Therapeutic Drug Monitoring of Cardiac Medications
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|ClinicalTrials.gov Identifier: NCT03667781|
Recruitment Status : Suspended (Covid-19)
First Posted : September 12, 2018
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment|
|Hypertension Coronary Artery Disease||Diagnostic Test: Therapeutic drug monitoring|
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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Pilot Study to Determine the Feasibility and Patient Acceptance of Therapeutic Drug Monitoring to Improve Medication Adherence|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Patients in cardiology clinic with uncontrolled hypertension despite being on 2 medications
Providers in cardiology clinic
Patients Blood Draw
Patients seen in interventional clinic for post PCI followup will have a venous blood draw which will be sent for therapeutic drug monitoring
Diagnostic Test: Therapeutic drug monitoring
Blood assay to evaluate for the presence of medications that the patient is prescribed. This is not being used for therapeutic purposes. It has already been validated in prior papers.
- Patient satisfaction [ Time Frame: Followup visit at 1 month from the initial visit ]Assessed by survey
- Provider Satisfaction [ Time Frame: Followup visit at 1 month from the initial visit ]Assessed by survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667781
|United States, Texas|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Wanpen Vongpatanasin||UT Southwestern|