Mobilizing the clinical trial ecosystem to drive adoption of master protocols.

Master protocol studies typically use an overarching protocol to answer several questions by guiding a variety of sub-studies. These sub-studies can incorporate multiple diseases, therapies, or both. Although this innovative approach offers many benefits, including the ability to deliver clinical research that is more patient-centric and efficient, several common barriers curtail widespread adoption. The Clinical Trials Transformation Initiative (CTTI) convened industry representatives, regulatory agencies, patient groups, and academic institutions to identify emerging best practices and develop resources designed to help sponsors and other stakeholders overcome these challenges. We first identify some broad changes needed in the clinical trials ecosystem to facilitate mainstream adoption of master protocol studies, and we subsequently summarize CTTI's resources designed to support this effort.

Attitudes Toward a Potential SARS-CoV-2 Vaccine : A Survey of U.S. Adults.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has rapidly instigated a global pandemic. Vaccine development is proceeding at an unprecedented pace. Once available, it will be important to maximize vaccine uptake and coverage. OBJECTIVE: To assess intent to be vaccinated against COVID-19 among a representative sample of adults in the United States and identify predictors of and reasons for vaccine hesitancy. DESIGN: Cross-sectional survey, fielded from 16 through 20 April 2020. SETTING: Representative sample of adults residing in the United States. PARTICIPANTS: Approximately 1000 adults drawn from the AmeriSpeak probability-based research panel, covering approximately 97% of the U.S. household population. MEASUREMENTS: Intent to be vaccinated against COVID-19 was measured with the question, "When a vaccine for the coronavirus becomes available, will you get vaccinated?" Response options were "yes," "no," and "not sure." Participants who responded "no" or "not sure" were asked to provide a reason. RESULTS: A total of 991 AmeriSpeak panel members responded. Overall, 57.6% of participants (n = 571) intended to be vaccinated, 31.6% (n = 313) were not sure, and 10.8% (n = 107) did not intend to be vaccinated. Factors independently associated with vaccine hesitancy (a response of "no" or "not sure") included younger age, Black race, lower educational attainment, and not having received the influenza vaccine in the prior year. Reasons for vaccine hesitancy included vaccine-specific concerns, a need for more information, antivaccine attitudes or beliefs, and a lack of trust. LIMITATIONS: Participants' intent to be vaccinated was explored before a vaccine was available and when the pandemic was affecting a narrower swath of the United States. Questions about specific information or factors that might increase vaccination acceptance were not included. The survey response rate was 16.1%. CONCLUSION: This national survey, conducted during the coronavirus pandemic, revealed that approximately 3 in 10 adults were not sure they would accept vaccination and 1 in 10 did not intend to be vaccinated against COVID-19. Targeted and multipronged efforts will be needed to increase acceptance of a COVID-19 vaccine when one becomes available. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Identifying monoclonal gammopathy of undetermined significance in electronic health data.

PURPOSE: Monoclonal gammopathy of undetermined significance (MGUS) is a prevalent yet largely asymptomatic precursor to multiple myeloma. Patients with MGUS must undergo regular surveillance and testing, with few known predictors of progression. We developed an algorithm to identify MGUS patients in electronic health data to facilitate large-scale, population-based studies of this premalignant condition. METHODS: We developed a four-step algorithm using electronic health record and health claims data from men and women aged 50 years or older receiving care from a large, multispecialty medical group between 2007 and 2015. The case definition required patients to have at least two MGUS ICD-9 diagnosis codes within 12 months, at least one serum and/or urine protein electrophoresis and one immunofixation test, and at least one in-office hematology/oncology visit. Medical charts for selected cases were abstracted then adjudicated independently by two physicians. We assessed algorithm validity by positive predictive value (PPV). RESULTS: We identified 833 people with at least two MGUS diagnosis codes; 429 (52%) met all four algorithm criteria. We randomly selected 252 charts for review, including 206 from patients meeting all four algorithm criteria. The PPV for the 206 algorithm-identified charts was 76% (95% CI, 70%-82%). Among the 49 cases deemed to be false positives (24%), 33 were judged to have multiple myeloma or another lymphoproliferative condition, such as lymphoma. CONCLUSIONS: We developed a simple algorithm that identified MGUS cases in electronic health data with reasonable accuracy. Inclusion of additional steps to eliminate cases with malignant disease may improve algorithm performance.

Hospital Volume and Outcomes of Noninvasive Ventilation in Patients Hospitalized With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease.

OBJECTIVE: To determine the relationship between hospital noninvasive ventilation caseload and outcomes among patients with an acute chronic obstructive pulmonary disease exacerbation. DESIGN: Cross-sectional study of 13,893 patients with chronic obstructive pulmonary disease treated with noninvasive ventilation. SETTING: A total of 243 U.S. hospitals participating in the Premier Inpatient Database. PATIENTS: A total of 13,893 patients admitted between July 2009 and June 2011. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Annual hospital volume of noninvasive ventilation was analyzed as a continuous variable, as well as after grouping it in four categories. The median hospital annual volume of noninvasive ventilation use was 627 and varied from 234 admissions in quartile 1 to 1,529 admissions in quartile 4. Noninvasive ventilation failure occurred in 15.2%, and in-hospital mortality was 6.5%. After adjusting for patient characteristics, relative to low-volume hospitals, high-volume hospitals did not have lower noninvasive ventilation failure (odds ratio quartile 4 vs quartile 1, 1.05; 95% CI, 0.65-1.68) or in-hospital mortality (odds ratio quartile 4 vs quartile 1, 0.88; 95% CI, 0.69-1.12). In a hierarchical multivariable analysis with adjustment for patient characteristics where volume was assessed as a continuous variable, hospital volume was not related to outcomes, including noninvasive ventilation failure (p = 0.87), in-hospital mortality (p = 0.88), 30-day readmission for chronic obstructive pulmonary disease (p = 0.83), or hospital length of stay (p = 0.12). CONCLUSIONS: The results of this large retrospective cohort study suggest that hospitals with higher noninvasive ventilation volume do not achieve better outcomes of patients with chronic obstructive pulmonary disease exacerbation treated with noninvasive ventilation; even hospitals with low noninvasive ventilation volume are able to successfully implement this intervention.

Primary care providers' views of discussing COVID-19 vaccination with vaccine hesitant patients: A qualitative study.

OBJECTIVE: To describe primary care providers' (PCPs) perspectives on discussing COVID-19 vaccination with their patients. METHODS: All PCPs from 11 primary care clinics at 3 health systems were invited to participate. Focus groups were conducted between December 2021-January 2022, and were recorded and transcribed. Participants were asked about their experience communicating about the COVID-19 vaccine. Themes and subthemes were inductively identified using thematic analysis. RESULTS: 40 PCPs participated. All PCPs viewed discussing COVID-19 vaccination as high priority. Strategies for promoting COVID-19 vaccination included influencing what people think and feel, building trust and leveraging their relationship with patients, and practical strategies such as on-site vaccination. Most strategies aimed at influencing what people think and feel and leveraging relationships were viewed as generally ineffective. On-site vaccine availability was identified as the most influential factor. PCPs expressed frustration by their interactions with vaccine hesitant patients, leading them to truncate their communication with these patients. CONCLUSIONS: Despite using a broad range of strategies, most PCPs were unable to change the strongly held beliefs among the most vaccine hesitant patients that were often informed by misinformation and mistrust. PRACTICE IMPLICATIONS: Promising strategies for promoting vaccination include social/relational (expressing empathy) and practical (on-site COVID-19 vaccine availability).

COVID-19 clinical trials: who is likely to participate and why?

Aim: To identify factors associated with willingness to participate in a COVID-19 clinical trial and reasons for and against participating. Materials & methods: We surveyed Massachusetts (MA, USA) residents online using the Dynata survey platform and via phone using random digit dialing between October and November 2021. Respondents were asked to imagine they were hospitalized with COVID-19 and invited to participate in a treatment trial. We assessed willingness to participate by asking, "Which way are you leaning" and why. We used multivariate logistic regression to model factors associated with leaning toward participation. Open-ended responses were analyzed using conventional content analysis. Results: Of 1071 respondents, 65.6% leaned toward participating. Multivariable analyses revealed college-education (OR: 1.59; 95% CI: 1.11, 2.27), trust in the healthcare system (OR: 1.32; 95% CI: 1.10, 1.58) and relying on doctors (OR: 1.77; 95% CI: 1.45, 2.17) and family or friends (OR: 1.31; 95% CI: 1.11, 1.54) to make health decisions were significantly associated with leaning toward participating. Respondents with lower health literacy (OR: 0.57; 95% CI: 0.36, 0.91) and who identify as Black (OR: 0.40; 95% CI: 0.24, 0.68), Hispanic (OR: 0.61; 95% CI: 0.38, 0.98), or republican (OR: 0.61; 95% CI: 0.38, 0.97) were significantly less likely to lean toward participating. Common reasons for participating included helping others, benefitting oneself and deeming the study low risk. Common reasons for leaning against were deeming the study high risk, disliking experimental treatments and not wanting to be a guinea pig. Conclusion: Our finding that vulnerable individuals and those with lower levels of trust in the healthcare system are less likely to be receptive to participating in a COVID-19 clinical trial highlights that work is needed to achieve a healthcare system that provides confidence to historically disadvantaged groups that their participation in research will benefit their community.

Long COVID awareness and receipt of medical care: a survey among populations at risk for disparities.

Introduction: The COVID-19 pandemic has been characterized by disparities in disease burden and medical care provision. Whether these disparities extend to long COVID awareness and receipt of medical care is unknown. We aimed to characterize awareness of long COVID and receipt of medical care for long COVID symptoms among populations who experience disparities in the United States (US). Methods: We conducted a cross-sectional survey among a national sample of US adults between January 26-February 5, 2023. We surveyed approximately 2,800 adults drawn from the Ipsos probability-based KnowledgePanel® who identify as White, Black, or Hispanic, with over-sampling of Black, Hispanic, and Spanish-proficient adults. Awareness of long COVID was assessed with the question, "Have you heard of long COVID? This is also referred to as post-COVID, Long-haul COVID, Post-acute COVID-19, or Chronic COVID." Respondents reporting COVID-19 symptoms lasting longer than 1 month were classified as having long COVID and asked about receipt of medical care. Results: Of the 2,828 respondents, the mean age was 50.4 years, 52.8% were female, 40.2% identified as Hispanic, 29.8% as Black, and 26.7% as White. 18% completed the survey in Spanish. Overall, 62.5% had heard of long COVID. On multivariate analysis, long COVID awareness was lower among respondents who identified as Black (OR 0.64; 95% CI 0.51, 0.81), Hispanic and completed the survey in English (OR 0.59; 95% CI 0.46, 0.76), and Hispanic and completed the survey in Spanish (OR 0.31, 95% C.I. 0.23, 0.41), compared to White respondents (overall p < 0.001). Long COVID awareness was also associated with educational attainment, higher income, having health insurance, prior history of COVID-19 infection, and COVID-19 vaccination. Among those reporting symptoms consistent with long COVID (n = 272), 26.8% received medical care. Older age, longer symptom duration and greater symptom impact were associated with receipt of medical care for long COVID symptoms. Of those who received care, most (77.8%) rated it as less than excellent on a 5-point scale. Discussion: This survey reveals limited awareness of long COVID and marked disparities in awareness according to race, ethnicity, and language. Targeted public health campaigns are needed to raise awareness.

Patients' Perspectives on Plans Generated During Primary Care Visits and Self-Reported Adherence at 3 Months: Data From a Randomized Trial.

BACKGROUND: Effective primary care necessitates follow-up actions by the patient beyond the visit. Prior research suggests room for improvement in patient adherence. OBJECTIVE: This study sought to understand patients' views on their primary care visits, the plans generated therein, and their self-reported adherence after 3 months. METHODS: As part of a large multisite cluster randomized pragmatic trial in 3 health care organizations, patients completed 2 surveys-the first within 7 days after the index primary care visit and another 3 months later. For this analysis of secondary outcomes, we combined the results across all study participants to understand patient adherence to care plans. We recorded patient characteristics and survey responses. Cross-tabulation and chi-square statistics were used to examine bivariate associations, adjusting for multiple comparisons when appropriate. We used multivariable logistic regression to assess how patients' intention to follow, agreement, and understanding of their plans impacted their plan adherence, allowing for differences in individual characteristics. Qualitative content analysis was conducted to characterize the patient's self-reported plans and reasons for adhering (or not) to the plan 3 months later. RESULTS: Of 2555 patients, most selected the top box option (9=definitely agree) that they felt they had a clear plan (n=2011, 78%), agreed with the plan (n=2049, 80%), and intended to follow the plan (n=2108, 83%) discussed with their provider at the primary care visit. The most common elements of the plans reported included reference to exercise (n=359, 14.1%), testing (laboratory, imaging, etc; n=328, 12.8%), diet (n=296, 11.6%), and initiation or adjustment of medications; (n=284, 11.1%). Patients who strongly agreed that they had a clear plan, agreed with the plan, and intended to follow the plan were all more likely to report plan completion 3 months later (P<.001) than those providing less positive ratings. Patients who reported plans related to following up with the primary care provider (P=.008) to initiate or adjust medications (P≤.001) and to have a specialist visit were more likely to report that they had completely followed the plan (P=.003). Adjusting for demographic variables, patients who indicated intent to follow their plan were more likely to follow-through 3 months later (P<.001). Patients' reasons for completely following the plan were mainly that the plan was clear (n=1114, 69.5%), consistent with what mattered (n=1060, 66.1%), and they were determined to carry through with the plan (n=887, 53.3%). The most common reasons for not following the plan were lack of time (n=217, 22.8%), having decided to try a different approach (n=105, 11%), and the COVID-19 pandemic impacted the plan (n=105, 11%). CONCLUSIONS: Patients' initial assessment of their plan as clear, their agreement with the plan, and their initial willingness to follow the plan were all strongly related to their self-reported completion of the plan 3 months later. Patients whose plans involved lifestyle changes were less likely to report that they had "completely" followed their plan. TRIAL REGISTRATION: ClinicalTrials.gov NCT03385512; https://clinicaltrials.gov/study/NCT03385512. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/30431.

Rationale and Design of Healthy at Home for COPD: an Integrated Remote Patient Monitoring and Virtual Pulmonary Rehabilitation Pilot Study.

Chronic Obstructive Pulmonary Disease (COPD) is a common, costly, and morbid condition. Pulmonary rehabilitation, close monitoring, and early intervention during acute exacerbations of symptoms represent a comprehensive approach to improve outcomes, but the optimal means of delivering these services is uncertain. Logistical, financial, and social barriers to providing healthcare through face-to-face encounters, paired with recent developments in technology, have stimulated interest in exploring alternative models of care. The Healthy at Home study seeks to determine the feasibility of a multimodal, digitally enhanced intervention provided to participants with COPD longitudinally over six months. This paper details the recruitment, methods, and analysis plan for the study, which is recruiting 100 participants in its pilot phase. Participants were provided with several integrated services including a smartwatch to track physiological data, a study app to track symptoms and study instruments, access to a mobile integrated health program for acute clinical needs, and a virtual comprehensive pulmonary support service. Participants shared physiologic, demographic, and symptom reports, electronic health records, and claims data with the study team, facilitating a better understanding of their symptoms and potential care needs longitudinally. The Healthy at Home study seeks to develop a comprehensive digital phenotype of COPD by tracking and responding to multiple indices of disease behavior and facilitating early and nuanced responses to changes in participants' health status. This study is registered at Clinicaltrials.gov (NCT06000696).

Impact of a physician recommendation on COVID-19 vaccination intent among vaccine hesitant individuals.

OBJECTIVE: To test the impact of varied physician recommendations on COVID-19 vaccine hesitancy. METHODS: We conducted a vignette-based experimental survey on Prolific, an online research platform. COVID-19 vaccine hesitant, adult panel members were assigned to one of five messages that varied by recommendation style (participatory vs explicit) and strategy (acknowledgement of concerns; comparison to the flu shot; statement that millions of people have already received it; emphasis on protecting others). Vaccine hesitancy was re-assessed with the question, "Would you get vaccinated at this visit?". RESULTS: Of the 752 participants, 60.1% were female, 43.4% Black, 23.6% Latino, and 33.0% White; mean age was 35.6 years. Overall, 33.1% of the initially "not sure" and 13.1% of the initially "no" participants became less hesitant following any recommendation. Among the "not sure" participants, 20.3% of those who received a participatory recommendation became less hesitant compared with 34.3%- 39.5% for the explicit recommendations. The "protect others" message was most effective among initially "no" participants; 19.8% become less hesitant, compared to 8.7% for the participatory recommendation. CONCLUSION: A physician recommendation may reduce COVID-19 vaccine hesitancy. PRACTICE IMPLICATIONS: An explicit recommendation and "protect others" message appear to be important elements of a physician recommendation for COVID-19 vaccination.

From COVID-19 Vaccine Hesitancy to Vaccine Acceptance: Results of a Longitudinal Survey.

OBJECTIVES: COVID-19 vaccines are widely available, but uptake is suboptimal. To develop strategies to increase vaccination rates, we sought to (1) characterize adults initially hesitant to be vaccinated for COVID-19 who later received the vaccine and (2) identify factors associated with their vaccination decision. METHODS: In January 2021, we conducted an online survey of US adults via Prolific that assessed vaccination intent, COVID-19-related knowledge and attitudes, and demographic characteristics. In May 2021, we recontacted respondents to assess vaccination status and factors influencing their vaccination decision. We used χ2 statistics and t tests to examine associations between respondents' vaccination status and their characteristics, knowledge, and attitudes. We analyzed reasons for vaccination using thematic analysis. RESULTS: Of 756 initially vaccine-hesitant respondents, 529 (70.0%) completed the follow-up survey. Nearly half of those initially not sure about vaccination (47.3%, 112 of 237) were vaccinated at follow-up, while 21.2% (62 of 292) of those initially planning not to be vaccinated were vaccinated at follow-up. Of those initially not sure, higher educational attainment, greater knowledge of COVID-19, and a doctor's recommendation were associated with vaccination. Of those initially intending not to be vaccinated, male sex, Democratic political affiliation, receipt of an influenza shot within 5 years, being more worried about COVID-19, and having greater COVID-19 knowledge were associated with increased likelihood of being vaccinated. Of 167 respondents who gave reasons for vaccination, protecting oneself and others (59.9%), practical issues (29.9%), social influences (17.4%), and vaccine safety (13.8%) were the main reasons. CONCLUSION: Providing information on the protective value of vaccination, implementing rules that make remaining unvaccinated burdensome, making vaccination easy, and providing social support may influence vaccine-hesitant adults to accept vaccination.

Pyk2 regulates H+-ATPase-mediated proton secretion in the outer medullary collecting duct via an ERK1/2 signaling pathway.

Acid-secreting intercalated cells respond to changes in systemic pH through regulation of apical H(+) transporters. Little is known about the mechanism by which these cells sense changes in extracellular pH (pH(o)). Pyk2 is a nonreceptor tyrosine kinase activated by autophosphorylation at Tyr402 by cell-specific stimuli, including decreased pH, and is involved in the regulation of MAPK signaling pathways and transporter activity. We examined whether the Pyk2 and MAPK signaling pathway mediates the response of transport proteins to decreased pH in outer medullary collecting duct cells. Immunoblot analysis of phosphorylated Pyk2 (Tyr402), ERK1/2 (Thr202/Tyr204), and p38 (Thr180/Tyr182) was used to assay protein activation. To examine specificity of kinase activation and its effects, we used Pyk2 small interfering RNA to knockdown Pyk2 expression levels, the Src kinase inhibitor 4-amino-5-(4-methylphenyl)-7-(t-butyl)pyrazolo[3,4-d]-pyrimidine (PP 1) to inhibit Pyk2 phosphorylation, and the MEK inhibitor U0126 to inhibit ERK1/2 phosphorylation. The pH-sensitive fluorescent probe 2'-7'-bis(carboxyethyl)-5(6)-carboxyfluorescein-acetoxymethyl ester (BCECF-AM) was used to assay H(+) transporter activity. The activity of H(+) transporters was measured as the rate of intracellular pH (pH(i)) recovery after an NH(4)Cl prepulse. We show that Pyk2 is endogenously expressed and activated by acid pH in mouse-derived outer medullary collecting duct (mOMCD1) cells. Incubation of mOMCD1 cells in acid media [extracellular pH (pH(o)) 6.7] increased the phosphorylation of Pyk2, ERK1/2, and p38. Reduction in pH(i) induced by an NH(4)Cl prepulse also increased the phosphorylation of Pyk2, ERK1/2, and p38. Consistent with our previous studies, we found that mOMCD1 cells exhibit H(+)-ATPase and H(+),K(+)-ATPase activity. Pyk2 inhibition by Pyk2 siRNA and PP 1 prevented Pyk2 phosphorylation as well as H(+)-ATPase-mediated recovery in mOMCD1 cells. In addition, ERK1/2 inhibition by U0126 prevented acid-induced ERK1/2 phosphorylation and H(+)-ATPase-mediated pH(i) recovery but not phosphorylation of p38. We conclude that Pyk2 and ERK1/2 are required for increasing H(+)-ATPase, but not H(+),K(+)-ATPase, activity at decreased pH(i) in mOMCD1 cells.

Can sharing clinic notes improve communication and promote self-management? A qualitative study of patients with COPD.

OBJECTIVE: To understand the impact of sharing clinic notes on communication and self-management among patients with COPD and to develop recommendations for writing patient-centered notes. METHODS: Thirty patients with COPD participated in 'think-aloud' interviews in which they reviewed their COPD-specific clinic note. Interviews were coded using conventional content analysis, organized by the six-function communication framework. RESULTS: Participants were predominantly White (93.3%), with a mean age of 65.5 years. More than half had a high school degree or less, half reported difficulty understanding spoken information, and nearly half sometimes need help reading medical materials. Patients indicated notes provided an opportunity to learn details of their condition and facilitated information sharing - strengthening information exchange. Reading notes enabled self-management through motivation, prompting information seeking, and reminding them of action steps. Patients reacted positively to statements suggesting the provider listened to them, saw them as a person, and was attentive to details, which fostered the relationship. Most patients reacted negatively to medical terminology, incorrect information, and wording that was perceived as disparaging. CONCLUSIONS: Sharing clinic notes with patients can promote information exchange, enable self-management, and strengthen the patient-provider relationship. PRACTICE IMPLICATIONS: Incorporating patients' recommendations for writing notes could strengthen the benefits of sharing notes.

Preferences for COVID-19 vaccination information and location: Associations with vaccine hesitancy, race and ethnicity.

This study examined the association between preferences for being informed about the COVID-19 vaccine and where to receive it with vaccination intent and race/ethnicity. We conducted an online survey, oversampling Black and Latino panel members. The 1668 participants were 53.2% female, 34.8% White, 33.3% Black, and 31.8% Latino. Participants who were vaccine hesitant (answered "not sure" or "no" to vaccination intent) were more likely to prefer a conversation with their doctor compared to those who answered "yes" (25.0% and 23.4% vs 7.8%, P < .001, respectively). Among participants who responded "not sure", 61.8% prefer to be vaccinated at a doctor's office, compared with 35.2% of those who responded "yes" (P < .001). Preferred location differed by race/ethnicity (P < .001) with 67.6% of Black "not sure" participants preferring a doctor's office compared to 60.2% of Latino and 54.9% of White "not sure" participants. These findings underscore the need to integrate healthcare providers into COVID-19 vaccination programs.

The Association of Nursing Home Characteristics and Quality with Adverse Events After a Hospitalization.

BACKGROUND/OBJECTIVES: We previously found high rates of adverse events (AEs) for long-stay nursing home residents who return to the facility after a hospitalization. Further evidence about the association of AEs with aspects of the facilities and their quality may support quality improvement efforts directed at reducing risk. DESIGN: Prospective cohort analysis. SETTING AND PARTICIPANTS: 32 nursing homes in the New England states. A total of 555 long-stay residents contributed 762 returns from hospitalizations. METHODS: We measured the association between AEs developing in the 45 days following discharge back to long-term care and characteristics of the nursing homes including bed size, ownership, 5-star quality ratings, registered nurse and nursing assistant hours, and the individual Centers for Medicare & Medicaid Services (CMS) quality indicators. We constructed Cox proportional hazards models controlling for individual resident characteristics that were previously found associated with AEs. RESULTS: We found no association of AEs with most nursing home characteristics, including 5-star quality ratings and the composite quality score. Associations with individual quality indicators were inconsistent and frequently not monotonic. Several individual quality indicators were associated with AEs; the highest tertile of percentage of residents with depression (4%-25%) had a hazard ratio (HR) of 1.65 [95% confidence interval (CI) 1.16, 2.35] and the highest tertile of the percentage taking antipsychotic medications (18%-35%) had an HR of 1.58 (CI 1.13, 2.21). The percentage of residents needing increased assistance with activities of daily living was statistically significant but not monotonic; the middle tertile (13% to <20%) had an HR of 1.69 (CI 1.16, 2.47). CONCLUSIONS AND IMPLICATIONS: AEs occurring during transitions between nursing homes and hospitals are not explained by the characteristics of the facilities or summary quality scores. Development of risk reduction approaches requires assessment of processes and quality beyond the current quality measures.

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 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.