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

NCT04098978 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Blood Pressure

Keywords

Children; Adolescents; Young Adults; Pediatric Hypertension; Pharmacoeconomics; Pharmacist

Outcome Measures

Primary Outcomes (4)

• Proportion of patients with adequately-controlled hypertension at 3 months.

  3 months

• Proportion of patients with adequately-controlled hypertension at 6 months.

  6 months

• Proportion of patients with adequately-controlled hypertension at 12 months.

  12 months

• Time to adequate control of hypertension.

  Defined as the first appointment with controlled hypertension.

  Through study completion, an average of 1 year.

Secondary Outcomes (6)

• Appointment adherence

  Through study completion, an average of 1 year.

• Number and type of serious adverse drug events

  Through study completion, an average of 1 year.

• Number of unplanned health care encounters related to hypertension

  Through study completion, an average of 1 year.

• Costs to patients

  Through study completion, an average of 1 year.

• Costs to communities

  Through study completion, an average of 1 year.

Study Arms (1)

Pharmacist Drug Therapy Management

EXPERIMENTAL

Other: Pharmacist Drug Therapy Management

Interventions

Pharmacist Drug Therapy Management OTHER

Patients will be seen by pharmacist for collaborative drug therapy management.

Pharmacist Drug Therapy Management

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisiana Monroe: lead
• Ochsner Health System: collaborator

Study Sites (1)

Ochsner Health Center for Children

West Monroe, Louisiana, 71292, United States

Location

Related Publications (13)

• 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.

  PMID: 23543372 BACKGROUND

• 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.

  PMID: 27933188 BACKGROUND

• 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.

  PMID: 29354549 BACKGROUND

• 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.

  PMID: 27605321 BACKGROUND

• 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.

  PMID: 28775188 BACKGROUND

• 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.

  PMID: 29527973 BACKGROUND

• 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.

  PMID: 27873322 BACKGROUND

• 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.

  PMID: 21768583 BACKGROUND

• 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.

  PMID: 28827377 BACKGROUND

• 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.

  PMID: 18559702 BACKGROUND

• 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.

  PMID: 29192011 BACKGROUND

• 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.

  PMID: 23821088 BACKGROUND

• 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.

  PMID: 28483010 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before-after comparison of intervention to traditional care

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 23, 2019
• Study Start: January 14, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon completion of study.

Locations

US (1)