Change in condition alerts for home care recipients: A stepped wedge cluster randomized trial.

Background/objectives Paid home care providers (caregivers) are in close, regular contact with people for whom they care (clients). This study evaluated whether caregivers, by noting changes in physical and mental health, could prevent hospitalizations. Design Stepped wedge cluster randomized trial with 4 sequences, 244 clusters, an open cohort, and continuous outcome assessment. Setting Franchises of a national home care company. Participants Eligible clusters were all franchises operating at the study start, excluding those in a previous pilot. The sample included all clients who received private-pay home care services from an eligible franchise, could be linked to Medicare enrollment records, and were enrolled in fee-for-service Medicare. Intervention A telephone- and app-based questionnaire at the end of each caregiving shift asked caregivers whether they noted changes in mental or physical health of their client. This generated a change-in-condition report that staff at the franchise office addressed at their discretion (e.g., by contacting clients or primary care providers). The control condition was no questionnaire. The study was unblinded. Clusters were randomized to four treatment sequences in eight strata of franchise characteristics. Measurements The primary outcome was hospitalization during months of home care enrollment. Secondary outcomes were emergency department (ED) visits and mortality. Results Two hundred and forty-four franchises were randomized to the four sequences (n = 40, 66, 68, 70 franchises, respectively) and 40,137 people were observed during 276,938 person-months of home care enrollment. We found no evidence of impact on hospitalization (odds ratio [OR] 1.03, 95% confidence interval [CI]: 0.97, 1.10), ED visits (OR 1.03, 95% CI: 0.98, 1.08), or mortality (OR 1.07, 95% CI: 0.96, 1.19). Conclusion A technology-enabled intervention to identify health changes among home care recipients did not show evidence of impact on hospitalizations, ED visits, or mortality. Providing change-in-condition reports to home care staff, without a structured response to manage these changes, was not effective at improving care.