HypertensionNCT03667781
Therapeutic Drug Monitoring of Cardiac Medications
An observational study of Hypertension and Coronary Artery Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Coronary Artery Disease
- What is being tested?
- Therapeutic drug monitoring
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 14 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients and providers seen in cardiology clinic for interview component. Patients seen in interventional clinic for their post PCI followup for the blood draw component.
Who may be able to join
- Subjects age ≥ 18 to 80 years with uncontrolled hypertension (average clinic blood pressure of at least 130/80 mmHg despite treatment with 2 or more antihypertensive drugs).
Who cannot join
- Presence of hypertensive emergency BP > 180/110 mmHg plus one of the following features: acute coronary syndrome, acute stroke, hypertensive encephalopathy, aortic dissection, or acute kidney injury,
- History of active substance abuse such as alcohol, cocaine, or narcotics
- Uncontrolled psychiatric disorder such as schizophrenia or major depression
- Pregnancy
- Homeless
- Stage V CKD or end stage renal disease (glomerular filtration rate < 15 ml/min/1.73 m2),
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- Self-report of nonadherence or unwillingness to follow medication regimen prescribed by the primary care physicians for any reasons,
- Presence of white coat hypertension (defined as normal 24-h ambulatory systolic BP or home BP of < 130 and diastolic BP of < 80 mmHg and clinic systolic BP of at least 140 mmHg or diastolic BP of at least 90 mmHg according to the AHA guidelines)
- Inability to read or write English, because participants may not be able to follow all study procedures or complete study questionnaires and surveys correctly which may lead to inaccurate data collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Determine the Feasibility and Patient Acceptance of Therapeutic Drug Monitoring to Improve Medication Adherence
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.
Read the detailed 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).
- Conditions
- Hypertension, Coronary Artery Disease
- Being tested
- Therapeutic drug monitoring
- Medical subject headings
- Hypertension, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic drug monitoringDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients Interviewed | Patients in cardiology clinic with uncontrolled hypertension despite being on 2 medications | |
| Providers Interviewed | 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 Receives: Diagnostic Test: Therapeutic drug monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Assessed by survey
Measured: Followup visit at 1 month from the initial visit
Secondary outcomes (1)
Provider Satisfaction
Assessed by survey
Measured: Followup visit at 1 month from the initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Aug 2018
- Primary completion31 May 2021
- Study completion14 May 2023
Why it stopped: funding has ended and Covid has prevented us to perform followup assessment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanpen Vongpatanasin, University of Texas Southwestern Medical Center
- Investigators
- Wanpen Vongpatanasin, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667781
- Sponsor's protocol ID
- STU 032018-023
- Status last verified
- May 2023
- First submitted
- 4 Sep 2018
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Determine the Feasibility and Patient Acceptance of Therapeutic Drug Monitoring to Improve Medication Adherence
- ClinicalTrials.gov ID
- NCT03667781
- Acronym / sponsor ID
- STU 032018-023
- Conditions
- Hypertension, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: funding has ended and Covid has prevented us to perform followup assessment
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 14 May 2023 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients Interviewed | – | –Patients in cardiology clinic with uncontrolled hypertension despite being on 2 medications |
| Providers Interviewed | – | –Providers in cardiology clinic |
| Patients Blood Draw | – | Diagnostic Test: Therapeutic drug monitoringPatients seen in interventional clinic for post PCI followup will have a venous blood draw which will be sent for therapeutic drug monitoring |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients and providers seen in cardiology clinic for interview component. Patients seen in interventional clinic for their post PCI followup for the blood draw component.
Key inclusion criteria (1 listed)
- Subjects age ≥ 18 to 80 years with uncontrolled hypertension (average clinic blood pressure of at least 130/80 mmHg despite treatment with 2 or more antihypertensive drugs).
Key exclusion criteria (9 listed)
- Presence of hypertensive emergency BP > 180/110 mmHg plus one of the following features: acute coronary syndrome, acute stroke, hypertensive encephalopathy, aortic dissection, or acute kidney injury,
- History of active substance abuse such as alcohol, cocaine, or narcotics
- Uncontrolled psychiatric disorder such as schizophrenia or major depression
- Pregnancy
- Homeless
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic drug monitoringBlood 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. | Diagnostic test | Patients Blood Draw |
Primary outcome
Patient satisfaction
Time frame: Followup visit at 1 month from the initial visit
Assessed by survey
1 secondary outcome
Provider Satisfaction
Time frame: Followup visit at 1 month from the initial visit
Results and safety
The study was stopped early (reason given: funding has ended and Covid has prevented us to perform followup assessment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanpen Vongpatanasin principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Coronary Artery Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: funding has ended and Covid has prevented us to perform followup assessment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: Followup visit at 1 month from the initial visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.