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HypertensionMEDCHATNCT01428011

Patient-Provider Communication and Medication Adherence

An observational study of Hypertension, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT01428011
Study groupRoleWhat they receive
No treatmentAfrican 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.

  1. 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)
  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.

  1. First posted2 Sep 2011 (estimated)
  2. Study start1 Mar 2014
  3. Primary completion22 Apr 2015
  4. Study completion22 Apr 2015

Resources

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)
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

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.

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