Two cluster randomised controlled trials to evaluate feedback in blood transfusion audits

Two linked cluster randomised trials to evaluate feedback interventions embedded within a national audit of blood transfusion practice

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15490813

Enrollment

152

Registered

2015-03-11

Start date

2015-04-01

Completion date

Unknown

Last updated

2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Haematology

Interventions

1. Enhanced Documents: Feedback with content written to deliver the relevant behaviour change techniques will be delivered as per usual practice by the NCA programme through written and graphic feedba

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Trust/health board (cluster) inclusion criteria: 1. Participating in the relevant national audit programme 2. Receive NHS permissions 3. Male and female 4. Lower age limit 18 years

Exclusion criteria

Exclusion criteria: Trust/health board (cluster) exclusion criteria: 1. Independent Hospitals (as clinicians involved in transfusion decisions at the NHS Trusts / Health Boards are also likely to practice at the independent Hospitals leading to potential contamination) 2. The four NHS Trusts that participated in the development of the intervention will still be invited to take part in the national audits but will not be randomised and will receive the enhanced feedback documents with post-feedback support. They will therefore not be included in the evaluation of the feedback of post feedback support. This is to prevent contamination whilst still allowing the site to be included in the NCA programme Reasons for non-participation will be documented and reported in the final trial report. Note that, where at least one hospital site within a cluster is eligible, the cluster will be regarded as eligible. Where multiple hospital sites are eligible within a cluster, the NCA may treat them as separate but they will be regarded as a single cluster for the purposes of randomisation.

Design outcomes

Primary

Measure	Time frame
The primary outcome for each audit topic, measured at the patient level and taken from the NCA follow-up audit, is whether a transfusion is categorised as unnecessary or not (binary). A clinical algorithm is agreed by the NCA BT Audit Group (which is a multidisciplinary team including content experts) alongside reviews of guidelines and the literature prior to finalising each baseline audit tool. For each audit topic, a statistical algorithm will be developed by the CTRU statisticians and piloted and approved by the NCA BT Audit Group prior to the baseline audit. This will minimise the risk of detection bias. The final versions will be included in the Statistical Analysis Plan. For the surgical audit, transfusion may occur pre-operatively, intra-operatively or post-operatively. There may also be multiple transfusion episodes after surgery but prior to discharge. As all patients will have had one or more transfusions over the entire operative period (14 days prior to surgery to 7 days following surgery), the primary outcome is whether any of these transfusions were unnecessary versus all transfusions being necessary (binary). The statistical algorithm given in the Statistical Analysis Plan will specify the statistical process needed to derive the primary outcome from the patient-level NCA audit. No clinical judgement will be required at a patient-level to categorise transfusions.	—

Measure

Time frame

The primary outcome for each audit topic, measured at the patient level and taken from the NCA follow-up audit, is whether a transfusion is categorised as unnecessary or not (binary). A clinical algorithm is agreed by the NCA BT Audit Group (which is a multidisciplinary team including content experts) alongside reviews of guidelines and the literature prior to finalising each baseline audit tool. For each audit topic, a statistical algorithm will be developed by the CTRU statisticians and piloted and approved by the NCA BT Audit Group prior to the baseline audit. This will minimise the risk of detection bias. The final versions will be included in the Statistical Analysis Plan. For the surgical audit, transfusion may occur pre-operatively, intra-operatively or post-operatively. There may also be multiple transfusion episodes after surgery but prior to discharge. As all patients will have had one or more transfusions over the entire operative period (14 days prior to surgery to 7 days following surgery), the primary outcome is whether any of these transfusions were unnecessary versus all transfusions being necessary (binary). The statistical algorithm given in the Statistical Analysis Plan will specify the statistical process needed to derive the primary outcome from the patient-level NCA audit. No clinical judgement will be required at a patient-level to categorise transfusions.

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Secondary

Measure	Time frame
1. To generate data to serve as inputs for an investigation of the relative cost-effectiveness of the two feedback interventions compared to usual NCA feedback in each audit topic from a NHS perspective 2. To investigate whether the two feedback interventions reduce volume of blood products transfused (i) across specialities within NHS trusts and health boards and (ii) for patients treated in specialities targeted by transfusion topics, when compared to usual feedback, up to 12 months following the release of feedback by the NCA 3. To investigate whether two feedback interventions reduce the number of errors reported to SHOT, when compared to usual feedback, up to 12 months following release of feedback by the NCA 4. To explore whether there are differential predictors (or moderators) of the effects of the two feedback interventions when compared to usual feedback (i.e. subgroup effects) 5. To explore the mechanisms by which the two feedback interventions affect outcome (i.e. mediators of the treatment effect) 6. To explore whether the effect of the two enhanced feedback interventions when compared to usual feedback differs according to the transfusion topic	—

Measure

Time frame

1. To generate data to serve as inputs for an investigation of the relative cost-effectiveness of the two feedback interventions compared to usual NCA feedback in each audit topic from a NHS perspective 2. To investigate whether the two feedback interventions reduce volume of blood products transfused (i) across specialities within NHS trusts and health boards and (ii) for patients treated in specialities targeted by transfusion topics, when compared to usual feedback, up to 12 months following the release of feedback by the NCA 3. To investigate whether two feedback interventions reduce the number of errors reported to SHOT, when compared to usual feedback, up to 12 months following release of feedback by the NCA 4. To explore whether there are differential predictors (or moderators) of the effects of the two feedback interventions when compared to usual feedback (i.e. subgroup effects) 5. To explore the mechanisms by which the two feedback interventions affect outcome (i.e. mediators of the treatment effect) 6. To explore whether the effect of the two enhanced feedback interventions when compared to usual feedback differs according to the transfusion topic

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026