Effectiveness and scalability of an electronic patient-reported outcome measure and decision support tool for family-centred and participation-focused early intervention: PROSPECT hybrid type 1 trial protocol.

INTRODUCTION: Early intervention (EI) endorses family-centred and participation-focused services, but there remain insufficient options for systematically enacting this service approach. The Young Children's Participation and Environment Measure electronic patient-reported outcome (YC-PEM e-PRO) is an evidence-based measure for caregivers that enables family-centred services in EI. The Parent-Reported Outcomes for Strengthening Partnership within the Early Intervention Care Team (PROSPECT) is a community-based pragmatic trial examining the effectiveness of implementing the YC-PEM e-PRO measure and decision support tool as an option for use within routine EI care, on service quality and child outcomes (aim 1). Following trial completion, we will characterise stakeholder perspectives of facilitators and barriers to its implementation across multiple EI programmes (aim 2). METHODS AND ANALYSIS: This study employs a hybrid type 1 effectiveness-implementation study design. For aim 1, we aim to enrol 223 caregivers of children with or at risk for developmental disabilities or delays aged 0-3 years old that have accessed EI services for three or more months from one EI programme in the Denver Metro catchment of Colorado. Participants will be invited to enrol for 12 months, beginning at the time of their child's annual evaluation of progress. Participants will be randomised using a cluster-randomised design at the EI service coordinator level. Both groups will complete baseline testing and follow-up assessment at 1, 6 and 12 months. A generalised linear mixed model will be fitted for each outcome of interest, with group, time and their interactions as primary fixed effects, and adjusting for child age and condition severity as secondary fixed effects. For aim 2, we will conduct focus groups with EI stakeholders (families in the intervention group, service coordinators and other service providers in the EI programme, and programme leadership) which will be analysed thematically to explain aim 1 results and identify supports and remaining barriers to its broader implementation in multiple EI programmes. ETHICS AND DISSEMINATION: This study has been approved by the institutional review boards at the University of Illinois at Chicago (2020-0555) and University of Colorado (20-2380). An active dissemination plan will ensure that findings have maximum reach for research and practice. TRIAL REGISTRATION NUMBER: NCT04562038.

Characterizing Health Care Delays and Interruptions in the United States During the COVID-19 Pandemic: Internet-Based, Cross-sectional Survey Study.

BACKGROUND: The COVID-19 pandemic has broader geographic spread and potentially longer lasting effects than those of previous disasters. Necessary preventive precautions for the transmission of COVID-19 has resulted in delays for in-person health care services, especially at the outset of the pandemic. OBJECTIVE: Among a US sample, we examined the rates of delays (defined as cancellations and postponements) in health care at the outset of the pandemic and characterized the reasons for such delays. METHODS: As part of an internet-based survey that was distributed on social media in April 2020, we asked a US-based convenience sample of 2570 participants about delays in their health care resulting from the COVID-19 pandemic. Participant demographics and self-reported worries about general health and the COVID-19 pandemic were explored as potent determinants of health care delays. In addition to all delays, we focused on the following three main types of delays, which were the primary outcomes in this study: dental, preventive, and diagnostic care delays. For each outcome, we used bivariate statistical tests (t tests and chi-square tests) and multiple logistic regression models to determine which factors were associated with health care delays. RESULTS: The top reported barrier to receiving health care was the fear of SARS-CoV-2 infection (126/374, 33.6%). Almost half (1227/2570, 47.7%) of the participants reported experiencing health care delays. Among those who experienced health care delays and further clarified the type of delay they experienced (921/1227, 75.1%), the top three reported types of care that were affected by delays included dental (351/921, 38.1%), preventive (269/921, 29.2%), and diagnostic (151/921, 16.4%) care. The logistic regression models showed that age (P<.001), gender identity (P<.001), education (P=.007), and self-reported worry about general health (P<.001) were significantly associated with experiencing health care delays. Self-reported worry about general health was negatively related to experiencing delays in dental care. However, this predictor was positively associated with delays in diagnostic testing based on the logistic regression model. Additionally, age was positively associated with delays in diagnostic testing. No factors remained significant in the multiple logistic regression for delays in preventive care, and although there was trend between race and delays (people of color experienced fewer delays than White participants), it was not significant (P=.06). CONCLUSIONS: The lessons learned from the initial surge of COVID-19 cases can inform systemic mitigation strategies for potential future disruptions. This study addresses the demand side of health care delays by exploring the determinants of such delays. More research on health care delays during the pandemic is needed, including research on their short- and long-term impacts on patient-level outcomes such as mortality, morbidity, mental health, people's quality of life, and the experience of pain.

Addressing the critical need for long-term mental health data during the COVID-19 pandemic: Changes in mental health from April to September 2020.

Despite the large amounts of research currently being conducted and the high number of editorials warning about the potential mental health impacts, there is a stunning lack of longitudinal mental health data on the effects of the pandemic. Yet, the pandemic may have sizable long-term impacts on psychological distress and health behaviors-these effects may be long-lasting and may disproportionately affect some demographic groups more than others. Data came from a longitudinal international study of the impacts of the COVID-19 pandemic on adults' psychological distress and wellbeing (N = 1567). We found high rates of depression (55% were diagnosable with probable depression at baseline), anxiety (65%), and risk for PTSD (51%). More than one-third of participants who reported that they drank alcohol indicated that their drinking had increased since the start of the pandemic. Over time, depressive symptoms and suicidal thoughts and behaviors increased significantly, but acute stress symptoms decreased. Specific demographic groups (people of color and sexual and gender minorities) appeared to be at high risk of distress across analyses. Our findings suggest high rates of depression, anxiety, acute stress, and other signs of distress like isolation, hopelessness, and use of substances to cope-even at five-month follow-up. Our findings suggest a need to prioritize availability of, and access to, mental health care during both the pandemic and the recovery.

Differences in Emotional Distress Among Black and White Breast Cancer Survivors During the Covid-19 Pandemic: a National Survey.

The Covid-19 pandemic is straining US healthcare resources, causing significant disruptions in cancer care. Prior to the pandemic, Black cancer survivors experienced a disproportionate burden of delays in cancer treatment compared to White cancer survivors. As a result of the pandemic, disruptions in care are widespread and affect cancer survivors regardless of race. This shift presented an opportunity to investigate differences in how Black and White cancer survivors experience disruptions in cancer care due to the pandemic. We conducted a national survey of adult breast cancer survivors, distributed online from 4/2/20 to 4/27/20. We used t-tests to compare cancer and non-cancer-related worry during the Covid-19 pandemic between Black and White breast cancer survivors. Analysis of data from 570 respondents (106 Black and 464 White) indicated significantly higher levels of distress among White respondents compared to Black respondents. Our results point to the importance of assessing race differences in emotional response to disruptions in cancer care during the pandemic. We suggest that differences in emotional distress may reflect differences in previous experience of treatment delays and coping strategies between Black and White breast cancer survivors.

Emotional Response of US Breast Cancer Survivors during the COVID-19 Pandemic.

In a sample of 633 US adult breast cancer survivors, we examined health-related worry as a function vulnerability as influenced by communication, trust, and planning with their cancer care team during the COVID-19 pandemic. We found significant positive correlations between communication and trust, communication and planning, and trust and planning. ANCOVAs with treatment status, immunocompromised status, and delays (separately) as IVs, trust as a covariate, and cancer-related worry as a DV, yielded significant models. A noteworthy finding is the presence of trust as a significant covariate in models of vulnerability and worry.

SCHEDULING DELAYED TREATMENT AND SURGERIES POST-PANDEMIC: A STAKEHOLDER ANALYSIS.

Many are interested in how to safely ramp up elective surgeries after national, state, and voluntary shutdowns of operating rooms to minimize the spread of COVID-19 infections to patients and providers. We conducted an analysis of diverse perspectives from stakeholders regarding how to trade off risks and benefits to patients, healthcare providers, and the local community. Our findings indicate that there are a large number of different categories of stakeholders impacted by the post-pandemic decisions to reschedule delayed treatments and surgeries. For a delayed surgery, the primary stakeholders are the surgeon with expertise about the clinical benefits of undergoing an operation and the patient's willingness to tolerate uncertainty and the increased risk of infection. For decisions about how much capacity in the operating rooms and in the inpatient setting after the surgery, the primary considerations are minimizing staff infections, preventing patients from getting COVID-19 during operations and during post-surgical recovery at the hospital, conserving critical resources such as PPE, and meeting the needs of hospital staff for quality of life, such as child care needs and avoiding infecting members of their household. The timing and selection of elective surgery cases has an impact on the ability of hospitals to steward finances, which in turns affects decisions about maintaining employment of staff when operating rooms and inpatient rooms are not being used.

Patient-reported treatment delays in breast cancer care during the COVID-19 pandemic.

PURPOSE: The coronavirus disease (COVID-19) pandemic has had a profound impact on cancer care in the US Guidelines focused on the management of COVID-19, rather than healthcare needs of breast cancer patients requiring access to crucial services. This US survey of breast cancer survivors characterizes treatment delays early period in the pandemic. METHODS: We developed a survey and administered it to 609 adult breast cancer survivors in the US. We used snowball sampling with invitations distributed via social media. We used logistic regression to select a model of delay from a pool of independent variables including race, cancer stage, site of care, health insurance, and age. We used descriptive statistics to characterize delay types. RESULTS: Forty-four percent of participants reported cancer care treatment delays during the pandemic. Delays in all aspects of cancer care and treatment were reported. The only variable which had a significant effect was age (97 (.95, 99), p < 0.001) with younger respondents (M = 45.94, SD = 10.31) reporting a higher incidence of delays than older respondents (M = 48.98, SD = 11.10). There was no significant effect for race, insurance, site of care, or cancer stage. CONCLUSIONS: Our findings reveal a pervasive impact of COVID-19 on breast cancer care and a gap in disaster preparedness that leaves cancer survivors at risk for poor outcomes. Delays are critical to capture and characterize to help cancer providers and healthcare systems develop effective and patient-tailored processes and strategies to manage cases during the current pandemic wave, subsequent waves, and future disasters.