Communication to Improve Shared Decision-Making in ADHD

NCT02716324 | Completed Results

• 1 other identifier: 15-012456
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to explore whether using an online patient portal plus a Care Manager is more effective than using an online portal alone in managing care for children with ADHD. Doctors at The Children's Hospital of Philadelphia currently use the online patient portal to help gather information from parents and teachers on ADHD symptoms, treatment, and medication side effects. The Care Manager is a person who meets with participants during the study to discuss their child's ADHD care. The Care Manager communicates with the child's doctor and teacher to communicate a parent's goals and preferences for their child's ADHD care.

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

Attention-Deficit/Hyperactivity Disorder; Shared-Decision Making; Care Manager; Children; Parents; Teachers

Outcome Measures

Primary Outcomes (1)

• Change in Vanderbilt Parent Rating Scales (VPRS)

  The VPRS is a public domain tool that consists of forms completed by the child's parent and includes 18 items corresponding to the DSM-5 ADHD symptom criteria, 8 performance items, and 12 items assessing side effects. The VPRS items are scaled on a 4-point Likert rating ("never" to "very often"), and the scales used in this study were restricted to the 18 ADHD symptom items. Total scores were used to measure ADHD Symptoms. Higher scores indicated worse outcome. VPRS were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. The VPRS measures ADHD symptoms and is scaled on a 4-point Likert rating ("never" to "very often"). The scale includes 18 ADHD symptom items with total scores ranges from 0-54.

  Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)

Secondary Outcomes (9)

• Mean Goal Attainment Scale (GAS) Score by Timepoint

  Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)

• Treatment Initiation and Use of Services

  9-12 months (Visit 4)

• Treatment Adherence and Use of Services

  9-12 months (Visit 4)

• School Performance

  Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)

• Student Engagement

  Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)

Study Arms (2)

ADHD Portal

ACTIVE COMPARATOR

In this arm, the ADHD Portal was used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents.

Other: ADHD Portal

ADHD Portal plus Care Manager (CM)

EXPERIMENTAL

In this arm, the ADHD Portal was combined with the CM. Clinicians, teachers, and parents used the ADHD Portal as standard of care. In addition, clinicians, teachers, parents, and any external mental health providers interacted with a CM, who had access to information contained in the ADHD Portal.

Behavioral: Care Manager CM); Other: ADHD Portal

Interventions

Care Manager CM) BEHAVIORAL

The CM was an individual responsible for communicating and coordinating ADHD care. The CM established rapport with families and communicated with them every 3 months or more frequently if needed to assess treatment use, identify new concerns, and help problem-solve. The CM also communicated with the patient's ADHD care team (pediatrician, teacher, mental health providers) to clarify family goals, communicate information, and coordinate treatment.

ADHD Portal plus Care Manager (CM)

ADHD Portal OTHER

The ADHD portal was a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment were measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents were encouraged to consult with their children when completing the tool.

ADHD Portal; ADHD Portal plus Care Manager (CM)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 5 through12 years old
• Receiving Attention-Deficit/Hyperactivity Disorder (ADHD) treatment from participating practices
• ADHD or Attention Deficit Disorder (ADD) diagnosis code, International Classification of Diseases (ICD) code ICD-10-CM F90.9 or F90.0, listed in the problem list or recorded at an ambulatory visit in the past year.
• Parental/guardian permission (informed consent) and if appropriate, child assent.

You may not qualify if:

• Autism spectrum disorder, ICD-10-CM F84.0
• Conduct disorder, ICD-10-CM F91.1
• Psychosis, ICD-10-CM F29
• Bipolar disorder, ICD-10-CM F31.9
• Suicide attempt, ICD-10-CM T14.91, or suicide ideation, ICD-10-CM R45.85
• Children and/or their parents/caregivers non-English speaking

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (6)

• Guevara JP, Rothbard A, Shera D, Zhao H, Forrest CB, Kelleher K, Schwarz D. Correlates of behavioral care management strategies used by primary care pediatric providers. Ambul Pediatr. 2007 Mar-Apr;7(2):160-6. doi: 10.1016/j.ambp.2006.12.006.

  PMID: 17368411 BACKGROUND

• Forrest CB, Glade GB, Baker AE, Bocian AB, Kang M, Starfield B. The pediatric primary-specialty care interface: how pediatricians refer children and adolescents to specialty care. Arch Pediatr Adolesc Med. 1999 Jul;153(7):705-14. doi: 10.1001/archpedi.153.7.705.

  PMID: 10401803 BACKGROUND

• Homonoff EE, Maltz PF. Developing and maintaining a coordinated system of community-based services to children. Community Ment Health J. 1991 Oct;27(5):347-58. doi: 10.1007/BF00752385.

  PMID: 1934995 BACKGROUND

• Guevara JP, Feudtner C, Romer D, Power T, Eiraldi R, Nihtianova S, Rosales A, Ohene-Frempong J, Schwarz DF. Fragmented care for inner-city minority children with attention-deficit/hyperactivity disorder. Pediatrics. 2005 Oct;116(4):e512-7. doi: 10.1542/peds.2005-0243.

  PMID: 16199679 BACKGROUND

• Wolraich ML, Bickman L, Lambert EW, Simmons T, Doffing MA. Intervening to improve communication between parents, teachers, and primary care providers of children with ADHD or at high risk for ADHD. J Atten Disord. 2005 Aug;9(1):354-68. doi: 10.1177/1087054705278834.

  PMID: 16371681 BACKGROUND

• Guevara JP, Power TJ, Bevans K, Snitzer L, Leavy S, Stewart D, Broomfield C, Shah S, Grundmeier R, Michel JJ, Berkowitz S, Blum NJ, Bryan M, Griffis H, Fiks AG. Improving Care Management in Attention-Deficit/Hyperactivity Disorder: An RCT. Pediatrics. 2021 Aug;148(2):e2020031518. doi: 10.1542/peds.2020-031518. Epub 2021 Jul 19.

  PMID: 34281997 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Case Managers

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Limitations and Caveats

Study was conducted within a single integrated health care system in the Philadelphia metropolitan area and results may not be generalizable to other health systems or geographic areas.

Results Point of Contact

• Title: James Guevara, MD MPH
• Organization: The Children's Hospital of Philadelphia

guevara@email.chop.edu

2155901130

Study Officials

• James Guevara, MD MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 23, 2016
• Study Start: March 10, 2016
• Primary Completion: May 9, 2018
• Study Completion: October 14, 2018
• Last Updated: November 25, 2019
• Results First Posted: September 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: July 14, 2020
• Access Criteria: Contact PI

Locations

US (1)