Table 3 Explanatory accounts for improvements in open disclosure: what works, when and how from a family perspective (bolded explanatory accounts for services (eas) have been included in final c-m–o configurations (Table 6)

EAfam1

EVENT IDENTIFICATION WITH FAMILY

Incident may be catastrophic or gradually identified; outcomes may be uncertain or develop over time (12 references)

Timely and reliable confirmation of incident [58]

Reduces prolonged anxiety [58]

EAfam2

Ongoing and flexible identification of incident type/severity [50, 63, 65] in meetings and record-keeping [50, 63, 65]; follow professional duty of candour and incentivised schemes to promote candour [48, 54]

Routine invitation to family to discuss the felt incident pre-discharge/systematic assessment of reported symptoms [63]; standardised checks embedded across maternity care pathways [63]

Shows respect for parents’ views and experiences [50, 63, 65]; promotes timely referrals [63] by ensuring that subsequent providers have information for care/referral account of incident to other providers [63, 65]; encourages services to engage with families [48]; may include disclosure of incidents with lower thresholds of severity [48, 54]

EAfam3

Sensitive timing of news [61, 64]; partner involvement [60]; acknowledgment of religious and cultural preferences, language needs, and use of tools with informed guidance [62, 64] to enable decision-making for investigations (e.g. post-mortem) [58]

Seen as necessary for ongoing involvement [58]; reduces psychological demands [61]; enables best decision-making that helps later coping [60, 62, 64]

EAfam4

Co-ordinated communication with original provider/across facilities when an event is identified later in a different facility [6]

Reduces need for repeated explanation [6]

EAfam5

Uncomplicated and supported access to own health records and information [50]

Reduces suspicion that the service is hiding things behind ‘patient confidentiality’ [50]

EAfam6

ONGOING CARE AFTER EVENT

When the incident has happened (7 references)

Positive interactions with healthcare staff via acknowledgment and prioritisation of the patient’s situation [58, 60,61,62]; reducing feelings of being ignored or having the event overlooked; emotional [61] and respectful care [50]; continuity/consistency of expert care [58] and information from all staff [61] required; information on how to navigate unexpected/unusual clinical situations [61]

Efforts are highly valued by families who are facing the unknown [61]; care needs are met [58]; reduces confusion/distress or felt/expressed frustration towards immediate care staff [61]; reduces sense of isolation, confusion, and vulnerability [65] and decreases long-term negative consequences of bereavement [62]; reduces loss of confidence in HCPs [61]; sets a positive tone at the start of reviews/investigations [50]

EAfam7

DISCLOSURE PROCESS

Structures and Strategies (8 references)

National guidance, mandates, and programmes drive and routinise formal disclosure procedures and translate these into clear unit policies to include: proactive family engagement; sensitivity to diversity and individual needs [6, 59]; prompt triggering for severe adverse events (various definitions) [6, 54, 64, 77, 81, 82]; possibility of consent to further investigations [59] and early discussion of review/investigation decisions [51, 77]

Avoids demands on family to’chase’ providers for information [6, 54, 64, 82]; changes their perception of events (‘self-preservation’ of service less often assumed) [50]; families feel treated as partners [6, 51, 59] (however these formal directives do not, in themselves ensure involvement of families in all events as regulations may be infrequently followed, e.g. definitions of severity may vary) [77]

EAfam8

Service Ethos (3 references)

Ongoing/established practices in an organisation that embed and sustain ‘taken for granted’ involvement [72, 75]; involvement/engagement reinforced by wider service/organisational practice and ethos [34]

Involvement becomes routine practice in incidents/situations [34, 72, 75]

EAfam9

Service Governance (references)

Representation of families via review/investigation committee membership [72]; service/Trust oversight of family involvement [51]

Sustains awareness of family in meetings [72]; increases a sense of family entitlement to involvement [51]; families are able to inform or oversee improvements [51]

EAfam10

Commissioners are pro-active in investigation/action plan oversight [77]; Board-level responsibility for Candour regulations (and for inclusion of parents and staff in investigation processes) [48]; networked governance structures to enhance disclosure practices (Board-level, Membership Councils, QI Steering Groups; Patient Leads) [49]; annual reporting of national bodies to include lay summaries [71]

Ensures better involvement/candour [48, 77]; reduces variability of investigations [77]; embeds an expectation of family involvement in routine management [49]; engages public sector in quality improvement processes [71]

EAfam11

Accessibility and Availability of Disclosure Process (12 references)

Routine and timely invitation for parents’ views, concerns, and questions after incident [6, 34, 50, 54, 70] (including what action to be taken) offered multiple times [34, 64, 70]

Reflects best practice as agreed by families [6]; reduces felt mistrust [50] (but invitation does not, in itself, result in parents asking questions) [34, 70]; gives time to reflect on events [70] and plan questions [54]; increases awareness of opportunities to be involved [34] and opportunities to return until the family feels less dissatisfied [64]

(However, systematic and routine engagement practices are no guarantee of active participation [72])

EAfam12

Family-centred/personalised approach to disclosure discussion/follow-up [50, 59, 80] with staff freely available to respond to variability [54]; including meeting specialist needs (e.g. language services) [80]; an open-door policy to when and how to contribute [59]

Decisions on degree and nature of involvement are possible [50, 54, 59, 80] and these rest with the family [50] or they have a voice in the process [80]; open-door policy may be retriggered in subsequent pregnancy [59]

EAfam13

Disclosure process explained [52, 76] in understandable way [77]

Leads to understandable information with minimal requirement of active involvement unless desired by family [77]; an opportunity for questions to be addressed [76]; the system feeling less ineffective or closed to families [52, 76]; decisions being made with people [76]. Reduces anxiety and confusion over accountability issues [52]

EAfam14

Places Enacted (9 references)

Booked meetings with families are formal and planned by lead clinicians [54], with space and time for the parent, in a comfortable environment [34, 54]

Shows families that the event is taken seriously; responses to questions are considered/more reliable [54]; families feel more able to prepare to raise questions and concerns [34]

EAfam15

Conducted (ideally face-to-face) with nominated clinical expert [64, 73], with awareness of family situation [60]; or with those originally involved in care [71] (or with further opportunity to meet with them) [54]

Reflects agreed best practice by parents [73]; provides emotional support [60] and chances to ask questions and discuss events directly [71] (and not just as a recipient of information [64]); shows respect for personal situation [54]

EAfam16

Exclusion of legal and external/ ‘arms-length’ presence at meetings [50, 81]

Increases direct communication of family with clinicians [81]; feels less intimidating [50]; increases trust; tensions are reduced [50] (legal advice to providers should be on meeting candour and patient involvement principles) [50]

EAfam17

Early Disclosure Conversations (12 references)

Staff skilled in active listening [6]; using ‘carefully chosen words’; aware of effects of language [75], posture, and conversational tone [69]; attuned to the family’s experience [54] (responsive to expressed needs and cultural preferences [6])

Seen as a crucial aspect of effective disclosure [6, 69, 75] that can lessen harm [54]. Improves human communication by health professionals, with the most significant change felt by patients [76]

EAfam18

Authentic [67], honest and direct [6, 51, 62], and timely apology [65] (uninhibited by felt litigation risk [51, 81]; and with the provision of a ‘safe space’ [50])

Maintains trust in clinician [67] or service⁶; is valued by some parents because it is empathic [62]/suggests partnership working with them [51]; can avoid damage to healthcare relationships [81]; and enables openness after mistakes [50]

EAfam19

Explanations (5 references)

Initial clarifications that not all investigations establish cause [58]; reviews/investigations might not answer all questions [80]; findings may be inconsistent across multiple investigations of same event [50]; focusing may focus on systems-change and not individual cases [80]

Reduces disappointment, distress [58] and mistrust [50]; may facilitate helpful signposting to additional information or organisations [80]; the identification of an accountable person might be expected by a family [80]

EAfam20

Exploring initial expectations: local review of care (including avoidability and future care issues) [34, 62, 64]

Local reviews (event and findings) are a critical/’life shaping event’ for many [34, 62, 64]. Families expect information on why (explaining past; planning future) and/or systems-wide improvement [71]

EAfam21

Consistency in Disclosure Process (7 references)

Improves the consistency of care and information [54, 58, 60]; leads to fewer staff asking the same questions [6]; shows that the event is not minimised or quickly forgotten [54]; provides opportunity for irreconcilable views to be explored [54]

EAfam22

Information-giving through course of multiple investigations (for same event for different purposes [50]); future possibility of a single, integrated report [34]; clarification of ‘investigation hierarchy’ [52]

Reduces inconsistency/ experience of un-coordinated services [50]; avoids contradictory information and advice [34]; reduces felt disagreement [52]

EAfam23

Navigation of Disclosure Process (10 references)

Named contact people for ongoing family support [6, 73], liaison, or advocacy from initial disclosure to inquest [50,51,52, 71, 73, 80]; continuity of contact where possible [80]; follow-on support arranged before discharge [51]

Agreed best practice by families [6, 51, 73]; positive effect on the experience of families overall [52]; supports ongoing [50], flexible, and diverse [80] involvement (including family feedback on investigation process) [73]

Note:[however stakeholders not agreed on if this liaison personnel or advocate should be independent of, or embedded in, investigating or clinical service] [71]

EAfam24

Family nominated advocate or HCP (such as bereavement midwife) to attend review meeting; ask questions on family’s behalf [72, 73]; explain particular circumstances in that review/investigation (e.g. delays) [82]

Leads to family representation [72, 73]; information-giving and reassurance to families on progress of progress [52, 73];

advocacy relationship might diffuse family anger and harm resulting from event or poor or delayed investigation process [50, 82]

EAfam25

Joined-up systems (PALS, complaints, incidents) [51]

Reduces points-of-contact for families [51]

EAfam26

DISCLOSURE DURING REVIEWS AND INVESTIGATIONS

When incident review and/or investigation initiated (24 references)

Family pro-actively included in decisions on review/investigation from outset [34, 50, 51, 77]; able to raise nonclinical range of questions and opinions; perspectives and comments accommodated (and independent investigator ‘checks’ this opinion-seeking has happened) [50]; centrality of family views embedded in review/investigation process [70] and process design [59, 70, 71, 73]

Inclusion of family experience and perspectives [50, 59] means that investigations or reviews more meaningful [34, 77] and effective [77] for the family (however est. 59% of reports where questions of family not addressed) [50]. Reduces distrust; accuracy and credibility of investigation are enhanced [50, 51]; involvement in finding explanations may alleviate harm [70]; engagement could be extended to other services [73]

EAfam27

Use of nationally agreed standards [77], with policies and local guidance with co-ordinated, consistent, and explicit rationale and approach for parent involvement [50, 72, 77]; standardised mortality review tools incorporate family involvement [34, 70, 71] standardised communication process (that allows tracking of progress) [77]

Reduces variation in involvement across cases and units [50, 51]; involvement more central to investigations/ investigation quality assessment [77]; more co-ordinated and consistent communication possible [77]; More likely to be informed of review and invited to raise questions, concerns [34, 70, 71] (concerns/questions raised by 58% of parents)

NB (policies do not necessarily guarantee respectful and caring family involvement [60])

EAfam28

Comprehensive reviews/investigations include whole care pathways [34, 58, 59] with multi-disciplinary/cross-service representation [76] with families and subsequent sharing of knowledge of events/effects beyond that service [65]

Incorporates overall family experience of care [58, 76]; prevents loss of information [76]; could avoid further investigations with costs to family [34]; enhances learning for system-improvements [34, 59] encourages wider service responsiveness to recommendations for ongoing or subsequent care requirements [65]

EAfam29

Structured and accessible general information for families on steps and timescales of review/investigation with family-centred design and delivery [48, 52, 58, 60, 70, 77, 82]

Minimal requirement for family’s active involvement if they choose [77]. Family more likely to be included in the process [52, 60]; decision-making [58]; ability to ask questions [70]; and understanding reasons for investigation [48] or time it may take [50, 82]

EAfam30

Clarification of the primary objective of that review/investigation for a family [80]

Reduces misunderstanding and disappointment [80]; directs appropriate questions and defines expected limitations of review [80]

NB (however families sometimes anticipate that review multiple purposes, from explaining what happened [34, 61] to recommendations for wider learning and prevention [61])

EAfam31

Specialist (emotional and practical) support and advocacy provision for families (and information on this) [50, 77]; user-groups advise on least harmful timings/approaches to family [73]

Necessary if families to be included in investigations [77]; agreed best practice [73]

EAfam32

Individualised/flexible or ‘open door’ opportunities for Involvement [51, 59] that are appropriately timed [54], high-quality review/investigation process (contribution to ToR, questions and report drafts) [34, 50, 75, 77, 80]; with named support of, and formal documentation of, parent feedback on this process [73]

Accommodates individual and changing needs [51, 59]; best practice principles (as agreed by parent representatives [73]);or expectation of active involvement [34, 77]. Families are more likely to be involved in and satisfied with report [50, 80]; there is an appreciation of honesty, openness, and detail [75]

EAfam33

Meaningful apology and explanation to family for avoidable harm [48,49,50, 77] (that is timely [65]) with assurances of learning [48, 49]; expression of regret from those accountable [48, 54]

Necessary recognition of the familiy [77] and accountability [48]; trauma may be reduced [49]; personal resolution possible [54]; trust in health care provision might be sustained [48]; and the situation is less likely to escalate to complaint about concerns or legal action to get answers [49, 50]. However, when apologies are offered too late (or the family are not ready to engage), trauma may be increased [65]

EAfam34

OUTCOMES OF DISCLOSURE PROCESS

Reporting and Feedback (9 references)

Informing /discussing with families as review/investigation continues [52, 71] (including delays) [50], as well as discussion of final report findings and feedback on involvement process [50, 52, 79, 80]

Prevents mistrust caused by either ‘closed door’ investigation and denial of ongoing discussion [71]; enables family concerns to be raised over time [52]; lessens information ‘drip feed’ (without possibility to ask questions) [50, 79]; final report more likely to be satisfactory [50]

NB: (however: 24% of respondents agreed with value of family feedback survey for ongoing quality improvement (may be onerous from families and should be optional) [52])

EAfam35

Reports are accurate, appear complete and without jargon [50, 77]; (if external) are forwarded to families before Trusts [77, 80]

Indicates that report is reliable, understandable [50, 77], and open from a family perspective [80]

EAfam36

System-Wide/QI Revisions (8 references)

Action (and accountability for this action) from review/investigation to prevent same event happening again [5, 6, 50, 59, 81]; selective in-depth investigations (including near-misses) to maximise learning [52]

Leading/initiating change based on event/experience [50, 65]

Families want this to make sense of loss [50, 59, 81]

NB: (however 83% families think that investigation had made no positive difference; 73% unclear on what learning had happened) [50]; some families want personal accountability for events [80]; exclusion of family’s own case from improvement programme might not be acceptable to them [52]

Leading/assuring change may be adequate in some situations [50, 65]

EAfam37

Family Resolutions (3 references)

Offer of fair compensation (if admission of fault) [82] and payment of expenses/further access to services of involvement in disclosure process in all situations [48, 81]

Appreciated by families [81]; may promote some family’s involvement in disclosure processes [48]; diffuses anger and may preserve relationships [82]

EAfam38

Indirect Social Revisions (7 references)

Public awareness (and information) on rights to raise concerns and to support/advocacy after incidents [50, 51]

Increases number of families informed/engaging [50]; decreases marginalisation after incident [51]

EAfam39

Revisions in clinicians’ awareness of effects of professional cultures on involvement and care [76]

Main barrier to involvement reduced for some, especially when more vulnerable and making decisions about involvement [76]

EAfam40

Improvements in communication skills of doctors [65]

Increases ability to deliver care more generally [65]

EAfam41

Wider awareness of value of family/patient insights along with clinical insights [50, 52, 80]

Recognition possible; reduces antagonism [50]; improves understanding of events [80]; view of families as disruptive is less likely [52]