Trial Outcomes & Findings for CommunityRx-Hunger (NCT NCT04171999)
NCT ID: NCT04171999
Last Updated: 2024-12-27
Results Overview
Self-efficacy is measured by Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from "not at all confident" to "completely confident."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
660 participants
Primary outcome timeframe
12 months
Results posted on
2024-12-27
Participant Flow
Prior to the randomized trial, 20 participants were enrolled as part of pre-testing.
Participant milestones
| Measure |
Usual Care + Intervention (Case)
Cases will receive the CommunityRx Intervention.
Community Rx-Hunger (CRx-H): The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member.
|
Usual Care (Control)
Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge.
|
|---|---|---|
|
Overall Study
STARTED
|
320
|
320
|
|
Overall Study
COMPLETED
|
318
|
319
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Usual Care + Intervention (Case)
Cases will receive the CommunityRx Intervention.
Community Rx-Hunger (CRx-H): The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member.
|
Usual Care (Control)
Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge.
|
|---|---|---|
|
Overall Study
deemed ineligible after randomization
|
2
|
1
|
Baseline Characteristics
Number analyzed in row differs from overall due to missing data and other response.
Baseline characteristics by cohort
| Measure |
Usual Care + Intervention (Case)
n=318 Participants
Cases will receive the CommunityRx Intervention.
Community Rx-Hunger (CRx-H): The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member.
|
Usual Care (Control)
n=319 Participants
Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge.
|
Total
n=637 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 9.2 • n=318 Participants
|
34.9 years
STANDARD_DEVIATION 9.2 • n=319 Participants
|
35 years
STANDARD_DEVIATION 9.2 • n=637 Participants
|
|
Sex: Female, Male
Female
|
298 Participants
n=316 Participants • Number analyzed in row differs from overall due to missing data and other response.
|
302 Participants
n=319 Participants • Number analyzed in row differs from overall due to missing data and other response.
|
600 Participants
n=635 Participants • Number analyzed in row differs from overall due to missing data and other response.
|
|
Sex: Female, Male
Male
|
18 Participants
n=316 Participants • Number analyzed in row differs from overall due to missing data and other response.
|
17 Participants
n=319 Participants • Number analyzed in row differs from overall due to missing data and other response.
|
35 Participants
n=635 Participants • Number analyzed in row differs from overall due to missing data and other response.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=318 Participants
|
41 Participants
n=319 Participants
|
92 Participants
n=637 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
267 Participants
n=318 Participants
|
278 Participants
n=319 Participants
|
545 Participants
n=637 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=318 Participants
|
0 Participants
n=319 Participants
|
0 Participants
n=637 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=318 Participants
|
0 Participants
n=319 Participants
|
1 Participants
n=637 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=318 Participants
|
1 Participants
n=319 Participants
|
3 Participants
n=637 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=318 Participants
|
0 Participants
n=319 Participants
|
0 Participants
n=637 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
246 Participants
n=318 Participants
|
259 Participants
n=319 Participants
|
505 Participants
n=637 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=318 Participants
|
27 Participants
n=319 Participants
|
63 Participants
n=637 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
6 Participants
n=318 Participants
|
12 Participants
n=319 Participants
|
18 Participants
n=637 Participants
|
|
Race/Ethnicity, Customized
Other
|
25 Participants
n=318 Participants
|
19 Participants
n=319 Participants
|
44 Participants
n=637 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
2 Participants
n=318 Participants
|
1 Participants
n=319 Participants
|
3 Participants
n=637 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis was restricted to caregivers who were food insecure at baseline and who completed the self-efficacy measure at 12 month follow-up.
Self-efficacy is measured by Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from "not at all confident" to "completely confident."
Outcome measures
| Measure |
Usual Care + Intervention (Case)
n=74 Participants
Cases will receive the CommunityRx Intervention.
Community Rx-Hunger (CRx-H): The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member.
|
Usual Care (Control)
n=74 Participants
Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge.
|
|---|---|---|
|
(Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers
Not at all confident
|
2 Participants
|
5 Participants
|
|
(Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers
Not very confident
|
9 Participants
|
4 Participants
|
|
(Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers
Uncertain
|
13 Participants
|
6 Participants
|
|
(Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers
Somewhat confident
|
18 Participants
|
33 Participants
|
|
(Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers
Completely confident
|
32 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: 7 days post discharge from the hospitalPopulation: Caregivers who completed the satisfaction measure at the 1 week follow up are included in the analysis population.
Satisfaction with hospital discharge is measured by the Hospital Consumer Assessment of Healthcare Providers Survey (HCAHPS); "Child HCAHPS" which includes 8 items (range 0-100 with higher values representing higher satisfaction). Response options are "Yes, definitely," "Yes, somewhat" and "No." The items ask about the child and the hospital related to their recent stay.
Outcome measures
| Measure |
Usual Care + Intervention (Case)
n=258 Participants
Cases will receive the CommunityRx Intervention.
Community Rx-Hunger (CRx-H): The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member.
|
Usual Care (Control)
n=262 Participants
Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge.
|
|---|---|---|
|
(Aim 2) Caregiver Satisfaction With Hospital Discharge
|
81.9 units on a scale
Standard Deviation 24.8
|
84.2 units on a scale
Standard Deviation 23.8
|
Adverse Events
Usual Care + Intervention (Case)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place