A Qualitative Study of Risks Related to Interhospital Transfer of Patients with Nontraumatic Intracranial Hemorrhage.

GOAL: Interhospital transfer (IHT) facilitates access to specialized neurocritical care but may also introduce unique risk. Our goal was to describe providers' perceptions of safety threats during IHT for patients with nontraumatic intracranial hemorrhage. MATERIALS AND METHODS: We employed qualitative, semi-structured interviews at an academic medical center receiving critically-ill neurologic transfers, and 5 referring hospitals. Interviewees included physicians, nurses, and allied health professionals with experience caring for patients transferred between hospitals for nontraumatic intracranial hemorrhage. Interviews continued until data saturation was reached. Coding occurred concurrently with interviews. Analysis was inductive, using the constant comparative method. FINDINGS: The predominant impediments to safe, high-quality neurocritical care transitions between hospitals are insufficient communication, gaps in clinical practice, and lack of IHT structure. Insufficient communication highlights the unique communication challenges specific to IHT, which overlay and compound known intrahospital communication barriers. Gaps in clinical practice revolve primarily around the provision of neurocritical care for this patient population, often subject to resource availability, by receiving hospital emergency medicine providers. Lack of structure outlines providers' questions that emerge when institutions fail to identify process channels, expectations, and accountability during complex neurocritical care transitions. CONCLUSIONS: The predominant impediments to safe, high-quality neurocritical care transitions between hospitals are insufficient communication, gaps in clinical practice, and lack of IHT structure. These themes serve as fundamental targets for quality improvement initiatives. To our knowledge, this is the first description of challenges to quality and safety in high-risk neurocritical care transitions through clinicians' voices.

A taxonomy and cultural analysis of intra-hospital patient transfers.

Existing research on intra-hospital patient transitions focuses chiefly on handoffs, or exchanges of information, between clinicians. Less is known about patient transfers within hospitals, which include but extend beyond the exchange of information. Using participant observations and interviews at a 1,541-bed, academic, tertiary medical center, we explored the ways in which staff define and understand patient transfers between units. We conducted observations of staff (n = 16) working in four hospital departments and interviewed staff (n = 29) involved in transfers to general medicine floors from either the Emergency Department or the Medical Intensive Care Unit between February and September 2015. The collected data allowed us to understand transfers in the context of several hospital cultural microsystems. Decisions were made through the lens of the specific unit identity to which staff felt they belonged; staff actively strategized to manage workload; and empty beds were treated as a scarce commodity. Staff concepts informed the development of a taxonomy of intra-hospital transfers that includes five categories of activity: disposition, or determining the right floor and bed for the patient; notification to sending and receiving staff of patient assignment, departure and arrival; preparation to send and receive the patient; communication between sending and receiving units; and coordination to ensure that transfer components occur in a timely and seamless manner. This taxonomy widens the study of intra-hospital patient transfers from a communication activity to a complex cultural phenomenon with several categories of activity and views them as part of multidimensional hospital culture, as constructed and understood by staff.

Care Transitions Between Hospitals and Skilled Nursing Facilities: Perspectives of Sending and Receiving Providers.

BACKGROUND: One in four Medicare patients hospitalized for acute medical illness is discharged to a skilled nursing facility (SNF); 23% of these patients are readmitted to the hospital within 30 days. The care transition from hospital to SNF is often marked by disruptions in care and poor communication among hospital and SNF providers. A study was conducted to identify the perspectives of sending and receiving providers regarding care transitions between the hospital and the SNF. METHODS: Hospital (N = 25) and SNF (N = 16) providers participated in qualitative interviews assessing patient transfers and experiences with unplanned hospital readmissions. Data were analyzed by a multidisciplinary coding team using the constant comparison method. RESULTS: Four main themes emerged: increasing patient complexity, identifying an optimal care setting, rising financial pressure, and barriers to effective communication. The data highlighted hospital and SNF providers' shared concerns about patient-level risk factors and escalating costs of care. The data also identified issues that separate hospital and SNF providers, including different access to resources and information. CONCLUSION: Hospital and SNF providers are challenged to meet the needs of complex patients. They are asked to establish comprehensive care plans for patients with significant medical and psychosocial issues while navigating tense relationships between health care institutions and rising financial pressures. The concerns of both hospital and SNF providers must be considered in order to develop practices that can improve the quality, cost, and safety of care transitions.

Telemonitoring in patients with heart failure.

BACKGROUND: Small studies suggest that telemonitoring may improve heart-failure outcomes, but its effect in a large trial has not been established. METHODS: We randomly assigned 1653 patients who had recently been hospitalized for heart failure to undergo either telemonitoring (826 patients) or usual care (827 patients). Telemonitoring was accomplished by means of a telephone-based interactive voice-response system that collected daily information about symptoms and weight that was reviewed by the patients' clinicians. The primary end point was readmission for any reason or death from any cause within 180 days after enrollment. Secondary end points included hospitalization for heart failure, number of days in the hospital, and number of hospitalizations. RESULTS: The median age of the patients was 61 years; 42.0% were female, and 39.0% were black. The telemonitoring group and the usual-care group did not differ significantly with respect to the primary end point, which occurred in 52.3% and 51.5% of patients, respectively (difference, 0.8 percentage points; 95% confidence interval [CI], -4.0 to 5.6; P=0.75 by the chi-square test). Readmission for any reason occurred in 49.3% of patients in the telemonitoring group and 47.4% of patients in the usual-care group (difference, 1.9 percentage points; 95% CI, -3.0 to 6.7; P=0.45 by the chi-square test). Death occurred in 11.1% of the telemonitoring group and 11.4% of the usual care group (difference, -0.2 percentage points; 95% CI, -3.3 to 2.8; P=0.88 by the chi-square test). There were no significant differences between the two groups with respect to the secondary end points or the time to the primary end point or its components. No adverse events were reported. CONCLUSIONS: Among patients recently hospitalized for heart failure, telemonitoring did not improve outcomes. The results indicate the importance of a thorough, independent evaluation of disease-management strategies before their adoption. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00303212.).

Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network.

Objectives: A multistakeholder expert group under the Women's Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent contraceptives. The group, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry and the patient community, was assembled to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess contraceptive medical product technologies. Design: We applied a Delphi survey method approach to achieve consensus on a core minimum data set for the future CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated and analyzed by a study design team from Weill Cornell Medicine. After the first survey, questions for subsequent surveys were based on the analysis process and conference call discussions with group members. This process was repeated two times over a 6-month time period until consensus was achieved. Results: Twenty-three experts participated in the Delphi process. Participation rates in the first and second round of the Delphi survey were 83% and 100%, respectively. The working group reached final consensus on 121 core data elements capturing reproductive/gynecological history, surgical history, general medical history, encounter information, long-acting/permanent contraceptive index procedures and follow-up, procedures performed in conjunction with the index procedure, product removal, medications, complications related to the long-acting and/or permanent contraceptive procedure, pregnancy and evaluation of safety and effectiveness outcomes. Conclusions: The WHT-CRN expert group produced a consensus-based core set of data elements that allow the study of current and future contraceptives. These data elements influence patient and provider decisions about treatments and include important outcomes related to safety and effectiveness of these medical devices, which may benefit other women's health stakeholders.

Organisational factors underpinning intra-hospital transfers: a guide for evaluating context in quality improvement.

During intra-hospital transfers, multiple clinicians perform coordinated tasks that leave patients vulnerable to undesirable outcomes. Communication has been established as a challenge to care transitions, but less is known about the organisational complexities within which transfers take place. We performed a qualitative assessment that included various professions to capture a multi-faceted understanding of intra-hospital transfers. Ethnographic observations and semi-structured interviews were conducted with clinicians and staff from the Medical Intensive Care Unit, Emergency Department, and general medicine units at a large, urban, academic, tertiary medical centre. Results highlight the organisational factors that stakeholders view as important for successful transfers: the development, dissemination, and application of protocols; robustness of technology; degree of teamwork; hospital capacity; and the ways in which competing hospital priorities are managed. These factors broaden our understanding of the organisational context of intra-hospital transfers and informed the development of a practical guide that can be used prior to embarking on quality improvement efforts around transitions of care.

Mapping the care transition from hospital to skilled nursing facility.

PURPOSE: Care transitions between hospitals and skilled nursing facilities (SNFs) are often associated with breakdowns in communication that may place patients at risk for adverse events. Less is known about how to address these issues in the context of busy patient care settings. We used process mapping to examine hospital discharge and SNF admission processes to identify opportunities for improvement. METHODS: A quality improvement (QI) team worked with frontline staff to create a process map illustrating the sequence of events involved with hospital discharge and SNF admission. The project was completed at an academic medical centre and two local SNFs in the north-eastern United States. Participants represented the care management, medicine, nursing, admissions, and physical therapy services. The data informed hospital QI interventions seeking to improve the quality and safety of hospital-SNF transfers and reduce unplanned hospital readmissions. RESULTS: The final process map highlighted numerous activities that need to be coordinated between care teams, including the time-sensitive exchange of clinical and administrative information. Participants shared insights about how care teams reach critical decisions about patient disposition and post-acute care utilization. CONCLUSIONS: Process mapping highlighted specific opportunities for improving communication between care teams. Participants advocated for earlier assessments of patients' functional status and support systems, including reliable at-home services. They also reasoned that improved communication would help patients and providers reach decisions together, coordinate work efforts, and better prepare for hospital discharge and SNF admission. This information can be used to improve patient care transitions between hospitals and SNFs.

Implementing a Warm Handoff Between Hospital and Skilled Nursing Facility Clinicians.

OBJECTIVES: Care transitions between hospitals and skilled nursing facilities (SNFs) are associated with disruptions in patient care and high risk for adverse events. Communication between hospital-based and SNF-based clinicians is often suboptimal; there have been calls to foster direct, real-time communication between sending and receiving clinicians to enhance patient safety. This article described the implementation of a warm handoff between hospital and SNF physicians and advanced practice providers at the time of hospital discharge. METHODS: Before patient transfer, hospital clinicians called SNF clinicians to provide information relevant to the continuation of safe patient care and offer SNF clinicians the opportunity to ask clarifying questions. The calls were documented in the hospital discharge summary. RESULTS: A total of 2417 patient discharges were eligible for inclusion. Warm handoffs were documented at an increasing rate throughout implementation of the intervention, beginning with 15.78% (n = 3) in stage 1, then 20.27% (n = 75) in stage 2, and finally 46.89% (n = 951) in stage 3. The overall average rate of documentation was 42.57%. Participant feedback indicated that clinicians were most concerned about understanding the purpose of the warm handoff, managing their workload, and improving the efficiency of the process. CONCLUSIONS: Use of a warm handoff showed promise in improving communication during hospital-SNF patient transfers. However, the implementation also highlighted specific barriers to the handoff related to organizational structures and clinician workload. Addressing these underlying issues will be critical in ensuring continued participation and support for efforts that foster direct communication among clinicians from different healthcare institutions.

Impact of Telemonitoring on Health Status.

BACKGROUND: Although noninvasive telemonitoring in patients with heart failure does not reduce mortality or hospitalizations, less is known about its effect on health status. This study reports the results of a randomized clinical trial of telemonitoring on health status in patients with heart failure. METHODS AND RESULTS: Among 1521 patients with recent heart failure hospitalization randomized in the Tele-HF trial (Telemonitoring to Improve Heart Failure Outcomes), 756 received telephonic monitoring and 765 usual care. Disease-specific health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within 2 weeks of discharge and at 3 and 6 months. Repeated measures linear regression models were used to assess differences in KCCQ scores between patients assigned to telemonitoring and usual care over 6 months. The baseline characteristics of the 2 treatment arms were similar (mean age, 61 years; 43% female and 39% black). Over the 6-month follow-up period, there was a statistically significant, but clinically small, difference between the 2 groups in their KCCQ overall summary and subscale scores. The average KCCQ overall summary score for those receiving telemonitoring was 2.5 points (95% confidence interval, 0.38-4.67; P=0.02) higher than usual care, driven primarily by improvements in symptoms (3.5 points; 95% confidence interval, 1.18-5.82; P=0.003) and social function (3.1 points; 95% confidence interval, 0.30-6.00; P=0.03). CONCLUSIONS: Telemonitoring results in statistically significant, but clinically small, improvements in health status when compared with usual care. Given that the KCCQ was a secondary outcome, the benefits should be confirmed in future studies. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00303212.

Do Non-Clinical Factors Improve Prediction of Readmission Risk?: Results From the Tele-HF Study.

OBJECTIVES: This study sought to determine whether a model that included self-reported socioeconomic, health status, and psychosocial characteristics obtained from patients recently discharged from hospitalizations for heart failure substantially improved 30-day readmission risk prediction compared with a model that incorporated only clinical and demographic factors. BACKGROUND: Existing readmission risk models have poor discrimination and it is unknown whether they would be markedly improved by the inclusion of patient-reported information. METHODS: As part of the Tele-HF (Telemonitoring to Improve Heart Failure Outcomes) trial, we conducted medical record abstraction and telephone interviews in a sample of 1,004 patients recently hospitalized for heart failure to obtain clinical, functional, and psychosocial information within 2 weeks of discharge. Candidate risk factors included 110 variables divided into 2 groups: demographic and clinical variables generally available from the medical record; and socioeconomic, health status, adherence, and psychosocial variables from patient interview. RESULTS: The 30-day readmission rate was 17.1%. Using the 3-level risk score derived from the restricted medical record variables, patients with a score of 0 (no risk factors) had a readmission rate of 10.9% (95% confidence interval [CI]: 8.2% to 14.2%), and patients with a score of 2 (all risk factors) had a readmission rate of 32.1% (95% CI: 22.4% to 43.2%), a C-statistic of 0.62. Using the 5-level risk score derived from all variables, patients with a score of 0 (no risk factors) had a readmission rate of 9.6% (95% CI: 6.1% to 14.2%), and patients with a score of 4 (all risk factors) had a readmission rate of 55.0% (95% CI: 31.5% to 76.9%), a C-statistic of 0.65. CONCLUSIONS: Self-reported socioeconomic, health status, adherence, and psychosocial variables are not dominant factors in predicting readmission risk for patients with heart failure. Patient-reported information improved model discrimination and extended the predicted ranges of readmission rates, but the model performance remained poor. (Telemonitoring to Improve Heart Failure Outcomes [Tele-HF]; NCT00303212).

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

BACKGROUND: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. METHODS AND RESULTS: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. CONCLUSION: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

Hospital variation in quality of discharge summaries for patients hospitalized with heart failure exacerbation.

BACKGROUND: Single-site studies have demonstrated inadequate quality of discharge summaries in timeliness, transmission, and content, potentially contributing to adverse outcomes. However, degree of hospital-level variation in discharge summary quality for patients hospitalized with heart failure (HF) is uncertain. METHODS AND RESULTS: We analyzed discharge summaries of patients enrolled in the Telemonitoring to Improve Heart Failure Outcomes (Tele-HF) study. We assessed hospital-level performance on timeliness (fraction of summaries completed on the day of discharge), documented transmission to the follow-up physician, and content (presence of components suggested by the Transitions of Care Consensus Conference). We obtained 1501 discharge summaries from 1640 (91.5%) patients discharged alive from 46 hospitals. Among hospitals contributing ≥ 10 summaries, the median hospital dictated 69.2% of discharge summaries on the day of discharge (range, 0.0%-98.0%; P<0.001); documented transmission of 33.3% of summaries to the follow-up physician (range, 0.0%-75.7%; P<0.001); and included 3.6 of 7 Transitions of Care Consensus Conference elements (range, 2.9-4.5; P<0.001). Hospital course was typically included (97.2%), but summaries were less likely to include discharge condition (30.7%), discharge volume status (16.0%), or discharge weight (15.7%). No discharge summary included all 7 Transitions of Care Consensus Conference-endorsed content elements, was dictated on the day of discharge, and was sent to a follow-up physician. CONCLUSIONS: Even at the highest performing hospital, discharge summary quality is insufficient in terms of timeliness, transmission, and content. Improvements in all aspects of discharge summary quality are necessary to enable the discharge summary to serve as an effective transitional care tool.