Skip to main content

Table 4 Changes to the intervention and trial methodology ahead of a definitive cluster randomised controlled trial

From: Improving the safety and experience of transitions from hospital to home: a cluster randomised controlled feasibility trial of the 'Your Care Needs You' intervention versus usual care

Problem identified during the feasibility trial

Change made for the definitive trial

Attrition of wards and participants

Over recruit wards and increase the recruitment target to 25 patients per ward over a 5-month period

A relatively high margin of error when using routinely coded emergency readmission data as the primary outcome for our target patient population

We will seek permission from the Confidentiality Advisory Group (CAG) and Research Ethics Committee (REC) to check the actual discharge destinations of patients in the definitive trial via a nonindividual consent process

Attrition of self-reported data at 30- and 90-day follow-ups

We will make the data collection periods at 5 and 30 days more distinct. We will provide a supportive telephone call to all participants at each follow up

Booklet use was influenced by patients’ fluctuating capacity and health. The prop-up feature was rarely used

The language in the booklet will be simplified and its overall length reduced. The prop-up feature will be removed. Staff training will include greater emphasis on communication with patients and encouraging the booklets use

Limited delivery of the patient-friendly care summary

Care summary tailored at a ward rather than individual level to reduce associated risks. Distributed flexibly at a suitable time during the patients stay

Difficulty accessing the patient film

Intervention wards will be provided with a tablet to show the patient film

Managing risks associated with the flexible activities to enhance health, medicines, daily activities, and escalation

Engage a broader multidisciplinary team earlier during study set-up to explore what types of activities staff could engage with

Difficulties implementing and distributing the intervention

Greater emphasis on leadership and teamwork during setup. Explore the supporting role of volunteers and/or quality improvement teams