Attention-deficit Hyperactivity
Conditions
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.
Interventions
OTHERPharmacist Care
Pharmacists will provide ADHD medication refill orders in response to secure message requests by parents, under the authorization of appropriate physicians.
OTHERPrimary Care Physician Care
Primary care pediatricians will provide ADHD medication refill orders in response to secure message requests by parents. This is usual care.
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants appropriately referred for a follow-up weight check | 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
| Measure | Time frame | Description |
|---|---|---|
| Timeliness of care | within 14 days after the refill request | Days between the refill request and the refill order, among patients eligible for a refill |
| Parent perception of effectiveness of care | 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 |
Countries
United States
Outcome results
None listed