Effects of In-Person Assistance vs Personalized Written Resources About Social Services on Household Social Risks and Child and Caregiver Health

This randomized clinical trial examined the effect of in-person social services navigation assistance vs a written information sheet on caregiver-reported social risk factors and child and caregiver health.


Introduction
Childhood social and economic adversity, such as food insecurity and housing instability, is associated with significant short-and long-term health risks, including higher likelihood of childhood behavioral problems, cognitive delay, unhealthy weight, and asthma, as well as adult obesity, diabetes, and cardiovascular disorders. [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15] Moreover, cumulative exposure to social and economic risk factors has been associated with worse health outcomes independent of the effects of individual risks. 8,16 In response to consistent and compelling evidence linking social and economic risks to health and well-being, multiple medical professional organizations have endorsed increased attention to social risk factors in the context of clinical care. [17][18][19] Although pediatricians have long recognized the influence of social context on health outcomes, 20 recent recommendations have accelerated social risk screening and social risk-related interventions in pediatric clinical settings.  Despite considerable diversity in existing pediatric clinical activities aimed at identifying and reducing social risk, little research has rigorously examined program effects or assessed the feasibility of scaling programs across pediatrics clinical settings. 47 In this study, we compare the effectiveness of 2 social risk-related interventions that differ in intensity and potential scalability: in-person social services navigation assistance offered for up to 3 months by a trained volunteer vs standardized, written information about community and government social services resources. Based on previous research, 23,25,48 we hypothesized that ongoing, in-person assistance would be more likely to reduce social risks and improve both child and caregiver health outcomes than would 1-time receipt of individualized information about relevant social resources.

Methods
This 2-group randomized clinical trial was approved by the institutional review board of the University of California, San Francisco. All adult caregivers completed written informed consent, and assent for participation was obtained from children 7 years or older. The complete study protocol is provided in Supplement 1. This study is reported following the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

Study Setting and Participant Eligibility
Study recruitment, enrollment, and follow-up were conducted from July 18, 2016, to March 8, 2019, in the pediatric urgent care clinic at an urban safety-net hospital serving primarily low-income, racially and ethnically diverse populations. Eligible participants were caregiver-child dyads with English-or Spanish-speaking caregivers 18 years or older who were familiar with the child's household environment and residing in the county of enrollment. Eligible children were aged 0 to 17 years. Only 1 child and 1 caregiver per household were enrolled. If 2 caregivers presented with the child, caregivers self-selected 1 to participate in the study. Families enrolled in a similar primary care-based hospital social services navigation initiative in the 6 months prior or subsequent to recruitment, children in foster care, or those being seen for physical abuse evaluations were excluded (Figure).

Study Procedures, Randomization, and Follow-up
Trained research assistants screened English-or Spanish-speaking families presenting in pediatric urgent care weekdays from 8:30 AM to 5:00 PM. Consenting dyads completed all baseline study activities in the clinical examination room during or directly after the child's medical visit. Research assistants administered baseline demographic characteristics and child health surveys on a tablet computer using Research Electronic Data Capture tools. 49 Caregivers and children were then given the option of self-completing or working with a research assistant to complete additional child and caregiver health questions. Biomarker samples also were collected from consenting families, although results from those analyses are not presented here. Participating dyads received a $50 gift card after completing baseline study activities.
After informed consent forms were completed and baseline data were collected, the research assistant left the room, and a patient navigator administered a brief social risk survey. The navigator then randomly assigned the participating dyad into 1 of 2 study groups using an automated computer-generated algorithm; randomization occurred within blocks (block size, 10 dyads).
Navigators were trained to provide social service navigation services and were periodically observed by supervising senior clinical research associates to ensure they followed study protocols. They were not involved with follow-up outcomes assessment.

Written Resources Intervention
Dyads randomized to receive written resources were given information about relevant government, hospital, and community social services. Prewritten informational handouts were populated with data on local resources based on the accumulated knowledge of navigators working in a similar hospital-based linkage program. Navigators individualized the resource sheets by highlighting resources most closely related to the top 3 priority social risk factors endorsed by the caregiver and by providing names of contacts at relevant organizations when available.

In-Person Assistance Intervention
Families randomized to in-person navigation services either received assistance immediately after randomization or were offered a telephone or in-person follow-up appointment at a different time.
As in the written resources group, during these visits navigators provided written information about resources related to the caregiver's prioritized social risk factors. Additionally, navigators helped to schedule appointments, complete forms, or provide other social services-related counseling and assistance. Information about protocols for providing written resources and additional supports is published elsewhere. 50 Following the initial visit, caregivers in the in-person assistance group were contacted by navigators by telephone, text message, or email every 2 weeks for 3 months until identified needs were met or caregivers declined further assistance, whichever came first.
Participating caregivers in both groups were contacted by telephone (and text message, email, and/or letters when telephone calls were unsuccessful) to schedule follow-up interviews 6 months after enrollment. Research assistants, still blinded to study group assignment, administered follow-up surveys using tablet computers. Follow-up interviews were conducted primarily in person in the pediatric urgent care clinic or interview rooms located in the same clinical building. If participants were unable to return to the study site (eg, moved out of the area or had work-related barriers), research assistants completed surveys during home visits or administered surveys by telephone. Participating dyads again received $50 gift cards in exchange for time spent on study activities.

Measures Demographic Characteristics and Social Risk Factors
Caregivers reported caregiver and/or child age, gender, race, Hispanic/Latino ethnicity, preferred language, family income, caregiver education level, and caregiver-child relationship. At baseline and 6-month follow-up, caregivers answered yes or no questions about their child and household's social situation. The 18-item social risk screening questionnaire was based on surveys used in earlier studies 25,26 and included items on housing stability and habitability, food and income security, child care and transportation needs, employment, legal concerns, medical insurance, and other public benefits enrollment (eAppendix in Supplement 2). Additional questions included whether the child and caregiver were connected to primary care, concerns about the child's experiences of bullying, and adult household members' mental health.

Child Health
At baseline and 6-month follow-up, child quality of life was assessed with the shortened version of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales developed for children ages 2 to 18 years, 51 the PedsQL 4.0 short form 15, 52 or the PedsQL Infant Scales developed for children ages 1 to 24 months. 53 The PedsQL uses parent proxy reports to assess child functioning across the following domains: physical functioning, emotional functioning, social functioning, and cognitive or school functioning. 54,55 Each item is scored on a 5-point Likert scale ranging from 0, indicating never a problem, to 4, almost always a problem, and converted to a 100-point scale, with higher scores indicating higher quality of life. Child global health was assessed by caregiver report using a single item from the 2016 to 2017 National Survey of Children's Health. This item is associated with health services use and other measures of child mental and physical health (range, 1-5, with higher score indicating better health). 56-58 Caregivers also reported the number of days in the past 6 months the child had missed school, camp, or other activities owing to illness. 59

Caregiver Physical and Mental Health
At baseline and 6-month follow-up, caregivers' current and recent physical and mental health status was assessed using a single global health item from the Patient-Reported Outcomes Measurement System Global short form version 1.1 (range, 1-5, with higher score indicating better health), which has been sensitive to change in other intervention studies. 60 Caregivers also completed the 4-item

Sample Size
The initial target sample size was 724 dyads, selected as a conservative sample size to allow for 80% power to detect effects similar to our previous work, 25 assuming 30% participant attrition. Owing to limitations in study funding, the study concluded with a sample of 611 dyads. The sample gave us approximately 80% power to detect small to medium standard effect sizes of 0.28 or greater between groups and effect sizes of 0.20 or greater to detect changes from preintervention to postintervention within each group.

Statistical Analysis
Baseline participant characteristics were compared between study groups and tested for significance using χ 2 or t tests and appropriate nonparametric tests for nonnormally distributed continuous variables. The cumulative number of social risks and health outcomes were compared by group assignment using generalized linear models with a normal distribution with identity link for continuous outcomes, Poisson distribution with log link for count outcomes, and binomial distribution with logit link for binary outcomes. Hypothesis tests were 2-sided with P < .05 considered statistically significant. Unadjusted differences between groups are presented, and adjustment models built on each other, including (1) adjusted with baseline outcomes entered as covariates and (2) child and caregiver demographic factors (ie, age, gender, and race/ethnicity) entered as covariates. In post hoc secondary analyses, we examined change in outcomes from baseline to follow-up within each group. Statistical analyses were conducted using SPSS statistical software version 25 (IBM Corp). Data were analyzed from January 1, 2019, to January 20, 2020.

Sample Characteristics
Of the 1222 families approached, 611 caregiver-child dyads were eligible and agreed to participate ( Figure). Child mean (SD) age was 6.1 (5.0) years; 438 children (79.1%) were Hispanic; and 315 children (51.6%) were girls ( Table 1). In total, 302 dyads were randomized to the written resources group and 309 dyads to the in-person assistance group. Attrition at follow-up was 27.8%, comparable to similar studies in safety-net settings, 22,64,65 with no differences between groups. A total of 225 dyads in the written resource sheet group and 216 dyads in the in-person assistance group were included in 6-month follow-up ( Figure). There were no statistically significant differences between participants with follow-up data vs participants who dropped out. Using multiple imputation models to estimate missing follow-up data, we also found no significant differences in the number of social risk factors or health measures between caregivers who reported follow-up data vs those who did not.
The number of social risks reported at baseline ranged from 0 to 18 of 18 total possible items, and the mean (SD) was 4.3 (3.2) risks (   Table 2.  In the in-person assistance group, caregivers met with navigators a mean of 4.34 (SD, 2.76; range, 0-10) times after the initial visit, and 1228 of 1289 visits (95.3%) were conducted by telephone. Visit duration ranged from 5 to 45 minutes. Forty-five dyads (14.4%) did not engage in any navigation follow-up, and 35 dyads (11.2%) engaged in 8 or more contacts.

Change in Social Risk Factors
There were no statistically significant differences between intervention groups in the number of social risk factors reported at follow-up with or without adjustment ( Table 3)

Change in Child Health
At follow-up, there were no statistically significant differences between intervention groups in the child health outcomes with or without adjustment (

Change in Caregiver Health
Similar to the child health measures, there were no statistically significant differences at follow-up in caregiver general health, depression symptoms, or perceived stress between intervention groups with or without adjustment (Table 3)

Discussion
This medium-sized randomized clinical trial examined the effects of 2 clinical interventions designed to reduce families' social and economic risks, a standardized handout that included information on available clinic, community, and government resources compared with the handout plus social services navigation assistance provided by a trained navigator for up to 3 months. There were no significant differences in the degree of change in social risk factors or child or caregiver health between the 2 interventions. Analyses within each trial arm showed significant decreases in reported social risk factors and improvements in both child and caregiver health from before to after the intervention. Social risk factors showing substantial reductions in both intervention groups included food insecurity, unstable or low-quality housing, problems paying bills, and difficulty affording transportation. These topics overlap with domains covered in common social risk screening tools endorsed by major professional organizations. 66,67 There have been several other trials in pediatric settings that examine the effectiveness of multidomain social risk screening and interventions, 22-24 although we are aware of only 1 that has included an intervention limited to providing written social resource information. 25 In this randomized clinical trial, the lack of significantly greater benefit when adding longitudinal, in-person navigator services to the delivery of written social resources information was unexpected, given that an earlier trial in this area 25 found significant differences between groups. Subtle but potentially important differences between these studies could help explain the disparate findings. It is possible that results of this study were affected by historical context, 68 including increased federal immigration enforcement and anti-immigrant rhetoric. This might have lowered the likelihood of risk disclosure or assistance-seeking behaviors, although the interaction is unlikely to have differentially affected trial groups. A second difference between studies may be the quality of the information contained in the resource sheets. Handouts used in the prior trial 25 relied on information developed by a county-contracted information and referral service and were updated only occasionally. In contrast, handouts used in this study were compiled by the navigators and included more regularly updated information about local social service providers. Handouts also incorporated 2 techniques recommended by the Agency for Healthcare Research and Quality to increase the usability of patient educational materials: adding contact names at relevant agencies and highlighting the resources most relevant to caregiver priorities. 69 The provision of more up-to-date, targeted information may have increased the effect of the handouts in the written resources-only group of this trial relative to the effect in the prior trial. 25 In brief, the greater the usefulness of the written resources, the less benefit may have been added by providing additional navigator services.

Limitations
There are multiple limitations of this study. First, the study was conducted in only 1 urgent care setting, and it is unclear whether our findings are generalizable to other locations and clinical settings. Second, 27.8% of study participants were lost to follow-up at 6 months. Notably, this represents less attrition than in comparable studies undertaken in low-resource settings. 22,25,64,65 Moreover, attrition did not differ between study groups and was not associated with key participant characteristics. Third, it is possible that the gift cards provided as part of the study influenced the positive postintervention outcomes in each group, although these should not have influenced the primary null findings between groups. Fourth, the surveys are based on participant self-report; they are therefore subject to classic respondent bias, which could have included underreporting or overreporting of social risks or health status. Fifth, the study compared the effect of different doses of a clinic-based intervention needed to decrease social risks. It would have been desirable to have a no-treatment control group to determine whether either or both levels of intervention significantly improved outcomes compared with screened but untreated controls. We did not add this condition owing to ethical concerns about assessing social risks without responding to endorsed needs.

Conclusions
This randomized clinical trial of pediatric urgent care social risk interventions revealed no significant differences between provision of high-quality, personalized social service written information with vs without the addition of 1-on-1 longitudinal navigation services. The health care sector's broad enthusiasm around activities to reduce patients' social risks has contributed to an urgent need to identify effective and scalable interventions, particularly in pediatric settings where innovation in this area has outpaced the availability of evidence. However, counterbalancing this enthusiasm are the costs of screening and referral programs. The finding of this randomized clinical trial of pediatric urgent care social risk interventions should be encouraging to systems that are considering these kinds of programs. These findings suggest that a relatively low-dose and lower-cost interventionhigh-quality, written information provided in the context of a single encounter-could be efficacious for pediatric populations, but similar interventions should be examined in studies designed to assess their effectiveness.