Communication to Improve Shared Decision-Making in ADHD

NCT ID: NCT02716324

Last Updated: 2019-11-25

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-10

Study Completion Date

2018-10-14

Brief Summary

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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.

Detailed Description

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Fragmentation in health care and poor communication across systems adversely impact engagement and adherence to treatment by children with ADHD and their families. Fragmentation of services for ADHD impairs communication and collaboration between families and primary care providers, mental health providers, and educators, and leads to suboptimal outcomes for children. Prior studies have documented that little communication and coordination exist among providers across different systems despite calls for better system integration.

Fragmentation in communication between providers has the potential to impair shared decision-making. To promote shared decision-making, we developed an electronic health record (EHR)-linked portal to collect information from parents, teachers and clinicians on children's ADHD symptoms and treatment-related preferences and goals. This has become standard of care at our institution. We also developed and pilot tested a ADHD Care Manager intervention which will be employed in this comparative effectiveness study.

303 participants were recruited from 11 primary care pediatric practices. Participants were randomly assigned to either the EHR portal alone, or the EHR portal plus a Care Manager. For those assigned to the EHR portal plus Care Manager, the Care Manager met with families at the beginning of the study to confirm their treatment preferences and goals, provide additional education on ADHD treatment, and distribute handouts on common concerns among ADHD patients and families. The Care Manager contacted families every 3 months or more frequently if needed by phone, email, or in-person to assess treatment use, identify new concerns, and assist families with problem-solving. The Care Manager also communicated with primary care clinicians, mental health providers, and teachers to clarify family treatment preferences and goals and address emerging treatment issues. Participants completed surveys that assessed ADHD symptoms, goal attainment, patient-reported outcomes, patient and family engagement, and treatment initiation and adherence.

Conditions

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Attention-Deficit/Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ADHD Portal

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.

Group Type ACTIVE_COMPARATOR

ADHD Portal

Intervention Type 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 plus Care Manager (CM)

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.

Group Type EXPERIMENTAL

Care Manager CM)

Intervention Type 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

Intervention Type 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.

Interventions

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Care Manager CM)

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.

Intervention Type BEHAVIORAL

ADHD Portal

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Guevara, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17368411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10401803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1934995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16199679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16371681 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34281997 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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15-012456

Identifier Type: -

Identifier Source: org_study_id

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