Clinical trial NCT03700697: A Clinical Process Support System for Primary Care to Address Family Stress
Official title: A Clinical Process Support System for Primary Care to Address Family Stress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Determinants of Health
Child Abuse
Lead sponsor: Total Child Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Center for Promotion of Child Development through Primary Care
name: Foresight Logic
First posted: 2018-10-09
Enrollment: 16630
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster randomized quality improvement intervention trial
Primary purpose: PREVENTION

Brief summary: This project is to create and test a "clinical process support system" that will improve the ability of primary child health care providers (PCPs) to screen for and address family stressors during routine child health visits that are associated with negative child outcomes in a manner that is feasible and acceptable to both clinicians and parents.

Detailed description: This project is to create and test a "clinical process support system" that will improve the ability of primary child health care providers (PCPs) to screen for and address family stressors during routine child health visits that are associated with negative child outcomes in a manner that is feasible and acceptable to both clinicians and parents. The family stressors assessed include: intimate partner violence (IPV), parental depression, parental stress, food insecurity, parental substance use and harsh punishment of the child. The system is designed to overcome known obstacles to addressing these issues during routine well child visits. These obstacles include: lack of PCP training in an evidence-based approach to the interview (e.g., motivational interviewing); lack of time; low parental expectations for addressing sensitive family issues during routine child "physicals"; and the usual absence of co-located mental health providers. The new Family Stress module will build on two foundations: 1) previous studies of screening using the Safe Environment for Every Kid (SEEK) tool, which showed reduced child maltreatment outcomes in two Randomized Control Trials; and 2) an existing online screening and decision support system (CHADIS). The goals are to support parents in reducing family risk and the exposure of the young child to their own Adverse Childhood Experiences (ACE), including child maltreatment.

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.

Eligibility criteria: Inclusion Criteria:

* Parents and their children 1 month to 4 months at enrollment.
* Parents and their children 16-20 months for comparison group.
* Primary Care Providers of any age.

Exclusion Criteria:

-Unable to speak and read English.

Primary outcomes:
measure: Compare intervention vs control percent parents for receiving help for Family Stressors
timeFrame: first 2 years of life
measure: Compare intervention vs control percent parents in rates of child maltreatment
timeFrame: first 2 years of life
measure: Compare intervention vs control percent parents in rates of harsh punishment
timeFrame: first 2 years of life
measure: Compare intervention vs control parents in percent reporting child behavior problems
timeFrame: first 2 years of life
measure: Compare intervention vs control percent parents for rate of atypical child development.
timeFrame: first 2 years of life
Secondary outcomes:
measure: Compare parent rating of physician competence and confidence handling family stressors between intervention and control groups
timeFrame: 12 months of child's age (Parent)
measure: Change in physician competence and confidence handling family stressors
timeFrame: 2 years from first measure (PCP)
measure: Compare intervention vs control group rates of missed well child visits
timeFrame: at 2 years of age
measure: Compare intervention vs control group rates of missed recommended immunizations
timeFrame: at 2 years of age
measure: Compare intervention vs control group parent-child relationship
timeFrame: 18 months of age
measure: Compare intervention vs control group parent-child relationship
timeFrame: 24 months of age
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Total Child Health
state: Maryland
Study officials:
affiliation: Total Child Health
name: Barbara Howard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ctr for Promotion of Child Dev. through Primary Care
name: Raymond Sturner, MD
role: PRINCIPAL_INVESTIGATOR
References: