This feasibility pilot study successfully achieved its goal of developing and pilot testing a TOC model tailored for self-identified Hispanic/Latino adults with diabetes transitioning from the hospital to the community.
The study was initially designed as a randomized pilot study to compare usual care versus a new transition of care but was subsequently modified to adjust to the realities of a pandemic-impacted healthcare system and research enterprise. Although patient care continued during the pandemic, the “usual care” was no longer the norm [28] because health systems worldwide had to change the usual process and procedures to accommodate the existing demands and overwhelming impact of the pandemic on healthcare systems, including limited bed availability, healthcare professional shortage and increased morbidity and mortality in the population due to COVID-19, particularly for patients with chronic diseases such as diabetes. [29]
In our study, we utilized the Plan-Do-Study-Act (PDSA) framework, traditionally employed for system wide improvements [30], to craft a TOC model that adapts to patient, provider, and system preferences. This malleable approach was rooted in the practicality of creating an evidence-based TOC model that could be continually reassessed and adjusted based on patient and provider feedback and changes to the healthcare environment. We recognize that a rigid, one-size-fits-all TOC model might not be optimal, particularly in a changing healthcare landscape. The PDSA framework allows us to test and redesign evidence-based interventions that can be implemented in real-world settings and has been proven beneficial in recent trials such as the Strategies and Opportunities to STOP Colon Cancer in Priory Populations (STOP CRC) trial in 2016.
The COVID-19 pandemic significantly impacted our study, namely the loss of our study coordinator, limiting our ability to reach sample size and achieve our new design goals. Nevertheless, 4 bilingual research team members successfully enrolled 12 participants in our study over an approximate 3-month recruitment period. Extrapolating this accrual rate of 4 participants per month, we estimate that a 4-month recruitment period is needed to reach a target number of 16 participants and a 7-to-15-month recruitment period for a randomized pilot study with 28 to 61 participants. There was only 1 participant that was lost to follow up during the study, so the retention rate was excellent. While the current small sample size restricts our ability to draw definitive conclusions on the impact of our newly developed TOC model on the predefined participant outcomes, our findings provide new information in the limited available literature about the TOC for Hispanic/Latino adult patients with diabetes from hospital to community settings. Our study suggests that a streamlined, patient-centered TOC model featuring bilingual staff can potentially decrease 30-day post-discharge ED visits and unplanned hospital readmissions. Furthermore, all participants enrolled in our study who completed the 30-day post-discharge phone call and of whom we had access to their medical records met the secondary participant outcomes. Indeed, none visited the ED or were readmitted to the hospital 30-days post discharge. They also all had hospital follow up visits with their providers within 2 weeks after discharge.
Our baseline questionnaires further identified critical healthcare concerns within the Hispanic/Latino community. These challenges included limited healthcare access before their hospitalization and issues with health literacy requiring assistance with reading instructions/pamphlets. Participant responses also suggested that a more paternalistic patient-provider relationship characterized their interactions with healthcare providers. Patients reported that they did not feel like “equal partners” in the healthcare relationship. Patients also expressed difficulty comprehending the purpose and effects of their prescribed medications, along with a sense of inadequacy in comprehending their medical test results. Lastly, patients did not feel confident in their ability to implement their medical treatment plans. Addressing these issues is key to the development of a successful TOC model.
In the context of our study, we draw attention to a relevant randomized controlled trial [25] known as the Mi Puente (“My Bridge”) Care Transitions Program, which focused on Hispanic/Latino adults dealing with multiple health conditions. Mi Puente results highlighted the critical need for strong connection to outpatient care for participants to improve the transition of care. [33]
Prior research highlights the importance of establishing a direct connection with outpatient services and leveraging pharmacist support for an effective discharge program. The Project RED Trial, [34] conducted at a Boston safety net hospital, particularly focused on bridging this gap for the discharge process of low-income Medicaid patients, predominantly of white or black non-Hispanic race. They piloted an “After-hospital care plan” (AHCP) that included critical components, including the reason for hospitalization, a discharge medication list, contact information with a picture of the primary care provider, follow-up guidance, and a calendar labeled with scheduled appointments and tests. Furthermore, a nurse discharge advocate was assigned during inpatient to address any barriers for patients, and a clinical pharmacist conducted telephone medication reviews 2–4 days post-discharge, resulting in a lower rate of hospitalization in the intervention group. Balaban et al. [35] performed a randomized control study at a Boston safety net hospital, demonstrating the benefits of having a primary “medical home” within the same healthcare system and timely outpatient follow-up to reduce re-hospitalization. Notably, 40% of participants in the intervention group were non-English speakers. Coleman et al. demonstrated the importance of incorporating the family caregiver to the Care Transitions Intervention (CTI) to avoid re-hospitalization. [36] In our study, over 60% of our participants identified the lack of social support from family/friends about diet and exercise routines changes.
Overall, multiple systematic reviews [37, 38, 39, 40] have shown beneficial effects of TOC interventions but these have been performed on smaller sample sizes and not always consistent. To date, there is no clear consensus on the “critical ingredients” required for a successful TOC model. However, the most effective interventions appear to have focused on multiple aspects of the care transition and targeted the outpatient care follow-up and access, a key component of our proposed TOC model.
This TOC model, therefore, has potential for success but requires resources. We have demonstrated the need for a culturally sensitive and applicable TOC model for the Hispanic/Latino population with higher rates of diabetes, diabetes-related complications, and hospital admissions related to diabetes. Patients and providers have stated that an EMR-generated discharge summary with simple language, visual cues, and essential information, including discharge diagnosis, medications and follow-up appointments is most helpful. A close link to outpatient healthcare and community organizations is essential to avoid any breakdown in transition.
It is important to acknowledge that our study was conducted in an urban setting with established community outpatient clinics with Spanish-speaking providers. This model may not be applicable to more rural centers or communities lacking these resources and infrastructure.