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)".

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

479 participants

Primary outcome timeframe

8 weeks

Results posted on

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

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

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

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 weeks

Population: 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

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 weeks

Population: 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

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 months

The 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

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 baseline

The 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

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 baseline

The 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

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 baseline

For 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

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 baseline

BP 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

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 baseline

Population: 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

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 months

The 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

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 baseline

BP 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths

Awareness

Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths

Assistance

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Grant Huang

Department of Veterans Affairs

Phone: (202) 443-5700

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place