HypertensionMEDCHATNCT01428011
Patient-Provider Communication and Medication Adherence
An observational study of Hypertension, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to understand how communication between African American and white patients with high blood pressure and his/her primary care provider effects whether a patient decides to take their high blood pressure medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 22 Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from Primary Care Clinics in New York City
Who may be able to join
- self-identification as black/African American or white/Caucasian
- Receiving care in the Bellevue Hospital Ambulatory Care Practice from the same primary care provider for at least 3 months;
- Diagnosed with hypertension (ICD: # 401-401.9)
- Taking at least one antihypertensive medication;
- Age18 years or older
- Fluent in English
Who cannot join
- Unable to give informed consent
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Bellevue Hospital Ambulatory Care Practive
New York, New York, 10016
About this study
Official title: Racial Differences in Patient-Provider Communication and Medication Adherence
The purpose of this study is to understand how communication between African American and white patients with high blood pressure and his/her primary care provider effects whether a patient decides to take their high blood pressure medications.
Read the detailed description
High blood pressure contributes to the racial disparities in death rates between minority patients and whites. Understanding the factors underlying racial disparities in high blood pressure-related outcomes is a major focus of Healthy People 2010. Several factors including access to care, patient preferences and lower socioeconomic status have been used to explain the differences seen in timely and effective delivery of preventive care between minority patients and whites. However, when these factors are controlled for, health disparities still exist. Recently, the Institute of Medicine identified interpersonal processes within the patient-provider relationship as a potential reason for the health disparities between minority and white patients. Specifically, providers' communication, including the ability to listen, collaborate, and be empathetic during the medical encounter has emerged as an important dimension of care that differs by race. Despite the increasing evidence that racial differences in patient-provider communication affects patient care, many of these studies have examined issues related to processes of care such as patient satisfaction with little attention to intermediate outcomes such as medication adherence. Further, studies that have used audio-taped analysis to examine racial differences in patient-provider communication are limited by one-dimensional coding systems that lack the ability to capture the mutual influence the patient and provider have on one another during the interaction. Thus, the potential pathways through which patient-provider communication contribute to high blood pressure-related disparities in minority patients compared to whites is not clearly understood. This proposed two-phase, mixed-methods research study, provides a unique opportunity to address these gaps by clarifying the effect of patient's race on patient-provider communication and medication adherence among 120 hypertensive African American and white patients receiving care in primary care practices. Specifically, findings from a qualitative analysis of patient-provider communication (Phase 1) will inform the development of a conceptual model that will be used to quantitatively evaluate the relationship between patient's race, patient-provider communication and medication adherence (Phase 2).
- Conditions
- Hypertension
- Keywords
- Hypertension, Patient-Provider Communication, Medication Adherence, Race Concordance
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | African American/Black and Caucasian/White patients with hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Medication adherence will be assessed as a continuous variable with the Medication Event Monitoring System (MEMS) and calculated as the percent of prescribed doses removed by the patient during the 3-month stud
Measured: 3-months
Secondary outcomes (1)
patient-provider communication
Patient-provider communication will be assessed with the validated Medical Interaction Process System (MIPS). Patient-provider communication will be defined as ratios using formulas derived from the audiotaped analysis. Ratios will be calculated by dividing the sum of all codes for the communication behavior of interest (e.g., provider dominated-talk) by the sum of all codes for the comparison communication behavior of interest (e.g., patient-dominated-talk).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study start1 Mar 2014
- Primary completion22 Apr 2015
- Study completion22 Apr 2015
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 NYU Langone HealthThe 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Antoinette Schoenthaler, EdD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428011
- Sponsor's protocol ID
- 10-00311
- Other IDs
- 1K23HL098564-01A1
- Acronym
- MEDCHAT
- Status last verified
- Oct 2017
- First submitted
- 31 Aug 2011
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Differences in Patient-Provider Communication and Medication Adherence
- ClinicalTrials.gov ID
- NCT01428011
- Acronym / sponsor ID
- MEDCHAT / 10-00311
- Conditions
- Hypertension
- Keywords
- Hypertension, Patient-Provider Communication, Medication Adherence, Race Concordance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 22 Apr 2015 (actual)
- Study completion
- 22 Apr 2015 (actual)
- First posted
- 2 Sep 2011 (estimated)
- 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 purpose of this study is to understand how communication between African American and white patients with high blood pressure and his/her primary care provider effects whether a patient decides to take their high blood pressure medications.
Detailed description
High blood pressure contributes to the racial disparities in death rates between minority patients and whites. Understanding the factors underlying racial disparities in high blood pressure-related outcomes is a major focus of Healthy People 2010. Several factors including access to care, patient preferences and lower socioeconomic status have been used to explain the differences seen in timely and effective delivery of preventive care between minority patients and whites. However, when these factors are controlled for, health disparities still exist. Recently, the Institute of Medicine identified interpersonal processes within the patient-provider relationship as a potential reason for the health disparities between minority and white patients. Specifically, providers' communication, including the ability to listen, collaborate, and be empathetic during the medical encounter has emerged as an important dimension of care that differs by race. Despite the increasing evidence that racial differences in patient-provider communication affects patient care, many of these studies have examined issues related to processes of care such as patient satisfaction with little attention to intermediate outcomes such as medication adherence. Further, studies that have used audio-taped analysis to examine racial differences in patient-provider communication are limited by one-dimensional coding systems that lack the ability to capture the mutual influence the patient and provider have on one another during the interaction. Thus, the potential pathways through which patient-provider communication contribute to high blood pressure-related disparities in minority patients compared to whites is not clearly understood. This proposed two-phase, mixed-methods research study, provides a unique opportunity to address these gaps by clarifying the effect of patient's race on patient-provider communication and medication adherence among 120 hypertensive African American and white patients receiving care in primary care practices. Specifically, findings from a qualitative analysis of patient-provider communication (Phase 1) will inform the development of a conceptual model that will be used to quantitatively evaluate the relationship between patient's race, patient-provider communication and medication adherence (Phase 2).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | –African American/Black and Caucasian/White patients with hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from Primary Care Clinics in New York City
Key inclusion criteria (6 listed)
- self-identification as black/African American or white/Caucasian
- Receiving care in the Bellevue Hospital Ambulatory Care Practice from the same primary care provider for at least 3 months;
- Diagnosed with hypertension (ICD: # 401-401.9)
- Taking at least one antihypertensive medication;
- Age18 years or older
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medication Adherence
Time frame: 3-months
Medication adherence will be assessed as a continuous variable with the Medication Event Monitoring System (MEMS) and calculated as the percent of prescribed doses removed by the patient during the 3-month stud
1 secondary outcome
patient-provider communication
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
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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.
Antoinette Schoenthaler, EdD principal investigator
NYU School of Medicine
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, run by NYU Langone Health 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 18 Oct 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medication Adherence (time frame: 3-months). 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 18 Oct 2017.