Effect of a Layperson-Delivered Telephone Program for People With Depressive Symptoms.

OBJECTIVE: This study investigated whether a layperson-delivered telephone program focusing on empathy could improve depressive symptoms among adults. METHODS: Data for a subset of participants from a randomized controlled trial (July 6-September 24, 2020) were analyzed to assess the impact of a telephone program on mental health. Participants in this post hoc analysis had baseline depressive symptoms and were assessed for depression, anxiety, loneliness, and isolation. RESULTS: Of the 240 people in the original sample, 58 had depressive symptoms (i.e., baseline scores of ≥10 on the eight-item Patient Health Questionnaire [PHQ-8]); 56 of the 58 were reassessed 4 weeks later. Participants in the intervention arm had greater improvements in PHQ-8 scores (baseline mean±SD=13.0±2.6, postintervention mean=9.2±3.0; mean difference=3.8, 95% CI=2.9-4.7) than participants in the control arm (mean difference=1.3, 95% CI=0.1-2.5) (p=0.013). CONCLUSIONS: This telephone intervention, delivered by a lay workforce, holds promise for reducing the burden on the clinical care system.

Effect of Brief Produce Exposure and Unconstrained Grocery Gift Cards on Caregiver Influence on Diet of Elementary Age Children: A Randomized Clinical Trial.

Importance: Children's diets affect health trajectories but are difficult to influence, especially for resource-constrained families. Objective: To assess the effectiveness of providing 4 weeks of grocery gift cards and small produce boxes to caregivers on their ability to support healthy shifts in children's diets. Design, Setting, and Participants: This 2-group randomized clinical trial was conducted from May to July 2021, with 4 weeks of intervention and follow-up at 8 weeks. Resources were provided curbside at 3 schools, 3 housing sites, and 1 after-school site for use at home. Participants consisted of 1 index child ages 5 to 11 years with 1 index caregiver from 68 low-income families. Data were analyzed from July 2021 through March 2022. Interventions: During each week for 4 weeks, caregivers were offered 10-lb (4.5 kg) boxes of fruits and vegetables, $10.00 grocery gift cards, an additional $10.00 gift card over the last 3 weeks triggered by a task completion, and a 1-time choice of a $25.00 food preparation tool. Main Outcomes and Measures: Index child and caregiver diets were measured together over the phone at baseline, 4 weeks, and 8 weeks using the 2019 to 2020 Texas School Physical Activity and Nutrition (SPAN) tool, which measures the number of times food items were eaten over the prior day to report a SPAN Healthy Eating Index (SHEI) score and subscores for specific categories of foods (range, 0-57, with higher scores indicating a more healthful diet). Results: Among 68 children (mean [SD] age, 8.2 [1.7] years; 35 [51.5%] girls) and caregivers (mean [SD] age, 37.9 [7.9] years; 63 mothers [92.6%]) from primarily low-income families, 26 caregivers were Hispanic or Latino (38.2%), while 18 caregivers were Black (26.4%), 25 caregivers were White (36.7%), and 24 caregivers had more than 1 race (35.3%). Most families were below the federal poverty level (41 of 60 families that reported income [68.3%]). Per participating caregiver, a mean (SD) 2.7 [1.4] fruit and vegetable boxes and $42.35 ($25.46) worth of gift cards were picked up over 4 weeks. Mean (SE) child SPAN SHEI increased from 32.03 (0.62) times/d to 33.75 (0.69) times/d at 4 weeks (ie, postintervention) and 34.03 (0.69) times/d 4 weeks later (ie, at 8 weeks of follow-up). Mean (SE) child fruit and vegetable intake increased from 5.31 (0.47) times/d to 5.78 (0.51) times/d postintervention and 6.03 (0.51) times/d at follow-up. Children in the control group did not have improved diet (overall mean [SE] SHEI: 31.48 [0.58] times/d at baseline, 31.68 [0.54] times/d postintervention, and 31.81 [0.52] times/d at follow-up; mean [SE] fruit and vegetable intake: 5.21 [0.45] times/d at baseline, 4.77 [0.45] times/d postintervention, and 4.68 [0.41] times/d at follow-up). Compared with children in the control group, mean SHEI was increased for children in the intervention group by 2.07 times/d postintervention and 2.23 times/d at follow-up. Improvements as a function of program dose were statistically significant for child SHEI (P = .01) and fruit and vegetable intake (P = .03). No significant changes in caregiver diets were found. Conclusions and Relevance: This study found that easily accessed fruits and vegetables and unconstrained grocery store cards provided directly to caregivers over 4 weeks resulted in improvements in child diet, which were sustained over 4 additional weeks. Future work may investigate whether diet improvement from a brief intervention optimized for caregiver flexibility reflects a natural maximum or potential for greater improvements on extension. Trial Registration: ClinicalTrials.gov Identifier: NCT04827654.

Effect of Layperson-Delivered, Empathy-Focused Program of Telephone Calls on Loneliness, Depression, and Anxiety Among Adults During the COVID-19 Pandemic: A Randomized Clinical Trial.

Importance: Loneliness is a risk factor for many clinical conditions, but there are few effective interventions deployable at scale. Objective: To determine whether a layperson-delivered, empathy-focused program of telephone calls could rapidly improve loneliness, depression, and anxiety in at-risk adults. Design, Setting, and Participants: From July 6 to September 24, 2020, we recruited and followed up 240 adults who were assigned to receive calls (intervention group) or no calls (control group) via block randomization. Loneliness, depression, and anxiety were measured using validated scales at enrollment and after 4 weeks. Intention-to-treat analyses were conducted. Meals on Wheels Central Texas (MOWCTX) clients received calls in their homes or wherever they might have been when the call was received. The study included MOWCTX clients who fit their service criteria, including being homebound and expressing a need for food. A total of 296 participants were screened, of whom 240 were randomized to intervention or control. Interventions: Sixteen callers, aged 17 to 23 years, were briefly trained in empathetic conversational techniques. Each called 6 to 9 participants over 4 weeks daily for the first 5 days, after which clients could choose to drop down to fewer calls but no less than 2 calls a week. Main Outcomes and Measures: Primary outcome was loneliness (3-item UCLA Loneliness Scale, range 3-9; and 6-item De Jong Giervald Loneliness [De Jong] Scale, range 0-6). Secondary outcomes were depression (Personal Health Questionnaire for Depression), anxiety (Generalized Anxiety Disorder scale), and self-rated health (Short Form Health Survey Questionnaire). Results: The 240 participants were aged 27 to 101 years, with 63% aged at least 65 years (n = 149 of 232), 56% living alone (n = 135 of 240), 79% women (n = 190 of 240), 39% Black or African American (n = 94 of 240), and 22% Hispanic or Latino (n = 52 of 240), and all reported at least 1 chronic condition. Of 240 participants enrolled, 13 were lost to follow-up in the intervention arm and 1 in the control arm. Postassessment differences between intervention and control after 4 weeks showed an improvement of 1.1 on the UCLA Loneliness Scale (95% CI, 0.5-1.7; P < .001; Cohen d of 0.48), and improvement of 0.32 on De Jong (95% CI, -0.20 to 0.81; P = .06; Cohen d, 0.17) for loneliness; an improvement of 1.5 on the Personal Health Questionnaire for Depression (95% CI, 0.22-2.7; P < .001; Cohen d, 0.31) for depression; and an improvement of 1.8 on the Generalized Anxiety Disorder scale (95% CI, 0.44 to 3.2; P < .001; Cohen d, 0.35) for anxiety. General physical health on the Short Form Health Questionnaire Survey showed no change, but mental health improved by 2.6 (95% CI, 0.81 to 4.4; P = .003; Cohen d of 0.46). Conclusions and Relevance: A layperson-delivered, empathy-oriented telephone call program reduced loneliness, depression, and anxiety compared with the control group and improved the general mental health of participants within 4 weeks. Future research can determine whether effects on depression and anxiety can be extended to maximize clinical relevance. Trial Registration: ClinicalTrials.gov Identifier: NCT04595708.

pSCANNER: patient-centered Scalable National Network for Effectiveness Research.

This article describes the patient-centered Scalable National Network for Effectiveness Research (pSCANNER), which is part of the recently formed PCORnet, a national network composed of learning healthcare systems and patient-powered research networks funded by the Patient Centered Outcomes Research Institute (PCORI). It is designed to be a stakeholder-governed federated network that uses a distributed architecture to integrate data from three existing networks covering over 21 million patients in all 50 states: (1) VA Informatics and Computing Infrastructure (VINCI), with data from Veteran Health Administration's 151 inpatient and 909 ambulatory care and community-based outpatient clinics; (2) the University of California Research exchange (UC-ReX) network, with data from UC Davis, Irvine, Los Angeles, San Francisco, and San Diego; and (3) SCANNER, a consortium of UCSD, Tennessee VA, and three federally qualified health systems in the Los Angeles area supplemented with claims and health information exchange data, led by the University of Southern California. Initial use cases will focus on three conditions: (1) congestive heart failure; (2) Kawasaki disease; (3) obesity. Stakeholders, such as patients, clinicians, and health service researchers, will be engaged to prioritize research questions to be answered through the network. We will use a privacy-preserving distributed computation model with synchronous and asynchronous modes. The distributed system will be based on a common data model that allows the construction and evaluation of distributed multivariate models for a variety of statistical analyses.