Experiences and Perceptions of Healthcare Stakeholders in Disclosing Errors and Adverse Events to Historically Marginalized Patients.

OBJECTIVES: We sought to assess the experiences and perceptions of healthcare stakeholders involved in the response to historically marginalized patients who have been harmed in healthcare. We investigated the challenges in disclosing errors and adverse events and the types of tools and resources that would better address the needs of historically marginalized patient populations. METHODS: We conducted separate focus groups with two healthcare stakeholder groups: (1) frontline clinicians directly involved in the clinical care of historically marginalized patients and (2) risk and patient safety professionals involved in the hospital response to care breakdowns. We conducted an inductive analysis of the qualitative data to identify thematic clusters. RESULTS: We interviewed 7 clinicians and 5 risk safety professionals, with a total sample size of 12 participants. Participants shared multilevel challenges in responding to historically marginalized patients after harm (system-, organizational-, and patient-level), such as fragmentation of care, lack of standardized protocols, and patient mistrust. Participants also identified their desired tools and resources for disclosure to meet the needs of historically marginalized patients, which included culturally appropriate toolkits, disclosure training, and the inclusion of multidisciplinary healthcare team members in the disclosure process. CONCLUSIONS: Our results suggest that multiple interventions will be needed to achieve the goal of prompt disclosure of errors and adverse events across all populations engaged in health care. Future studies should investigate the perspectives of historically marginalized patients and their family members on how error and adverse event disclosure conversations should unfold.

Effects of Practicing With and Obtaining Crowdsourced Feedback From the Video-Based Communication Assessment App on Resident Physicians' Adverse Event Communication Skills: Pre-post Trial.

BACKGROUND: US residents require practice and feedback to meet Accreditation Council for Graduate Medical Education mandates and patient expectations for effective communication after harmful errors. Current instructional approaches rely heavily on lectures, rarely provide individualized feedback to residents about communication skills, and may not assure that residents acquire the skills desired by patients. The Video-based Communication Assessment (VCA) app is a novel tool for simulating communication scenarios for practice and obtaining crowdsourced assessments and feedback on physicians' communication skills. We previously established that crowdsourced laypeople can reliably assess residents' error disclosure skills with the VCA app. However, its efficacy for error disclosure training has not been tested. OBJECTIVE: We aimed to evaluate the efficacy of using VCA practice and feedback as a stand-alone intervention for the development of residents' error disclosure skills. METHODS: We conducted a pre-post study in 2020 with pathology, obstetrics and gynecology, and internal medicine residents at an academic medical center in the United States. At baseline, residents each completed 2 specialty-specific VCA cases depicting medical errors. Audio responses were rated by at least 8 crowdsourced laypeople using 6 items on a 5-point scale. At 4 weeks, residents received numerical and written feedback derived from layperson ratings and then completed 2 additional cases. Residents were randomly assigned cases at baseline and after feedback assessments to avoid ordinal effects. Ratings were aggregated to create overall assessment scores for each resident at baseline and after feedback. Residents completed a survey of demographic characteristics. We used a 2×3 split-plot ANOVA to test the effects of time (pre-post) and specialty on communication ratings. RESULTS: In total, 48 residents completed 2 cases at time 1, received a feedback report at 4 weeks, and completed 2 more cases. The mean ratings of residents' communication were higher at time 2 versus time 1 (3.75 vs 3.53; P<.001). Residents with prior error disclosure experience performed better at time 1 compared to those without such experience (ratings: mean 3.63 vs mean 3.46; P=.02). No differences in communication ratings based on specialty or years in training were detected. Residents' communication was rated higher for angry cases versus sad cases (mean 3.69 vs mean 3.58; P=.01). Less than half of all residents (27/62, 44%) reported prior experience with disclosing medical harm to patients; experience differed significantly among specialties (P<.001) and was lowest for pathology (1/17, 6%). CONCLUSIONS: Residents at all training levels can potentially improve error disclosure skills with VCA practice and feedback. Error disclosure curricula should prepare residents for responding to various patient affects. Simulated error disclosure may particularly benefit trainees in diagnostic specialties, such as pathology, with infrequent real-life error disclosure practice opportunities. Future research should examine the effectiveness, feasibility, and acceptability of VCA within a longitudinal error disclosure curriculum.

Video-Based Communication Assessment of Physician Error Disclosure Skills by Crowdsourced Laypeople and Patient Advocates Who Experienced Medical Harm: Reliability Assessment With Generalizability Theory.

BACKGROUND: Residents may benefit from simulated practice with personalized feedback to prepare for high-stakes disclosure conversations with patients after harmful errors and to meet American Council on Graduate Medical Education mandates. Ideally, feedback would come from patients who have experienced communication after medical harm, but medical researchers and leaders have found it difficult to reach this community, which has made this approach impractical at scale. The Video-Based Communication Assessment app is designed to engage crowdsourced laypeople to rate physician communication skills but has not been evaluated for use with medical harm scenarios. OBJECTIVE: We aimed to compare the reliability of 2 assessment groups (crowdsourced laypeople and patient advocates) in rating physician error disclosure communication skills using the Video-Based Communication Assessment app. METHODS: Internal medicine residents used the Video-Based Communication Assessment app; the case, which consisted of 3 sequential vignettes, depicted a delayed diagnosis of breast cancer. Panels of patient advocates who have experienced harmful medical error, either personally or through a family member, and crowdsourced laypeople used a 5-point scale to rate the residents' error disclosure communication skills (6 items) based on audiorecorded responses. Ratings were aggregated across items and vignettes to create a numerical communication score for each physician. We used analysis of variance, to compare stringency, and Pearson correlation between patient advocates and laypeople, to identify whether rank order would be preserved between groups. We used generalizability theory to examine the difference in assessment reliability between patient advocates and laypeople. RESULTS: Internal medicine residents (n=20) used the Video-Based Communication Assessment app. All patient advocates (n=8) and 42 of 59 crowdsourced laypeople who had been recruited provided complete, high-quality ratings. Patient advocates rated communication more stringently than crowdsourced laypeople (patient advocates: mean 3.19, SD 0.55; laypeople: mean 3.55, SD 0.40; P<.001), but patient advocates' and crowdsourced laypeople's ratings of physicians were highly correlated (r=0.82, P<.001). Reliability for 8 raters and 6 vignettes was acceptable (patient advocates: G coefficient 0.82; crowdsourced laypeople: G coefficient 0.65). Decision studies estimated that 12 crowdsourced layperson raters and 9 vignettes would yield an acceptable G coefficient of 0.75. CONCLUSIONS: Crowdsourced laypeople may represent a sustainable source of reliable assessments of physician error disclosure skills. For a simulated case involving delayed diagnosis of breast cancer, laypeople correctly identified high and low performers. However, at least 12 raters and 9 vignettes are required to ensure adequate reliability and future studies are warranted. Crowdsourced laypeople rate less stringently than raters who have experienced harm. Future research should examine the value of the Video-Based Communication Assessment app for formative assessment, summative assessment, and just-in-time coaching of error disclosure communication skills.

Risk Communication After Health Care Exposures: An Experimental Vignette Survey With Patients.

Purpose. We investigated how health care systems should communicate with patients about possible exposures to blood-borne pathogens that may have occurred during their care. Our goal was to determine how best to communicate uncertain risk information in a way that would minimize harm to patients, maintain their trust, and encourage patients to seek follow-up treatment. Methods. Participants (N = 1103) were randomized to receive one of six vignette surveys; 997 (98.4%) responded. All vignettes described the same event, but differed by risk level and recommendations (lower risk v. higher risk) and by communication mode (telephone, letter, social media). We measured participants' perceived risk of blood-borne infection, trust in the health care system, and shared decision making about next clinical steps. Open-ended questions were analyzed using grounded thematic analysis. Results. When the vignette requested patients to undergo testing and practice certain health behaviors (higher risk), participants' likelihood of seeking follow-up testing for blood-borne pathogens and their understanding of health issues increased. Perceived trust was unaffected by risk level or communication processes. Qualitative data indicated a desire for telephone communication from providers known to the patient. Limitations. It is not clear whether higher risk language or objective risk levels in vignettes motivated patients' behavioral intentions. Conclusion. Using higher risk language when disclosing large-scale adverse events increased participants' willingness to seek follow-up care. Implications. Health care organizations' disclosures should focus on the next steps to take after health care exposures. This communication should involve helping patients to understand their personal health issues better, make them feel that they know which steps to take following the receipt of this information, and encouraging them to seek follow-up infectious disease testing in order to better take care of themselves.

From implementation to sustainment: A large-scale adverse event disclosure support program generated through embedded research in the Veterans Health Administration.

In 2008, the Veterans Health Administration published a groundbreaking policy on disclosing large-scale adverse events to patients in order to promote transparent communication in cases where harm may not be obvious or even certain. Without embedded research, the evidence on whether or not implementation of this policy was generating more harm than good among Veteran patients was unknown. Through an embedded research-operations partnership, we conducted four research projects that led to the development of an evidence-based large-scale disclosure toolkit and disclosure support program, and its implementation across VA healthcare. Guided by the Consolidated Framework for Implementation Research, we identified specific activities corresponding to planning, engaging, executing, reflecting and evaluating phases in the process of implementation. These activities included planning with operational leaders to establish a shared research agenda; engaging with stakeholders to discuss early results, establishing buy-in of our efforts and receiving feedback; joining existing operational teams to execute the toolkit implementation; partnering with clinical operations to evaluate the toolkit during real-time disclosures; and redesigning the toolkit to meet stakeholders' needs. Critical lessons learned for implementation success included a need for stakeholder collaboration and engagement, an organizational culture involving a strong belief in evidence, a willingness to embed researchers in clinical operation activities, allowing for testing and evaluation of innovative practices, and researchers open to constructive feedback. At the conclusion of the research, VA operations worked with the researchers to continue to support efforts to spread, scale-up and sustain toolkit use across the VA healthcare system, with the final goal to establish long-term sustainability.

Using crowdsourced analog patients to provide feedback on physician communication skills.

OBJECTIVE: Effective physician-patient communication is important, but physicians who are seeking to improve have few opportunities for practice or receive actionable feedback. The Video-based Communication Assessment (VCA) provides both. Using the VCA, physicians respond to communication dilemmas depicted in brief video vignettes; crowdsourced analog patients rate responses and offer comments. We characterized analog patients' comments and generated actionable recommendations for improving communication. METHODS: Physicians and residents completed the VCA; analog patients rated responses and answered:"What would you want the provider to say in this situation?" We used qualitative analysis to identify themes. RESULTS: Forty-three participants completed the VCA; 556 analog patients provided 1035 comments. We identified overarching themes (e.g., caring, empathy, respect) and generated actionable recommendations, incorporating analog patient quotes. CONCLUSION: While analog patients' comments could be provided directly to users, conducting a thematic analysis and developing recommendations for physician-patient communication reduced the burden on users, and allowed for focused feedback. Research is needed into physicians' reactions to the recommendations and the impact on communication. PRACTICE IMPLICATIONS: Physicians seeking to improve communication skills may benefit from practice and feedback. The VCA was designed to provide both, incorporating the patient voice on how best to communicate in clinical situations.

Communication Training, Adverse Events, and Quality Measures: 2 Retrospective Database Analyses in Washington State Hospitals.

OBJECTIVE: Washington State's HealthPact program was launched in 2011 as part of AHRQ's Patient Safety and Medical Liability Reform initiative. HealthPact delivered interdisciplinary communication training to health-care professionals with the goal of enhancing safety. We conducted 2 exploratory, retrospective database analyses to investigate training impact on the frequency of adverse events (AEs) and select quality measures across 3 time frames: pretraining (2009-2011), transition (2012), and posttraining (2013). METHODS: Using administrative data from Washington State's Comprehensive Hospital Abstract Reporting System (CHARS) and clinical registry data from the Surgical Care and Outcomes Assessment Program (SCOAP), we compared proportions of AEs and quality measures between HealthPact (n = 4) and non-HealthPact (n = 93-CHARS; n = 48-SCOAP) participating hospitals. Risk ratios enabled comparisons between the 2 groups. Multivariable logistic regression enabled investigation of the association between training and the frequency of AEs. RESULTS: Approximately 9.4% (CHARS) and 7.7% (SCOAP) of unique patients experienced 1 AE or greater. In CHARS, the odds of a patient experiencing an AE in a HealthPact hospital were initially (pretraining) higher than in a non-HealthPact hospital (odds ratio [OR], 1.13; 95% confidence interval [CI], 1.10-1.17), lower in transition (OR, 0.80; 95% CI, 0.76-0.83) and posttraining (OR, 0.72; 95% CI, 0.69-0.75) periods. In SCOAP, ORs were consistently lower in HealthPact hospitals: pretraining (OR, 0.87; 95% CI, 0.80-0.95), transition (OR, 0.75; 95% CI, 0.70-0.81), and posttraining (OR, 0.63; 95% CI, 0.58-0.68). The proportion of at-risk patients that experienced each individual AE was low (<1%) throughout. Adherence to quality measures was high. CONCLUSIONS: Interprofessional communication training is an area of intense activity nationwide. A broad-based training initiative may play a role in mitigating AEs.

Long-Term Impacts Faced by Patients and Families After Harmful Healthcare Events.

BACKGROUND: Patients and families report experiencing a multitude of harms from medical errors resulting in physical, emotional, and financial hardships. Little is known about the duration and nature of these harms and the type of support needed to promote patient and family healing after such events. We sought to describe the long-term impacts (LTIs) reported by patients and family members who experienced harmful medical events 5 or more years ago. METHODS: We performed a content analysis on 32 interviews originally conducted with 72 patients or family members about their views of the factors contributing to their self-reported harmful event. Interviews selected occurred 5 or more years after the harmful event and were grouped by time since event, 5 to 9 years (22 interviews) or 10 or more years (10 interviews) for analysis. We analyzed these interviews targeting spontaneous references of ongoing impacts experienced by the participants. RESULTS: Participants collectively described the following four LTIs: psychological, social/behavioral, physical, and financial. Most cited psychological impacts with half-reporting ongoing anger and vivid memories. More than half reported ongoing physical impacts and one-third experienced ongoing financial impacts. Long-term social and behavioral impacts such as alterations in lifestyle, self-identity, and healthcare seeking behaviors were the most highly reported. CONCLUSIONS: These patients and families experienced many profound LTIs after their harmful medical event. For some, these impacts evolved into secondary harms ongoing 10 years and more after the event. Our results draw attention to the persistent impacts patients and families may experience long after harmful events and the need for future research to understand and support affected patients and families.

Disclosure Coaching: An Ask-Tell-Ask Model to Support Clinicians in Disclosure Conversations.

ABSTRACT: Error disclosure is a high-stakes, emotionally charged interaction for patients and families as well as clinicians. A failed disclosure can result in emotional distress, reduced patient and family trust, litigation, and lost opportunities to learn from and prevent subsequent errors. However, many clinicians have little expertise in handling these challenging interactions and can inadvertently make a bad situation worse. Even those clinicians who have had formal disclosure training may have trouble remembering what they were taught when faced with the need to actually discuss an error with patients. Providing just-in-time coaching to clinicians is recommended by national standards. However, there is scant training material to guide error disclosure coaches. Therefore, we developed an "Ask-Tell-Ask" model and materials to guide the disclosure coaching process. The Ask-Tell-Ask model is well-suited to provide clinicians with targeted interactive teaching immediately before a disclosure without overwhelming them with lecture-style facts that they are unlikely to retain. Such teaching would ideally be provided by trained disclosure coaches, available for just-in-time support of clinicians throughout the disclosure process. The Ask-Tell-Ask model can also help risk managers, department heads, clinical managers, attending physicians, service chiefs, and others who assist clinicians with error disclosure. Here, we describe a comprehensive approach to coaching developed over years of coaching experience that incorporates the model, its rationale, step-by-step coaching strategies and guidance (including sample scripts), and organizational considerations regarding implementation of a coaching program to support patient-centered transparent communication after harmful events.

Encouraging Patients to Speak up About Problems in Cancer Care.

OBJECTIVES: Many patients with cancer believe that something has gone wrong in their care but are reluctant to speak up. This pilot study sought to evaluate the impact of an intervention of active outreach to patients undergoing cancer treatment, wherein patients were encouraged to speak up if they had concerns about their care and to describe the types of concerns patients reported. METHODS: Patients receiving cancer care at two sites were randomly assigned to an intervention or control group. Intervention patients received a brochure encouraging them to speak up about any concerns and an outreach telephone call during which the interviewer explicitly asked about concerns. Participants in both groups received baseline and follow-up questionnaires assessing their perceptions of their care and whether anything had "gone wrong" and provided ratings of health care providers' communication and responsiveness. Qualitative content coding was used to categorize patient-reported concerns collected through the baseline and follow-up questionnaires (both groups) and during telephone outreach (intervention patients only). The primary outcome was the number of patients reporting a concern about their care. Communication and responsiveness ratings for intervention and control group patients were compared using t tests. RESULTS: Of the 60 patients in the intervention group, 34 (56.7%) reported at least one problem or concern, compared with 16 (29.1%) of the 55 patients in the control group (P = 0.003). The telephone outreach in particular resulted in more than half of those reached reporting a new concern (55.3%). We detected no impact of the intervention on patients' ratings of communication or support for speaking up. CONCLUSIONS: Patients in this study reported a variety of concerns in response to active outreach, demonstrating that active outreach to patients can provide healthcare teams and systems the opportunity to offer a real-time response to the patient, identify where system improvements are needed, and implement policies, procedures, or programs to prevent recurrences.

We Want to Know-A Mixed Methods Evaluation of a Comprehensive Program Designed to Detect and Address Patient-Reported Breakdowns in Care.

BACKGROUND: Patients have important insights into care experiences, including breakdowns, but are often reluctant to speak up. The We Want to Know (WWTK) program was designed to make it easy for hospitalized patients to speak up about breakdowns in care and receive a response. METHODS: The WWTK program was implemented from June 2014 through May 2017 at a large, community hospital in Baltimore. Core program features include (1) multiple channels for patients to report breakdowns, (2) campaign materials to increase patient awareness of the WWTK program, and (3) a specialist to facilitate resolution of breakdowns. This program was evaluated using mixed methods to assess the frequency and type of reported breakdowns, patient awareness of the program, and stakeholder perspectives. RESULTS: WWTK specialists interviewed 4,676 patients; 822 (17.6%) reported a breakdown in care. Of these, 313 (38.1%) had not spoken with anyone at the hospital about the breakdown, and 547 (66.5%) described associated harm. There were also 55 patient-initiated reports to WWTK; 41 (74.5%) of these reported a care breakdown. Patients had not spoken with anyone at the hospital in 12 (29.3%) patient-initiated cases; 38 (92.7%) described associated harm. Hospital stakeholders found the level of detail and timeliness of reports to be helpful. CONCLUSION: Active outreach to hospitalized patients detects substantially more breakdowns in care than patient-initiated reporting. Both approaches identify breakdowns that are consequential to patients and provide opportunities to respond to individual patients.

Communicating with patients about diagnostic errors in breast cancer care: Providers' attitudes, experiences, and advice.

OBJECTIVE: To gain understanding of breast cancer care providers' attitudes regarding communicating with patients about diagnostic errors, to inform interventions to improve patient- provider discussions. METHODS: Focus groups were held in three U.S. states involving 41 breast cancer care providers from a variety of specialties. Discussions focused on providers' experiences with potential errors in breast cancer diagnosis, communication with patients following three hypothetical diagnostic vignettes, and suggestions for how and why diagnostic errors in breast cancer care should be communicated. Transcripts were qualitatively analyzed. RESULTS: Providers were more willing to inform breast cancer patients of a diagnostic error when they felt it would be helpful, when they felt responsible for the error, when they were less concerned about litigation, and when the patient asked directly. CONCLUSIONS: Breast cancer care providers experience several challenges when considering whether to inform a patient about diagnostic errors. A better understanding of patients' preferences for open communication, combined with customized tools and training, could increase clinicians' comfort with these difficult discussions. PRACTICE IMPLICATIONS: Providers gave suggestions to facilitate discussions about diagnostic errors when these events occur, including themes of education, honesty, and optimism.

Communicating with patients about breakdowns in care: a national randomised vignette-based survey.

BACKGROUND: Many patients are reluctant to speak up about breakdowns in care, resulting in missed opportunities to respond to individual patients and improve the system. Effective approaches to encouraging patients to speak up and responding when they do are needed. OBJECTIVE: To identify factors which influence speaking up, and to examine the impact of apology when problems occur. DESIGN: Randomised experiment using a vignette-based questionnaire describing 3 care breakdowns (slow response to call bell, rude aide, unanswered questions). The role of the person inquiring about concerns (doctor, nurse, patient care specialist), extent of the prompt (invitation to patient to share concerns) and level of apology were varied. SETTING: National online survey. PARTICIPANTS: 1188 adults aged ≥35 years were sampled from an online panel representative of the entire US population, created and maintained by GfK, an international survey research organisation; 65.5% response rate. MAIN OUTCOMES AND MEASURES: Affective responses to care breakdowns, intent to speak up, willingness to recommend the hospital. RESULTS: Twice as many participants receiving an in-depth prompt about care breakdowns would (probably/definitely) recommend the hospital compared with those receiving no prompt (18.4% vs 8.8% respectively (p=0.0067)). Almost three times as many participants receiving a full apology would (probably/definitely) recommend the hospital compared with those receiving no apology (34.1% vs 13.6% respectively ((p<0.0001)). Feeling upset was a strong determinant of greater intent to speak up, but a substantial number of upset participants would not 'definitely' speak up. A more extensive prompt did not result in greater likelihood of speaking up. The inquirer's role influenced speaking up for two of the three breakdowns (rudeness and slow response). CONCLUSIONS: Asking about possible care breakdowns in detail, and offering a full apology when breakdowns are reported substantially increases patients' willingness to recommend the hospital.