- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01428011
Patient-Provider Communication and Medication Adherence (MEDCHAT)
October 16, 2017 updated by: NYU Langone Health
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
114
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Bellevue Hospital Ambulatory Care Practive
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients will be recruited from Primary Care Clinics in New York City
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unable to give informed consent
- Refuse to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
No treatment
African American/Black and Caucasian/White patients with hypertension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient-provider communication
Time Frame: Baseline
|
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).
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Antoinette Schoenthaler, EdD, NYU School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2014
Primary Completion (Actual)
April 22, 2015
Study Completion (Actual)
April 22, 2015
Study Registration Dates
First Submitted
August 31, 2011
First Submitted That Met QC Criteria
September 1, 2011
First Posted (Estimate)
September 2, 2011
Study Record Updates
Last Update Posted (Actual)
October 18, 2017
Last Update Submitted That Met QC Criteria
October 16, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-00311
- 1K23HL098564-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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