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| Name | Class |
|---|---|
| Ochsner Health System | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist Drug Therapy Management | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist Drug Therapy Management | Other | Patients will be seen by pharmacist for collaborative drug therapy management. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Appointment adherence | Proportion of appointments attended | 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. |
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Inclusion criteria:
The same inclusion criteria will apply to control patients except that:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Health Center for Children | West Monroe | Louisiana | 71292 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23543372 | Background | 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. | |
| 27933188 | 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. |
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De-identified IPD will be available to researchers within the University of Louisiana Monroe based on IRB review and approval.
Upon completion of study.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Before-after comparison of intervention to traditional care
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| 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. | Through study completion, an average of 1 year. |
| Costs to patients | Includes direct medical, direct nonmedical, indirect costs | Through study completion, an average of 1 year. |
| Costs to communities | Includes healthcare resource utilization, lost productivity | Through study completion, an average of 1 year. |
| Cost to healthcare systems and payors | Through study completion, an average of 1 year. |
| 29354549 | 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. |
| 27605321 | 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. |
| 28775188 | 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. |
| 29527973 | 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. |
| 27873322 | 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. |
| 21768583 | 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. |
| 28827377 | 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. |
| 18559702 | 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. |
| 29192011 | 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. |
| 23821088 | 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. |
| 28483010 | 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. |