to -0.00; P=.048) and understanding health information well enough to know what to do (-0.17, 95% CI -0.34 to -0.00; P=.03), as well as both physical (-3.29, 95% CI -5.62 to -0.96; P=.006) and mental HRQoL (-3.08, 95% CI -5.64 to -0.52; P=.02), improved in the digital outpatient intervention arm compared with the control arm.

conclusionsThis study explored digital outpatient care. Although no statistical differences were observed in patients' health literacy after 6 months, our data indicate an improvement in health literacy domains and HRQoL at 3 months. The participants reported high satisfaction with the digital outpatient care intervention, and our findings highlight the potential of digital interventions in outpatient care.

trial registrationClinicalTrials.gov NCT05068869; https://clinicaltrials.gov/ct2/show/NCT05068869. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/46649.