Table 1 Design characteristics, scientific aims, and corresponding outcomes of two CommunityRx clinical trials
CommunityRx-Hunger (protocol date November 16, 2020) | CommunityRx-Dementia (protocol date November 13, 2020) | |
|---|---|---|
Study design | Double-blind randomized controlled trial (both researcher and participant blinded to study arm) | Single-blind randomized controlled trial (participant blinded to study arm) |
Study population | Parents and caregivers of hospitalized children (N = 640) | Family and friend caregivers of home-dwelling people with Alzheimer’s disease and related dementias (N = 344) |
Setting | Inpatient units at an urban academic children’s hospital | Adult outpatient clinics at an urban academic medical center |
Inclusion criteria | • Self-identifies as the primary caregiver of a child younger than 18 years of age admitted to the children’s hospital • English- or Spanish-speaking • Resides in a target ZIP code • Access to a cell phone and willing to use for research participation • Agrees to receive text messages from the study | • Self-identifies as a caregiver of a home-dwelling person with Alzheimer’s Disease or related dementia using an adaptation of the BRFSSa caregiver module • Resides in a target ZIP code • Access to a cell phone willing to use for research participation • Agrees to receive text messages from the study |
Exclusion criteria | • Minor caregivers who are not emancipated minors according to Illinois State law • Non-parental minor caregivers • Caregivers of hospitalized healthy newborns • Caregivers of children who are admitted for less than 24 hours • Caregivers of children hospitalized at index hospitalization with a diagnosis of disordered eating • Enrollment in pre-test | • Recalls participating in CommunityRx in the past • Minor caregivers who are not emancipated minors according to Illinois State law • Enrollment in pre-test |
Screening | USDA 18-item food security screenerb (prior 12 months) | CMS AHC 10-item HRSR screenerc |
Stratification | Food secure (score of 0–2) vs. food insecure (score of ≥ 3)b | HRSR status (no HRSRs vs. one or more HRSRs) |
Randomization | 1:1 randomization, stratified by food security status | 1:1 randomization, stratified by HRSR status |
Usual care | Information from hospital staff including available food options in the hospital and the Feed1st food pantry program, regular visits from Child Life Services and referral to social work (if appropriate) | Information from hospital staff, which may include transmission of information about community resources |
Survey Timepoints | Baseline, 1W, 1 M, 3 M, 6 M, 12 M post-discharge | Baseline, 1W, 1 M, 3 M, 12 M post-index clinical encounter |
Study endpoint | 12 M | 12 M |
Scientific aims with primary and secondary outcomes | Aim 1: Among caregivers of hospitalized children experiencing household food insecurity, evaluate the longitudinal effects of CommunityRx-Hunger versus usual care on self-efficacy for finding resources (primary outcome), severity of household food insecurity, adult and child nutrition and health, and child healthcare utilization (secondary outcomes) | Aim 1: Among dementia caregivers with unmet HRSNs, evaluate the longitudinal effects of CommunityRx-Dementia versus usual care on caregiver self-efficacy (primary outcome) and psychosocial (unmet needs, social isolation, well-being, burden, depression, stress), behavioral (community resource use), health and healthcare utilization (secondary outcomes) |
Aim 2: Among all caregivers of hospitalized children, evaluate the effects of CommunityRx-Hunger versus usual care on caregiver satisfaction with care (primary outcome), caregiver and child health and caregiver stigma during hospitalization (secondary outcomes) | Aim 2: Among all dementia caregivers, evaluate the effects of CommunityRx-Dementia versus usual care on the healthcare experience, including satisfaction with care (primary outcome), experiences of stigma during clinical care and likelihood of sharing community resource information with others |