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Completed

NCT Number: NCT06388694

Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests

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.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California

Oakland, California, 94612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pharmacist care

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

Other

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

Primary outcomes

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

    Time frame: within 7 days after the refill request

    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

Secondary outcomes

  1. Timeliness of care

    Time frame: within 14 days after the refill request

    Days between the refill request and the refill order, among patients eligible for a refill

  2. Parent perception of effectiveness of care

    Time frame: within 3 weeks after the refill request

    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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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