Table 5 Explanatory accounts for improvements in open disclosure: what works, when and how from a service perspective (bolded explanatory accounts for services (eas) have been included in final c-m–o configurations (Table 6)

EAsv85

EVENT IDENTIFICATION

Incident uncertain/unfolding

Routine invitation to discuss felt harm prior to discharge or during an assessment of reported symptoms [63]; standardised checks on women’s experiences embedded across maternity care pathways [63]; and family perspective included in clinical records and incident analysis [65]

Leads to the development of trauma-informed maternity service [63]; reduces the possibility of litigation by families who feel ignored [63] and the loss of vital information for patient care [65]

EAsv2

Extension of thresholds of harm (‘less’ serious incidents) [50, 63]; wider interest of improvement leads/committees in ‘trigger’ incidents [51] (with possibility of extension of these thresholds over time) [75]

Enhances view of service areas requiring improvement [50, 51, 63, 75]

EAsv3

Following ‘Being Open’ guidance and Regulation 20 (Duty of Candour) [32, 50]with all reviews including a systematic and critical review of care [58]

Increases reporting of incidents [50]; improves discussions with families [32]; meets regulatory requirements [50]; creates more opportunities to learn from mistakes and substandard care [50, 58]and meets drive to improve maternity safety [32]

EAsv4

ONGOING CARE

AFTER EVENT

When the incident has happened and during ongoing maternity care

Organisation-wide [48, 78]staff training in Being Open purpose [48],policy/principles [49], and communication skills [78]

Leads to fewer possible repercussions for Trust (aggrieved families) [49]; workforce competencies are more widespread [78]; becomes more likely for disclosure to be enacted in local practice [48, 78]

EAsv5

DISCLOSURE PROCESS

Improvement Strategies and Infrastructures

Specialist, multi-disciplinary ‘event response team’ manage processes across service [49, 78] and immediate response to trigger events [78]; team selected by peers [78]

Disclosure processes will be more consistent/coordinated, there will be clear accountability [49, 78]; leadership positions/expertise will be developed [78]; a ‘tenants of disclosure model’ can be operationalised [78]; duplication likely to be reduced [49]and advice and standards more likely to be consistent [48]

EAsv6

Concerted and resourced implementation strategy (including policy, guidelines, training, and evaluation of effect) [48, 53], maximum use of IT [77]with whole service engagement [75]capacity to integrate patient experience intelligence [51]

Will meet the broad objectives of a pilot [53]; OD more likely embedded in organisation (not a discretionary activity) [48, 75, 77]; more effective identification of improvement focus possible [51]

EAsv7

Comprehensive protocol/guidance (identification, disclosure, investigation, appropriate resolution) [78]

Meets one condition of programme implementation [78]

EAsv8

Dedicated, senior person to implement disclosure guidance (in Trust [51]; in regional partnerships [72])

Ensures clear and consistent leadership for implementation [51, 72]

EAsv9

Gaining and sustaining senior medical ‘buy-in’ (with responsibilities for implementation and case reporting [78]) [6, 9, 51] and by local site engagement, with benefits evidenced to them [78] and local services having opportunities to adjust protocols to meet their own service conditions [78]

Encourages support by senior medical staff (required to promote uptake by colleagues [51, 78]; reassures junior staff [6]; is crucial to ongoing practice [48] and policy implementation [78]

EAsv10

Disclosure identified as more than clinical competence and is identified as a service, organisational issue about workload, supervision, rapid organisational change [48], documentation [78], administration, and co-ordination [6]; there is communication/discussion and coordination of protocol and practice across units [78]

Embeds organisation-wide practice of openness [9, 78]; reduces burden of disclosure in individual clinicians; and enhances possibility of patient-centred disclosure practice [48]

EAsv11

Trusts’ prompt referral of/comprehensive information on incident to external body [32]

Possibility of reduced litigation (parents get answers and/or assistance more quickly) [32]

EAsv12

Organisational regulation [54, 80] with accommodation of differences in organisational maturity (how well systems support practice) [52]

Enables clear accountability for disclosure [80]; but variations across units are expected during early implementation [52]

EAsv13

Disclosure, apology, and early redress embedded in quality improvement work [82]

May reduce the need for the regulation of organisations [82]

EAsv14

National frameworks/guidance on programmes for all Trusts and services [51, 72] (including for Board leads, staff skills, protected time, minimum data collection, and reporting requirements) [51]

Promotes a clear and consistent policy for family engagement and its requirements [51, 72], combining specificity with flexibility [72]

EAsv15

Investments in staff education to address gap between disclosure guidelines and clinicians’ practice [69], including supported space for clinicians and patients to negotiate the practical demands/contradictions of disclosure [48]

Effective disclosure becomes part of patient safety programmes [69]; and becomes more than ‘in principle’ agreement [48]

EAsv16

Risk management formalised/embedded in improvement work/aspect of cultural change [49, 82] committed risk managers identified to embed disclosure protocol in each unit [78]

Incidents of disclosure are likely to increase [82]; evidence of impact of disclosure on reduction of incidents will be collected [49]; implementation of disclosure will be successful [78]

EAsv17

Staff commitment to disclosure (notably, risk managers [82], senior clinicians [70], board and medical director/nominated consultant) with time and resources [51]; consistent communication of commitment [78]

Continuity of disclosure practice will be possible [70, 78, 82]; financial and HR investment in high-quality systems and processes more likely [51]

EAsv18

Established provider service team reporting in Board and Commissioners into the divisions and ‘down’ to wards and local forums [49]

Develops high-quality safety assurance with grassroots identification of risk and improvement implementation [49]

EAsv19

‘Joined- up’ intelligence from reviews/incidents, patient experience, complains and support services by Trust Boards [50]

Enhances insights for safety improvement [50]

EAsv20

Adoption/development of legacy interventions (e.g., review tools, training, and engagement methods) [34, 51, 74, 77]

Creates a shorter/easier journey to improvement; interventions are more reliable [34, 51, 74, 77]

EAsv21

Ethos

Disclosure communication enacted as moral-ethical obligation of clinicians (not an administrative task) [54]; enacted in service-wide early response teams to encourage disclosure [78]

Embeds disclosure as an aspect of care s in each clinical service [54, 78]

EAsv22

Parents central in guidance [50, 74] and practice development [51]

Enhances effectiveness of guidance [50, 74]; strengthens partnerships with families [51, 74]

EAsv23

Change in NHS safety culture (with holistic work programme on structure, skills, capacity, and cultural reform) [52]; culture change in ‘healthcare micro-systems’ (over wider systems reform) [82]

Refocuses SI management from punitive/political process to learning for improvement [52] (52% of 2017 survey respondents said not yet achieved” [52]); different programs for Trust settlement after incidents possible [82]

EAsv24

Change in inspection and Board priorities from how investigations conducted and completed (within timeframe) to learning disseminated and embedded [50]

Practice will be valued for learning and improvement (not for meeting short targets) [50]

EAsv25

‘High-level’ leadership in promoting ‘Just culture [32, 50]; desire to learn a central organisational value [51] (e.g. Provider Boards, Commissioners, and Regulators); embedded and consistent culture of openness/candour [49, 58]

Change more likely to happen within units [32, 50] when incidents, complaints, and concerns are seen as learning opportunities [52, 88] and when service-user experience is part of this learning [58]

EAsv26

Organisation/Unit Legacies

When implementation approaches recognise the different capacities of organisations to drive attitude and practice change so that gradual and uneven change is expected in organisations [78] and varying degrees of foundational systems and expertise in organisations are anticipated [51, 52, 74]

Differentiated systems for support of staged implementation plans can be developed [52, 74]

EAsv27

Established success/experience in other family engagement practices [74]

Disclosure is more successful [74]

EAsv28

Governance

Local Maternity Systems [72] and Health-Board/Trust buy-in [75] (with trained [52] executive and non-executive people leading these processes) [62]; resourcing is available [77]; there are clear and consistent guidance/standards/processes/tools [50] and time for development of expertise in their application [74, 77]; there is a Board-level family advocate [51] and minimum standard of training for all Board members [52]

Consistent disclosure improvements and learning are possible [5, 50, 62, 77]; investigating and learning emphasised [52, 72] in time (with variations between services expected) [74]; staff implementing family engagement are held to account [51]

EAsv29

Strong governance structures (e.g. review groups, including regular executive reviews [51, 75]; promotion of unit reporting for external benchmarking [72]; monitoring of training effectiveness [72, 75] and involvement guideline compliance [72])

Essential for service improvement/learning and acting on lessons [51] and improvement monitoring [72]

EAsv30

Commissioning that includes: lead for incident reporting and process improvement [50] and for maternity safety [32]; commissioners have time and training to quality assure disclosure and investigations [72]

More coordinated improvement work [50]; clarification of accountabilities [72]; family participation more likely to be achieved [72]

EAsv31

Commissioners’ responsibility for investigation reporting/action plans with family involvement [72]; Board-level clarification and resourcing of Candour regulations (and inclusion of parents and staff in investigation processes) [32]

Regulation will be met [32, 72]; variability of investigations will be reduced [72]

EAsv32

Inspection bodies include: mortality reviews/investigations [50]; compliance to family involvement guidelines [72] (e.g. to benchmark Trust leadership)

Improvements in national oversight and support for learning from failings; improvements in family involvement in national oversight would improve [50, 72]

EAsv33

Local Maternity Systems, supported by strategic partnership Boards, responsible for improving investigation process (and MVP involvement in it) [72]

National recommendations can be co-designed and included in local SI processes [72]

EAsv34

Royal College clinical leadership and guidance to Trust/service investigators [50]; professional-led national quality improvement introduced [62]

Costs of external investigations teams (c£100 k per investigation) will be reduced [50]; national standards and objectives will be established [62]

EAsv35

Value of user-voice already established in organisation/clinical governance (co-production-user forums) [51, 76]

Reduction in the cultural resistance to involving families in making improvements in reviews/investigation processes [51] (however practice of user-involvement will always be more challenging than other aspects of clinical governance, especially where addresses difficult issue of ‘poor outcomes’) [76]

EAsv36

Networked governance structures to enhance disclosure practices (e.g. Board-level, Membership Councils, QI Steering Groups; Patient Leads) [49, 72]; annual reporting of national bodies to include lay summaries [62]

More effective learning and engagement for Sis and involvement of families [49, 62, 72]

EAsv37

Accessibility/Availability

Family-centred approach to engagement in reviews and investigations [50], including information materials noting multiple opportunities to engage [34]; and staff training in this perspective [76]

Increases satisfaction of families [50]; family engagement is improved [34], care planning and delivery are improved [76]

EAsv38

Culture that supports meaningful apology for any harm [49, 50, 81] and explanation of circumstances without blame [81], including legal protection [82]

Reduces likelihood of escalation or legal claim [49, 50, 81]

NB: (limited potential to reduce malpractice claims by US families with birth-injured infants) [82]

EAsv39

Explanations

Comprehensive assessments of care during review [72]; correspondence in care standard assessments (between services and external bodies) [32]

Delays in settlements for families are mitigated [32] (possible reduction of costs) [32]; learning from cases for care systems improvements are increased [32, 72]

EAsv40

Inclusion of family and carer understandings of events [50, 80], with understanding that common understanding of what happened might not be reached [80]

Increases opportunities for learning from family experience of care across complete care pathway) [50, 80]; reduces possibility of ongoing conflict if family listened to [80]

EAsv41

Investigations include clinical and legal experts (examining all relevant documents) [32]

Investigations can bridge ‘claims, safety and learning functions of the organisation’ [32]

EAsv42

Consistency in Disclosure Process

Formal, family engagement guidance (shared between services and between external organisations) [32, 80], and review tools [62], are co-developed with staff and parent advisors [34, 77]

Leads to more consistent information and shared resources [80] that are relavent [34, 62, 77], avoid duplication [32], and are available to the service

EAsv43

Navigation Strategies

Named professional/patient representative or advocate to manage co-ordination of information between parents and clinicians [71, 75]

Leads to the provision of crucial infrastructure for improvement of ‘Being Open’ guidance [32] (more information and relational consistency between Trusts and family [71])

NB: (unclear if that person should be ‘fully independent’ of clinical team) [71, 75]

EAsv44

DISCLOSURE DURING REVIEWS AND INVESTIGATIONS

When incident review and/or investigation initiated

Investigation Leadership that is expert in family liaison and includes risk management /governance team (not consultant in charge) [34, 49]

Enhances the reliability and consistency of findings [49]; the incorporation of action plans into clinical governance plans [34] and findings more likely to be underpinned by ethos of candour [51]

EAsv45

Robust review/investigation process including whole care pathway (multi-agency [59]; cross-department [34]; multi-discipline [34, 62, 74, 76, 79]); parents’ perspective [34]; external or independent peer-review [34, 72], and adequate RCA methodology [72]

Enhances learning from the incident by more comprehensive for improvement planning [34, 59, 62, 74]; encourages care variation and grading from a multi-disciplinary perspective [34, 79], along with the use of ‘fresh eyes’ to identify systems issues [34, 62, 72] to identify active and latent failure [72] and the wider development of cross-sector relationships [76]

NB (but 17% reported PMRs 2018–19 completed by 1–2 same discipline clinicians [34]; 1:5 PMRs 2018–19 had external member input [34])

EAsv46

Planning [50] and training [79] for multi-disciplinary/sector review/investigation (establishing ToR, leadership, expectations of contributions and time-lines reflecting complexity [34, 50], and building of cross-sector relationships) [50]; investigators trained in RCA techniques [50]

Enhances reliability of review/investigation processes and completion in a realistic timeframe [34, 50, 79]

EAsv47

Independent, structured peer-reviews underpinned by just culture approach [72]

Reduces risk of ‘political highjack’; increases possibilities for the identification of systems-factors in development of action plans [72]

NB (costs estimated as £2,100 per peer-reviewed case) [72]

EAsv48

OUTCOMES OF DISCLOSURE PROCESS

System-Wide/QI Resolution

Board and trusts governance teams invested in action planning for post-review ongoing quality and safety improvement [34]

Shared ownership of actions and system-level changes more likely [34]

EAsv49

Focus of national bodies on improvement processes rather than completion deadlines [50]

Reduces focus by Boards on more immediate targets and greater focus on longer-term systematic change [50]

EAsv50

Integration/standardisation [50] of (internal; external) data collection/surveillance systems [53]; robust mechanisms to disseminate learning from investigations or benchmarking beyond single Trust [50] (e.g. across local maternity system); beyond single external bodies [32]; administrative support for Trusts to engage [32]

Increases opportunities for national learning from local reporting [53]; possible reduction in repeated mistakes [50]; more rapid learning [32]; engagement possible [32]

EAsv51

Ongoing review process/audit spirals or cycles [62]

Supports (re)evaluation of recommendations and their implementation [62]

EAsv52

In-Case Resolution

Meeting ongoing care requirements [80], including offer of fair compensation, and if admission of fault [82], costs payments [74, 81], and informed sign-posting for expert follow-up [80]

Diffuses anger towards individuals or service and may help to preserve relationship with family [74, 80,81,82]

EAsv53

Trust/employer recognition of duty of care to affected staff [32]; investment in dedicated joined-up post-incident support [32]; changed perspectives staff HR during investigation (e.g. time off work not a penalty) [52]

Leads to the development of joined-up and dedicated systems for effective post-incident staff support /workforce wellbeing/OD improvement [32]; staff less traumatised/likely to feel penalised [52]; staff more likely to be retained [32]

EAsv54

Wider Social Influences

Professional insurance policies support participation in disclosure procedures [78]

Impact/use of disclosure protocols increases; organisations promotion of disclosure work and systems/team perspectives on issues for improvement not undermined [78]

EAsv55

Litigation fear and costs managed [72, 78] (e.g. protected spaces [50]); external agency interventions [32, 82]

More reviews happen [72]; open communication is more likely (expected to reduce complaint and litigation need [32, 50, 82]; evidence that decreases malpractice costs [78]; legal duty not breached [50]

EAsv56

Consumer-perspective on incidents (personal/psychological [63]), disclosure, involvement routinised [54]

Consumer experience is incorporated into wider patient safety issues [54]; ‘cultural shift’ from bio-medical perspectives on incident [54, 63]

EAsv57

Increasing public pressure on policy makers [53]; costs of clinical negligence claims (connected to marginalisation of families) [32]

High-level drivers on organisations to secure disclosure improvements [32, 53]