Trial Outcomes & Findings for Unmet Social Needs Study (NCT NCT04977583)
NCT ID: NCT04977583
Last Updated: 2025-04-30
Results Overview
Defined as participant connecting to one or more resources since the index unmet need screen and assessed via a participant survey administered 8 weeks following the index unmet need screen. The survey will ask: "Since you completed the unmet social need screen on (insert date), were you able to connect with any of the programs or resources for help with (insert need(s) identified)".
COMPLETED
NA
479 participants
8 weeks
2025-04-30
Participant Flow
Recruitment took place from April 2022 - June 2023. Trained research assistants (RAs) recruited participants by phone.
Participants needed to screen positive for one of nine needs to be assigned to an arm. Participants with zero needs were not eligible for the trial and thus not randomized to an arm.
Participant milestones
| Measure |
Screening
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
161
|
160
|
158
|
|
Overall Study
8 Week Screen
|
143
|
141
|
133
|
|
Overall Study
6 Month Screen
|
135
|
133
|
138
|
|
Overall Study
COMPLETED
|
150
|
154
|
144
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
14
|
Reasons for withdrawal
| Measure |
Screening
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
4
|
13
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
1
|
Baseline Characteristics
Unmet Social Needs Study
Baseline characteristics by cohort
| Measure |
Screening
n=161 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=160 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=158 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Total
n=479 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.58 years
STANDARD_DEVIATION 11.55 • n=5 Participants
|
63.96 years
STANDARD_DEVIATION 12.17 • n=7 Participants
|
64.16 years
STANDARD_DEVIATION 11.50 • n=5 Participants
|
64.24 years
STANDARD_DEVIATION 11.72 • n=4 Participants
|
|
Sex/Gender, Customized
Gender · Women
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Men
|
148 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
435 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Transgender Women
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
150 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
449 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
87 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Baseline Average Needs per Participant
|
2.45 Count of social needs
STANDARD_DEVIATION 1.36 • n=5 Participants
|
2.53 Count of social needs
STANDARD_DEVIATION 1.61 • n=7 Participants
|
2.54 Count of social needs
STANDARD_DEVIATION 1.39 • n=5 Participants
|
2.51 Count of social needs
STANDARD_DEVIATION 1.45 • n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: One participant in arm 3 was excluded from analysis due to missing race information.
Defined as participant connecting to one or more resources since the index unmet need screen and assessed via a participant survey administered 8 weeks following the index unmet need screen. The survey will ask: "Since you completed the unmet social need screen on (insert date), were you able to connect with any of the programs or resources for help with (insert need(s) identified)".
Outcome measures
| Measure |
Screening
n=161 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=160 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=157 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Number of Participants Who Connected With a New Resource
|
40 Participants
|
41 Participants
|
51 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: One participant in arm 3 was excluded from analysis due to missing race information.
Defined as a count of resources that a participant connected to since the index unmet need screen and assessed via a participant survey administered 8 weeks following the index unmet need screen. The survey will ask: "Since you completed the unmet social need screen on (insert date), were you able to connect with any of the programs or resources for help with (insert need(s) identified)".
Outcome measures
| Measure |
Screening
n=161 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=160 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=157 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Mean Count of Resources Connected To
|
0.40 Count of resources connected
Standard Deviation .79
|
0.40 Count of resources connected
Standard Deviation 0.83
|
0.47 Count of resources connected
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 6 monthsThe investigators will compare the results from the index screen for unmet needs to those from the unmet needs screen administered six months after the index screen. The investigators will define unmet need reduction in two ways. This measure is one or more of baseline unmet needs no longer identified as an unmet need at the 6-month rescreen.
Outcome measures
| Measure |
Screening
n=161 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=160 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=158 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Unmet Need Reduction - Any
|
82 Participants
|
73 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: 12 months compared to baselineThe measure is change in Emergency Department and urgent care visits. Change is calculated as (mean at 12 months - mean at baseline). The investigators will assess this measure using CDW.
Outcome measures
| Measure |
Screening
n=161 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=160 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=158 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Emergent Visits (Urgent Care and Emergency Department Visits)
|
0.19 Mean difference in emergent visits
Standard Deviation 2.36
|
0.53 Mean difference in emergent visits
Standard Deviation 2.64
|
-0.01 Mean difference in emergent visits
Standard Deviation 2.15
|
SECONDARY outcome
Timeframe: 12 months compared to baselineThe investigators will assess adherence to CVD and CVD risk factor medications, including all possible drug class codes (CV000-CV900, encompassing Antilipemic agents and antihypertensives for the subsets of patients prescribed these medications) and, among the subset of patients with DM, diabetes medications (HS501-509). The measure will be based on pharmacy dispensing data from CDW to specify the proportion of days covered (PDC) of each medication. To calculate this, the investigators will count the # of days dispensed in relation to the dispensing period. The numerator will be based on the prescription fill dates and # of days dispensed to determine the number of outpatient days for which each medication was supplied. Patients will be considered adherent if they achieved a PDC \> 80%. The measure is change in medication adherence. Change is calculated as (mean at 12 months - mean at baseline). The investigators will assess this measure using CDW.
Outcome measures
| Measure |
Screening
n=161 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=160 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=158 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Medication Adherence
|
0.01 med adherence% post - med adherence% pre
Standard Deviation 0.15
|
0.01 med adherence% post - med adherence% pre
Standard Deviation 0.12
|
0.03 med adherence% post - med adherence% pre
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: 12 months compared to baselineFor each patient, the investigators will calculate a no-show rate, or the proportion of primary care and cardiology appointments that are classified as no-show, relative to the total number of appointments scheduled in both, following the approach taken by other VA investigators using CDW data to assess this metric. The numerator ("no-shows") consists of appointments marked as a no-show and appointments canceled by the patient or clinic after the appointment time. The denominator ("total appointments") consists of no-shows and completed appointments. The measure is change in no shows. Change is calculated as (mean at 12 months - mean at baseline). The investigators will assess this measure using CDW.
Outcome measures
| Measure |
Screening
n=161 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=160 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=158 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Clinic Visit Appointment Attendance ("No-show")
|
-0.14 Number of appointments missed
Standard Deviation 1.52
|
-0.06 Number of appointments missed
Standard Deviation 1.40
|
0.22 Number of appointments missed
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: 12 months compared to baselineBP is measured at every PC visit, and the investigators will obtain these measurements from CDW. In the rare case of missing BP data, the investigators will exclude such Veterans from the analysis. Because BP outcomes are also affected by clinicians' adjustment or titration of antihypertensive medications, the investigators will assess the effects of controlling for treatment intensification (TI), using methods similar to the published approaches used in prior work. The investigators will use the following formula to measure TI: (visits with medication changes-visits with elevated BP) / (number of clinic visits).
Outcome measures
| Measure |
Screening
n=161 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=160 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=158 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Systolic Blood Pressure (BP)
|
-1.20 Mean change in mmHg
Standard Deviation 9.37
|
-0.27 Mean change in mmHg
Standard Deviation 12.80
|
-0.23 Mean change in mmHg
Standard Deviation 13.61
|
SECONDARY outcome
Timeframe: 12 months compared to baselinePopulation: This only contains people who are indicated as having diabetes
HbA1c is available from CDW. The investigators anticipate approximately 40% of our RCT sample to have DM, based on a preparatory-to-research analysis of CDW data. To ensure the values reflect health status around the time of the index screen and the 6 and 12-month follow-up window, the investigators will only include Veterans with DM who have an Hba1c in the 6 months prior to each time point. Approximately 17% of patients with DM do not have an HbA1c test within VA in the prior year.
Outcome measures
| Measure |
Screening
n=75 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=81 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=52 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Hemoglobin A1c (HbA1c)
|
-0.42 Mean % glycated hemoglobin
Standard Deviation 1.11
|
-0.03 Mean % glycated hemoglobin
Standard Deviation 1.43
|
0.11 Mean % glycated hemoglobin
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: 6 monthsThe investigators will compare the results from the index screen for unmet needs to those from the unmet needs screen administered six months after the index screen. The investigators will define unmet need reduction in two ways. This measure is percentage of baseline needs not reported as unmet needs at 6-month rescreen.
Outcome measures
| Measure |
Screening
n=161 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=160 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=158 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Unmet Need Reduction - Percent
|
30.37 Percent of Needs not reported as unmet
Standard Deviation 36.6
|
27.11 Percent of Needs not reported as unmet
Standard Deviation 35.98
|
27.88 Percent of Needs not reported as unmet
Standard Deviation 35.91
|
SECONDARY outcome
Timeframe: 12 months compared to baselineBP is measured at every PC visit, and the investigators will obtain these measurements from CDW. In the rare case of missing BP data, the investigators will exclude such Veterans from the analysis. Because BP outcomes are also affected by clinicians' adjustment or titration of antihypertensive medications, the investigators will assess the effects of controlling for treatment intensification (TI), using methods similar to the published approaches used in prior work. The investigators will use the following formula to measure TI: (visits with medication changes-visits with elevated BP) / (number of clinic visits).
Outcome measures
| Measure |
Screening
n=161 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=160 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=158 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Diastolic Blood Pressure (BP)
|
-0.43 Mean change in mmHg
Standard Deviation 6.11
|
-1.17 Mean change in mmHg
Standard Deviation 7.07
|
-0.11 Mean change in mmHg
Standard Deviation 7.44
|
POST_HOC outcome
Timeframe: 8 weeksPopulation: Participants in arm 3 could refuse to speak with a social worker. This analysis is with arm 3 refusals removed. The participant with no race info refused arm 3 and is excluded from the 125.
Defined as participant connecting to one or more resources since the index unmet need screen and assessed via a participant survey administered 8 weeks following the index unmet need screen. The survey will ask: "Since you completed the unmet social need screen on (insert date), were you able to connect with any of the programs or resources for help with (insert need(s) identified)".
Outcome measures
| Measure |
Screening
n=161 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=160 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=125 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Number of Participants Who Connected With a New Resource (With Arm 3 Refusals Removed)
|
40 Participants
|
41 Participants
|
44 Participants
|
POST_HOC outcome
Timeframe: 8 weeksPopulation: Elixhauser score \>=4 only.
Defined as participant connecting to one or more resources since the index unmet need screen and assessed via a participant survey administered 8 weeks following the index unmet need screen. The survey will ask: "Since you completed the unmet social need screen on (insert date), were you able to connect with any of the programs or resources for help with (insert need(s) identified)". This was an ad-hoc sub-group analysis consisting of Veterans with an Elixhauser score of 4 or greater. The Elixhauser comorbidity index is a measure of comorbidity based on ICD-10 codes. A higher number indicates more comorbidities. The scale is 0-30.
Outcome measures
| Measure |
Screening
n=96 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=89 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=79 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Number of Participants Who Connected With a New Resource (Elixhauser Score >=4 Only)
|
21 Participants
|
23 Participants
|
31 Participants
|
POST_HOC outcome
Timeframe: 8 weeksPopulation: VA Priority groups 4 \& 5 only
Defined as participant connecting to one or more resources since the index unmet need screen and assessed via a participant survey administered 8 weeks following the index unmet need screen. The survey will ask: "Since you completed the unmet social need screen on (insert date), were you able to connect with any of the programs or resources for help with (insert need(s) identified)". This was an ad-hoc sub-group analysis consisting of Veterans in VA priority groups 4 \& 5 (of which 95% of Veterans were in priority group 5). Veterans applying for VHA healthcare are assigned to one of eight priority groups based on eligibility criteria including income and service connected disability. A lower score signifies a higher priority for enrollment. Veterans in priority group 5 are unique in that they're eligibility is based not on disability, but on income status (i.e. Medicaid eligibility).
Outcome measures
| Measure |
Screening
n=43 Participants
Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
|
Awareness
n=48 Participants
Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
Assistance
n=52 Participants
Participants in this arm will receive the same interventions as Arm 2 (screened by phone for unmet social needs, receive post card listing generic resources, and receive tailored resource sheets) plus be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.
Unmet Need Screening: Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
Unmet Need Referral - Resource Sheet: Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
|
|---|---|---|---|
|
Number of Participants Who Connected With a New Resource (VA Priority Groups 4 & 5 Only)
|
5 Participants
|
9 Participants
|
18 Participants
|
Adverse Events
Screening
Awareness
Assistance
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