Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests

NCT ID: NCT06388694

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2024-07-31

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.

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.

Conditions

Attention-deficit Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Pharmacist Care

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

Group Type: EXPERIMENTAL

Pharmacist Care

Intervention Type: OTHER

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

Primary Care Physician Care

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

Group Type: ACTIVE_COMPARATOR

Primary Care Physician Care

Intervention Type: OTHER

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

Interventions

Pharmacist Care

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tracy A Lieu

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Northern California Division of Research

Locations

Kaiser Permanente Northern California

Oakland, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RDO KPNC 24-056

Identifier Type: -

Identifier Source: org_study_id