Implementation of Electronic Shared Decision-Making Support for Early Intervention

NCT04562038 | Completed DMC

• 2 other identifiers: 2020-0555AOTFIR20KHETANI
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Family-centered care is a best practice approach to delivering high quality early intervention (EI) services for children 0-3 years old with developmental needs. Yet, family engagement in designing and monitoring their child's EI service plan is suboptimal. Families need a valid, reliable, and useful tool to share in decisions about the scope of their child's EI service plan. The investigators will achieve a major advance in contributing occupational therapy expertise to improve family engagement when designing and monitoring their child's EI services. The investigators will test the use of an evidence-based electronic tool with families at one EI program, when the child is due for an annual review of progress in the program. The investigators will also gather input from families, practitioners, and program leadership to identify facilitators and barriers to its use in multiple EI programs. This project tries to test an innovation in how the investigators deliver family-centered and participation-focused care. Study results will yield evidence for the effectiveness of the electronic intervention on parent activation, EI service plan focus, EI service use quantity, parent perceptions of EI service quality, and child functioning.

Conditions

Child Development Disorder; Development Delay

Keywords

early intervention; participation; shared decision-making; electronic; family-centered care

Outcome Measures

Primary Outcomes (4)

• Measure of Processes of Care (MPOC-20)

  Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.

  Baseline (pre-intervention)

• Measure of Processes of Care (MPOC-20)

  Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.

  4 weeks

• Measure of Processes of Care (MPOC-20)

  Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.

  6 months

• Measure of Processes of Care (MPOC-20)

  Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.

  12 months

Secondary Outcomes (13)

• Parent Patient Activation Measure (P-PAM)

  Baseline (pre-intervention)

• Parent Patient Activation Measure (P-PAM)

  4 weeks

• Parent Patient Activation Measure (P-PAM)

  6 months

• Parent Patient Activation Measure (P-PAM)

  12 months

• Parent Participation Engagement measure (PPEM)

  Baseline (pre-intervention)

Study Arms (2)

YC-PEM e-PRO

EXPERIMENTAL

Participants are administered an electronic patient-reported outcome measure to obtain information about parent priorities, and they obtain a summary report of their responses to share with their early intervention team for discussion during the annual IFSP meeting.

Behavioral: Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)

Family Assessment

NO INTERVENTION

Participants are scheduled to complete a semi-structured family interview to obtain information about parent priorities, for use during the annual IFSP meeting

Interventions

Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO) BEHAVIORAL

The Young Children's Participation in Environment Measure (YC-PEM) is an evidence-based option for comprehensive proxy assessment of a young child's current and desired participation in occupations across home, daycare, and community settings. The YC-PEM is an electronic patient-reported outcome (e-PRO) that provides individual caregivers a valid, reliable, and feasible way to communicate information about their child's current participation in home and community activities and areas of participation need. The gained information is then summarized and shared with the child's EI provide team to identify intervention priorities and goal attainment strategies in partnership with families. For quality improvement, EI programs can aggregate the YC-PEM e-PRO data to examine trends in participation as a function of EI service use. It is therefore a promising electronic health systems intervention to enhance the parent-practitioner relationship, and an NIH common data element for trials.

YC-PEM e-PRO

Eligibility Criteria

• Age: 3 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Caregiver identifies as a parent or legal guardian of a child enrolled in early intervention
• Caregiver is at least 18 years old
• Caregiver reads, writes, and speaks English
• Caregiver has internet and telephone access
• Caregiver has a child who has received early intervention services for 3 or more months

You may not qualify if:

• Caregiver is not the parent or legal guardian of a child enrolled in early intervention
• Caregiver is 0-17 years old
• Caregiver does not read, write, or speak English
• Caregiver does not have internet or telephone access
• Caregiver does not have a child who has received early intervention services for 3 or more months

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Rocky Mountain Human Services: collaborator
• University of Colorado, Denver: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Rocky Mountain Human Services

Denver, Colorado, 80231, United States

Location

Related Publications (1)

• Kaelin V, Villegas V, Chen YF, Murphy N, Papautsky E, Litfin J, Leland N, Maheshwari V, McManus B, Khetani M; High Value Early Intervention Research Group. Effectiveness and scalability of an electronic patient-reported outcome measure and decision support tool for family-centred and participation-focused early intervention: PROSPECT hybrid type 1 trial protocol. BMJ Open. 2022 Jan 4;12(1):e051582. doi: 10.1136/bmjopen-2021-051582.

  PMID: 34983760 DERIVED

MeSH Terms

Conditions

Developmental Disabilities; Learning Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary A Khetani

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: September 24, 2020
• Study Start: October 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 30, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)