Background
Methods/design
Study design and setting
Trial participants
Recruitment
Clusters
Randomisation
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Trust or health board size based on number of audit cases. For each audit, we will review the number of cases submitted to baseline audit per cluster, break these down into thirds (large, medium and small) and later report the final cut-off points used.
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Regional Transfusion Committee (RTC). These cover geographical regions and undertake activities to promote good transfusion practice and to oversee local Hospital Transfusion Committees.
Feedback interventions
Standard feedback
Enhanced content
Enhanced follow-on support
Endpoints
Surgical audit | |
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Secondary outcomes | • Total volume of allogeneic red cells transfused (units at trust-level; units at patient-level); • Total number of incidents reported to SHOT (count at trust-level); • Number of definitely, probably or possibly preventable incidents reported to SHOT within clinical specialties targeted by the audit (count at trust-level) |
Supportive outcomes | • Pre-operative transfusion (unnecessary/necessary) • Post-operative transfusion (unnecessary/necessary) • Individual NCA audit standard met • Total volume of red cells issued (units at trust-level) • Total volume of red cells wasted (units at trust-level) |
Intermediate outcomes (mediators) | Include: • Whether the planned surgery date equals the actual surgery date • Volume of post-operative cell salvage transfused • Hb level • Length of post-operative hospital stay |
Trust process level data | • Intervention fidelity • Organizational structures and resources • Tier of data collectors |
Haematology audit | |
Secondary outcomes | • Total volume of allogeneic red cells transfused (units at trust-level; units at patient-level); • Total volume of platelets transfused (units at patient-level); • Total number of incidents reported to SHOT (count at trust-level); • Number of definitely, probably or possibly preventable incidents reported to SHOT within clinical specialties targeted by the audit (count at trust-level) |
Supportive outcomes | • Red cell transfusion alone (unnecessary/necessary) • Platelet transfusion alone (unnecessary/necessary) • Individual NCA audit standard met • Total volume of red cells issued (units at trust-level) • Total volume of red cells wasted (units at trust-level) • Total volume of platelets issued (units at trust-level) • Total volume of platelets wasted (units at trust-level) |
Intermediate outcomes (mediators) | Include: • Whether the Hb level was checked after each unit was transfused • Whether the platelet count was measured after each unit was transfused |
Trust process level data | • Intervention fidelity • Organizational structures and resources • Tier of data collectors |
Data collection
Audit data
Contamination events
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Hospital Transfusion Team (e.g. Transfusion Practitioners) communicate with colleagues in other NHS trusts and health boards as part of their role;
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NHS BT Patient Blood Management Practitioners communicate with colleagues in other NHS trusts and health boards;
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Clinical Audit Leads;
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NCABT writing group;
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Clinical staff—junior medical staff training and on rotation between different units and senior medical staff working across different sites;
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NCABT Programme Manager and Statistician;
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The AFFINITIE trial team.
Organisational survey
Data collectors
Data on intervention delivery
Resource use and costs
Item | Measures of resource use | Additional notes |
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Audit data collection | Time of hospital personnel (data collectors) recorded for a sub-sample | Job title and the time taken to extract the audit data from case notes or hospital information systems will be collected on the audit data collection form To minimise burden on sites, the time taken to enter the data onto the NCA system will be estimated by having NCA personnel enter data for a number of ‘mock’ audit cases |
Development and delivery of standard content feedback and enhanced content feedback | Time of NCA personnel in designing and populating documents with audit data, including the NCA audit writing groups and associated support | The NCA clinical audit leads and statistician team will record the amount of time taken to perform each of these activities. |
Delivery of the enhanced follow-on support | Time of personnel delivering and receiving the enhanced follow-on support, including the web-based toolkit plus telephone support | AFFINITIE team members delivering the enhanced follow-on support will record the duration of telephone support and the use of the online toolkit |