HypertensionNCT04098978

Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension

A study testing Pharmacist Drug Therapy Management in people with Hypertension and Blood Pressure, run by University of Louisiana Monroe at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 4 to 20 years
Conditions the study is for: Hypertension, Blood Pressure
What is being tested?: Pharmacist Drug Therapy Management
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 266 participants
Where: 1 siteUnited States
Study dates: 14 Jan 2020to 31 Dec 2021
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 4 to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Diagnosis of elevated blood pressure or hypertension.
Physician decision to treat with drug therapy or lifestyle modifications and physician referral to pharmacist.
Consent both to therapy with pharmacist and participation in study (Note: in the state of Louisiana, patients must provide consent to be treated in a collaborative drug therapy management program).
For patients younger than 18, informed assent and parental permission to participate in the study. For patients who turn 18 during the study, informed consent will be obtained on the first visit after they turn 18.
Males and females; age 4-20 at enrollment
Willingness to adhere to study regimen

Show all 9Show fewer

The same inclusion criteria will apply to control patients except that:
They will have been treated at the clinic for hypertension or elevated blood pressure during the control period.
A waiver of consent has been obtained for historical data.

Who cannot join

Physical preclusion to taking blood pressure, such as lack of limbs or any congenital or acquired anatomical defect preventing routine measurement of blood pressure
Participation in another treatment or intervention study for hypertension during the study period
Inability to speak English
For patients under 18 years old, not having at least one parent or guardian able to speak English
Patients who are pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

Ochsner Health Center for Children
West Monroe, Louisiana, 71292

Other trials in United States

About this study

This study will measure the effect of a novel pharmacy practice model on pediatric patients with hypertension. In North Louisiana, many patients have to travel to see subspecialists for treatment for hypertension and elevated blood pressure, which has many costs including direct medical costs, direct nonmedical costs, and indirect costs like missed time from work, school, or social obligations. Also, many patients who have to travel to get to their appointments have a high rate of missed appointments, which can be bad for overall health.

This study will use a pharmacist to perform collaborative drug therapy management with pediatric cardiologists to manage therapy for patients with hypertension or elevated blood pressure. Patients will monitor blood pressure at home and follow up with the pharmacist by telecommunications. Pharmacist drug therapy management and telemedicine have been studied separately, but this is the first study with pharmacist drug therapy management by telemedicine for pediatric patients. If this model is successful, it could be replicated in other rural areas to improve patient care and reduce healthcare costs.

Conditions: Hypertension, Blood Pressure
Being tested: Pharmacist Drug Therapy Management
Keywords: Children, Adolescents, Young Adults, Pediatric Hypertension, Pharmacoeconomics, Pharmacist
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pharmacist Drug Therapy ManagementOther
Patients will be seen by pharmacist for collaborative drug therapy management.

Study groups in NCT04098978
Study group	Role	What they receive
Pharmacist Drug Therapy Management	Experimental	Not described Receives: Other: Pharmacist Drug Therapy Management

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients with adequately-controlled hypertension at 3 months.
Measured: 3 months
Proportion of patients with adequately-controlled hypertension at 6 months.
Measured: 6 months
Proportion of patients with adequately-controlled hypertension at 12 months.
Measured: 12 months
Time to adequate control of hypertension.
Defined as the first appointment with controlled hypertension.
Measured: Through study completion, an average of 1 year.

Secondary outcomes (6)

Appointment adherence
Proportion of appointments attended
Measured: Through study completion, an average of 1 year.
Number and type of serious adverse drug events
Number of serious adverse drug events in aggregate and subgrouped.
Measured: Through study completion, an average of 1 year.
Number of unplanned health care encounters related to hypertension
Surrogate for adverse event associated with treatment or disease state.
Measured: Through study completion, an average of 1 year.
Costs to patients
Includes direct medical, direct nonmedical, indirect costs
Measured: Through study completion, an average of 1 year.
Costs to communities
Includes healthcare resource utilization, lost productivity
Measured: Through study completion, an average of 1 year.
Cost to healthcare systems and payors
Measured: Through study completion, an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 202031 Dec 2021

First posted23 Sep 2019
Study start14 Jan 2020
Primary completion31 Dec 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Single group
Model description: Before-after comparison of intervention to traditional care
Masking: None (open label)
Enrolment: 266 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04098978
Sponsor's protocol ID: 1
Status last verified: Jun 2022
First submitted: 18 Sep 2019
Last updated: 6 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified IPD will be available to researchers within the University of Louisiana Monroe based on IRB review and approval.

Publications

Syed ST, Gerber BS, Sharp LK. Traveling towards disease: transportation barriers to health care access. J Community Health. 2013 Oct;38(5):976-93. doi: 10.1007/s10900-013-9681-1.
PubMed 23543372
Stumetz KS, Yi-Frazier JP, Mitrovich C, Briggs Early K. Quality of care in rural youth with type 1 diabetes: a cross-sectional pilot assessment. BMJ Open Diabetes Res Care. 2016 Nov 24;4(1):e000300. doi: 10.1136/bmjdrc-2016-000300. eCollection 2016.
PubMed 27933188
Dalton K, Byrne S. Role of the pharmacist in reducing healthcare costs: current insights. Integr Pharm Res Pract. 2017 Jan 25;6:37-46. doi: 10.2147/IPRP.S108047. eCollection 2017.
PubMed 29354549
Hawes EM, Misita C, Burkhart JI, McKnight L, Deyo ZM, Lee RA, Howard C, Eckel SF. Prescribing pharmacists in the ambulatory care setting: Experience at the University of North Carolina Medical Center. Am J Health Syst Pharm. 2016 Sep 15;73(18):1425-33. doi: 10.2146/ajhp150771.
PubMed 27605321
Kruse CS, Krowski N, Rodriguez B, Tran L, Vela J, Brooks M. Telehealth and patient satisfaction: a systematic review and narrative analysis. BMJ Open. 2017 Aug 3;7(8):e016242. doi: 10.1136/bmjopen-2017-016242.
PubMed 28775188
Victor RG, Lynch K, Li N, Blyler C, Muhammad E, Handler J, Brettler J, Rashid M, Hsu B, Foxx-Drew D, Moy N, Reid AE, Elashoff RM. A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops. N Engl J Med. 2018 Apr 5;378(14):1291-1301. doi: 10.1056/NEJMoa1717250. Epub 2018 Mar 12.
PubMed 29527973
Weeks G, George J, Maclure K, Stewart D. Non-medical prescribing versus medical prescribing for acute and chronic disease management in primary and secondary care. Cochrane Database Syst Rev. 2016 Nov 22;11(11):CD011227. doi: 10.1002/14651858.CD011227.pub2.
PubMed 27873322
Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011 Jul 19;155(2):97-107. doi: 10.7326/0003-4819-155-2-201107190-00005.
PubMed 21768583
Flynn JT, Kaelber DC, Baker-Smith CM, Blowey D, Carroll AE, Daniels SR, de Ferranti SD, Dionne JM, Falkner B, Flinn SK, Gidding SS, Goodwin C, Leu MG, Powers ME, Rea C, Samuels J, Simasek M, Thaker VV, Urbina EM; SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017 Sep;140(3):e20171904. doi: 10.1542/peds.2017-1904. Epub 2017 Aug 21.
PubMed 28827377
Chen X, Wang Y. Tracking of blood pressure from childhood to adulthood: a systematic review and meta-regression analysis. Circulation. 2008 Jun 24;117(25):3171-80. doi: 10.1161/CIRCULATIONAHA.107.730366. Epub 2008 Jun 16.
PubMed 18559702
Flynn JT, Kaelber DC, Baker-Smith CM, et al; SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017; 140(3):e20171904. Pediatrics. 2017 Dec;140(6):e20173035. doi: 10.1542/peds.2017-3035. No abstract available.
PubMed 29192011
Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549.
PubMed 23821088
Twigg G, Motsko J, Thomas J, David T. Pharmacist-Managed Diabetes Center Interventions Ensure Quality and Safety in Elderly Patients. Consult Pharm. 2017 May 1;32(5):299-310. doi: 10.4140/TCP.n.2017.299.
PubMed 28483010

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension
ClinicalTrials.gov ID: NCT04098978
Acronym / sponsor ID: 1
Conditions: Hypertension, Blood Pressure
Keywords: Children, Adolescents, Young Adults, Pediatric Hypertension, Pharmacoeconomics, Pharmacist
Study type: Interventional
Recruitment status: Completed
Enrolment: 266 participants (actual)
Lead sponsor: University of Louisiana MonroeUniversity, hospital or other
Collaborators: Ochsner Health System
Study start: 14 Jan 2020 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 23 Sep 2019 (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.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Before-after comparison of intervention to traditional care

Arm	Type	Receives
Pharmacist Drug Therapy Management	Experimental	Other: Pharmacist Drug Therapy Management

Who may qualify

Ages: 4 to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

Diagnosis of elevated blood pressure or hypertension.
Physician decision to treat with drug therapy or lifestyle modifications and physician referral to pharmacist.
Consent both to therapy with pharmacist and participation in study (Note: in the state of Louisiana, patients must provide consent to be treated in a collaborative drug therapy management program).
For patients younger than 18, informed assent and parental permission to participate in the study. For patients who turn 18 during the study, informed consent will be obtained on the first visit after they turn 18.
Males and females; age 4-20 at enrollment

Key exclusion criteria (5 listed)

Physical preclusion to taking blood pressure, such as lack of limbs or any congenital or acquired anatomical defect preventing routine measurement of blood pressure
Participation in another treatment or intervention study for hypertension during the study period
Inability to speak English
For patients under 18 years old, not having at least one parent or guardian able to speak English
Patients who are pregnant

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 Drug Therapy ManagementPatients will be seen by pharmacist for collaborative drug therapy management.	Other	Pharmacist Drug Therapy Management

Primary outcome

Proportion of patients with adequately-controlled hypertension at 3 months.
Time frame: 3 months
Proportion of patients with adequately-controlled hypertension at 6 months.
Time frame: 6 months
Proportion of patients with adequately-controlled hypertension at 12 months.
Time frame: 12 months
Time to adequate control of hypertension.
Time frame: Through study completion, an average of 1 year.
Defined as the first appointment with controlled hypertension.

6 secondary outcomes

Appointment adherence
Time frame: Through study completion, an average of 1 year.
Number and type of serious adverse drug events
Time frame: Through study completion, an average of 1 year.
Number of unplanned health care encounters related to hypertension
Time frame: Through study completion, an average of 1 year.
Costs to patients
Time frame: Through study completion, an average of 1 year.
Costs to communities
Time frame: Through study completion, an average of 1 year.
Cost to healthcare systems and payors
Time frame: Through study completion, an average of 1 year.

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 6 Jun 2022.
Background: PubMed 23543372Syed ST, Gerber BS, Sharp LK. Traveling towards disease: transportation barriers to health care access. J Community Health. 2013 Oct;38(5):976-93. doi: 10.1007/s10900-013-9681-1.
Background: PubMed 27933188Stumetz KS, Yi-Frazier JP, Mitrovich C, Briggs Early K. Quality of care in rural youth with type 1 diabetes: a cross-sectional pilot assessment. BMJ Open Diabetes Res Care. 2016 Nov 24;4(1):e000300. doi: 10.1136/bmjdrc-2016-000300. eCollection 2016.
Background: PubMed 29354549Dalton K, Byrne S. Role of the pharmacist in reducing healthcare costs: current insights. Integr Pharm Res Pract. 2017 Jan 25;6:37-46. doi: 10.2147/IPRP.S108047. eCollection 2017.
Background: PubMed 27605321Hawes EM, Misita C, Burkhart JI, McKnight L, Deyo ZM, Lee RA, Howard C, Eckel SF. Prescribing pharmacists in the ambulatory care setting: Experience at the University of North Carolina Medical Center. Am J Health Syst Pharm. 2016 Sep 15;73(18):1425-33. doi: 10.2146/ajhp150771.
Background: PubMed 28775188Kruse CS, Krowski N, Rodriguez B, Tran L, Vela J, Brooks M. Telehealth and patient satisfaction: a systematic review and narrative analysis. BMJ Open. 2017 Aug 3;7(8):e016242. doi: 10.1136/bmjopen-2017-016242.
Background: PubMed 29527973Victor RG, Lynch K, Li N, Blyler C, Muhammad E, Handler J, Brettler J, Rashid M, Hsu B, Foxx-Drew D, Moy N, Reid AE, Elashoff RM. A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops. N Engl J Med. 2018 Apr 5;378(14):1291-1301. doi: 10.1056/NEJMoa1717250. Epub 2018 Mar 12.
Background: PubMed 27873322Weeks G, George J, Maclure K, Stewart D. Non-medical prescribing versus medical prescribing for acute and chronic disease management in primary and secondary care. Cochrane Database Syst Rev. 2016 Nov 22;11(11):CD011227. doi: 10.1002/14651858.CD011227.pub2.
Background: PubMed 21768583Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011 Jul 19;155(2):97-107. doi: 10.7326/0003-4819-155-2-201107190-00005.
Background: PubMed 28827377Flynn JT, Kaelber DC, Baker-Smith CM, Blowey D, Carroll AE, Daniels SR, de Ferranti SD, Dionne JM, Falkner B, Flinn SK, Gidding SS, Goodwin C, Leu MG, Powers ME, Rea C, Samuels J, Simasek M, Thaker VV, Urbina EM; SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017 Sep;140(3):e20171904. doi: 10.1542/peds.2017-1904. Epub 2017 Aug 21.
Background: PubMed 18559702Chen X, Wang Y. Tracking of blood pressure from childhood to adulthood: a systematic review and meta-regression analysis. Circulation. 2008 Jun 24;117(25):3171-80. doi: 10.1161/CIRCULATIONAHA.107.730366. Epub 2008 Jun 16.
Background: PubMed 29192011Flynn JT, Kaelber DC, Baker-Smith CM, et al; SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017; 140(3):e20171904. Pediatrics. 2017 Dec;140(6):e20173035. doi: 10.1542/peds.2017-3035. No abstract available.
Background: PubMed 23821088Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549.
Individual participant dataSharing planned: Yes. De-identified IPD will be available to researchers within the University of Louisiana Monroe based on IRB review and approval.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Drug Therapy Management in people with Hypertension and Blood Pressure, run by University of Louisiana Monroe 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 9 inclusion and 5 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 6 Jun 2022. 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?

Proportion of patients with adequately-controlled hypertension at 3 months. (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT04098978, which also lists 13 linked publications.

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 6 Jun 2022.