AsthmaWECARE01NCT02451059
Reducing Socioeconomic Disparities in Health at Pediatric Visits
A study testing WE CARE survey, WE CARE Community Resource Handout and Patient Navigator in people with Asthma and Obesity, run by Boston Medical Center at 6 sites in United States.
Trial summary
This research project is aimed to assess the effectiveness and impact of a pediatric-based intervention aimed at reducing low-income families' unmet material needs (food, housing, employment, childcare, household heat, education and learning the English language ) on child health. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Asthma, Obesity, Health Care Utilization
- What is being tested?
- WE CARE survey, WE CARE Community Resource Handout and Patient Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,205 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2015to 29 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is on Medicaid insurance
- Is attending routine newborn visit
Who cannot join
- Premature (less than or equal to 32 weeks GA)
- Has a chronic disease
- Has Neonatal Abstinence Syndrome
- Has a foster parent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
South End Community Health Center
Boston, Massachusetts, 02118
Dorchester House Multi-Service Center
Boston, Massachusetts, 02122
Codman Square Health Center
Boston, Massachusetts, 02124
Uphams Corner Health Center
Dorchester, Massachusetts, 02125
Mattapan Community Health Center
Mattapan, Massachusetts, 02126
Greater Roslindale Medical and Dental Center
Roslindale, Massachusetts, 02131
About this study
This research project is aimed to assess the effectiveness and impact of a pediatric-based intervention aimed at reducing low-income families' unmet material needs (food, housing, employment, childcare, household heat, education and learning the English language ) on child health.
Read the detailed description
This project builds upon the PI's prior studies including a recently completed cluster randomized controlled trial (RCT) at community health centers in Boston, which demonstrated a positive impact on provider referrals, discussion, and family receipt of resources.
This study will specifically test the effectiveness of a further strengthened intervention "WE CARE 2.0" on provider referrals and family receipt of resources, along with its impact on child health, health care utilization, and developmental outcomes. Finally, we will gather information from stakeholders at the health centers in order to learn more about the facilitators and barriers to implementation of the model.
The study will take place at six community health centers in the Greater Boston area. The centers will be randomized to either an intervention or control site. Data will be collected on referrals, receipt of resources, and child outcomes from the child's electronic medical record (EMR) from birth to age 3. Focus groups will be used to gather implementation data from intervention health center personnel.
The WE CARE 2.0 intervention consists of: 1) WE CARE surveys which parents complete prior to their child's well-child visits; 2) information technology (IT) generated provider referrals which providers use to provide families with resource information sheets; 3) peer patient navigators who assist families in connecting to available resources and updating providers; and 4) training sessions for providers and office staff.
Families attending the control health centers will receive standard of care. Of note, since the health centers share a common EMR and for ethical reasons, control sites will have access to the IT generated referral mechanism.
- Conditions
- Asthma, Obesity, Health Care Utilization, Health Care Disparities, Basic Unmet Social Needs, Blood Pressure
- Being tested
- WE CARE survey, WE CARE Community Resource Handout, Patient Navigator
- Keywords
- community resource, well-child care visit, low-income
- Medical subject headings
- Asthma, Obesity, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WE CARE surveyBehavioural
The WE CARE survey, consists of 14 questions used to identify seven unmet material needs (education, employment, food security, housing, childcare, household heat, language). The survey will be administered with patient's developmental screening forms at all health supervision visits from birth to two years of age. The office staff will instruct parents to give the WE CARE survey, along with the developmental screening tool, to their child's provider at the visit.
WE CARE Community Resource HandoutBehavioural
Also called Resource Referral
Providers will be trained to review the WE CARE survey at health supervision visits and generate referrals thru the EMR. Specifically, they will receive a one-hour teaching session one week prior to the study implementation. The goals for the session will include providing an overview of pediatric practice guidelines, introducing the WE CARE survey, reviewing the referral process, and discussing the role of peer patient navigators. Study staff will conduct periodic booster sessions; study staff will also train new providers should there be staff turnover
Patient NavigatorBehavioural
The peer patient navigator will offer guidance to families with accessing community resources. They will be available at least .5 days per week at intervention health centers to meet with families and offer guidance as well as be available via a hotline number. The navigator will speak with families and offer guidance on community resources and offer assistance with completing applications. In addition, they will offer to schedule and, if desired, accompany parents to the agencies. Interpreter services will be utilized at the health centers in case the navigator does not speak the parent's language. The navigator will also place an update note in the EMR within 1-month post-visit and one week after any contact with families.
| Study group | Role | What they receive |
|---|---|---|
| Intervention-WE CARE | Experimental | 1. The WE CARE survey is used to identify unmet material needs; it will be administered with patient's developmental screening forms at all health supervision visits from birth to two years of age.
2. Providers will be trained to review the WE CARE survey at health supervision visits and generate our WE CARE community resource handouts (referrals) through the EMR.
3. A peer patient navigator will offer personalized guidance to families with accessing community resources. The patient navigator will be available for at least a 1/2 day per week at each intervention health center to meet with families and offer guidance. Providers can communicate the patient navigator to refer families via the electronic medical record and families will also have the opportunity to contact the peer navigator at any time via the hotline number listed on the referral information sheets. Receives: Behavioral: WE CARE survey; Behavioral: WE CARE Community Resource Handout; Behavioral: Patient Navigator |
| Control-Standard of Care | No intervention | Participants in the delayed-intervention control group will receive standard pediatric care. However, since the health centers share a common EMR, and for ethical reasons, investigators will also embed the health IT referral mechanism into the EMR at the control sites. Control providers will be made aware of this prior to the start of the study. Although this may potentially reduce the effect size, the investigator's prior study found that the impact on referral rates of provider access to resource information was minimal. Families at control health centers will not receive the WE CARE surveys at health supervision visits and will not have access to the peer patient navigators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care utilization
Investigators will measure whether child is up to date with well child visits between 0-3 years of age. Investigators will measure whether child is up to date on their immunizations between 0-3 years of age. Investigators will measure if and how many times child has been hospitalized or had a visit to the emergency department (ED) between 0-3 years of age.
Measured: Throughout child's enrollment in study (0 years through 3 years of age)
Secondary outcomes (8)
Child maltreatment
Investigators will measure in the child's EMR whether or not there are any reports of child maltreatment and/or involvement with the Department of Child and Families, at any point, from age 0-3 years of age.
Measured: Throughout child's enrollment in study (0 years through 3 years of age)
Developmental delay
Investigators will measure whether a developmental delay has been added to the child's problem list in their EMR or if provider has noted a concern of a developmental delay in their routine well-child care notes, at any point, from age 0-3 years of age.
Measured: Throughout child's enrollment in study (0 years through 3 years of age)
Obesity
Investigators will record the child's reported BMI at their 2-year, 30-month, and 3-year well child care visits from the EMR
Measured: Measured at 2-year, 30-month, and 3-year well child care visits (as recommended by the American Academy of Pediatrics)
Asthma
Investigators will record whether asthma or concerns about asthma have been added to child's problem list in the EMR or noted in the EMR by child's provider at any point, from age 0-3 years of age.
Measured: Throughout child's enrollment in study (0 years through 3 years of age)
Blood pressure
We will record the child's reported blood pressure number as measured at their 3-year well child care visit. We will gather this information from the EMR.
Measured: Measured at 3-year well child care visits
Provider referrals
Investigators will measure if and how many times a provider made a referral/printed out a community resource handout for patients during their enrollment in the study at any point, from age 0-3 years of age.
Measured: Throughout child's enrollment in study (0 years through 3 years of age)
Family receipt of community based resource
Investigators will determine whether families who were printed out community resource handouts had been able to receive services from a community based resource organization. This will be recorded in the EMR by the patient navigator at anytime from age 0-3 years of age.
Measured: Throughout child's enrollment in study (0 years through 3 years of age)
Focus group data gathered by audio recordings then transcribed and coded
Investigators will gain insight into the context and implementation of the augmented WE CARE model from providers and administrative staff at the intervention sites
Measured: During 1st month pilot phase and again after investigators have enrolled our the cohort, approximately 3 years after the first focus groups and the study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startSep 2015
- Primary completion29 Dec 2020
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Community Health Education Research and Service, Inc., National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Arvin Garg, MD MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451059
- Sponsor's protocol ID
- H-33061
- Other IDs
- 1R01MD007793-01A1
- Acronym
- WECARE01
- Status last verified
- May 2021
- First submitted
- 14 May 2015
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Socioeconomic Disparities in Health at Pediatric Visits
- ClinicalTrials.gov ID
- NCT02451059
- Acronym / sponsor ID
- WECARE01 / H-33061
- Conditions
- Asthma, Obesity, Health Care Utilization, Health Care Disparities, Basic Unmet Social Needs, Blood Pressure
- Keywords
- community resource, well-child care visit, low-income
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,205 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Center for Community Health Education Research and Service, Inc., National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Sep 2015 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
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 effectiveness and impact of a pediatric-based intervention aimed at reducing low-income families' unmet material needs (food, housing, employment, childcare, household heat, education and learning the English language ) on child health.
Detailed description
This project builds upon the PI's prior studies including a recently completed cluster randomized controlled trial (RCT) at community health centers in Boston, which demonstrated a positive impact on provider referrals, discussion, and family receipt of resources.
This study will specifically test the effectiveness of a further strengthened intervention "WE CARE 2.0" on provider referrals and family receipt of resources, along with its impact on child health, health care utilization, and developmental outcomes. Finally, we will gather information from stakeholders at the health centers in order to learn more about the facilitators and barriers to implementation of the model.
The study will take place at six community health centers in the Greater Boston area. The centers will be randomized to either an intervention or control site. Data will be collected on referrals, receipt of resources, and child outcomes from the child's electronic medical record (EMR) from birth to age 3. Focus groups will be used to gather implementation data from intervention health center personnel.
The WE CARE 2.0 intervention consists of: 1) WE CARE surveys which parents complete prior to their child's well-child visits; 2) information technology (IT) generated provider referrals which providers use to provide families with resource information sheets; 3) peer patient navigators who assist families in connecting to available resources and updating providers; and 4) training sessions for providers and office staff.
Families attending the control health centers will receive standard of care. Of note, since the health centers share a common EMR and for ethical reasons, control sites will have access to the IT generated referral mechanism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention-WE CARE | Experimental | Behavioral: WE CARE survey, Behavioral: WE CARE Community Resource Handout, Behavioral: Patient Navigator1. The WE CARE survey is used to identify unmet material needs; it will be administered with patient's developmental screening forms at all health supervision visits from birth to two years of age. 2. Providers will be trained to review the WE CARE survey at health supervision visits and generate our WE CARE community resource handouts (referrals) through the EMR. 3. A peer patient navigator will offer personalized guidance to families with accessing community resources. The patient navigator will be available for at least a 1/2 day per week at each intervention health center to meet with families and offer guidance. Providers can communicate the patient navigator to refer families via the electronic medical record and families will also have the opportunity to contact the peer navigator at any time via the hotline number listed on the referral information sheets. |
| Control-Standard of Care | No intervention | –Participants in the delayed-intervention control group will receive standard pediatric care. However, since the health centers share a common EMR, and for ethical reasons, investigators will also embed the health IT referral mechanism into the EMR at the control sites. Control providers will be made aware of this prior to the start of the study. Although this may potentially reduce the effect size, the investigator's prior study found that the impact on referral rates of provider access to resource information was minimal. Families at control health centers will not receive the WE CARE surveys at health supervision visits and will not have access to the peer patient navigators |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Child is on Medicaid insurance
- Is attending routine newborn visit
Key exclusion criteria (4 listed)
- Premature (less than or equal to 32 weeks GA)
- Has a chronic disease
- Has Neonatal Abstinence Syndrome
- Has a foster parent
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 CARE surveyThe WE CARE survey, consists of 14 questions used to identify seven unmet material needs (education, employment, food security, housing, childcare, household heat, language). The survey will be administered with patient's developmental screening forms at all health supervision visits from birth to two years of age. The office staff will instruct parents to give the WE CARE survey, along with the developmental screening tool, to their child's provider at the visit. | Behavioural | Intervention-WE CARE |
| WE CARE Community Resource HandoutAlso: Resource ReferralProviders will be trained to review the WE CARE survey at health supervision visits and generate referrals thru the EMR. Specifically, they will receive a one-hour teaching session one week prior to the study implementation. The goals for the session will include providing an overview of pediatric practice guidelines, introducing the WE CARE survey, reviewing the referral process, and discussing the role of peer patient navigators. Study staff will conduct periodic booster sessions; study staff will also train new providers should there be staff turnover | Behavioural | Intervention-WE CARE |
| Patient NavigatorThe peer patient navigator will offer guidance to families with accessing community resources. They will be available at least .5 days per week at intervention health centers to meet with families and offer guidance as well as be available via a hotline number. The navigator will speak with families and offer guidance on community resources and offer assistance with completing applications. In addition, they will offer to schedule and, if desired, accompany parents to the agencies. Interpreter services will be utilized at the health centers in case the navigator does not speak the parent's language. The navigator will also place an update note in the EMR within 1-month post-visit and one week after any contact with families. | Behavioural | Intervention-WE CARE |
Primary outcome
Health care utilization
Time frame: Throughout child's enrollment in study (0 years through 3 years of age)
Investigators will measure whether child is up to date with well child visits between 0-3 years of age. Investigators will measure whether child is up to date on their immunizations between 0-3 years of age. Investigators will measure if and how many times child has been hospitalized or had a visit to the emergency department (ED) between 0-3 years of age.
8 secondary outcomes
Child maltreatment
Time frame: Throughout child's enrollment in study (0 years through 3 years of age)
Developmental delay
Time frame: Throughout child's enrollment in study (0 years through 3 years of age)
Obesity
Time frame: Measured at 2-year, 30-month, and 3-year well child care visits (as recommended by the American Academy of Pediatrics)
Asthma
Time frame: Throughout child's enrollment in study (0 years through 3 years of age)
Blood pressure
Time frame: Measured at 3-year well child care visits
Provider referrals
Time frame: Throughout child's enrollment in study (0 years through 3 years of age)
Family receipt of community based resource
Time frame: Throughout child's enrollment in study (0 years through 3 years of age)
Focus group data gathered by audio recordings then transcribed and coded
Time frame: During 1st month pilot phase and again after investigators have enrolled our the cohort, approximately 3 years after the first focus groups and the study initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: No
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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
Boston University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WE CARE survey, WE CARE Community Resource Handout and Patient Navigator in people with Asthma and Obesity, run by Boston Medical Center at 6 sites 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 4 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 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Health care utilization (time frame: Throughout child's enrollment in study (0 years through 3 years of age)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2021.