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Patient-Provider Communication and Medication Adherence (MEDCHAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01428011
First received: August 31, 2011
Last updated: March 9, 2016
Last verified: March 2016
  Purpose
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.

Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Racial Differences in Patient-Provider Communication and Medication Adherence

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Medication Adherence [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • patient-provider communication [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 120
Study Start Date: March 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment
African American/Black and Caucasian/White patients with hypertension

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from Primary Care Clinics in New York City
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428011

Locations
United States, New York
Bellevue Hospital Ambulatory Care Practive
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Antoinette Schoenthaler, EdD NYU School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01428011     History of Changes
Other Study ID Numbers: 10-00311  1K23HL098564-01A1 
Study First Received: August 31, 2011
Last Updated: March 9, 2016
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
Hypertension
Patient-Provider Communication
Medication Adherence
Race Concordance

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2016