Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests

Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Attention-deficit Hyperactivity
• Intervention / Treatment: Other: Pharmacist Care; Other: Primary Care Physician Care

Detailed Description

Importance. Enhancing the management of messages from patients and providing high-quality, consistent care are top priorities for The Permanente Medical Group (TPMG) and Kaiser Foundation Hospitals/Health Plan (KFH/P). A special extension of the Ryan Haight Act currently enables providers to prescribe controlled substances via telehealth interactions, but expires in December 2024. Information about the quality of care provided via telehealth prescribing of controlled substances by pharmacists and primary care physicians would be helpful to inform care delivery within Kaiser Permanente and beyond.

Objective. To compare pharmacist management of secure message requests for refills of attention deficit hyperactivity disorder (ADHD) medications with primary care physician management regarding quality of care, efficiency of service, and parent satisfaction.

Design, setting, and participants. This cluster randomized clinical trial will include parents of children in Kaiser Permanente Northern California who request ADHD medication refills via secure messages from April 29 to June 28, 2024. Of KPNC's 63 facilities eligible for inclusion, we will assign 32 to Pharmacist Care and 31 to PCP Care.

Intervention. In the intervention group, a regional team of pharmacists will manage ADHD medication refill requests made via secure message using a standard protocol. In the comparison group, primary care physicians (pediatricians and family medicine physicians) will manage these visits using a similar protocol.

Main Outcomes and Measures. The primary outcome is whether a patient who did not have a weight recorded in the 6 months before the refill request was referred for a primary care follow-up visit. Secondary outcomes are the days from the secure message request to the prescription order and medication fill, and parent satisfaction.

Potential Results. We will test the hypotheses that Pharmacist Care compared with PCP Care will have higher quality of care, faster time to prescriptions and fills, and higher patient satisfaction.

Potential Conclusions and Relevance. If pharmacist care for ADHD medication refill requests has better or similar outcomes compared with PCP care, this will provide evidence supporting continuation of this approach. This study's findings will be useful for KPNC and to inform discussions about renewing the special extension of the Ryan Haight Act that allows this approach.

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Northern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist Care; Pharmacists will provide ADHD medication refill orders in response to secure message requests by parents, under the authorization of appropriate physicians.	Other: Pharmacist Care; Pharmacists will provide ADHD medication refill orders in response to secure message requests by parents, under the authorization of appropriate physicians.
Active Comparator: Primary Care Physician Care; Primary care pediatricians will provide ADHD medication refill orders in response to secure message requests by parents.	Other: Primary Care Physician Care; Primary care pediatricians will provide ADHD medication refill orders in response to secure message requests by parents. This is usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeliness of care	Days between the refill request and the refill order, among patients eligible for a refill	within 14 days after the refill request
Parent perception of effectiveness of care	Parent or caregiver perception of effectiveness of care given by the provider responding to the secure message request, as measured by a 5-point LIkert scale using Excellent, Very Good, Good, Fair, and Poor response options	within 3 weeks after the refill request

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Tracy A Lieu, Kaiser Permanente Northern California Division of Research

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Actual): June 21, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: RDO KPNC 24-056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No