A Clinical Process Support System for Primary Care to Address Family Stress
NCT ID: NCT03700697
Last Updated: 2020-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
16630 participants
INTERVENTIONAL
2018-07-09
2021-08-31
Brief Summary
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Detailed Description
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The innovations in this method of addressing family stressors and overcoming the above obstacles include:
1. Time efficiencies. Time is saved through pre-visit online data collection, saving both interview and clinical documentation time and staff time saved for patient education and needed referrals.
2. Creating the environment for psychosocial care. This is done through a combination of pre-visit questionnaires with agenda broadening questions (best and hardest parts of parenting), inclusion of parental background from Adverse Childhood Experiences (ACE) and Positive Childhood Experiences inquiries in clinical discussions; individualized text and resources for the family in the Care Portal; milestones to "celebrate" in each child's "MemoryBook"; and empathetic and reflective responses from the PCP.
3. Efficient training. Training is done using innovative "moment of care" teleprompters created instantly in response to the individual parent issues from the pre-visit tools to support the difficult conversations and a motivational interview begun by the computer needed to move families towards services.
4. Care communication. Practices will be able to share data with their own colocated services or be linked electronically with outside local resources using a unique online "consent to share information" functionality that also facilitates determining if the referral appointment was completed. Visit notes and documentation of attendance at a consultation will be shared with consent between the PCP and referral agency or professional to facilitate two-way communication for coordinated care.
Design: A cluster randomized quality improvement intervention using the clinical process support family stress module in routine care for children 0-3 years will be conducted in 30 primary care practices. The project will enroll as many 0-4 month olds as possible and follow them to age 24 months and a cohort of 18-24 month olds as controls using online consent (not requiring staff time). For this 2.5 year project the study staff will ask physicians and office staff to complete a one hour online training, offices to notify parents to complete CHADIS when scheduling well-child visits for children 0-3 years old with the questionnaire assignments for the project including Family Assessment of Safety and Stress (FASS), and primary care clinicians to use the CHADIS Family Stress module including the care coordination functionality during the visits when that site is randomized to the intervention period. At the end of the project the study requires clinicians to complete a survey and provide information from the medical records for participating children about immunization completion and missed visits. This information can be collected in a variety of ways depending on each electronic record.
Outcomes: The outcomes anticipated for the proposed study include improved parent connection to services and parent-child relationships, and reduced family stressors, child behavior problems, harsh punishment, and Child Protection referrals for abuse and neglect. Expected outcomes include that higher parent satisfaction with the enhanced clinical process will result in lower rates of missed visits and delayed immunizations. These results should provide evidence of the effectiveness of PCP screening and referral to reduce family stressors and the evidence needed for full United States Preventive Services Task Force endorsement of this clinical process support tool for reducing child maltreatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Family Stress Module Intervention
Primary care clinicians will use the CHADIS Family Stress Module including the reviewing ACE, Positive Childhood Experiences, and FASS Plus questionnaires at designated child ages; address family stressors revealed using the motivational interviewing teleprompter and refer parents with stressors as indicated using the care coordination functionality.
Family Stress Module Intervention
as above
Controls
Control primary care providers will provide care as usual.
No interventions assigned to this group
Interventions
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Family Stress Module Intervention
as above
Eligibility Criteria
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Inclusion Criteria
* Parents and their children 16-20 months for comparison group.
* Primary Care Providers of any age.
Exclusion Criteria
1 Month
2 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Center for Promotion of Child Development through Primary Care
UNKNOWN
Foresight Logic
OTHER
Total Child Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara Howard, MD
Role: PRINCIPAL_INVESTIGATOR
Total Child Health
Raymond Sturner, MD
Role: PRINCIPAL_INVESTIGATOR
Ctr for Promotion of Child Dev. through Primary Care
Locations
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Total Child Health
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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