Table 6 Five programme theories for improvements in open disclosure.(c-m–o configurations identified from eas relevant to families (eafam, see Table 3), staff (easf, see Table 4), and services (eav, see Table 5)
INITIAL PROGRAMME THEORY | Context | Mechanism | Outcome | |||
|---|---|---|---|---|---|---|
Incident | Institutional Conditions and Systems | Resources, constraints, and opportunities shaping this element | Reasons, responses, and assumptions involved in this element | More immediate changes in experience, perspectives, and behaviours | Longer-terms changes in perspectives, values, and practices | |
MEANINGFUL ACKNOWLEDGEMENT THAT HARM HAS HAPPENED | Circumstances and conditions of harm identified (irrespective of whether this is avoidable) | Â | -Senior leadership buy-in to implementation of OD (EAv6) | Â | Â | -OD becomes embedded as a taken-for-granted aspect of clinical care (EAv6) |
|  |  | Legislation for disclosure of some incidents (EAv3) Professional Duties and Codes of Conduct for disclosure (EAfam2) Incentivised safety improvement schemes with prescribed thresholds for disclosure (EAfam2) | -Expert clinician availability, time, attention, and continuity for initial and subsequent family meetings (including meeting preparation time) (EAsf31;5) (EAv6) - ‘Safe space’ for the lead clinician to undertake a formal meeting with parents, without fear of litigation (EAfam18, EAsf11) | -Honest, timely, and personalised acknowledgment of harm to the family that includes empathic apology in context with an ongoing clinical relationship; sensitivity to the family’s needs for further discussion and recognition of/meeting family entitlement to NHS compensation (EAfam1;2;18;33) (EAsf21) -Involvement of family in disclosure conversations and processes organised around their situation and needs (EAsf31) | For families… -Might recover family trust or confidence in the clinician or the service (EAfam2;18) -Reduces secondary harm (by improved incidence of disclosure) (EAfam1;33) (EAv3;6) -Families are less likely to always feel aggrieved (EAsv3) For staff… -The trauma and anxiety of the event may be alleviated if an incident is discussed openly with a family (EAsf18) | For families… -Reduces damage to wider health care relationships caused by not recognising/ignoring harm done (respect for family experience) (EAfam2;18) May lead to active and more satisfying participation in reviews/investigations and inclusion of incidents defined by family as significant (EAfam2) |
|  |  |  | -Service investments for developing and sustaining expertise and confidence of clinicians engaging with injured families (EAsf10;18) (EAv5) |  | For families… -Possibilities for more families to have a voice in disclosure conversations, to attend meetings, and to be heard (EAsf10) For staff… -Increased confidence and expertise in undertaking disclosure (EAsf10) | For staff… -Increased confidence and expertise in undertaking other sensitive meetings and conversations (EAv5) -May result in greater awareness of family-defined events of harm and care (EAfam6) (EAsf5) |
|  |  |  | -Inter-professional, intra-service and inter-service working to recognise emergency of harm over time (EAv45) -Pre-discharge assessment of possible harm to a family (EAfam6) |  | For families… -Possibilities for the family to identify and report harm and receive a sincere and relevant response to their concerns in situations that would ordinarily be unknown to the service (EAfam6) (EAsf5) -May lead to more timely reparations (treatment or compensation) (EAfam2;6) | For services… -Increased service investments in guidance and staff (EAv9) -Creates possibilities for service learning (EAv3;45) -OD becomes embedded as ongoing and wide-spread clinical activity (EAv6) |
CLINICIANS WHO ARE SKILLED IN OD |  | Professional and organisational obligations to conduct empathic disclosure with families (EAsf8;20) -Employer obligations to staff (EAsf20) | -Service investments in specialist communication training and its commissioning for clinical leads (EAfam17;18) (EAsf9;31) (EAv15;17) -Cognitive aids to support disclosure conversation (EAsf21) -Time to prepare for disclosure conversations with families (EAsf17;19) Ongoing peer support (formalised in mentorship) for OD practice development (EAsf31) -Availability of time during staff induction and in-service meetings to disseminate best practice examples of disclosure with families (EAsf5) -Coordinated investment in learning between clinical and corporate leads to carry an ‘organisational ethos’ of no-blame (EAsf1;4;12;23) | -Staff who are committed to OD as a practice (EAv 15) and who are able to ‘bridge the gap’ between in principle agreement and practice change (EAv17) (EAsf14) -Learning by mentorship and role modelling (EAsf13) -Confidence to innovate aids and guidance in response to events and family situations (EAsf26) -Staff have the opportunity and authority to disseminate new approaches to wider clinical team (necessary for revisions of practice) (EAsf35) -Availability of clinical leads to mentor junior staff in disclosure skills (EAsf7) (EAv10) | For families… -Expertise and felt safety of clinicians is necessary for meaningful apology and open conversation, which impacts families (EAfam17;18) -May mean that a family feels recognised when guidelines improvised to their needs (EAsf26) For staff… -Anxiety and uncertainty (emotional toll) around encounters with harmed families may be reduced; more positive relationships with families may be possible (EAsf13) -Increases confidence and competence in disclosure conversations; relationships with family may be preserved (EAsf13;17;19;31) | For families… -Possibility of more widespread openness in senior clinician responses to events of harm and enquiries about harm (EAsf14) For staff… -Could encourage staff to trigger formal response of suspected adverse event (EAsf1;32) -Openness to families more likely to become the ‘mind set’ of practitioners (EAsf13) -Emotional and social support needs (during investigation and post-incident) will be met by teams on a routine basis (EAsf4;6;20;33) |
CLINICIANS WHO FEEL SAFE PRACTICING OD |  |  | -Post-incident clinician support to explain events (individual and team debriefings) (EAsf33) -Availability of joined-up and consistent post-incident emotional support during incident investigations (including commissioning of appropriate post-incident care/counselling support if required)(EAsf6) (EAv53) -Dedicated post-incident support for individuals (educational supervisors or commissioned services) (EAsf32); organisations meet duty of care to staff (EAv53) | -Trust in colleagues, managers, and educators to seek emotional support during investigation (EAsf32) | For families… More likely that disclosure will happen in the future (EAsf33) | For staff… -Possibility of revised perspectives on infallibility (and recognition of clinician needs for emotional care) (EAsf36) For services… -More likely to retain trainees and staff; more likely to embed meaningful disclosure practices as ‘taken-for granted’ aspect of patient care (EAsf5;32) (EAv10;53) -Desired practice of OD more likely to be supported by staff (EAv10) |
FAMILY INVOLVEMENT IN REVIEWS AND INVESTIGATIONS |  | National and local programmes for examining events of harm that seek to include family questions or perspectives during incident review or investigation processes (EAfam7) (EAsf31) | -Organisational governance and professional leadership promoting family involvement in the process (including the family voice) (EAfam9) (EAv14;25;28;29;31;32;34) -Dedicated time for named clinician or independent person to act as an advisory ‘link’ between family and organisations (EAfam23;24) (EAsf24;28) (EAv43) -Family-centred/open-door policies for involvement (EAfam12;32) -Guidelines for staff for family engagement processes and use of these guidelines (EAfam7;34) (EAv42) -Family advocacy (service or charity based) representing family concerns (EAfam31) (EAv35;42) Family navigator systems (EAfam23;24) -Spaces for cross-service working (e.g., with GPs and bereavement specialists) to address longer-term family needs (questions and conversations) (EAfam28) -Provision of interpreters (EAfam3;7) Availability of family therapeutic support during process (EAfam31) Family-centred care pathway with post-discharge care planning (EAfam28) | -Service ethos of family involvement promoted in governance and to professional staff (EAfam8) -Personalised approach that increases availability and accessibility of involvement in review/investigations is possible (EAfam12); disclosure processes are explained in a way the family understands (EAfam13), face-to-face, with time and space for the family (EAfam15;23;24); continuity of family involvement (EAfam23) -Relational care of the family (responsive to situation, background, changing needs, circumstances) (EAfam12;15;17;23;24) (EAsf4) | -For families… Do not have to ‘chase’ information on their review/investigation (EAfam8) and mistrust is reduced (EAfam7) -Clarification of processes reduces confusion and mistrust (EAv42;34); gives the family opportunity for questions (EAfam14;15;23;24;26;28) -Engagement in process can be adjusted to the family’s needs, interests, and situation (EAfam12;15;32) Specialist support for social diversity and/or emotional needs necessary for some families to be involved in investigation process is provided (EAfam7;12;31) -Family perspectives and questions represented during reviews and investigations (EAv40) For staff… -Clarification of processes (EAv42) -Family involvement is an aspect of the clinical or independent role (not discretionary) (EAsf28) For services… -May prevent complaint or litigation by diffusing anger, but may increase demands on the service by an expert family advocate (EAfam24) | For families… -May strengthen consistency of routine practices of family involvement throughout reviews and investigations, including family-centred approaches to this involvement (EAfam9) (EAsf24) -Possibilities of active partnership working with clinicians and/or services (EAfam8) For staff… -May increase knowledge and confidence and decrease the emotional demands of working with harmed families (EAsf28) -May enhance interest and commitment of staff to involve families in reviews/investigations (EAv14;25;35;40;42) -May establish new perspectives on family/staff relationships (EAsf28) For services… -May strengthen family-centred approaches across the service more generally (EAv28;40) |
MAKING SENSE OF WHAT HAPPENED |  | National and local programmes for examining events of harm that seek to include family questions or perspectives during incident review or investigation processes (EAfam7) (EAsf31) Availability of different frameworks for incident reviews and investigations in maternity care (EAfam22) | -Policies and guidance for incident review and investigation reporting, that include family perspective (EAv45) -Protocols and incentives for and prompt referral to other reviews and independent investigators (EAv11) -Organisational support and resourcing for clinicians to respond to family questions about investigation findings (EAsf7;17) | -Incorporation of family perspectives on the event (these may differ from service perspective or clinical records (EAsf17;19) (EAv14) or may be used to supplement these views and records) (EAfam26) (EAsf10;36) -Multiple explanations may be presented to family and explained in the integrated report (EAfam20;22) -May align the expectations of families with what is possible (EAfam19) May establish some negotiated understanding with families who require individual accountability for the incident (EAfam19) (EAsf10) | For families… -Report is accurate and accommodates family perspective, is complete and free from jargon, and is forwarded to families before being forwarded to organisation (EAfam35) -When shared understanding can be agreed, a sense of resolution, relief, lifting of guilt, and less mistrust of clinicians or service is possible. When disagreements over events continue, then further distrust in clinicians or service results (EAfam19;20;22) (EAv11;45) For staff… -Increased confidence to discuss the event with colleagues; where a ‘fair culture’ approach is taken, staff feel less fearful of blame or loss of reputation (EAsf10;17;19) -When family expertise is incorporated into the understanding of the event, skills in responding to family perspectives and concerns are enhanced (EAsf26) For services… -Development of different or more comprehensive understanding of an event because of the family’s contribution (EAv45) -Possibility of reduced litigation when families have answers to their questions and prompt referrals are done (EAv11) | For families… -Families more likely to feel confident in the process and in the honesty of the service (EAv14) -Greater possibility for securing practice and service improvement that includes family experience (EAfam22) Revisions in public understanding of clinical authority and infallibility (EAfam20) For staff… -Revised perspectives on bio-medical authority and infallibility (EAsf36) -Open discussion of adverse incidents is normalised (without immediate fears to reputational damage) (EAsf7) For services… -Family expertise and experience possibly available as additional learning resource (EAfam26) If disagreements continue, then possible reduction of distrust and legal action by families (Eafam19; 22) |
SEEING THAT THINGS HAVE CHANGED |  |  | -Comprehensive and structured organisational investments in OD (candour training, guidelines, leadership) to enhance openness for the purpose of systems-improvement (EAv45) -Increased organisational accountability for acting on systems-errors (external monitoring and benchmarking) (EAv12) | -Embedded open (not defensive) responses to families and to incident reporting for service improvement (EAsf35) -May encourage or undermine openness to families and organisations depending on implementation (EAsv35) | For families… -Reassurance that lessons have been learned; might help to make sense of loss (EAfam36); clarification of service accountability (EAv11;EAv48) For staff… -Reported reduction in post-event trauma when corrective actions after the incident are taken and evident (EAfam36;9) (EAsf35) (EAv11) For services… Enhanced learning (EAv45;11;12) | For families… -Organisational commitment to (or demonstration of) change because of systems failings might generate new perspectives on user involvement in education and services (EAfam9) For staff… -Ongoing normalisation of discussions about incidents (between colleagues and with families) might be possible (EAsf1;7;23) -Families involved in updates on post-incident actions/accountabilities (EAfam36) |
|  |  |  | -Revision of management, corporate, and inspection priorities from completion of narrow deadlines to demonstration of learning towards systematic improvement (EAv48) -Development of senior risk and safety teams (aligned with quality improvement teams and governance, including family representation) (EAfam9) (EAsf1;7) (EAv48) -Protocols and incentives for (and prompt referral to) other reviews and independent investigators (EAv11) | -Shift from improvement as a short-term target/completion deadline to an ongoing process (EAv48) |  | For services… -Safety challenges and recommended improvement strategies are more visible and the is an investment in their long-term completion (EAv48) -New practices of service accountability to the public, including harmed families, might be developed (through user-voice in Board, Council, and QI meetings and collaborative improvement work) (EAfam9) (EAv50) |
|  |  |  | -Cross-boundary/whole pathway working (e.g. primary care and counselling, for communication and learning about incidents in maternity units (EAv50;EAfam28) | -Requires cross-sector clarification of leadership, investigation methodologies, and approaches to learning and accountability (EAv50) | For families… Recommendations more likely to reflect their experience of an incident (EAfam28) | For services… *Ongoing opportunities to identify more immediate and longer-term practice and service failings (EAv45;50) |
|  |  |  | -Individual patients or families with opportunity and networks to press for change in a unit or across the wider service to address events like those they experienced (EAfam9) | -Family with social capital to influence professional leads and with motives and networks for dissemination of learning (EAfam28) | For families… -Learning alleviates the harm of the incident (EAfam28) -Recognition of some individuals’ or families’ ‘expertise by experience’ by professional bodies and their members (EAsf23) For staff… Learning from incidents (EAfam28) | For families, staff and services… -Safety improvement might happen in some services (EAfam28) -Development of staff skills and awareness of the value of family insights, including informing safety and care priorities (EAfam28) |