Clinical Trials Logo

Clinical Trial Summary

The investigators will interview patients and providers of patients who have hypertension and are seen in cardiology clinic about ways to discuss therapeutic drug monitoring with patients. The investigators will use these interviews to crease discussion tools to discuss therapeutic drug monitoring. The investigators will then draw one venous blood sample in a different group of patients who are seen in interventional clinic for 1 month followup after PCI. The investigators will assay this blood for therapeutic drug monitoring and will provide the results to their providers for discussion at their regularly scheduled followup cardiology visit. The investigators will have the patients and providers fill out a survey afterwards to determine how they viewed therapeutic drug monitoring.


Clinical Trial Description

The investigators will begin by conducting interviews with patients who have uncontrolled hypertension, defined as SBP>130 or DBP>80 mmHg despite treatment with > 2 antihypertensive drugs, from the Primary Care internal Medicine (PCiM) clinic and the cardiology clinic in the Parkland Health and Hospital System (Parkland). after obtaining informed consent for participation, we will explain therapeutic drug monitoring (TDM) as one method for accurately assessing the amount of prescribed antihypertensive medication in a patient's system and how that can be helpful to their physicians to effectively treat them. in these interviews, the investigators will assess reasons why patients may be nonadherent, why they may be reluctant to acknowledge this to their provider, explore how TDM could contradict patient self-report about adherence, how this contradiction could affect the patient-provider relationship, and how TDM could be used in a way that is acceptable to patients that enhances both the patient-provider relationship and improves patient health outcomes. The investigators anticipate conducting 10 interviews, after completing the patient interviews, the investigators will use what we have learned to guide the cognitive interviews with the hypertension clinicians. Provider participants will be recruited among physicians and nurses working in the PCiM and cardiology clinics at Parkland. The investigators will explore their responses to patient concerns, explore concerns about discussing and using TDM, especially how they might communicate the results of TDM testing that contradict patient self-reported medication adherence. After completing both patient and provider interviews, the investigators will create a TDM intervention discussion tool for providers to use and pilot this tool with a small group of TDM intervention pilot participants. This is an outline of the steps but the investigators will submit the surveys and discussion tools to the IRB for evaluation once they are developed. This will be done by a separate modification after the initial approval of the study once we have conducted the initial interviews. This group of participants will not be the same as the ones who were interviewed earlier. The discussion tool will include guidance to providers about explaining TDM and how it's useful for measuring adherence as well as prompts for addressing concerns patients identified in our interviews with them. The investigators will conduct this pilot intervention with 20 patients recruited from the PCiM and cardiology clinics who are being seen for their first follow-up visit post hospitalization, usually one month after discharge. Patients will be consented to participate in this TDM intervention, which will include measuring blood pressure, obtaining blood specimens for TDM, and eliciting patient self-report about medication adherence. Patients will be given their test results when they return for their next visit, usually 1-2 months later. although the blood assays for drug levels are not certified by CLIA nor approved by the FDA, the investigators are not using drug level information to change dosing or titrate the medications the patient are taking. During this second visit, the provider will then review the patient's TDM results and use the TDM discussion tool to guide conversation about discrepancies and potential barriers to adherence. The investigators will assess patients' reactions to and satisfaction with the discussion about TDM and its implications, and measure their blood pressure. Participants' reactions will be assessed by a survey tool.

The investigators will also assess perspectives about the patient's response to TDM and the effectiveness of using the TDM intervention discussion tool for facilitating the conversation with the patient. There are commercial assays that are FDA approved for used already. although the investigators do not use those assays, the Vanderbilt assays have been validated and published (though not approved by FDA). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03667781
Study type Observational
Source University of Texas Southwestern Medical Center
Contact Shishir Sharma
Phone (214) 633-5555
Email shishir.sharma@phhs.org
Status Recruiting
Phase
Start date October 2018
Completion date June 2019

See also
  Status Clinical Trial Phase
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Recruiting NCT03397524 - Tailored Drug Titration Through Artificial Intelligence N/A
Recruiting NCT03632668 - Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072 Phase 1
Recruiting NCT02699645 - Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Phase 3
Recruiting NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Enrolling by invitation NCT03660631 - Dissemination of the Cardiovascular Risk Service N/A
Recruiting NCT02796313 - Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities N/A
Recruiting NCT03266510 - Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function N/A
Completed NCT00508365 - Evaluation of Potential for Orthostatic Hypotension in Elderly Hypertensives Phase 1
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Not yet recruiting NCT03678207 - The Effectiveness of a Preoperative Blood Pressure Screening Program to Identify Undiagnosed Hypertension in Ambulatory Surgery Patients
Recruiting NCT03249753 - The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects Phase 1
Completed NCT03100812 - Asian American Partnerships in Research and Empowerment (AsPIRE) N/A
Recruiting NCT03288142 - The Smart Hypertension Control Study N/A
Recruiting NCT03099343 - Tailored Messaging to Reduce Sodium Intake N/A
Completed NCT02147626 - Heart Health 4 Moms N/A
Not yet recruiting NCT03661177 - Reclaiming Indigenous Food and Health N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Safety and Efficacy of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Withdrawn NCT03292393 - Social Norms and Antihypertensive Medication Adherence N/A
Not yet recruiting NCT01620788 - Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment Phase 3