Basic Unmet Material NeedsPROSWECARENCT02918435
Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices
A study testing WE CARE in people with Basic Unmet Material Needs and Patient Satisfaction, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
This research project is aimed to assess the implementation, effectiveness, and sustainability of a pediatric-based intervention aimed at reducing families' unmet material needs (food, housing, employment, childcare, household utilities, education) in pediatric practices throughout the United States. Read more about this study
- Who is it for?
- Ages 2 months to 10 years
- Conditions the study is for
- Basic Unmet Material Needs, Patient Satisfaction, Receipt of Community Resources
- What is being tested?
- WE CARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,073 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents/legal guardians (aged at least 18 years) of children aged 2 months through 10 years whose child presents for a health supervision visit
- Providers and staff involved in the implementation component of the WE CARE intervention arm
Who cannot join
- Foster parents, parents who speak neither English or Spanish, and previously enrolled parents
Trial locations and contacts
1 site in 1 country.
About this study
This research project is aimed to assess the implementation, effectiveness, and sustainability of a pediatric-based intervention aimed at reducing families' unmet material needs (food, housing, employment, childcare, household utilities, education) in pediatric practices throughout the United States.
Read the detailed description
The investigators prior work has focused on developing a pediatric primary care-based intervention, WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education), aimed at addressing poor families' material needs - food security, employment, parental education, housing stability, household heat, and childcare - by systematically screening for these needs and referring families to existing community-based services. To date, the investigators have tested WE CARE primarily in community health centers (CHCs); their randomized controlled trial (RCT) demonstrated WE CARE's efficacy on parental receipt of community-based resources. However, over 80% of low-income children receive care from providers in traditional pediatric practices (i.e. non-CHCs). The investigators therefore will conduct a large-scale, Hybrid Type 2 effectiveness-implementation trial in eighteen pediatric practices in the US. A stepped wedge study cluster RCT design will be used to implement WE CARE in all practices using two common strategies used to integrate systems-based interventions into primary care - a previously facilitated "on-site" strategy in which content experts provide training sessions and on-going consultation; and a self-directed "web-based" method modeled after the American Academy of Pediatrics' practice transformation strategy. Of note, due to the COVID-19 pandemic, the on-site strategy was changed to a "study team facilitated live webinar" implementation strategy. The proposed study's specific aims are to: 1) demonstrate the non-inferiority of the self-directed, web-based strategy for implementing WE CARE, in comparison to the facilitated on-site strategy; 2) demonstrate WE CARE's effectiveness on increasing parental receipt of community resources; and 3) assess the sustainability of WE CARE in pediatric practices. The investigators hypothesize that WE CARE will have equivalent fidelity via the two strategies. Based on prior work, the investigators hypothesize that WE CARE will significantly increase parental receipt of community resources three months post-visit compared to usual care. The investigators also expect WE CARE to be sustained 1.5-, 2-, and 2.5-years post-implementation; they expect to gather data from over 2,700 chart reviews, 2,520 parents, and 360 providers and office staff. This proposal has significant public health implications for the delivery of primary care to low-income children.
- Conditions
- Basic Unmet Material Needs, Patient Satisfaction, Receipt of Community Resources, Provider Referrals
- Being tested
- WE CARE, Usual Care
- Keywords
- WE CARE, Pediatric practices
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WE CAREBehavioural
The WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) survey consists of 12 questions used to identify six unmet material needs (education, employment, food security, housing, childcare, household utilities). It will be administered at health supervision visits during the WE CARE phase at each study site. The Family Resource Book will contain resource information sheets for each of these needs listing available community resources. A physician champion will conduct regular booster sessions every 4 months and train new providers should there be staff turnover.
Usual CareOther
Standard pediatric care.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care-Control | Active comparator | Participants in the usual care group will receive standard pediatric care. Receives: Other: Usual Care |
| Study team facilitated live webinar WE CARE implementation arm | Experimental | WE CARE will be implemented in the study site using a facilitated "live webinar" strategy. 1. Participants will receive the WE CARE survey at health supervision visits; this survey will be used to identify unmet material needs. 2. Providers will be trained on WE CARE via a live webinar facilitated by the study team which will teach them how to review the survey and provide referrals (community resource information sheets) from a Family Resource Book located in each exam room. Receives: Behavioral: WE CARE |
| Self-directed pre-recorded webinar WE CARE implementation arm | Experimental | WE CARE will be implemented in the study site using a pre-recoded webinar implementation strategy. 1. Participants will receive the WE CARE survey at health supervision visits; this survey will be used to identify unmet material needs. 2. Providers will be trained on WE CARE via self-directed pre-recorded webinar which will teach them how to review the survey and provide referrals (community resource information sheets) from a Family Resource Book located in each exam room. Receives: Behavioral: WE CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of Community Resources
Effectiveness outcome of WE CARE on caregiver receipt of community resources. This is measured by whether the caregiver of the child received new resources related to any of the listed domains as a result of a referral through the WE CARE program
Measured: 3 months post-index visit
Provider Referrals for Unmet Material Needs Received at Visit
The number of provider referrals for unmet needs during a care visit for community resources that were self-reported by parent participants.
Measured: At the index visit
Secondary outcomes (14)
Sustainability of WE CARE--Survey Distribution
Sustainability of WE CARE as measured by the number of surveys distributed across participating care practices.
Measured: 6 months, 12 months, 18 months and 24 months post implementation of WE CARE at practice
Sustainability of WE CARE--Appropriate Referrals Made by Providers
Sustainability of WE CARE as measured by the number of appropriate provider referrals to community resources for families who indicated that they wanted help with a need on a WE CARE screener.
Measured: 6 months, 12 months, 18 months and 24 months post implementation of WE CARE at practice
Parental Assessment of Patient Satisfaction
Parental assessment of satisfaction of pediatric care received as measured by the Clinician and Group Survey.
Measured: At the index visit
Parental Assessment of Family Centeredness
Parental assessment of family centeredness of pediatric care received as measured by the National Survey of Children's Health (2016).
Measured: At the index visit
Parental Assessment of Care Coordination - Extra Help
Parental assessment of the care coordination of pediatric care received as measured via the National Survey of Children's Health (2016).
"During the past 3 months, have you felt that you could have used extra help arranging or coordinating your child's care among the different health care providers or services?"
Since this measure is recording the opinions of parents based on a question, the unit would be of participants who responded yes or no to the question above.
Measured: 3-months post-index visit
Parental Assessment of Care Coordination - Amount of Help
Parental assessment of the care coordination of pediatric care received as measured via the National Survey of Children's Health (2016).
"If yes, during the past 3 months, how often did you get as much help as you wanted with arranging or coordinating your child's health care?"
Measured: 3-months post-index visit
Parental Assessment of Care Coordination - Satisfaction
Parental assessment of the care coordination of pediatric care received as measured via the National Survey of Children's Health (2016).
"Overall, how satisfied are you with the communication among your child's doctors and other health care providers?"
Since this measure is recording the opinions of parents based on a question, the unit would be of participants who responded yes or no to the question above. The number analyzed may differ from the overall number analyzed due to participants not responding to all the prompts on the survey.
Measured: At the index visit
Provider and Office Staff Acceptability of WE CARE
Assessed post-implementation through qualitative interviews with providers and office staff exploring perceptions of WE CARE's acceptability, including satisfaction with the screening and referral process, perceived appropriateness and usefulness, fit with clinic workflow, burden, and willingness to continue using WE CARE.
Measured: Post-implementation (within 3 months of completion of the Implementation period)
Appropriateness of WE CARE-Utilization
Providers and Office staff appropriateness views on WE CARE measured via survey question on level of satisfaction with training materials for WE Care, as measured by responses on whether they Disagree Strongly, Disagree, Undecided, Agree or Agree Strongly with statements related to utilization, resources, training, and support.
Measured: Baseline
Appropriateness of WE CARE-Resources
Providers and Office staff appropriateness views on WE CARE measured via survey question on level of satisfaction with training materials for WE Care, as measured by responses on whether they Disagree Strongly, Disagree, Undecided, Agree or Agree Strongly with statements related to utilization, resources, training, and support.
Measured: Baseline
Appropriateness of WE CARE-Training
Providers and Office staff appropriateness views on WE CARE measured via survey question on level of satisfaction with training materials for WE Care, as measured by responses on whether they Disagree Strongly, Disagree, Undecided, Agree or Agree Strongly with statements related to utilization, resources, training, and support.
Measured: Baseline
Appropriateness of WE CARE-Support
Providers and Office staff appropriateness views on WE CARE measured via survey question on level of satisfaction with training materials for WE Care, as measured by responses on whether they Disagree Strongly, Disagree, Undecided, Agree or Agree Strongly with statements related to utilization, resources, training, and support.
Measured: Baseline
Discussion of Unmet Needs (e.g., Food Insecurity) at Child's Well-child Care Visit
Measurement of whether discussion of unmet social needs occurred during pediatric visit.
Measured: At the index visit
Parent Recollection of Receipt of Referrals
Parental recollection of receipt of referrals during pediatric care received.
Measured: 3 months post-index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start7 Oct 2019
- Primary completion26 Sep 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Basic Unmet Material NeedsStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Research in Office Settings, Continuity Research Network, Boston University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Arvin Garg, University of Massachusetts, Worcester
- Investigators
- Arvin Garg, MD, MPH, Principal investigator, University of Massachusets Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918435
- Sponsor's protocol ID
- H-35482
- Other IDs
- R01HD090191
- Acronym
- PROSWECARE
- Status last verified
- Nov 2026
- First submitted
- 26 Sep 2016
- Last updated
- 6 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garg A, Toy S, Tripodis Y, Silverstein M, Freeman E. Addressing social determinants of health at well child care visits: a cluster RCT. Pediatrics. 2015 Feb;135(2):e296-304. doi: 10.1542/peds.2014-2888. Epub 2015 Jan 5.
PubMed 25560448Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.
PubMed 17766528
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices
- ClinicalTrials.gov ID
- NCT02918435
- Acronym / sponsor ID
- PROSWECARE / H-35482
- Conditions
- Basic Unmet Material Needs, Patient Satisfaction, Receipt of Community Resources, Provider Referrals
- Keywords
- WE CARE, Pediatric practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,073 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Pediatric Research in Office Settings, Continuity Research Network, Boston University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 6 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research project is aimed to assess the implementation, effectiveness, and sustainability of a pediatric-based intervention aimed at reducing families' unmet material needs (food, housing, employment, childcare, household utilities, education) in pediatric practices throughout the United States.
Detailed description
The investigators prior work has focused on developing a pediatric primary care-based intervention, WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education), aimed at addressing poor families' material needs - food security, employment, parental education, housing stability, household heat, and childcare - by systematically screening for these needs and referring families to existing community-based services. To date, the investigators have tested WE CARE primarily in community health centers (CHCs); their randomized controlled trial (RCT) demonstrated WE CARE's efficacy on parental receipt of community-based resources. However, over 80% of low-income children receive care from providers in traditional pediatric practices (i.e. non-CHCs). The investigators therefore will conduct a large-scale, Hybrid Type 2 effectiveness-implementation trial in eighteen pediatric practices in the US. A stepped wedge study cluster RCT design will be used to implement WE CARE in all practices using two common strategies used to integrate systems-based interventions into primary care - a previously facilitated "on-site" strategy in which content experts provide training sessions and on-going consultation; and a self-directed "web-based" method modeled after the American Academy of Pediatrics' practice transformation strategy. Of note, due to the COVID-19 pandemic, the on-site strategy was changed to a "study team facilitated live webinar" implementation strategy. The proposed study's specific aims are to: 1) demonstrate the non-inferiority of the self-directed, web-based strategy for implementing WE CARE, in comparison to the facilitated on-site strategy; 2) demonstrate WE CARE's effectiveness on increasing parental receipt of community resources; and 3) assess the sustainability of WE CARE in pediatric practices. The investigators hypothesize that WE CARE will have equivalent fidelity via the two strategies. Based on prior work, the investigators hypothesize that WE CARE will significantly increase parental receipt of community resources three months post-visit compared to usual care. The investigators also expect WE CARE to be sustained 1.5-, 2-, and 2.5-years post-implementation; they expect to gather data from over 2,700 chart reviews, 2,520 parents, and 360 providers and office staff. This proposal has significant public health implications for the delivery of primary care to low-income children.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care-Control | Active comparator | Other: Usual CareParticipants in the usual care group will receive standard pediatric care. |
| Study team facilitated live webinar WE CARE implementation arm | Experimental | Behavioral: WE CAREWE CARE will be implemented in the study site using a facilitated "live webinar" strategy. 1. Participants will receive the WE CARE survey at health supervision visits; this survey will be used to identify unmet material needs. 2. Providers will be trained on WE CARE via a live webinar facilitated by the study team which will teach them how to review the survey and provide referrals (community resource information sheets) from a Family Resource Book located in each exam room. |
| Self-directed pre-recorded webinar WE CARE implementation arm | Experimental | Behavioral: WE CAREWE CARE will be implemented in the study site using a pre-recoded webinar implementation strategy. 1. Participants will receive the WE CARE survey at health supervision visits; this survey will be used to identify unmet material needs. 2. Providers will be trained on WE CARE via self-directed pre-recorded webinar which will teach them how to review the survey and provide referrals (community resource information sheets) from a Family Resource Book located in each exam room. |
Who may qualify
- Ages
- 2 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parents/legal guardians (aged at least 18 years) of children aged 2 months through 10 years whose child presents for a health supervision visit
- Providers and staff involved in the implementation component of the WE CARE intervention arm
Key exclusion criteria (1 listed)
- Foster parents, parents who speak neither English or Spanish, and previously enrolled parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WE CAREThe WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) survey consists of 12 questions used to identify six unmet material needs (education, employment, food security, housing, childcare, household utilities). It will be administered at health supervision visits during the WE CARE phase at each study site. The Family Resource Book will contain resource information sheets for each of these needs listing available community resources. A physician champion will conduct regular booster sessions every 4 months and train new providers should there be staff turnover. | Behavioural | Self-directed pre-recorded webinar WE CARE implementation arm, Study team facilitated live webinar WE CARE implementation arm |
| Usual CareStandard pediatric care. | Other | Usual Care-Control |
Primary outcome
Receipt of Community Resources
Time frame: 3 months post-index visit
Effectiveness outcome of WE CARE on caregiver receipt of community resources. This is measured by whether the caregiver of the child received new resources related to any of the listed domains as a result of a referral through the WE CARE program
Provider Referrals for Unmet Material Needs Received at Visit
Time frame: At the index visit
The number of provider referrals for unmet needs during a care visit for community resources that were self-reported by parent participants.
14 secondary outcomes
Sustainability of WE CARE--Survey Distribution
Time frame: 6 months, 12 months, 18 months and 24 months post implementation of WE CARE at practice
Sustainability of WE CARE--Appropriate Referrals Made by Providers
Time frame: 6 months, 12 months, 18 months and 24 months post implementation of WE CARE at practice
Parental Assessment of Patient Satisfaction
Time frame: At the index visit
Parental Assessment of Family Centeredness
Time frame: At the index visit
Parental Assessment of Care Coordination - Extra Help
Time frame: 3-months post-index visit
Parental Assessment of Care Coordination - Amount of Help
Time frame: 3-months post-index visit
Parental Assessment of Care Coordination - Satisfaction
Time frame: At the index visit
Provider and Office Staff Acceptability of WE CARE
Time frame: Post-implementation (within 3 months of completion of the Implementation period)
Appropriateness of WE CARE-Utilization
Time frame: Baseline
Appropriateness of WE CARE-Resources
Time frame: Baseline
Appropriateness of WE CARE-Training
Time frame: Baseline
Appropriateness of WE CARE-Support
Time frame: Baseline
Discussion of Unmet Needs (e.g., Food Insecurity) at Child's Well-child Care Visit
Time frame: At the index visit
Parent Recollection of Receipt of Referrals
Time frame: 3 months post-index
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25560448Garg A, Toy S, Tripodis Y, Silverstein M, Freeman E. Addressing social determinants of health at well child care visits: a cluster RCT. Pediatrics. 2015 Feb;135(2):e296-304. doi: 10.1542/peds.2014-2888. Epub 2015 Jan 5.
- Background: PubMed 17766528Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvin Garg, MD, MPH principal investigator
University of Massachusets Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WE CARE in people with Basic Unmet Material Needs and Patient Satisfaction, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of Community Resources (time frame: 3 months post-index visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02918435, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.