Race Concordant Patient-provider RelationshipNCT04315402
The Impact of Provider Demographics on Patients' Continuity of Care
An observational study of Race Concordant Patient-provider Relationship and Race Discordant Patient-provider Relationship, run by TriHealth Inc. at 1 site in United States.
Trial summary
The race concordance of providers to their patients impacts a patient's investment and agency in the patient-provider relationship. The mistrust of medicine within the African American population remains and patients feel unengaged in their care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Race Concordant Patient-provider Relationship, Race Discordant Patient-provider Relationship, Rate of No-show at Follow-up Visits
- What is being tested?
- prospective, descriptive study via survey
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to Mar 2021
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients of the Faculty Medical Center seeing OB/GYN residents * Those requiring follow-up (less than 6 months)
Who may be able to join
- Female Patient seeing OB/GYN resident at FMC
- 18 years or older
- <36 weeks pregnant or GYN patient
- If GYN patient, must have problem requiring follow-up within 6 months
- Have not previously completed the survey
Who cannot join
- Less than 18 years of age
- High risk clinic patients (Tuesday afternoons)
- Patients without a follow-up less than 6 months as scheduled at check out
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, 45220
Ganga Devaiah, MS, ganga_devaiah@trihealth.com
About this study
The race concordance of providers to their patients impacts a patient's investment and agency in the patient-provider relationship. The mistrust of medicine within the African American population remains and patients feel unengaged in their care. Race concordant provider-patient rela-tionships would improve the equity of patient care in our clinic.
Read the detailed description
The patients of the obstetrics and gynecology resident clinic at Good Samaritan Hospital have a poor follow-up rate for their gynecologic and prenatal care visits. In addition, patients oftentimes voice frustration over the care that they receive and sometimes remark that they feel their provider was "racist." These patients often have complex social situations that cannot be solved in one office visit but perhaps the providers' ability to gain the trust of the minority patients is inadequate. The residents in the OB/GYN program are 80% white with no African American representation. If patients are unable to connect with caregivers due to cross-cultural differences, this could be remedied by training current residents in cross-cultural communication or re-cruitment of a resident class more representative of the majority African American patient population. This project will provide perspective on the minority patients' needs in the provider-patient relationship and allow providers to reexamine their ability to gain trust with the ultimate goal to increase follow-up rates. Follow-up rates for prenatal care are directly linked to improved maternal and fetal outcomes. The investigators goals are threefold: to gain clarity on whether or not a more diverse resident group would be helpful in gaining the trust of patients, to assess the current state of the well-established historical and generational mistrust of medical care by the African American patients of the clinic, and to explore how patient perception of their provider impacts their rate of follow up in the large community hospital clinic.
- Conditions
- Race Concordant Patient-provider Relationship, Race Discordant Patient-provider Relationship, Rate of No-show at Follow-up Visits
- Being tested
- prospective, descriptive study via survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective, descriptive study via surveyOther
- Survey administered at check out.
- Patient's rate of follow-up data gathered via chart review.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (provider-patient concordant) | Not described Receives: Other: prospective, descriptive study via survey | |
| Group 2 (provider-patient discordant) | Not described Receives: Other: prospective, descriptive study via survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's rate of follow-up
Whether or not patient was present at their next scheduled GYN or OB follow-up appointment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start12 Aug 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Race Concordant Patient-provider RelationshipStudies of the same condition, open and under way.
- 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
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nima Patel, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315402
- Sponsor's protocol ID
- 19-105
- Status last verified
- Oct 2020
- First submitted
- 17 Mar 2020
- Last updated
- 12 Oct 2020
- 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 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Provider Demographics on Patients' Continuity of Care
- ClinicalTrials.gov ID
- NCT04315402
- Acronym / sponsor ID
- 19-105
- Conditions
- Race Concordant Patient-provider Relationship, Race Discordant Patient-provider Relationship, Rate of No-show at Follow-up Visits
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 19 Mar 2020 (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 race concordance of providers to their patients impacts a patient's investment and agency in the patient-provider relationship. The mistrust of medicine within the African American population remains and patients feel unengaged in their care. Race concordant provider-patient rela-tionships would improve the equity of patient care in our clinic.
Detailed description
The patients of the obstetrics and gynecology resident clinic at Good Samaritan Hospital have a poor follow-up rate for their gynecologic and prenatal care visits. In addition, patients oftentimes voice frustration over the care that they receive and sometimes remark that they feel their provider was "racist." These patients often have complex social situations that cannot be solved in one office visit but perhaps the providers' ability to gain the trust of the minority patients is inadequate. The residents in the OB/GYN program are 80% white with no African American representation. If patients are unable to connect with caregivers due to cross-cultural differences, this could be remedied by training current residents in cross-cultural communication or re-cruitment of a resident class more representative of the majority African American patient population. This project will provide perspective on the minority patients' needs in the provider-patient relationship and allow providers to reexamine their ability to gain trust with the ultimate goal to increase follow-up rates. Follow-up rates for prenatal care are directly linked to improved maternal and fetal outcomes. The investigators goals are threefold: to gain clarity on whether or not a more diverse resident group would be helpful in gaining the trust of patients, to assess the current state of the well-established historical and generational mistrust of medical care by the African American patients of the clinic, and to explore how patient perception of their provider impacts their rate of follow up in the large community hospital clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (provider-patient concordant) | – | Other: prospective, descriptive study via survey |
| Group 2 (provider-patient discordant) | – | Other: prospective, descriptive study via survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients of the Faculty Medical Center seeing OB/GYN residents * Those requiring follow-up (less than 6 months)
Key inclusion criteria (5 listed)
- Female Patient seeing OB/GYN resident at FMC
- 18 years or older
- <36 weeks pregnant or GYN patient
- If GYN patient, must have problem requiring follow-up within 6 months
- Have not previously completed the survey
Key exclusion criteria (3 listed)
- Less than 18 years of age
- High risk clinic patients (Tuesday afternoons)
- Patients without a follow-up less than 6 months as scheduled at check out
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 |
|---|---|---|
| prospective, descriptive study via survey* Survey administered at check out. * Patient's rate of follow-up data gathered via chart review. | Other | Group 1 (provider-patient concordant), Group 2 (provider-patient discordant) |
Primary outcome
Patient's rate of follow-up
Time frame: 6 months
Whether or not patient was present at their next scheduled GYN or OB follow-up appointment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Individual participant dataSharing planned: No
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.
Nima Patel, MD principal investigator
TriHealth Inc.
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 Race Concordant Patient-provider Relationship and Race Discordant Patient-provider Relationship, run by TriHealth Inc. 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ganga Devaiah, MS (513-862-2341, ganga_devaiah@trihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's rate of follow-up (time frame: 6 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 12 Oct 2020.