Table 1 BCC fidelity dimensions (Bellg et al. [11]) and their application in the AFFINITIE trial

Provide information about treatment dose in intervention and control/comparison condition: length of contacts (min), number of contacts, content of treatment, duration of contact over time

Method to ensure dose is equivalent between conditions.

• Hospitals in the intervention and control trial arms for intervention 1 will both receive at least one feedback report and feedback PowerPoint presentations as per standard practice.

• However, dose may differ in terms of the number of feedback reports received per condition, as the enhanced feedback report condition includes multiple feedback reports following a graded entry approach (i.e. level 1—key findings → level 3—detailed supplementary findings report).

• N/A; All hospitals randomised to the enhanced condition for intervention 2 will receive the toolkit and initial telephone support at equivalent doses. However, hospitals in the control condition for intervention 2 will not receive an equivalent dose of intervention 2 as the comparator is a standard practice/no intervention condition.

Method to ensure dose is equivalent for participants within conditions.

• The enhancement guidance manual will be used to produce a report template containing the proposed enhancements, which will be populated with hospital specific data for each hospital. Using a template report will help ensure the format and content of reports is consistent across hospital specific reports.

• The same web-based toolkit will be delivered to all intervention 2 hospitals. Dose is standard within condition.

• All hospitals will receive one initial facilitator-initiated telephone support call.

Specification of intervention provider credentials that are needed

Theoretical model upon which the intervention is based is clearly articulated: - The active ingredients are specified and incorporated into the intervention. - Use of experts or protocol review group to determine whether the intervention protocol reflects the underlying theoretical model or clinical guidelines.

Potential confounders that limit the ability to make conclusions at the end of the trial are identified.

Plan to address possible setbacks in implementation (i.e. back-up systems or providers)

• NHS Blood and Transplant and the National Comparative Audit have employed extra staff to support the conduct of the audits and trial data collection. IT staff are available to support systems issues for report upload. These measures will help ensure the audits keep to timeline.

• NHS Blood and Transplant and the National Comparative Audit have employed extra staff to support the conduct of the audits and trial data collection. These measures will help ensure the audits keep to timeline. IT staff have also been appointed to support the maintenance of the web-based toolkit.

• Further telephone support will be available, whereby hospitals may speak to an intervention provider to discuss any issues encountered with using the web-based toolkit.

If more than one intervention is described, all interventions are described equally well

• Intervention will be described in intervention development paper using relevant reporting checklist (identified via the Enhancing the Quality and Transparency Of Health Research network http://www.equator-network.org/home/)

• Intervention will be described in intervention development paper using relevant reporting checklist (identified via the Enhancing the Quality and Transparency Of Health Research network http://www.equator-network.org/home/)

Description of how providers will be trained (manual of training procedures)

Standardisation of provider training (especially if multiple waves of training are needed for multiple groups of providers)

• Standardised training materials, including an enhancement guidance manual and prototype training reports

• One full-day training workshop delivered by intervention developers for enhanced audit writing group intervention developers

• Standardised training materials, including a telephone support manual and flow chart

• Three training sessions delivered by intervention developers to intervention facilitators

Assessment of provider skill acquisition

• Preliminary draft enhanced reports will be content analysed to assess the extent to which proposed enhancements and theoretically consistent BCTs have been applied as intended

• Documented in a skill acquisition record form

• Intervention facilitators role-play delivery of telephone support sessions to a range of possible scenarios

• Assess extent to which intended BCTs are delivered according to the telephone support manual

• Documented in skill acquisition record form

Characteristics being sought and/or avoided in a treatment provider are articulated a priori.

• Not met: audit lead and report writing group recruited by the National Comparative Audit of blood transfusion as per standard audit practice

• Requisite knowledge and skills for intervention providers outlined in job description

At the hiring stage, assessment of whether or not there is a good fit between the provider and the intervention (e.g. ensure that providers find the intervention acceptable, credible and potentially efficacious).

• Not met: audit lead and report writing group recruited by the National Comparative Audit of blood transfusion as per standard audit practice

• Interview questions and tasks (e.g. BCT coding exercise) were chosen to assess whether applicants for the intervention facilitator roles possessed requisite knowledge and skills in behaviour change.

Method to ensure that content and dose of intervention is delivered as specified.

• Provision of an enhancement guidance manual and enhancement application ‘checklist’

• Telephone support manual, telephone support flow chart and BCT checklist

• Telephone support delivery log

Assessment and monitoring of provider skill maintenance over time

• Promoted by intervention developers providing ongoing support to audit writing group during preparation of the reports (i.e. iterative review of draft reports and feedback on how to increase delivery of proposed enhancements and theoretically consistent BCTs)

• Analysis of sub-sample of audio-recorded telephone support sessions

• Assess the extent to which BCTs according to the telephone support manual and flowchart are delivered across intervention delivery period

Mechanism to assess if the provider actually adhered to the intervention plan/use of treatment manual/whether active ingredients delivered

• Content analysis of template for enhanced reports to check for application of intended enhancements

• Content analysis of toolkit + sub-sample of audio-recorded telephone support sessions to check that intended BCTs delivered

In the case of computer delivered interventions, method to assess participants’ contact with the information

• See receipt component; web-analytics data will be collected on participant engagement with interventions in terms of number of downloads of each feedback report from the hospital web-page

• See receipt component; web-analytics data will be collected on participant engagement with interventions in terms of number of log ins into the toolkit

There is a plan for the assessment of whether or not proscribed components were delivered (e.g. components that are unnecessary or unhelpful)

• The enhancement guidance specifies three different graded entry levels of feedback reports and outlines the format and BCTs that are to be delivered in each report. A content analysis will be conducted of the template for the different levels of the feedback reports to verify whether any proscribed components were included in each report

• Content analysis of feedback reports delivered to standard/comparator arm to monitor for possible contamination/loss of treatment differentiation in terms of BCTs delivered

• Telephone support providers have been instructed to maintain treatment discrimination between the trial arms by not discussing what is being delivered in other trial arms when providing telephone support. A sub-sample of telephone support sessions will be audio-recorded and examined for disclosure of content delivered across trial arms

There is a plan for how contamination between conditions will be prevented

• Two separate but equivalent feedback report writing groups have been established to write the enhanced and standard feedback reports

• A protocol for documenting and monitoring possible sources of contamination has been developed and will be implemented throughout the trial. AFFINITIE does not aim to prevent contamination, but rather document it

• Intervention facilitators will deliver telephone support on two separate proactive and reactive telephone support lines (one for hospitals receiving enhanced reports, and one for hospitals receiving standard reports)

• A protocol for documenting and monitoring possible sources of contamination has been developed and will be implemented throughout the trial

There is an a priori specification of treatment fidelity (e.g. providers adhere to delivering >80% components)

Method to ensure that content and dose of intervention is delivered as specified

• Content analysis of template for enhanced reports to check for application of intended enhancements

• Examination of each NCA hospital web-page to check whether the intended feedback report(s) were uploaded according to trial arm allocation

• Content analysis of toolkit + sub-sample of audio-recorded telephone support sessions to check that intended BCTs delivered

• Examination of each NCA hospital web-page to check that a link to the web-based toolkit was delivered to the intended hospitals according to trial arm allocation

•Telephone support delivery log

There is an assessment of the degree to which participants understood the intervention

• Questionnaires sent to clinical staff in all participating hospitals three months post intervention delivery to assess the extent to which they understood the key findings and recommendations in the feedback reports

• Semi-structured interviews with clinical staff in a sub-sample of hospitals to examine in greater depth the extent to which clinical staff understood the content of the feedback reports

• Questionnaires sent to clinical staff in all participating hospitals allocated to receive intervention 2 3 months post intervention delivery to assess the extent to which they understood how to use the toolkit

• Semi-structured interviews with clinical staff in a sub-sample of hospitals to examine in greater depth the extent to which the clinical staff understood how to use the toolkit

There is specification of strategies that will be used to improve participant comprehension of the intervention

• The enhanced feedback reports were piloted in four hospitals to assess feasibility and acceptability. The reports and enhancement guidance were revised post piloting accordingly, to maximise comprehension and acceptability

• The toolkit was piloted in four hospitals to assess feasibility and acceptability. The toolkit was revised post piloting accordingly, to maximise comprehension and acceptability

• Subsequent versions of the toolkit were subject to additional usability testing in hospitals and refined as necessary prior to trial

The participants’ ability to perform the intervention skills will be assessed during the intervention period

• Intervention 1 is delivered only once, and there are no pre-specified skills hospitals are expected to perform for Intervention 1 during intervention delivery.

• Web analytics of toolkit data (e.g. extent of completion of the dissemination, goal setting, problem solving and action planning tasks)

A strategy will be used to improve subject performance of intervention skills during the intervention period.

• Not met: intervention 1 is only delivered once; no additional contacts will be made with hospitals by the audit writing group following delivery of the feedback reports

• Intervention 2 as a whole aims to improve transfusion clinical staffs’ response to feedback by supporting clinical staff to plan their dissemination and response to feedback.

• Provision of an initial facilitator-initated telephone support session to all hospitals allocated to receive intervention 2, to encourage engagement with the toolkit and discuss any initial issues or questions

• Additional telephone support will be available on an as needed basis to all hospitals receiving intervention 2 for 3 months following intervention delivery

Multicultural factors considered in the development of and delivery of the intervention (e.g. provide in native language; protocol is consistent with the values of the target group)

Strategy to assess intervention recipients’ performance of the intervention skills in settings in which intervention might be applied.

• Questionnaires are sent to clinical staff in all participating hospitals 3-month post intervention delivery to assess the extent to which they read the feedback reports, discuss the feedback reports with colleagues and implement any change in light of the findings/ recommendations provided and possible contextual influences on enactment.

• Semi-structured interviews with clinical staff in a sub-sample of hospitals to examine in greater depth the extent to which they read the feedback reports, discussed the feedback reports with colleagues and implemented any change in light of the findings/recommendations provided.

• Questionnaires are sent to clinical staff in all participating hospitals allocated to receive intervention 2 3-month post intervention delivery to assess the extent to which they disseminated the feedback, implement any developed action plans, re-monitor their clinical practice using the tools provided and possible contextual influences on enactment

• Semi-structured interviews with clinical staff in a sub-sample of hospitals to examine in greater depth the extent to which they disseminated the feedback, implemented any developed action plans and re-monitored their clinical practice using the tools provided