Phase 2 cluster randomized controlled trial of a multi-component non-pharmacological intervention to prevent delirium for hospitalized people with advanced cancer: The PRESERVE pilot study.

We developed a non-pharmacological delirium prevention intervention and pilot tested it with 65 patients with advanced cancer in four palliative care units. Two palliative care units immediately delivered the intervention, two units delivered it after a ‘control’ period, and all units regularly assessed patients for delirium. The main measure was how often patients received its six domains (eating and drinking, sleep, exercise, reorientation, vision and hearing, and family partnership). We decided that if at least 60% patients fully received the intervention that it would not need to be changed in a larger trial. We also measured how often delirium occurred; how severe it was; whether the intervention caused any harm; and asked 39 people what they thought about it in brief interviews. The two units that first delivered the intervention did so fully for 5% patients (partially for 25%). The units that delivered it later did so fully for 25% patients (partially for 45%). Delirium occurred within one week of admission for 32% of patients in control units and 20% of intervention unit patients. There was no difference in delirium severity. The intervention did not cause harm. The interviews informed how to simplify the intervention and involve family caregivers and volunteers. The main conclusion was that a larger trial will be feasible and acceptable with a modified intervention.