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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098978
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: University of Louisiana Monroe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 20 Years

Eligibility

Inclusion criteria:

• 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

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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Ochsner Health Center for Children	West Monroe	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisiana Monroe	Ochsner Health System

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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). pii: e20171904. doi: 10.1542/peds.2017-1904. Epub 2017 Aug 21. Erratum in: Pediatrics. 2017 Nov 30;:. Erratum in: Pediatrics. 2018 Sep;142(3):. — View Citation

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). pii: e20173035. doi: 10.1542/peds.2017-3035. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. eCollection 2016. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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:CD011227. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with adequately-controlled hypertension at 3 months.		3 months
Primary	Proportion of patients with adequately-controlled hypertension at 6 months.		6 months
Primary	Proportion of patients with adequately-controlled hypertension at 12 months.		12 months
Primary	Time to adequate control of hypertension.	Defined as the first appointment with controlled hypertension.	Through study completion, an average of 1 year.
Secondary	Appointment adherence	Proportion of appointments attended	Through study completion, an average of 1 year.
Secondary	Number and type of serious adverse drug events	Number of serious adverse drug events in aggregate and subgrouped.	Through study completion, an average of 1 year.
Secondary	Number of unplanned health care encounters related to hypertension	Surrogate for adverse event associated with treatment or disease state.	Through study completion, an average of 1 year.
Secondary	Costs to patients	Includes direct medical, direct nonmedical, indirect costs	Through study completion, an average of 1 year.
Secondary	Costs to communities	Includes healthcare resource utilization, lost productivity	Through study completion, an average of 1 year.
Secondary	Cost to healthcare systems and payors		Through study completion, an average of 1 year.