Effect of a Social Care Intervention on Health Care Experiences of Caregivers of Hospitalized Children: A Randomized Clinical Trial.

Importance: Health-related social risks (HRSRs), like food and housing insecurity, are stigmatized conditions that, when addressed in clinical settings, could inadvertently compromise health care experiences. Objective: To test the noninferiority hypothesis that a low-intensity, high-scale social care intervention does not promote experiences of discrimination or diminish satisfaction with care compared to usual care. Design, Setting, and Participants: This was a double-blind randomized clinical trial conducted from November 2020 to June 2022 with 12-month follow-up analyzing data obtained 1 week after baseline intervention at a 155-bed academic urban children's hospital with 5300 annual admissions. Participants were recruited from their children's hospital rooms during their children's inpatient hospital stays. Inclusion criteria were identifying as the primary caregiver of a child younger than 18 years who was hospitalized in the general, intensive care, or transplant units; living in 1 of 42 target zip codes; and consenting to receive text messages. Caregivers of healthy newborns and caregivers of children expected to be hospitalized for less than 24 hours or greater than 30 days were excluded. A total of 637 eligible parents and caregivers were enrolled. Interventions: Participants were randomized to usual care or usual care plus CommunityRx, a low-intensity, universally delivered, electronic medical record-integrated social care assistance intervention providing personalized information about local resources alongside education about HRSRs and how to access additional support. Usual care included an admission brochure about hospital-based free food options and nonsystematic provision of resource information. Main Outcomes and Measures: Experiences of discrimination, measured using the Discrimination in Medical Settings Scale (range 7-35; higher scores indicate more frequent discrimination) and satisfaction with hospital discharge 1 week postdischarge using Child HCAHPS (range 0-100; higher scores indicate higher satisfaction). The a priori noninferiority margins (control minus intervention) were -0.9 (discrimination) and 1.6 (satisfaction). Results: Of 637 eligible caregiver participants, most identified as female (n = 600 [94.3%]), Black (n = 505 [79.4%]), and had household income less than $50 000 per year (n = 488 [78.5%]). One-third were experiencing food insecurity (n = 223). Half of participants reported discrimination experiences during the pediatric hospitalization (n = 259). Discrimination experiences among the intervention group were noninferior to those among the control group (mean [SD] score: control, 10.3 [4.7] vs intervention, 10.0 [4.6]; difference, 0.2; 90% CI, -0.5 to 0.9). Mean (SD) satisfaction with discharge was high (control, 84.2 [23.8] vs intervention, 81.9 [24.8]), but evidence was insufficient to support intervention noninferiority for this end point (difference, 2.3; 90% CI, -1.2 to 5.8). Food security status did not moderate the relationship between intervention and either outcome. Conclusions and Relevance: The findings suggest that a universally delivered social care assistance intervention did not promote caregiver experiences of discrimination during a child's hospitalization but were inconclusive regarding satisfaction. Trial Registration: ClinicalTrials.gov Identifier: NCT04171999.

CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials.

BACKGROUND: CommunityRx is an evidence-based social care intervention delivered to family and friend caregivers ("caregivers") at the point of healthcare to address health-related social risks (HRSRs). Two CommunityRx randomized controlled trials (RCTs) are being fielded concurrently on Chicago's South Side, a predominantly African American/Black community. CommunityRx-Hunger is a double-blind RCT enrolling caregivers of hospitalized children. CommunityRx-Dementia is a single-blind RCT enrolling caregivers of community-residing people with dementia. RCTs with caregivers face recruitment barriers, including caregiver burden and lack of systematic strategies to identify caregivers in clinical settings. COVID-19 pandemic-related visitor restrictions exacerbated these barriers and prompted the need for iteration of the protocols from in-person to remote operations. This study describes these protocols and methods used for successful iteration to overcome barriers. METHODS AND FINDINGS: CommunityRx uses individual-level data to generate personalized, local community resource referrals for basic, health and caregiving needs. In early 2020, two in-person RCT protocols were pre-tested. In March 2020, when pandemic conditions prohibited face-to-face clinical enrollment, both protocols were iterated to efficient, caregiver-centered remote operations. Iterations were enabled in part by the Automated Randomized Controlled Trial Information-Communication System (ARCTICS), a trial management system innovation engineered to integrate the data collection database (REDCap) with community resource referral (NowPow) and SMS texting (Mosio) platforms. Enabled by engaged Community Advisory Boards and ARCTICS, both RCTs quickly adapted to remote operations. To accommodate these adaptations, launch was delayed until November (CommunityRx-Hunger) and December (CommunityRx-Dementia) 2020. Despite the delay, 65% of all planned participants (CommunityRx-Hunger n = 417/640; CommunityRx-Dementia n = 222/344) were enrolled by December 2021, halfway through our projected enrollment timeline. Both trials enrolled 13% more participants in the first 12 months than originally projected for in-person enrollment. DISCUSSION: Our asset-based, community-engaged approach combined with widely accessible institutional and commercial information technologies facilitated rapid migration of in-person trials to remote operations. Remote or hybrid RCT designs for social care interventions may be a viable, scalable alternative to in-person recruitment and intervention delivery protocols, particularly for caregivers and other groups that are under-represented in traditional health services research. TRIAL REGISTRATION: ClinicalTrials.gov: CommunityRx-Hunger (NCT04171999, 11/21/2019); CommunityRx for Caregivers (NCT04146545, 10/31/2019).

Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care.

Background: CommunityRx is an evidence-based social care intervention delivered to family and friend caregivers ("caregivers") at the point of healthcare to address health-related social risks (HRSRs). CommunityRx-Hunger is a double-blind randomized controlled trial (RCT) that enrolls caregivers of hospitalized children. CommunityRx-Dementia is a single-blind RCT that enrolls caregivers of community-residing people with dementia. Clinical trials that enroll caregivers face recruitment barriers, including caregiver burden and lack of systematic strategies to identify and track caregivers. COVID-19 pandemic-related visitor restrictions exacerbated these barriers and prompted the need for iteration of the CommunityRx protocols from in-person to remote operations. This study describes the novel methods used to iterate existing RCT protocols and factors contributing to their successful iteration. Methods: CommunityRx uses individual-level data to generate personalized community resource referrals for basic, health and caregiving needs. Our research program uses an asset-based, community-engaged approach including study-specific community advisory boards (CABs). In early 2020, both RCT protocols were pre-tested in-person. In March 2020, when pandemic conditions prohibited enrollment during clinical encounters, both protocols were iterated to efficient, caregiver-centered remote operations. Iterations were enabled in part by the Automated Randomized Controlled Trial Information-Communication System (ARCTICS), a trial management system innovation engineered to integrate the data collection database (REDCap) with community resource referral (NowPow) and SMS texting (Mosio) platforms. Results: Enabled by engaged CABs and ARCTICS, both RCTs quickly adapted to remote operations. Designed before the pandemic, we had planned to launch both trials by March 2020 and complete enrollment by December 2021. The pandemic postponed launch until November (CommunityRx-Hunger) and December (CommunityRx-Dementia) 2020. Despite the delay, 65% of all planned participants (CommunityRx-Hunger n = 417/640; CommunityRx-Dementia n = 222/344) were enrolled by December 2021, halfway through our projected enrollment timeline. Both trials enrolled 13% more participants in 12 months than originally projected in-person. Conclusions: Our asset-based, community-engaged approach combined with widely accessible institutional and commercial information technologies facilitated rapid migration to remote trial operations. Remote or hybrid RCT designs for social care interventions may be a viable, scalable alternative to in-person recruitment and intervention delivery protocols, particularly for caregivers and other groups that are under-represented in traditional health services research. Trial Status: Both studies are registered on ClinicalTrials.gov: CommunityRx-Hunger (NCT04171999); CommunityRx for Caregivers (NCT04146545); My Diabetes My Community (NCT04970810).

Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial.

BACKGROUND: Adherence to self-guided interventions tends to be very low, especially in people with depression. Prior studies have demonstrated that enhancements may increase adherence, but little is known about the efficacy of various enhancements in comparison to, or in combination with, one another. OBJECTIVE: The aim of our study is to test whether 3 enhancements-facilitator contact (FC), an online discussion board, and virtual badges (VB)-alone, or in combination, improve adherence to a self-guided, web-based intervention for depression. We also examined whether age, gender, race, ethnicity, comfort with technology, or baseline depression predicted adherence or moderated the effects that each enhancement had on adherence. METHODS: Participants were recruited through web-based sources and, after completing at least 4 out of 7 daily emotion reports, were sequentially assigned to 1 of 9 conditions-the intervention alone; the intervention plus 1, 2, or all 3 enhancements; or an emotion reporting control condition. The intervention was a positive psychological program consisting of 8 skills that specifically targeted positive emotions, and it was delivered over 5 weeks in a self-guided, web-based format. We operationalized adherence as the number of skills accessed. RESULTS: A total of 602 participants were enrolled in this study. Participants accessed, on average, 5.61 (SD 2.76) of 8 skills. The total number of enhancements participants received (0-3) did not predict the number of skills accessed. Participants who were assigned to the VB+FC condition accessed significantly more skills than those in the intervention only conditions. Furthermore, participants in arms that received the combination of both the VB and FC enhancements (VB+FC and VB+FC+online discussion board) accessed a greater number of skills relative to the number of skills accessed by participants who received either VB or FC without the other. Moderation analyses revealed that the receipt of VB (vs no VB) predicted higher adherence among participants with moderately severe depression at baseline. CONCLUSIONS: The results suggested that the VB+FC combination significantly increased the number of skills accessed in a self-guided, web-based intervention for elevated depression. We have provided suggestions for refinements to these enhancements, which may further improve adherence. TRIAL REGISTRATION: ClinicalTrials.gov NCT02861755; http://clinicaltrials.gov/ct2/show/NCT02861755.

The national landscape of culminating experiences in master's programs in health and biomedical informatics.

Health and biomedical informatics graduate-level degree programs have proliferated across the United States in the last 10 years. To help inform programs on practices in teaching and learning, a survey of master's programs in health and biomedical informatics in the United States was conducted to determine the national landscape of culminating experiences including capstone projects, research theses, internships, and practicums. Almost all respondents reported that their programs required a culminating experience (97%). A paper (not a formal thesis), an oral presentation, a formal course, and an internship were required by ≥50% programs. The most commonly reported purposes for the culminating experience were to help students extend and apply the learning and as a bridge to the workplace. The biggest challenges were students' maturity, difficulty in synthesizing information into a coherent paper, and ability to generate research ideas. The results provide students and program leaders with a summary of pedagogical methods across programs.

The MARIGOLD study: Feasibility and enhancement of an online intervention to improve emotion regulation in people with elevated depressive symptoms.

BACKGROUND: This manuscript describes the first two phases of pilot testing MARIGOLD, an online self-guided positive emotion skills intervention for adults with elevated depressive symptoms, along with enhancements to overcome retention and adherence problems reported in previous research. METHODS: Adults with elevated depressive symptoms were recruited online and assessed at baseline, post-intervention, 1- and 3-month follow-up. Phase 1 participants (n = 58) were randomized to MARIGOLD, daily emotion reporting, or waitlist. Phase 2 participants (n = 79) were randomized to MARIGOLD plus one enhancement: online discussion board (ODB), virtual badges (VB), or facilitator contact (FC). Post-intervention interviews assessed acceptability. Intention-to-treat analyses examined retention, adherence, and preliminary efficacy. RESULTS: In both phases, retention and adherence did not differ between groups. MARIGOLD skills were highly acceptable, but qualitative results indicate web-based features (e.g., log-in, ODB, VB) require refinement prior to larger testing. Neither phase demonstrated between-group differences in preliminary efficacy. In Phase 1 within-group analyses, MARIGOLD and emotion reporting control demonstrated a similar pattern of findings (stable depressive symptoms, increased positive emotion, decreased negative emotion and stress), whereas the waitlist group significantly increased in depressive mood. Most Phase 2 within-group analyses demonstrated the expected pattern of results (i.e., decreases in PHQ-8 and negative emotion, increases in positive emotion). However, CES-D scores were stable in FC; perceived stress was stable in FC and ODB. LIMITATIONS: This pilot study is not powered to evaluate efficacy. CONCLUSION: Positive emotion skills, plus enhancements for web-based, self-guided delivery, warrant additional study in people with elevated depressive symptoms.

A Self-Paced, Web-Based, Positive Emotion Skills Intervention for Reducing Symptoms of Depression: Protocol for Development and Pilot Testing of MARIGOLD.

BACKGROUND: Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion. OBJECTIVE: The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention. METHODS: This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources. RESULTS: The project was funded in August 2014, and data collection was completed in May 2018. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. CONCLUSIONS: Findings from this investigation will enable us to develop an optimal package of intervention content and enhancement strategies for individuals with elevated symptoms of depression. If this intervention proves to be effective, it will provide a cost-effective, anonymous, appealing, and flexible approach for reducing symptoms of depression and improving psychological adjustment through increasing positive emotion. TRIAL REGISTRATION: ClinicalTrials.gov NCT01964820 (Phase 1); https://clinicaltrials.gov/ct2/show/NCT01964820 (Archived by WebCite at http://www.webcitation.org/6zpmKBcyX). ClinicalTrials.gov NCT02861755 (Phase 2); https://clinicaltrials.gov/ct2/show/NCT02861755 (Archived by WebCite at http://www.webcitation.org/6zpmLmy8k). REGISTERED REPORT IDENTIFIER: RR1-10.2196/10494.

Psychological Well-being and Physical Health: Associations, Mechanisms, and Future Directions.

A paradigm shift in public health and medicine has broadened the field from a singular focus on the ill effects of negative states and psychopathology to an expanded view that examines protective psychological assets that may promote improved physical health and longevity. We summarize recent evidence of the link between psychological well-being (including positive affect, optimism, life meaning and purpose, and life satisfaction) and physical health, with particular attention to outcomes of mortality and chronic disease incidence and progression. Within this evolving discipline there remain controversies and lessons to be learned. We discuss measurement-related challenges, concerns about the quality of the evidence, and other shortcomings in the field, along with a brief discussion of hypothesized biobehavioral mechanisms involved. Finally, we suggest next steps to move the field forward.

Author Reply: Illuminating the Health Benefits of Psychological Assets.

This reply addresses observations of Drs. Larsen, Kruse & Sweeny, and Scherer in their reviews of our published work on the link between positive psychological assets and outcomes of physical health. Inspired by Obama's Precision Medicine Initiative we argue that the interplay between the emotion spectrum and health is likely a complex and heterogeneous amalgam of known and yet unidentified elements melding at the individual level. When exploring the emotion-health link, researchers are challenged to grapple with complex system models by considering multiple hierarchies of information that span individual-level factors, genetic blueprints, culture and environmental context. Research is needed to more fully elucidate the mechanism through which emotion influences health, with careful consideration of differences across race/ethnicity, culture, and context.