Challenges & barriers for real-time integration of drones in emergency cardiac care: Lessons from the United States, Sweden, & Canada.

Importance: Out-of-hospital cardiac arrest (OHCA) is a leading cause of morbidity and mortality in the US and Europe (∼600,000 incident events annually) and around the world (∼3.8 million). With every minute that passes without cardiopulmonary resuscitation or defibrillation, the probability of survival decreases by 10%. Preliminary studies suggest that uncrewed aircraft systems, also known as drones, can deliver automated external defibrillators (AEDs) to OHCA victims faster than ground transport and potentially save lives. Objective: To date, the United States (US), Sweden, and Canada have made significant contributions to the knowledge base regarding AED-equipped drones. The purpose of this Special Communication is to explore the challenges and facilitators impacting the progress of AED-equipped drone integration into emergency medicine research and applications in the US, Sweden, and Canada. We also explore opportunities to propel this innovative and important research forward. Evidence review: In this narrative review, we summarize the AED-drone research to date from the US, Sweden, and Canada, including the first drone-assisted delivery of an AED to an OHCA. Further, we compare the research environment, emergency medical systems, and aviation regulatory environment in each country as they apply to OHCA, AEDs, and drones. Finally, we provide recommendations for advancing research and implementation of AED-drone technology into emergency care. Findings: The rates that drone technologies have been integrated into both research and real-life emergency care in each country varies considerably. Based on current research, there is significant potential in incorporating AED-equipped drones into the chain of survival for OHCA emergency response. Comparing the different environments and systems in each country revealed ways that each can serve as a facilitator or barrier to future AED-drone research. Conclusions and relevance: The US, Sweden, and Canada each offers different challenges and opportunities in this field of research. Together, the international community can learn from one another to optimize integration of AED-equipped drones into emergency systems of care.

Referral to Community-Based Rehabilitation Following Acute Stroke: Findings From the COMPASS Pragmatic Trial.

BACKGROUND: Few studies on care transitions following acute stroke have evaluated whether referral to community-based rehabilitation occurred as part of discharge planning. Our objectives were to describe the extent to which patients discharged home were referred to community-based rehabilitation and identify the patient, hospital, and community-level predictors of referral. METHODS: We examined data from 40 North Carolina hospitals that participated in the COMPASS (Comprehensive Post-Acute Stroke Services) cluster-randomized trial. Participants included adults discharged home following stroke or transient ischemic attack (N=10 702). In this observational analysis, COMPASS data were supplemented with hospital-level and county-level data from various sources. The primary outcome was referral to community-based rehabilitation (physical, occupational, or speech therapy) at discharge. Predictor variables included patient (demographic, stroke-related, medical history), hospital (structure, process), and community (therapist supply) measures. We used generalized linear mixed models with a hospital random effect and hierarchical backward model selection procedures to identify predictors of therapy referral. RESULTS: Approximately, one-third (36%) of stroke survivors (mean age, 66.8 [SD, 14.0] years; 49% female, 72% White race) were referred to community-based rehabilitation. Rates of referral to physical, occupational, and speech therapists were 31%, 18%, and 10%, respectively. Referral rates by hospital ranged from 3% to 78% with a median of 35%. Patient-level predictors included higher stroke severity, presence of medical comorbidities, and older age. Female sex (odds ratio, 1.24 [95% CI, 1.12-1.38]), non-White race (2.20 [2.01-2.44]), and having Medicare insurance (1.12 [1.02-1.23]) were also predictors of referral. Referral was higher for patients living in counties with greater physical therapist supply. Much of the variation in referral across hospitals remained unexplained. CONCLUSIONS: One-third of stroke survivors were referred to community-based rehabilitation. Patient-level factors predominated as predictors. Variation across hospitals was notable and presents an opportunity for further evaluation and possible targets for improved poststroke rehabilitative care. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.

Improving the Quality of Upper Urinary Tract Stone Surgery: External Validation of a Statewide Collaborative's Efforts to Reduce Emergency Department Visits After Ureteroscopy.

PURPOSE: The ROCKS (Reducing Operative Complications from Kidney Stones) program in MUSIC (Michigan Urological Surgery Improvement Collaborative) was created to optimize ureteroscopy outcomes. Through data collection, distribution of reports, patient education, and standardization of medication, post-ureteroscopy emergency department visits in Michigan have declined. It is unclear whether this is because of statewide quality efforts or due to national trends. We therefore sought to understand emergency department visit rates in Michigan compared to a national data set. MATERIALS AND METHODS: We compared the MUSIC ROCKS clinical registry in Michigan against a national cohort, Optum's de-identified Clinformatics Data Mart, from 2016-2021 (excluding Michigan). We identified patients who underwent ureteroscopy and the proportion who had a postoperative emergency department visit within 30 days. Emergency department rates were modeled over time, adjusting for age, gender, comorbidity, and ureteral stenting. RESULTS: We identified 24,688 patients in MUSIC ROCKS and 99,340 in the Clinformatics Data Mart database who underwent ureteroscopy. The risk-adjusted emergency department visit rate in MUSIC ROCKS significantly declined over the study period (10.5% in 2016 to 6.9% in 2021, P < 0.001) while the mean emergency department visit rate in the Clinformatics Data Mart cohort was 9.9% and did not change over time (9.6% in 2016 to 10% in 2021). Comparing emergency department visits between the cohorts, the MUSIC ROCKS rate significantly declined relative to the Clinformatics Data Mart (P < 0.001) over the study period. CONCLUSIONS: Postoperative emergency department visit rates in Michigan have declined significantly after ureteroscopy since the establishment of MUSIC ROCKS. This decline outpaced national rates, providing evidence that systematic quality initiatives can improve urological care.

Post-acute Ambulatory Care Service Use Among Patients Discharged Home After Stroke or TIA: The Cluster-randomized COMPASS Study.

BACKGROUND AND OBJECTIVES: We examined transitional care management within 90 days and 1 year following discharge home among acute stroke and transient ischemic attack patients from the Comprehensive Post-Acute Stroke Services (COMPASS) Study, a cluster-randomized pragmatic trial of early supported discharge conducted in 41 hospitals (40 hospital units) in North Carolina, United States. METHODS: Data for 2262 of the total 6024 (37.6%; 1069 intervention and 1193 usual care) COMPASS patients were linked with the Centers for Medicare and Medicaid Services fee-for-service Medicare claims. Time to the first ambulatory care visit was examined using Cox proportional hazard models adjusted for patient characteristics not included in the randomization protocol. RESULTS: Only 6% of the patients [mean (SD) age 74.9 (10.2) years, 52.1% women, 80.3% White)] did not have an ambulatory care visit within 90 days postdischarge. Mean time (SD) to first ambulatory care visit was 12.0 (26.0) and 16.3 (35.1) days in intervention and usual care arms, respectively, with the majority of visits in both study arms to primary care providers. The COMPASS intervention resulted in a 27% greater use of ambulatory care services within 1 year postdischarge, relative to usual care [HR=1.27 (95% CI: 1.14-1.41)]. The use of transitional care billing codes was significantly greater in the intervention arm as compared with usual care [OR=1.87 (95% CI: 1.54-2.27)]. DISCUSSION: The COMPASS intervention, which was aimed at improving stroke post-acute care, was associated with an increase in the use of ambulatory care services by stroke and transient ischemic attack patients discharged home and an increased use of transitional care billing codes by ambulatory providers.

Familial caregiving following stroke: findings from the comprehensive post-acute stroke services (COMPASS) pragmatic cluster-randomized transitional care study.

BACKGROUND: Stroke patients discharged home often require prolonged assistance from caregivers. Little is known about the real-world effectiveness of a comprehensive stroke transitional care intervention on relieving caregiver strain. OBJECTIVES: To describe the effect of the COMPASS transitional care (COMPASS-TC) intervention on caregiver strain and characterize the types, duration, and intensity of caregiving. METHODS: The cluster-randomized COMPASS pragmatic trial evaluated the effectiveness of COMPASS-TC versus usual care with patients with mild stroke and TIA at 40 hospitals in North Carolina, USA. Of 5882 patients enrolled, 4208 (71%) identified a familial caregiver. A follow-up Caregiver Questionnaire, including the Modified Caregiver Strain Index, was administered at approximately three months post-discharge. Demographics and frequency, duration, and intensity of caregiving were compared between groups. RESULTS: 1228 caregivers (29%) completed the questionnaire. Completion was positively associated with older patient age, white race, and spousal relationship. One-third of the caregivers provided ≥30 hours of care per week and 889 (79%) provided care ≥9 weeks. Average standardized caregiver strain was 21.9 (0-100), increasing with stroke severity and comorbidity burden. Women caregivers reported higher strain than men. Treatment allocation was not associated with caregiver strain. CONCLUSIONS: This sample of mild stroke and TIA survivors received significant assistance from familial caregivers. However, caregiver strain was relatively low. Findings support the importance of familial caregiving in stroke, the continued disproportionate burden on women within the family, and the need for future research on caregiver support.

Skilled Nursing and Inpatient Rehabilitation Facility Use by Medicare Fee-for-Service Beneficiaries Discharged Home After a Stroke: Findings From the COMPASS Trial.

OBJECTIVES: To examine the effect of a comprehensive transitional care model on the use of skilled nursing facility (SNF) and inpatient rehabilitation facility (IRF) care in the 12 months after acute care discharge home following stroke; and to identify predictors of experiencing a SNF or IRF admission following discharge home after stroke. DESIGN: Cluster randomized pragmatic trial SETTING: Forty-one acute care hospitals in North Carolina. PARTICIPANTS: 2262 Medicare fee-for-service beneficiaries with transient ischemic attack or stroke discharged home. The sample was 80.3% White and 52.1% female, with a mean (SD) age of 74.9 (10.2) years and a mean ± SD National Institutes of Health stroke scale score of 2.3 (3.7). INTERVENTION: Comprehensive transitional care model (COMPASS-TC), which consisted of a 2-day follow-up phone call from the postacute care coordinator and 14-day in-person visit with the postacute care coordinator and advanced practice provider. MAIN OUTCOME MEASURES: Time to first SNF or IRF and SNF or IRF admission (yes/no) in the 12 months following discharge home. All analyses utilized multivariable mixed models including a hospital-specific random effect to account for the non-independence of measures within hospital. Intent to treat analyses using Cox proportional hazards regression assessed the effect of COMPASS-TC on time to SNF/IRF admission. Logistic regression was used to identify clinical and non-clinical predictors of SNF/IRF admission. RESULTS: Only 34% of patients in the intervention arm received COMPASS-TC per protocol. COMPASS-TC was not associated with a reduced hazard of a SNF/ IRF admission in the 12 months post-discharge (hazard ratio, 1.20, with a range of 0.95-1.52) compared to usual care. This estimate was robust to additional covariate adjustment (hazard ratio, 1.23) (0.93-1.64). Both clinical and non-clinical factors (ie, insurance, geography) were predictors of SNF/IRF use. CONCLUSIONS: COMPASS-TC was not consistently incorporated into real-world clinical practice. The use of a comprehensive transitional care model for patients discharged home after stroke was not associated with SNF or IRF admissions in a 12-month follow-up period. Non-clinical factors predictive of SNF/IRF use suggest potential issues with access to this type of care.

Out-of-Hospital Cardiac Arrest Bystander Defibrillator Search Time and Experience With and Without Directional Assistance: A Randomized Simulation Trial in a Community Setting.

INTRODUCTION: Probability of survival after out-of-hospital cardiac arrest (OHCA) doubles when a bystander initiates cardiopulmonary resuscitation and uses an automated external defibrillator (AED) rapidly. National, state, and community efforts have increased placement of AEDs in public spaces; however, bystander AED use remains less than 2% in the United States. Little is known about the effect of giving bystanders directional assistance to the closest public access AED. METHODS: We conducted 35 OHCA simulations using a life-sized manikin with participants aged 18 through 65 years who searched for public access AEDs in 5 zones on a university campus. Zones varied by challenges to pedestrian AED acquisition and number of fixed AEDs. Participants completed 2 searches-first unassisted and then with verbal direction to the closest AED-and we compared AED delivery times. We conducted pretest and posttest surveys. RESULTS: In all 5 zones, the median time from simulated OHCA onset to AED delivery was lower when the bystander received directional assistance. Time savings (minutes:seconds) varied by zone, ranging from a median of 0:53 (P = 0.14) to 3:42 (P = 0.02). Only 3 participants immediately located the closest AED without directional assistance; more than half reported difficulty locating an AED. CONCLUSIONS: These findings may inform strategies to ensure that AEDs are consistently marked and placed in visible, accessible locations. Continued emphasis on developing strategies to improve lay bystanders' ability to locate and use AEDs may improve AED retrieval times and OHCA outcomes.

Hospital Readmissions and Mortality Among Fee-for-Service Medicare Patients With Minor Stroke or Transient Ischemic Attack: Findings From the COMPASS Cluster-Randomized Pragmatic Trial.

Background Mortality and hospital readmission rates may reflect the quality of acute and postacute stroke care. Our aim was to investigate if, compared with usual care (UC), the COMPASS-TC (Comprehensive Post-Acute Stroke Services Transitional Care) intervention (INV) resulted in lower all-cause and stroke-specific readmissions and mortality among patients with minor stroke and transient ischemic attack discharged from 40 diverse North Carolina hospitals from 2016 to 2018. Methods and Results Using Medicare fee-for-service claims linked with COMPASS cluster-randomized trial data, we performed intention-to-treat analyses for 30-day, 90-day, and 1-year unplanned all-cause and stroke-specific readmissions and all-cause mortality between INV and UC groups, with 90-day unplanned all-cause readmissions as the primary outcome. Effect estimates were determined via mixed logistic or Cox proportional hazards regression models adjusted for age, sex, race, stroke severity, stroke diagnosis, and documented history of stroke. The final analysis cohort included 1069 INV and 1193 UC patients (median age 74 years, 80% White, 52% women, 40% with transient ischemic attack) with median length of hospital stay of 2 days. The risk of unplanned all-cause readmission was similar between INV versus UC at 30 (9.9% versus 8.7%) and 90 days (19.9% versus 18.9%), respectively. No significant differences between randomization groups were seen in 1-year all-cause readmissions, stroke-specific readmissions, or mortality. Conclusions In this pragmatic trial of patients with complex minor stroke/transient ischemic attack, there was no difference in the risk of readmission or mortality with COMPASS-TC relative to UC. Our study could not conclusively determine the reason for the lack of effectiveness of the INV. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.

Impact of Using Drones in Emergency Medicine: What Does the Future Hold?

The use of unmanned aerial vehicles or "drones" has expanded in the last decade, as their technology has become more sophisticated, and costs have decreased. They are now used routinely in farming, environmental surveillance, public safety, commercial product delivery, recreation, and other applications. Health-related applications are only recently becoming more widely explored and accepted. The use of drone technology in emergency medicine is especially promising given the need for a rapid response to enhance patient outcomes. The purpose of this paper is to describe some of the main current and expanding applications of drone technology in emergency medicine and to describe challenges and future opportunities. Current applications being studied include delivery of defibrillators in response to out-of-hospital cardiac arrest, blood and blood products in response to trauma, and rescue medications. Drones are also being studied and actively used in emergency response to search and rescue operations as well as disaster and mass casualty events. Current challenges to expanding their use in emergency medicine and emergency medical system (EMS) include regulation, safety, flying conditions, concerns about privacy, consent, and confidentiality, and details surrounding the development, operation, and maintenance of a medical drone network. Future research is needed to better understand end user perceptions and acceptance. Continued technical advances are needed to increase payload capacities, increase flying distances, and integrate drone networks into existing 9-1-1 and EMS systems. Drones are a promising technology for improving patient survival, outcomes, and quality of life, particularly for those in areas that are remote or that lack funds or infrastructure. Their cost savings compared with ground transportation alone, speed, and convenience make them particularly applicable in the field of emergency medicine. Research to date suggests that use of drones in emergency medicine is feasible, will be accepted by the public, is cost-effective, and has broad application.

Implementation of Complex Interventions: Lessons Learned From the Patient-Centered Outcomes Research Institute Transitional Care Portfolio.

BACKGROUND: Despite the well-documented risks to patient safety associated with transitions from one care setting to another, health care organizations struggle to identify which interventions to implement. Multiple strategies are often needed, and studying the effectiveness of these complex interventions is challenging. OBJECTIVE: The objective of this study was to present lessons learned in implementing and evaluating complex transitional care interventions in routine clinical care. RESEARCH DESIGN: Nine transitional care study teams share important common lessons in designing complex interventions with stakeholder engagement, implementation, and evaluation under pragmatic conditions (ie, using only existing resources), and disseminating findings in outlets that reach policy makers and the people who could ultimately benefit from the research. RESULTS: Lessons learned serve as a guide for future studies in 3 areas: (1) Delineating the function (intended purpose) versus form (prespecified modes of delivery of the intervention); (2) Evaluating both the processes supporting implementation and the impact of adaptations; and (3) Engaging stakeholders in the design and delivery of the intervention and dissemination of study results. CONCLUSION: These lessons can help guide future pragmatic studies of care transitions.

Partial nephrectomy should be classified as an inpatient procedure: Results from a statewide quality improvement collaborative.

OBJECTIVES: To examine length of stay (LOS) and readmission rates for all minimally-invasive partial nephrectomy (MIPN) and MI radical nephrectomy (MIRN) performed for localized renal masses ≤7 cm in size (cT1RM) within 12 Michigan urology practices. Both RN and PN are commonly performed in treating cT1RM. Although technically more complex and associated with higher complication rates, Centers for Medicare & Medicaid Services considers MIPN an outpatient procedure and MIRN is inpatient. METHODS: We collected data for renal surgeries for cT1RM at MUSIC-KIDNEY practices between May 2017-February 2020. Data abstractors recorded clinical, radiographic, pathologic, surgical, and short-term follow-up data into the registry for cT1RM patients. RESULTS: Within MUSIC-KIDNEY, 807 patients underwent MI renal surgery at 12 practices. Median LOS for cT1RM patients after MIPN (n = 531, 66%) was 2 days and after MIRN (n = 276, 34%) was also 2 days. Among patients undergoing laparoscopic or robotic PN, 171 (32%), 230 (43%), and 130 (24%) stayed ≤1, 2, ≥3 days. Among patients undergoing laparoscopic or robotic RN, 81 (29%), 112 (41%), and 83 (30%) stayed ≤1, 2, ≥3 days. No significant difference was observed between MIPN and MIRN on LOS commensurate with outpatient surgery (≤1-day, OR = 0.97, P = 0.87). CONCLUSIONS: Less than one-third of patients had a LOS ≤1-day and LOS was comparable for MIPN and MIRN. Centers for Medicare & Medicaid Services should be advised that MIPN is a more complex surgery than MIRN, most patients receiving a MIPN will require a ≥2-day hospital stay and it would be more appropriate to classify MIPN an inpatient procedure with MIRN.

Comprehensive Stroke Care and Outcomes: Time for a Paradigm Shift.

Worldwide, stroke is prevalent, costly, and disabling in >80 million survivors. The burden of stroke is increasing despite incredible progress and advancements in evidence-based acute care therapies and despite the substantial changes being made in acute care stroke systems, processes, and quality metrics. Although there has been increased global emphasis on the importance of postacute stroke care, stroke system changes have not expanded to include postacute care and outcome follow-up. Our objectives are to describe the gaps and challenges in postacute stroke care and suboptimal stroke outcomes; to report on stroke survivors' and caregivers' perceptions of current postacute stroke care and their call for improvements in follow-up services for recovery and secondary prevention; and, ultimately, to make the case that a paradigm shift is needed in the definition of comprehensive stroke care and the designation of Comprehensive Stroke Center. Three recommendations are made for a paradigm shift in comprehensive stroke care: (1) criteria should be established for designation of rehabilitation readiness for Comprehensive Stroke Centers, (2) The American Heart Association/American Stroke Association implement an expanded Get With The Guidelines-Stroke program and criteria for comprehensive stroke centers to be inclusive of rehabilitation readiness and measure outcomes at 90 days, and (3) a public health campaign should be launched to offer hopeful and actionable messaging for secondary prevention and recovery of function and health. Now is the time to honor the patients' and caregivers' strongest ask: better access and improved secondary prevention, stroke rehabilitation, and personalized care.

Movement Matters, and So Does Context: Lessons Learned From Multisite Implementation of the Movement Matters Activity Program for Stroke in the Comprehensive Postacute Stroke Services Study.

The purpose of this Special Communication is to discuss the rationale and design of the Movement Matters Activity Program for Stroke (MMAP) and explore implementation successes and challenges in home health and outpatient therapy practices across the stroke belt state of North Carolina. MMAP is an interventional component of the Comprehensive Postacute Stroke Services Study, a randomized multicenter pragmatic trial of stroke transitional care. MMAP was designed to maximize survivor health, recovery, and functional independence in the community and to promote evidence-based rehabilitative care. MMAP provided training, tools, and resources to enable rehabilitation providers to (1) prescribe physical activity and exercise according to evidence-based guidelines and programs, (2) match service setting and parameters with survivor function and benefit coverage, and (3) align treatment with quality metric reporting to demonstrate value-based care. MMAP implementation strategies were aligned with the Expert Recommendations for Implementing Change project, and MMAP site champion and facilitator survey feedback were thematically organized into the Consolidated Framework for Implementation Research domains. MMAP implementation was challenging, required modification and was affected by provider- and system-level factors. Program and study participation were limited and affected by practice priorities, productivity standards, and stroke patient volume. Sites with successful implementation appeared to have empowered MMAP champions in vertically integrated systems that embraced innovation. Findings from this broad evaluation can serve as a road map for the design and implementation of other comprehensive, complex interventions that aim to bridge the currently disconnected realms of acute care, postacute care, and community resources.

Delivery of Automated External Defibrillators via Drones in Simulated Cardiac Arrest: Users' Experiences and the Human-Drone Interaction.

BACKGROUND: Survival after out-of-hospital cardiac arrest (OHCA) in the United States is approximately 10%. Automatic external defibrillators (AEDs) are effective when applied early, yet public access AEDs are used in <2% of OHCAs. AEDs are often challenging for bystanders to locate and are rarely available in homes, where 70% of OHCAs occur. Drones have the potential to deliver AEDs to bystanders efficiently; however, little is known about the human-drone interface in AED delivery. OBJECTIVES: To describe user experiences with AED-equipped drones in a feasibility study of simulated OHCA in a community setting. METHODS: We simulated an OHCA in a series of trials with age-group/sex-matched participant pairs, with one participant randomized to search for a public access AED and the other to call a mock 9-1-1 telephone number that initiated the dispatch of an AED-equipped drone. We investigated user experience of 17 of the 35 drone recipient participants via semi-structured qualitative interviews and analyzed audio-recordings for key aspects of user experience. RESULTS: Drone recipient participants reported largely positive experiences, highlighting that this delivery method enabled them to stay with the victim and continue cardiopulmonary resuscitation. Concerns were few but included drone arrival timing and direction as well as bystander safety. Participants provided suggestions for improvements in the AED-equipped drone design and delivery procedures. CONCLUSION: Participants reported positive experiences interacting with an AED-equipped drone for a simulated OHCA in a community setting. Early findings suggest a role for drone-delivered AEDs to improve bystander AED use and improve outcomes for OHCA victims.

Randomized Pragmatic Trial of Stroke Transitional Care: The COMPASS Study.

Background The objectives of this study were to develop and test in real-world clinical practice the effectiveness of a comprehensive postacute stroke transitional care (TC) management program. Methods and Results The COMPASS study (Comprehensive Post-Acute Stroke Services) was a pragmatic cluster-randomized trial where the hospital was the unit of randomization. The intervention (COMPASS-TC) was initiated at 20 hospitals, and 20 hospitals provided their usual care. Hospital staff enrolled 6024 adult stroke and transient ischemic attack patients discharged home between 2016 and 2018. COMPASS-TC was patient-centered and assessed social and functional determinates of health to inform individualized care plans. Ninety-day outcomes were evaluated by blinded telephone interviewers. The primary outcome was functional status (Stroke Impact Scale-16); secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, and falls. The primary analysis was intention to treat. Of intervention hospitals, 58% had uninterrupted intervention delivery. Thirty-five percent of patients at intervention hospitals attended a COMPASS clinic visit. The primary outcome was measured for 59% of patients and was not significantly influenced by the intervention. Mean Stroke Impact Scale-16 (±SD) was 80.6±21.1 in TC versus 79.9±21.4 in usual care. Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]). No other secondary outcomes differed. Conclusions Although designed according to the best available evidence with input from various stakeholders and consistent with Centers for Medicare and Medicaid Services TC policies, the COMPASS model of TC was not consistently incorporated into real-world health care. We found no significant effect of the intervention on functional status at 90 days post-discharge. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.

Implementation of a Transitional Care Model for Stroke: Perspectives From Frontline Clinicians, Administrators, and COMPASS-TC Implementation Staff.

BACKGROUND AND OBJECTIVES: Stroke is a chronic, complex condition that disproportionally affects older adults. Health systems are evaluating innovative transitional care (TC) models to improve outcomes in these patients. The Comprehensive Post-Acute Stroke Services (COMPASS) Study, a large cluster-randomized pragmatic trial, tested a TC model for patients with stroke or transient ischemic attack discharged home from the hospital. The implementation of COMPASS-TC in complex real-world settings was evaluated to identify successes and challenges with integration into the clinical workflow. RESEARCH DESIGN AND METHODS: We conducted a concurrent process evaluation of COMPASS-TC implementation during the first year of the trial. Qualitative data were collected from 4 sources across 19 intervention hospitals. We analyzed transcripts from 43 conference calls with hospital clinicians, individual and group interviews with leaders and clinicians from 9 hospitals, and 2 interviews with the COMPASS-TC Director of Implementation using iterative thematic analysis. Themes were compared to the domains of the RE-AIM framework. RESULTS: Organizational, individual, and community factors related to Reach, Adoption, and Implementation were identified. Organizational readiness was an additional key factor to successful implementation, in that hospitals that were not "organizationally ready" had more difficulty addressing implementation challenges. DISCUSSION AND IMPLICATIONS: Multifaceted TC models are challenging to implement. Facilitators of implementation were organizational commitment and capacity, prioritizing implementation of innovative delivery models to provide comprehensive care, being able to address challenges quickly, implementing systems for tracking patients throughout the intervention, providing clinicians with autonomy and support to address challenges, and adequately resourcing the intervention. CLINICAL TRIAL REGISTRATION: NCT02588664.

How engagement of a diverse set of stakeholders shaped the design, implementation, and dissemination of a multicenter pragmatic trial of stroke transitional care: The COMPASS study.

Evidence is limited on how to synthesize and incorporate the views of stakeholders into a multisite pragmatic trial and how much academic teams change study design and protocol in response to stakeholder input. This qualitative study describes how stakeholders contributed to the design, conduct, and dissemination of findings of a multisite pragmatic clinical trial, the COMprehensive Post-Acute Stroke Services (COMPASS) Study. We engaged stakeholders as integral research partners by embedding them in study committees and community resource networks that supported local sites. Data stemmed from formal focus groups and continuous participation in working groups. Guided by Grounded Theory, we extracted themes from focus group and meeting notes. These were discussed as a team and with other stakeholder groups for feasibility. A consensus approach was used. Stakeholder input changed many aspects of the study including: the care model that treated stroke as a chronic condition after hospital discharge, training for hospital-based providers who often lacked awareness of the barriers to recovery that patients face, support for caregivers who were essential for stroke patients' recovery, and for community-based health and social service providers whose services can support recovery yet often go underutilized. Stakeholders brought value to both pragmatic research and health service delivery. Future studies should test the impact of elements of study implementation informed by stakeholders vs those that are not.