Parents' Psychological and Decision-Making Outcomes following Prenatal Diagnosis with Complex Congenital Heart Defect: An Exploratory Study.

Background. Parents with a fetus diagnosed with a complex congenital heart defect (CHD) are at high risk of negative psychological outcomes. Purpose. To explore whether parents' psychological and decision-making outcomes differed based on their treatment decision and fetus/neonate survival status. Methods. We prospectively enrolled parents with a fetus diagnosed with a complex, life-threatening CHD from September 2018 to December 2020. We tested whether parents' psychological and decision-making outcomes 3 months posttreatment differed by treatment choice and survival status. Results. Our sample included 23 parents (average Age[years]: 27 ± 4, range = 21-37). Most were women (n = 18), non-Hispanic White (n = 20), and married (n = 21). Most parents chose surgery (n = 16), with 11 children surviving to the time of the survey; remaining parents (n = 7) chose comfort-directed care. Parents who chose comfort-directed care reported higher distress (x¯ = 1.51, s = 0.75 v. x¯ = 0.74, s = 0.55; Mdifference = 0.77, 95% confidence interval [CI], 0.05-1.48) and perinatal grief (x¯ = 91.86, s = 22.96 v. x¯ = 63.38, s = 20.15; Mdifference = 27.18, 95% CI, 6.20-48.16) than parents who chose surgery, regardless of survival status. Parents who chose comfort-directed care reported higher depression (x¯ = 1.64, s = 0.95 v. x¯ = 0.65, s = 0.49; Mdifference = 0.99, 95% CI, 0.10-1.88) than parents whose child survived following surgery. Parents choosing comfort-directed care reported higher regret (x¯ = 26.43, s = 8.02 v. x¯ = 5.00, s = 7.07; Mdifference = 21.43, 95% CI, 11.59-31.27) and decisional conflict (x¯ = 20.98, s = 10.00 v. x¯ = 3.44, s = 4.74; Mdifference = 17.54, 95% CI; 7.75-27.34) than parents whose child had not survived following surgery. Parents whose child survived following surgery reported lower grief (Mdifference = -19.71; 95% CI, -39.41 to -0.01) than parents whose child had not. Conclusions. The results highlight the potential for interventions and care tailored to parents' treatment decisions and outcomes to support parental coping and well-being. Highlights: Question: Do the psychological and decision-making outcomes of parents differ based on their treatment decision and survival outcome following prenatal diagnosis with complex CHD?Findings: In this exploratory study, parents who decided to pursue comfort-directed care after a prenatal diagnosis reported higher levels of psychological distress and grief as well as higher decisional conflict and regret than parents who decided to pursue surgery.Meaning: The findings from this exploratory study highlight potential differences in parents' psychological and decision-making outcomes following a diagnosis of complex CHD for their fetus, which appear to relate to the treatment approach and the treatment outcome and may require tailoring of psychological and decision support.

Study protocol for a longitudinal observational study of disparities in sleep and cognition in older adults: the DISCO study.

INTRODUCTION: Cognitive dysfunction, a leading cause of mortality and morbidity in the USA and globally, has been shown to disproportionately affect the socioeconomically disadvantaged and those who identify as black or Hispanic/Latinx. Poor sleep is strongly associated with the development of vascular and metabolic diseases, which correlate with cognitive dysfunction. Therefore, sleep may contribute to observed disparities in cognitive disorders. The Epidemiologic Study of Disparities in Sleep and Cognition in Older Adults (DISCO) is a longitudinal, observational cohort study that focuses on gathering data to better understand racial/ethnic sleep disparities and illuminate the relationship among sleep, race and ethnicity and changes in cognitive function. This investigation may help inform targeted interventions to minimise disparities in cognitive health among ageing adults. METHODS AND ANALYSIS: The DISCO study will examine up to 495 individuals aged 55 and older at two time points over 24 months. An equal number of black, white and Hispanic/Latinx individuals will be recruited using methods aimed for adults traditionally under-represented in research. Study procedures at each time point will include cognitive tests, gait speed measurement, wrist actigraphy, a type 2 home polysomnography and a clinical examination. Participants will also complete self-identified assessments and questionnaires on cognitive ability, sleep, medication use, quality of life, sociodemographic characteristics, diet, substance use, and psychological and social health. ETHICS AND DISSEMINATION: This study was approved by the Northwestern University Feinberg School of Medicine Institutional Review Board. Deidentified datasets will be shared via the BioLINCC repository following the completion of the project. Biospecimen samples from the study that are not being analysed can be made available to qualified investigators on review and approval by study investigators. Requests that do not lead to participant burden or that conflict with the primary aims of the study will be reviewed by the study investigators.

Parents' quality of life and health after treatment decision for a fetus with severe congenital heart defect.

PURPOSE: This exploratory study examines differences in parents' quality of life by treatment decision and the child's survival outcome in the context of life-threatening congenital heart disease (CHD). DESIGN AND METHODS: Parents of a fetus or neonate diagnosed with severe CHD enrolled in the observational control group of a clinical trial (NCT04437069) and completed quality of life (i.e., contact with clinicians, social support, partner relationship, state of mind), mental and physical health survey measures. Comparisons were made between parents who chose comfort-directed care or surgery and between those whose child did and did not survive. RESULTS: Parents who chose surgery and their child did not survive reported the most contact with their clinicians. Parents who chose comfort-directed care reported lower social support than parents who chose surgery and their child did not survive as well as poorer state of mind compared to parents who chose surgery. CONCLUSIONS: Some aspects of parents' quality of life differed based on their treatment decision. Parents who choose comfort-directed care are vulnerable to some negative outcomes. PRACTICE IMPLICATIONS: Decision support tools and bereavement resources to assist parents with making and coping with a complex treatment decision is important for clinical care.

Randomized evaluation of decision support interventions for atrial fibrillation: Rationale and design of the RED-AF study.

BACKGROUND: Shared decision making (SDM) improves the likelihood that patients will receive care in a manner consistent with their priorities. To facilitate SDM, decision aids (DA) are commonly used, both to prepare a patient before their clinician visit, as well as to facilitate discussion during the visit. However, the relative efficacy of patient-focused or encounter-based DAs on SDM and patient outcomes remains largely unknown. We aim to directly estimate the comparative effectiveness of two DA's on SDM observed in encounters to discuss stroke prevention strategies in patients with atrial fibrillation (AF). METHODS: The study aims to recruit 1200 adult patients with non-valvular AF who qualify for anticoagulation therapy, and their clinicians who manage stroke prevention strategies, in a 2x2 cluster randomized multi-center trial at six sites. Two DA's were developed as interactive, online, non-linear tools: a patient decision aid (PDA) to be used by patients before the encounter, and an encounter decision aid (EDA) to be used by clinicians with their patients during the encounter. Patients will be randomized to PDA or usual care; clinicians will be randomized to EDA or usual care. RESULTS: Primary outcomes are quality of SDM, patient decision making, and patient knowledge. Secondary outcomes include anticoagulation choice, adherence, and clinical events. CONCLUSION: This trial is the first randomized, head-to-head comparison of the effects of an EDA versus a PDA on SDM. Our results will help to inform future SDM interventions to improve patients' AF outcomes and experiences with stroke prevention strategies.

Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect.

INTRODUCTION: Parents who receive the diagnosis of a life-threatening, complex heart defect in their fetus or neonate face a difficult choice between pursuing termination (for fetal diagnoses), palliative care or complex surgical interventions. Shared decision making (SDM) is recommended in clinical contexts where there is clinical equipoise. SDM can be facilitated by decision aids. The International Patient Decision Aids Standards collaboration recommends the inclusion of values clarification methods (VCMs), yet little evidence exists concerning the incremental impact of VCMs on patient or surrogate decision making. This protocol describes a randomised clinical trial to evaluate the effect of a decision aid (with and without a VCM) on parental mental health and decision making within a clinical encounter. METHODS AND ANALYSIS: Parents who have a fetus or neonate diagnosed with one of six complex congenital heart defects at a single tertiary centre will be recruited. Data collection for the prospective observational control group was conducted September 2018 to December 2020 (N=35) and data collection for two intervention groups is ongoing (began October 2020). At least 100 participants will be randomised 1:1 to two intervention groups (decision aid only vs decision aid with VCM). For the intervention groups, data will be collected at four time points: (1) at diagnosis, (2) postreceipt of decision aid, (3) postdecision and (4) 3 months postdecision. Data collection for the control group was the same, except they did not receive a survey at time 2. Linear mixed effects models will assess differences between study arms in distress (primary outcome), grief and decision quality (secondary outcomes) at 3-month post-treatment decision. ETHICS AND DISSEMINATION: This study was approved by the University of Utah Institutional Review Board. Study findings have and will continue to be presented at national conferences and within scientific research journals. TRIAL REGISTRATION NUMBER: NCT04437069 (Pre-results).

Provider insights on shared decision-making with families affected by CHD.

BACKGROUND AND OBJECTIVES: Little data exist on provider perspectives about counselling and shared decision-making for complex CHD, ways to support and improve the process, and barriers to effective communication. The goal of this qualitative study was to determine providers' perspectives regarding factors that are integral to shared decision-making with parents faced with complex CHD in their fetus or newborn; and barriers and facilitators to engaging in effective shared decision-making. METHODS: We conducted semi-structured interviews with providers from different areas of practice who care for fetuses and/or children with CHD. Providers were recruited from four geographically diverse centres. Interviews were recorded, transcribed, and analysed for key themes using an open coding process with a grounded theory approach. RESULTS: Interviews were conducted with 31 providers; paediatric cardiologists (n = 7) were the largest group represented, followed by nurses (n = 6) and palliative care providers (n = 5). Key barriers to communication with parents that providers identified included variability among providers themselves, factors that influenced parental comprehension or understanding, discrepant expectations, circumstantial barriers, and trust/relationship with providers. When discussing informational needs of parents, providers focused on comprehensive short- and long-term outcomes, quality of life, and breadth and depth that aligned with parental goals and needs. In discussing resources to support shared decision-making, providers emphasised the need for comprehensive, up-to-date information that was accessible to parents of varying situations and backgrounds. CONCLUSIONS: Provider perspectives on decision-making with families with CHD highlighted key communication issues, informational priorities, and components of decision support that can enhance shared decision-making.

Barriers and Facilitators to Enrollment and Retention in the National Diabetes Prevention Program: Perspectives of Women and Clinicians Within a Health System.

Background: More than 10% of US adults are living with type 2 diabetes. The Centers for Disease Control and Prevention established the National Diabetes Prevention Program (National DPP) in 2010 in an effort to delay or prevent this disease among individuals at high risk. Unfortunately, enrollment and retention rates are low. This qualitative study aims to understand barriers and facilitators to enrolling and completing the National DPP among women, and to provide recommendations for improvement. Methods: Semistructured interviews were conducted with the following: (1) women who were eligible for the National DPP, but declined to enroll (n=11); (2) women who enrolled in the National DPP, but did not complete the program (n=12); and (3) clinicians who treat women eligible for the National DPP (n=12). Transcripts of the interviews were coded using content analysis. Results: The 35 interviews (23 patients and 12 clinicians) provided further insight into known barriers, such as the cost of the program, the time that it takes, and inconvenient locations. The study also identified previously undiscovered barriers, including the program not meeting participants' expectations and facilitating referrals. Furthermore, improved communication between clinicians, patients, and National DPP staff could ensure that both clinicians and National DPP staff are aware of patients' goals and their individual barriers to success. Conclusions: Enrollment and retention in the National DPP may be improved with additional communication, more training for National DPP staff to work more closely with participants, adding better incentives to participation, and making the program more accessible through flexibility in time and/or locations.

Experiences of a Health System's Faculty, Staff, and Trainees' Career Development, Work Culture, and Childcare Needs During the COVID-19 Pandemic.

Importance: In March 2020, US public buildings (including schools) were shut down because of the COVID-19 pandemic, and 42% of US workers resumed their employment duties from home. Some shutdowns remain in place, yet the extent of the needs of US working parents is largely unknown. Objective: To identify and address the career development, work culture, and childcare needs of faculty, staff, and trainees at an academic medical center during a pandemic. Design, Setting, and Participants: For this survey study, between August 5 and August 20, 2020, a Qualtrics survey was emailed to all faculty, staff, and trainees at University of Utah Health, an academic health care system that includes multiple hospitals, community clinics, and specialty centers. Participants included 27 700 University of Utah Health faculty, staff, and trainees who received a survey invitation. Data analysis was performed from August to November 2020. Main Outcomes and Measures: Primary outcomes included experiences of COVID-19 and their associations with career development, work culture, and childcare needs. Results: A total of 5030 participants completed the entire survey (mean [SD] age, 40 [12] years); 3738 (75%) were women; 4306 (86%) were White or European American; 561 (11%) were Latino or Latina (of any race), Black or African American, American Indian, Alaska Native, and Native Hawaiian or Pacific Islander; and 301 (6%) were Asian or Asian American. Of the participants, 2545 (51%) reported having clinical responsibilities, 2412 (48%) had at least 1 child aged 18 years or younger, 3316 (66%) were staff, 791 (16%) were faculty, and 640 (13%) were trainees. Nearly one-half of parents reported that parenting (1148 participants [49%]) and managing virtual education for children (1171 participants [50%]) were stressors. Across all participants, 1061 (21%) considered leaving the workforce, and 1505 (30%) considered reducing hours. Four hundred forty-nine faculty (55%) and 397 trainees (60%) perceived decreased productivity, and 2334 participants (47%) were worried about COVID-19 impacting their career development, with 421 trainees (64%) being highly concerned. Conclusions and Relevance: In this survey of 5030 faculty, staff, and trainees of a US health system, many participants with caregiving responsibilities, particularly women, faculty, trainees, and (in a subset of cases) those from racial/ethnic groups that underrepresented in medicine, considered leaving the workforce or reducing hours and were worried about their career development related to the pandemic. It is imperative that medical centers support their employees and trainees during this challenging time.