Preventive Health ServicesNCT02262962
Well-Child Care Redesign: A New Model of Care for Children in Low-Income Families
A study testing Redesigned Well-Child Care in people with Preventive Health Services and Health Promotion, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this research is to design and test a new model for delivery of well-child care (WCC) for children ages 0-3 years in a sample of low-income parents. The investigators used an innovative expert panel and community advisory board process to develop this new model for the delivery of WCC to low-income… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preventive Health Services, Health Promotion
- What is being tested?
- Redesigned Well-Child Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jan 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent or guardian of an infant who is 12 months of age or younger
- Speaks English or Spanish
- Is 18 years of age or older
Who cannot join
- Has plans to move out of Los Angeles county within the next 12 months
- Has plans to change the primary care location for the index child within the next 12 months.
- Parent or guardian is an employee of one of the primary care clinics that are part of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Children's Discovery and Innovation Institute
Los Angeles, California, 90024
About this study
The purpose of this research is to design and test a new model for delivery of well-child care (WCC) for children ages 0-3 years in a sample of low-income parents. The investigators used an innovative expert panel and community advisory board process to develop this new model for the delivery of WCC to low-income families in partnership with our partner community pediatric practices. The new model of care utilizes a trained health educator, or "Parent Coach" at every well-visit from 0-3 years of age. The Parent Coach provides a range of services, including health education and guidance, developmental screening, and psychosocial screening and services. The Parent Coach works with the Primary Care Physician to ensure that the family's needs are met for that well-visit. As a part of this new model for well-child care, the parent also uses a web-based tool to help prioritize needs for the visit and complete any necessary pre-visit screening. Parents receive additional education and guidance from a text message service and have access to the Parent Coach outside of the visit.
The randomized controlled trial (RCT) of this new model of care will include 250 families who will be enrolled at participating clinics if the child is under 1 year of age. Parents will receive the intervention for 12 months and will complete surveys to collect data on their experiences of care. Our hypothesis is that this new model of care will be more patient-centered and more effective in providing recommended preventive care services than usual care, and that it will be a sustainable and feasible model for the partner practices.
Read the detailed description
During Phase 1, we used an innovative expert panel and community advisory board process to develop a new structural model for delivery of well-child care (WCC) to low-income families. The new model of care was developed using a WCC Framework that considered alternative structure for care: non-physician providers (nurses, lay health educators, social workers), non-traditional formats (group visits, internet, phone), and non-clinical locations (daycare centers, home visits, grocery stores) for each of six major WCC visits (physical exam, immunizations/laboratory screening, behavioral/developmental services, anticipatory guidance, psychosocial screenings, and sick visits/after-hours care), as well as a feasible mechanism for provider reimbursement. The model that was developed was a Team-Based Care, Parent Coach Model for WCC.
Recruitment of study participants carried on for approximately six months. We posted flyers in two Los Angeles pediatric clinics. The flyers instructed parents to contact the study investigators by phone or email, or alternatively speak with the office receptionist, if interested in participating. A bilingual (English and Spanish) research associate (RA) was available 2-3 days per week in each clinic site to answer questions that interested parents may have had; that person was also available by phone and email 5 days a week to respond to requests for information. A parent who saw a flyer in the clinic on the day of their visit could have approached the clinic receptionist, expressed an interest in the study, and then directed to either speak with the RA in a private room at the clinic. Additionally, when parents arrived for a visit for a child in the age range specified for the study, they were handed a 1-page flyer regarding the study during check-in at the receptionist's desk. The flyers instructed parents to call, email, or speak in person privately with the study RA if they were interested in participating or needed more information.
Eligible parents were informed of their intervention assignment and were asked for contact information and to complete a 10 minute survey. All parents were informed that they would be contacted 6-months and 12-months post-enrollment to complete two additional surveys. Parents in the intervention group were informed that they may be randomly selected to participate in an additional component to provide study staff with additional information regarding the health services that the parent received during the 12 months that he/she was enrolled in the study.
During enrollment the parents in the intervention group were informed of the additional services available to them. Parents were able to enroll in a text messaging program which provides parents with age-tailored health information through texts. The texts are available in English and Spanish. They contain information such as: car seat safety, dental care for baby and reminders to schedule child's physicals. The second service available to parents is a web-based parent tool called the Well Visit Planner (WVP) tool. The tool gives parents the opportunity to customize their child's upcoming routine physical. The WVP also gives the parents an opportunity to learn about developmental milestones that their child should be meeting. Lastly, parents are given the opportunity to choose priorities to discuss with the physician and the Parent Coach. The data from the pre-visit tool is automatically uploaded to the electronic health record, where red flags indicate areas of further need.
The Parent Coach is also available to intervention patients at the two participating clinics. The Parent Coach is a trained child bilingual health education specialist that will be available at each clinic at least two days a week and over the phone at least one day a week. She is available to help parents schedule appointments and review flagged items on the Well Visit Planner tool. The Parent Coach addresses psychosocial, developmental and behavioral concerns that parents may have. She is also gives parents tips on how parents can help their baby grow and develop. In addition, she is trained to check if the baby is developing normally and if there is reason for concern she will bring it to the attention of the pediatrician at clinic and help parents with referrals for further testing.
Enrollment into the RCT began in June 2013 and ran through December 2013. We enrolled 251 patients over two clinical sites. Half of the participants at each clinic were placed in the control group (n= 125) and the other half in the intervention group (n=126). Research associates are available over the phone and in person at to complete parents follow- up surveys. The 12 month post enrollment surveys are schedule to be completed in December 2014.
- Conditions
- Preventive Health Services, Health Promotion
- Being tested
- Redesigned Well-Child Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redesigned Well-Child CareOther
The Well-Child Visits will be enhanced using a newly-designed model of care. Parents will have access to Parent Coach during child's routine well visits, Well Baby Help Line, Well-Visit Planner, and HealthyTxt Messaging service.
| Study group | Role | What they receive |
|---|---|---|
| Usual Well-Child Care | No intervention | No change in Well-Child Visits. |
| Redesigned Well-Child Care | Experimental | The Redesigned Well-Child Visits will be enhanced using a newly-designed model of care. Parents will have access to Parent Coach during child's routine well visits, Well Baby Help Line, Well-Visit Planner, and text messaging services (HealthyTxt). Receives: Other: Redesigned Well-Child Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of Recommended Preventive Care Services
This is a composite measure
Measured: At 12 months post enrollment
Secondary outcomes (1)
Receipt of Recommended Preventive Care Services
This is a composite measure
Measured: At 6 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJun 2005
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preventive Health ServicesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Tumaini R Coker, University of California, Los Angeles
- Investigators
- Tumaini Coker, MD/MBA, Principal investigator, UCLA Department of General Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262962
- Sponsor's protocol ID
- 1R40MC21516
- Other IDs
- K23HD062677, R40MC21516
- Status last verified
- Jun 2016
- First submitted
- 3 Oct 2014
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16.
PubMed 24936004Coker TR, Chacon S, Elliott MN, Bruno Y, Chavis T, Biely C, Bethell CD, Contreras S, Mimila NA, Mercado J, Chung PJ. A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20153013. doi: 10.1542/peds.2015-3013. Epub 2016 Feb 10.
PubMed 26908675
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well-Child Care Redesign: A New Model of Care for Children in Low-Income Families
- ClinicalTrials.gov ID
- NCT02262962
- Acronym / sponsor ID
- 1R40MC21516
- Conditions
- Preventive Health Services, Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2005
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Oct 2014 (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.
The purpose of this research is to design and test a new model for delivery of well-child care (WCC) for children ages 0-3 years in a sample of low-income parents. The investigators used an innovative expert panel and community advisory board process to develop this new model for the delivery of WCC to low-income families in partnership with our partner community pediatric practices. The new model of care utilizes a trained health educator, or "Parent Coach" at every well-visit from 0-3 years of age. The Parent Coach provides a range of services, including health education and guidance, developmental screening, and psychosocial screening and services. The Parent Coach works with the Primary Care Physician to ensure that the family's needs are met for that well-visit. As a part of this new model for well-child care, the parent also uses a web-based tool to help prioritize needs for the visit and complete any necessary pre-visit screening. Parents receive additional education and guidance from a text message service and have access to the Parent Coach outside of the visit.
The randomized controlled trial (RCT) of this new model of care will include 250 families who will be enrolled at participating clinics if the child is under 1 year of age. Parents will receive the intervention for 12 months and will complete surveys to collect data on their experiences of care. Our hypothesis is that this new model of care will be more patient-centered and more effective in providing recommended preventive care services than usual care, and that it will be a sustainable and feasible model for the partner practices.
Detailed description
During Phase 1, we used an innovative expert panel and community advisory board process to develop a new structural model for delivery of well-child care (WCC) to low-income families. The new model of care was developed using a WCC Framework that considered alternative structure for care: non-physician providers (nurses, lay health educators, social workers), non-traditional formats (group visits, internet, phone), and non-clinical locations (daycare centers, home visits, grocery stores) for each of six major WCC visits (physical exam, immunizations/laboratory screening, behavioral/developmental services, anticipatory guidance, psychosocial screenings, and sick visits/after-hours care), as well as a feasible mechanism for provider reimbursement. The model that was developed was a Team-Based Care, Parent Coach Model for WCC.
Recruitment of study participants carried on for approximately six months. We posted flyers in two Los Angeles pediatric clinics. The flyers instructed parents to contact the study investigators by phone or email, or alternatively speak with the office receptionist, if interested in participating. A bilingual (English and Spanish) research associate (RA) was available 2-3 days per week in each clinic site to answer questions that interested parents may have had; that person was also available by phone and email 5 days a week to respond to requests for information. A parent who saw a flyer in the clinic on the day of their visit could have approached the clinic receptionist, expressed an interest in the study, and then directed to either speak with the RA in a private room at the clinic. Additionally, when parents arrived for a visit for a child in the age range specified for the study, they were handed a 1-page flyer regarding the study during check-in at the receptionist's desk. The flyers instructed parents to call, email, or speak in person privately with the study RA if they were interested in participating or needed more information.
Eligible parents were informed of their intervention assignment and were asked for contact information and to complete a 10 minute survey. All parents were informed that they would be contacted 6-months and 12-months post-enrollment to complete two additional surveys. Parents in the intervention group were informed that they may be randomly selected to participate in an additional component to provide study staff with additional information regarding the health services that the parent received during the 12 months that he/she was enrolled in the study.
During enrollment the parents in the intervention group were informed of the additional services available to them. Parents were able to enroll in a text messaging program which provides parents with age-tailored health information through texts. The texts are available in English and Spanish. They contain information such as: car seat safety, dental care for baby and reminders to schedule child's physicals. The second service available to parents is a web-based parent tool called the Well Visit Planner (WVP) tool. The tool gives parents the opportunity to customize their child's upcoming routine physical. The WVP also gives the parents an opportunity to learn about developmental milestones that their child should be meeting. Lastly, parents are given the opportunity to choose priorities to discuss with the physician and the Parent Coach. The data from the pre-visit tool is automatically uploaded to the electronic health record, where red flags indicate areas of further need.
The Parent Coach is also available to intervention patients at the two participating clinics. The Parent Coach is a trained child bilingual health education specialist that will be available at each clinic at least two days a week and over the phone at least one day a week. She is available to help parents schedule appointments and review flagged items on the Well Visit Planner tool. The Parent Coach addresses psychosocial, developmental and behavioral concerns that parents may have. She is also gives parents tips on how parents can help their baby grow and develop. In addition, she is trained to check if the baby is developing normally and if there is reason for concern she will bring it to the attention of the pediatrician at clinic and help parents with referrals for further testing.
Enrollment into the RCT began in June 2013 and ran through December 2013. We enrolled 251 patients over two clinical sites. Half of the participants at each clinic were placed in the control group (n= 125) and the other half in the intervention group (n=126). Research associates are available over the phone and in person at to complete parents follow- up surveys. The 12 month post enrollment surveys are schedule to be completed in December 2014.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Well-Child Care | No intervention | –No change in Well-Child Visits. |
| Redesigned Well-Child Care | Experimental | Other: Redesigned Well-Child CareThe Redesigned Well-Child Visits will be enhanced using a newly-designed model of care. Parents will have access to Parent Coach during child's routine well visits, Well Baby Help Line, Well-Visit Planner, and text messaging services (HealthyTxt). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent or guardian of an infant who is 12 months of age or younger
- Speaks English or Spanish
- Is 18 years of age or older
Key exclusion criteria (3 listed)
- Has plans to move out of Los Angeles county within the next 12 months
- Has plans to change the primary care location for the index child within the next 12 months.
- Parent or guardian is an employee of one of the primary care clinics that are part of the study.
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 |
|---|---|---|
| Redesigned Well-Child CareThe Well-Child Visits will be enhanced using a newly-designed model of care. Parents will have access to Parent Coach during child's routine well visits, Well Baby Help Line, Well-Visit Planner, and HealthyTxt Messaging service. | Other | Redesigned Well-Child Care |
Primary outcome
Receipt of Recommended Preventive Care Services
Time frame: At 12 months post enrollment
This is a composite measure
1 secondary outcome
Receipt of Recommended Preventive Care Services
Time frame: At 6 months post enrollment
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 22 Jun 2016.
- Background: PubMed 24936004Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16.
- Derived from this study: PubMed 26908675Coker TR, Chacon S, Elliott MN, Bruno Y, Chavis T, Biely C, Bethell CD, Contreras S, Mimila NA, Mercado J, Chung PJ. A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20153013. doi: 10.1542/peds.2015-3013. Epub 2016 Feb 10.
- 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.
Tumaini Coker, MD/MBA principal investigator
UCLA Department of General Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Redesigned Well-Child Care in people with Preventive Health Services and Health Promotion, run by University of California, Los Angeles 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 3 inclusion and 3 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 22 Jun 2016. 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?
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?
Receipt of Recommended Preventive Care Services (time frame: At 12 months post enrollment). 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 NCT02262962, 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 22 Jun 2016.