Improving the safety and experience of transitions from hospital to home: a cluster randomised controlled trial of an intervention to involve older people in their care (Your Care Needs You).

Background: Transitions from hospital to home are risky for older people. The role of patient involvement in supporting safe transitions is unclear.

Objective: To assess the clinical effectiveness of an intervention to improve the safety and experience of care transitions for older people.

Trial Design: Cluster randomised controlled trial.

Participants: Eleven National Health Service acute hospital trusts and 42 wards (clusters) routinely providing care for older people (aged 75 years and older) planning to transition back home.

Intervention: Patient involvement ward-level intervention-Your Care Needs You (YCNY).

Outcomes: Unplanned hospital readmission rates within 30 days of discharge (primary outcome). Secondary outcomes included readmissions at 60 and 90 days post-discharge, experience of transitions and safety events.

Randomisation: Ward as the unit of randomisation from varying medical specialities randomised to YCNY or care-as-usual on a 1:1 basis.

Blinding: Ward staff, research nurses and researchers were unblinded. Patients were unaware of treatment allocation. Statisticians were blinded to the primary outcome data until statistical analysis plan sign-off.

Results: Using a mixed effects logistic regression we saw no significant difference in unplanned 30-day readmission rates (OR 0.93; 95% CI, 0.78 to 1.10; P = .372) between intervention (17%) and control (19%). At all timepoints, rates were lower in the intervention group. The total number of readmissions was lower in the intervention group (all timepoints) reaching statistical significance across 90-days with 13% fewer readmissions (IRR: 0.87; 95% CI 0.76 to 0.99) than the control. At 30-days only, intervention group patients reported better experiences of transitions and significantly fewer safety events. Serious adverse events were similarly observed in both groups [YCNY: 26 (52.0%), Care-as-usual: 24 (48.0%)]. None related to treatment.

Conclusions: YCNY did not significantly impact on unplanned hospital readmissions at 30 days but in some secondary outcomes we did find evidence of clinical benefit.