NCT06388694

Brief Summary

This cluster randomized trial will compare pharmacist management of secure message requests for refills of attention deficit hyperactivity medications with primary care physician management regarding quality of care, timeliness of service, and parent care experience.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

April 22, 2024

Last Update Submit

August 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants appropriately referred for a follow-up weight check

    Percentage of participants referred for a follow-up visit for a weight check, among those who had not had a weight check in the 6 months prior to the medication refill request

    within 7 days after the refill request

Secondary Outcomes (2)

  • Timeliness of care

    within 14 days after the refill request

  • Parent perception of effectiveness of care

    within 3 weeks after the refill request

Study Arms (2)

Pharmacist Care

EXPERIMENTAL

Pharmacists will provide ADHD medication refill orders in response to secure message requests by parents, under the authorization of appropriate physicians.

Other: Pharmacist Care

Primary Care Physician Care

ACTIVE COMPARATOR

Primary care pediatricians will provide ADHD medication refill orders in response to secure message requests by parents.

Other: Primary Care Physician Care

Interventions

Pharmacists will provide ADHD medication refill orders in response to secure message requests by parents, under the authorization of appropriate physicians.

Pharmacist Care

Primary care pediatricians will provide ADHD medication refill orders in response to secure message requests by parents. This is usual care.

Primary Care Physician Care

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parent or caregiver requested an ADHD medication refill via a secure message

You may not qualify if:

  • The ADHD medication refill request was not straightforward and had to be handled by the primary care provider (and thus not eligible for random assignment to Pharmacist Care or PCP Care)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Related Publications (1)

  • Lieu TA, Parry D, deLaunay A, Margaret Warton E, Prausnitz S, Ahmed O, Mancha MR, Smallberg E, Quesenberry C, Lee K, Reed M; Permanente Medical Group Virtual Care Study Team. Pharmacist care for attention-deficit/hyperactivity disorder electronic medication refills: A cluster randomized trial. J Manag Care Spec Pharm. 2025 Nov;31(11):1156-1165. doi: 10.18553/jmcp.2025.31.11.1156.

MeSH Terms

Interventions

Physicians, Primary Care

Intervention Hierarchy (Ancestors)

PhysiciansHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Tracy A Lieu

    Kaiser Permanente Northern California Division of Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 29, 2024

Study Start

May 6, 2024

Primary Completion

June 21, 2024

Study Completion

July 31, 2024

Last Updated

August 30, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations