Attention-deficit HyperactivityNCT06388694
Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests
A study testing Pharmacist Care and Primary Care Physician Care in people with Attention-deficit Hyperactivity, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Attention-deficit Hyperactivity
- What is being tested?
- Pharmacist Care and Primary Care Physician Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2024to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent or caregiver requested an ADHD medication refill via a secure message
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California
Oakland, California, 94612
About this study
Official title: 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.
Read the 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
- Being tested
- Pharmacist Care, Primary Care Physician Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist CareOther
Pharmacists will provide ADHD medication refill orders in response to secure message requests by parents, under the authorization of appropriate physicians.
Primary Care Physician CareOther
Primary care pediatricians will provide ADHD medication refill orders in response to secure message requests by parents. This is usual care.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Care | Experimental | Pharmacists will provide ADHD medication refill orders in response to secure message requests by parents, under the authorization of appropriate physicians. Receives: 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. Receives: Other: Primary Care Physician Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 7 days after the refill request
Secondary outcomes (2)
Timeliness of care
Days between the refill request and the refill order, among patients eligible for a refill
Measured: 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
Measured: within 3 weeks after the refill request
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start6 May 2024
- Primary completion21 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention-deficit HyperactivityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy A Lieu, Principal investigator, Kaiser Permanente Northern California Division of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388694
- Sponsor's protocol ID
- RDO KPNC 24-056
- Status last verified
- Aug 2024
- First submitted
- 22 Apr 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41171067
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06388694
- Acronym / sponsor ID
- RDO KPNC 24-056
- Conditions
- Attention-deficit Hyperactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Care | Experimental | Other: Pharmacist CarePharmacists will provide ADHD medication refill orders in response to secure message requests by parents, under the authorization of appropriate physicians. |
| Primary Care Physician Care | Active comparator | Other: Primary Care Physician CarePrimary care pediatricians will provide ADHD medication refill orders in response to secure message requests by parents. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parent or caregiver requested an ADHD medication refill via a secure message
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist CarePharmacists 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 CarePrimary care pediatricians will provide ADHD medication refill orders in response to secure message requests by parents. This is usual care. | Other | Primary Care Physician Care |
Primary outcome
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
2 secondary outcomes
Timeliness of care
Time frame: within 14 days after the refill request
Parent perception of effectiveness of care
Time frame: within 3 weeks after the refill request
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Derived from this study: PubMed 41171067Lieu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy A Lieu principal investigator
Kaiser Permanente Northern California Division of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist Care and Primary Care Physician Care in people with Attention-deficit Hyperactivity, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants appropriately referred for a follow-up weight check (time frame: within 7 days after the refill request). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06388694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.