Perception of Skin of Color Clinics in African AmericansNCT02375659
Black Patients' Lived Experiences and Perceptions of Skin of Color Clinics
An observational study of Perception of Skin of Color Clinics in African Americans, run by Northwestern University at 1 site in United States.
Trial summary
Across the U.S. Skin of Color (SOC) clinics have been established with the goal of providing medical care and supporting research related to patients with skin of color. There have been no formal studies evaluating why patients seek medical care at SOC clinics or treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perception of Skin of Color Clinics in African Americans
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Sep 2017
- 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: African American patients evaluated at the Northwestern Center for Ethnic Skin
Who may be able to join
- Evaluated in the Northwestern Center for Ethnic Skin between February 1, 2015 and February 1, 2016.
- Evaluated by Drs. Stavonnie Patterson or Roopal Kundu
- Age 18 or older
- Self identified as African American/Black
- All subjects must have given signed, informed consent prior to participation in study.
Who cannot join
- English speaking as interpreters not available
- Existing mental health conditions that may interfere with focus group discussion
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Across the U.S. Skin of Color (SOC) clinics have been established with the goal of providing medical care and supporting research related to patients with skin of color. There have been no formal studies evaluating why patients seek medical care at SOC clinics or treatment outcomes. Reasons may include past experiences with other providers, the perception that providers working in these clinics have a special interest or knowledge in caring for patients with skin of color and thus may provide better care, the expectation of cultural sensitivity, the hope that their provider may have a similar ethnic background, and/or ease of communication with their provider. Through focus group discussions we aim to identify the factors influencing a patient's choice to seek medical care at a SOC clinic and to gain insight into the presence and impact of racial concordance between provider and patient. The current study will focus on self-identified African American patients with interest in conducting similar sessions with patients of other ethnicities and races in the future.
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 |
|---|---|---|
| Focus group | Each focus group (4 total) will be approximately 90 minutes in duration. A trained facilitator will pose 8 scripted questions to the focus group participants and manage the conversation, ensuring all participants have an opportunity to respond and steering the conversation to remain on task. A note-taker will also be present at the focus group to document via handwritten notes the flow and content of the focus group conversation. All focus groups will be audio taped and transcribed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common thematic responses of discussion groups
Audiotapes of focus group discussions will be transcribed, and the transcripts will be analyzed via a 'long-hand' inductive approach by two dermatologists and one psychologist. For each of the 8 posed focus group questions, the reviewers will independently induce a common thematic response. Collectively, they will then compare their independently derived themes, identifying themes of agreement and disagreement. Areas of disagreement will be further reviewed until a mutually agreed upon final set of themes is identified. The raw data corresponding to the item in question will be classified according to its theme.
Measured: 100 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Perception of Skin of Color Clinics in African AmericansStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Stout
- Responsible party
- Principal investigator, Stavonnie Patterson, Northwestern University
- Investigators
- Stavonnie Patterson, MD, Principal investigator, Northwestern UniversityKristina Gorbatenko-Roth, PhD, LP, Principal investigator, University of Wisconsin, StoutNeil Prose, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375659
- Sponsor's protocol ID
- SSLP100114
- Status last verified
- Oct 2017
- First submitted
- 24 Feb 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barr DA, Wanat SF. Listening to patients: cultural and linguistic barriers to health care access. Fam Med. 2005 Mar;37(3):199-204.
PubMed 15739136Beach MC, Gary TL, Price EG, Robinson K, Gozu A, Palacio A, Smarth C, Jenckes M, Feuerstein C, Bass EB, Powe NR, Cooper LA. Improving health care quality for racial/ethnic minorities: a systematic review of the best evidence regarding provider and organization interventions. BMC Public Health. 2006 Apr 24;6:104. doi: 10.1186/1471-2458-6-104.
PubMed 16635262Cooper LA, Roter DL, Johnson RL, Ford DE, Steinwachs DM, Powe NR. Patient-centered communication, ratings of care, and concordance of patient and physician race. Ann Intern Med. 2003 Dec 2;139(11):907-15. doi: 10.7326/0003-4819-139-11-200312020-00009.
PubMed 14644893Cooper-Patrick L, Gallo JJ, Gonzales JJ, Vu HT, Powe NR, Nelson C, Ford DE. Race, gender, and partnership in the patient-physician relationship. JAMA. 1999 Aug 11;282(6):583-9. doi: 10.1001/jama.282.6.583.
PubMed 10450723Majette GR. Access to health care: what a difference shades of color make. Ann Health Law. 2003;12(1):121-42, table of contents.
PubMed 12705206Michalopoulou G, Falzarano P, Arfken C, Rosenberg D. Physicians' cultural competency as perceived by African American patients. J Natl Med Assoc. 2009 Sep;101(9):893-9. doi: 10.1016/s0027-9684(15)31036-1.
PubMed 19806846Phillips KL, Chiriboga DA, Jang Y. Satisfaction with care: the role of patient-provider racial/ethnic concordance and interpersonal sensitivity. J Aging Health. 2012 Oct;24(7):1079-90. doi: 10.1177/0898264312453068. Epub 2012 Aug 6.
PubMed 22869897Sauaia A, Dellavalle RP. Health care inequities: an introduction for dermatology providers. Dermatol Clin. 2009 Apr;27(2):103-7, v. doi: 10.1016/j.det.2008.12.001.
PubMed 19254652
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Black Patients' Lived Experiences and Perceptions of Skin of Color Clinics
- ClinicalTrials.gov ID
- NCT02375659
- Acronym / sponsor ID
- SSLP100114
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Wisconsin, Stout
- Study start
- Feb 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 2 Mar 2015 (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.
Across the U.S. Skin of Color (SOC) clinics have been established with the goal of providing medical care and supporting research related to patients with skin of color. There have been no formal studies evaluating why patients seek medical care at SOC clinics or treatment outcomes. Reasons may include past experiences with other providers, the perception that providers working in these clinics have a special interest or knowledge in caring for patients with skin of color and thus may provide better care, the expectation of cultural sensitivity, the hope that their provider may have a similar ethnic background, and/or ease of communication with their provider. Through focus group discussions we aim to identify the factors influencing a patient's choice to seek medical care at a SOC clinic and to gain insight into the presence and impact of racial concordance between provider and patient. The current study will focus on self-identified African American patients with interest in conducting similar sessions with patients of other ethnicities and races in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus group | – | –Each focus group (4 total) will be approximately 90 minutes in duration. A trained facilitator will pose 8 scripted questions to the focus group participants and manage the conversation, ensuring all participants have an opportunity to respond and steering the conversation to remain on task. A note-taker will also be present at the focus group to document via handwritten notes the flow and content of the focus group conversation. All focus groups will be audio taped and transcribed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- African American patients evaluated at the Northwestern Center for Ethnic Skin
Key inclusion criteria (5 listed)
- Evaluated in the Northwestern Center for Ethnic Skin between February 1, 2015 and February 1, 2016.
- Evaluated by Drs. Stavonnie Patterson or Roopal Kundu
- Age 18 or older
- Self identified as African American/Black
- All subjects must have given signed, informed consent prior to participation in study.
Key exclusion criteria (2 listed)
- English speaking as interpreters not available
- Existing mental health conditions that may interfere with focus group discussion
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
Common thematic responses of discussion groups
Time frame: 100 minutes
Audiotapes of focus group discussions will be transcribed, and the transcripts will be analyzed via a 'long-hand' inductive approach by two dermatologists and one psychologist. For each of the 8 posed focus group questions, the reviewers will independently induce a common thematic response. Collectively, they will then compare their independently derived themes, identifying themes of agreement and disagreement. Areas of disagreement will be further reviewed until a mutually agreed upon final set of themes is identified. The raw data corresponding to the item in question will be classified according to its theme.
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 26 Oct 2017.
- Background: PubMed 15739136Barr DA, Wanat SF. Listening to patients: cultural and linguistic barriers to health care access. Fam Med. 2005 Mar;37(3):199-204.
- Background: PubMed 16635262Beach MC, Gary TL, Price EG, Robinson K, Gozu A, Palacio A, Smarth C, Jenckes M, Feuerstein C, Bass EB, Powe NR, Cooper LA. Improving health care quality for racial/ethnic minorities: a systematic review of the best evidence regarding provider and organization interventions. BMC Public Health. 2006 Apr 24;6:104. doi: 10.1186/1471-2458-6-104.
- Background: PubMed 14644893Cooper LA, Roter DL, Johnson RL, Ford DE, Steinwachs DM, Powe NR. Patient-centered communication, ratings of care, and concordance of patient and physician race. Ann Intern Med. 2003 Dec 2;139(11):907-15. doi: 10.7326/0003-4819-139-11-200312020-00009.
- Background: PubMed 10450723Cooper-Patrick L, Gallo JJ, Gonzales JJ, Vu HT, Powe NR, Nelson C, Ford DE. Race, gender, and partnership in the patient-physician relationship. JAMA. 1999 Aug 11;282(6):583-9. doi: 10.1001/jama.282.6.583.
- Background: PubMed 12705206Majette GR. Access to health care: what a difference shades of color make. Ann Health Law. 2003;12(1):121-42, table of contents.
- Background: PubMed 19806846Michalopoulou G, Falzarano P, Arfken C, Rosenberg D. Physicians' cultural competency as perceived by African American patients. J Natl Med Assoc. 2009 Sep;101(9):893-9. doi: 10.1016/s0027-9684(15)31036-1.
- Background: PubMed 22869897Phillips KL, Chiriboga DA, Jang Y. Satisfaction with care: the role of patient-provider racial/ethnic concordance and interpersonal sensitivity. J Aging Health. 2012 Oct;24(7):1079-90. doi: 10.1177/0898264312453068. Epub 2012 Aug 6.
- Background: PubMed 19254652Sauaia A, Dellavalle RP. Health care inequities: an introduction for dermatology providers. Dermatol Clin. 2009 Apr;27(2):103-7, v. doi: 10.1016/j.det.2008.12.001.
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.
Stavonnie Patterson, MD principal investigator
Northwestern University
Kristina Gorbatenko-Roth, PhD, LP principal investigator
University of Wisconsin, Stout
Neil Prose, MD principal investigator
Duke University
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 Perception of Skin of Color Clinics in African Americans, run by Northwestern University 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 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 26 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?
Common thematic responses of discussion groups (time frame: 100 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375659, which also lists 8 linked publications.
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 26 Oct 2017.