Study outcomes and corresponding hypotheses evaluated within the HEADS-UP trial
| Outcome component | Relevant hypothesis | Rationale for outcome selection | |
|---|---|---|---|
| Primary outcome | Excess length of stay | Improved clinical outcomes through ward and support service improvements | Length of stay reflects efficient resource use, and possibly quality of care.35 Length of stay varies substantially within institutions, with wide differences between the acute admissions unit and downstream wards. Using excess length of stay as an outcome increases study power, facilitating statistical detection of a meaningful change in outcome without requiring an excessive number of wards or data collection period. |
| Secondary outcomes: clinical outcomes | Mortality | Improved clinical outcomes through ward and support service improvements | Correlates with quality of care36 and may relate to performance in non-technical skill domains.37 |
| Readmission | Improved clinical outcomes through ward and support service improvements | Need to confirm that improvements in hospital efficiency do not come at the expense of increased readmissions. 37% of medical readmissions are avoidable,38 a proportion that can be reduced with targeted quality improvement initiatives.39–41 | |
| Complications of care | Improved situational awareness will mitigate patient risks | Agreement that these outcomes are appropriate patient safety indicators.42 Reliable reporting of these outcomes to confirm adherence to stringent centrally mandated targets.43 44 | |
| Secondary outcomes: processes of care | Escalation of care | Earlier team recognition of the deteriorating patient will facilitate processes underpinning escalation of care | Multidisciplinary interventions, increasing team situational awareness,45 may address staff reluctance to appropriately escalate their concerns.24 46 |
| Secondary outcomes: staff outcomes | Staff engagement with traditional reporting system | Team-wide recognition of adverse events will improve engagement with existing incident reporting systems | More reports overall, with a lower contribution from reports of slips and falls, are associated with more positive safety culture and risk management ratings.47 |
| Safety and teamwork climate | Empowerment of junior clinicians, with structured communication tool, will improve perceptions of safety and teamwork | Improved safety climate is associated with organisation-wide reduction in adverse events.48 SAQ scores previously assessed both in inpatient settings and in the UK.33 | |
HEADS-UP, Hospital Event Analysis Describing Significant Unanticipated Problems; SAQ, Safety Attitudes Questionnaire.