Physical DisabilityNCT02626910
Understanding Disparities in Healthcare and Primary Care Provider Quality
An observational study of Physical Disability, run by University of Pennsylvania at 1 site in United States.
Trial summary
The project proposes to fill gaps in the understanding of disparities in healthcare and primary care provider (PCP) quality from the perspectives of adult Medicare beneficiaries with disabilities compared to those without disabilities. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Disability
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2013to 1 Jul 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Both: both female and male participants are being studied
Who may be able to join
- Second Life: People with disabilities - only those with disabilities from Second Life.
- Second Life: People without disabilities - only those without disabilities from Second Life.
- Second Life: clinicians - only clinicians from Second Life.
- Urban: either those with or without disabilities
Who cannot join
- Second Life: People with disabilities - does not include those without disabilities or clinicians from Second Life.
- Second Life: People without disabilities - does not include those with disabilities or clinicians from Second Life.
- Second Life: clinicians - does not include those with or without disabilities from Second Life.
- Urban: does not include clinicians
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Patient Centered Outcomes Research Institute: Mrs. A and Mr. B
The project proposes to fill gaps in the understanding of disparities in healthcare and primary care provider (PCP) quality from the perspectives of adult Medicare beneficiaries with disabilities compared to those without disabilities. Studies document racial/ethnic, economic, and education-related disparities, but little is known about healthcare disparities related to disability.
Read the detailed description
BACKGROUND: The project proposes to fill gaps in the understanding of disparities in healthcare and primary care provider (PCP) quality from the perspectives of adult Medicare beneficiaries with disabilities compared to those without disabilities. Studies document racial/ethnic, economic, and education-related disparities, but little is known about healthcare disparities related to disability.
OBJECTIVE: The investigators' goal is to engage stakeholders as peers and partners in the development of an evidence-based Patient-Inspired Surveillance Tool for documenting variations in healthcare and PCP quality and any outcome consequences associated with these variations among people with disabilities (PWD) and people without disabilities (PWOD). The tool is intended to provide guidance on programs and policies to ameliorate disparities, improve function, and enhance autonomy in populations of people.
METHODS: The investigators will explore perceptions about the determinants of healthcare and PCP quality in partnership with stakeholders including PWD, PWOD, family of PWD, and healthcare providers in efforts to better understand underlying determinants of healthcare disparities that might be accelerating clinical deterioration. Applying population weighted data and multi-variable methods to patient information included in the Medicare Current Beneficiary Survey (MCBS), the investigators will determine the presence or absence of perceived problems across 5 healthcare and PCP quality "comparators" and (if present) the magnitude of impact on likelihood of patients' functional improvement, functional decline, institutionalization, or death referenced to no status change by 1, 2, and 3 years. A decade of data from the MCBS (on about 40,000 working age and elderly patients) will be applied to ensure adequate statistical power for comparisons. Stakeholders will help interpret the implications of findings and partner with clinician researchers in building the Tool.
PATIENT OUTCOMES: For aim 2, the outcome will be healthcare and PCP quality across 5 "quality comparators" including patients' perceptions about care coordination and quality, access barriers, technical skills of PCP, interpersonal skills of PCP, and the quality of information provided by PCP. Comparisons will be cross sectional contrasting the proportions of people at each stage of disability referenced to PWOD perceiving lower verses higher quality on each comparator. These 5 comparators will become the exposure for aims 3 and 4.
For aims 3 and 4, the outcome will include "no change" (individual remains at the same Activity of Daily Living (ADL)/Instrumental Activity of Daily Living (IADL) stage), "functional improvement" (recovery to a lower ADL/IADL stage), "functional decline" (deterioration to a higher stage of ADL/IADL limitation), "institutionalization" (long-term nursing home), or "death." Comparison will be longitudinal prediction at 1, 2, and 3 years in contrast to no change according to each comparator.
- Conditions
- Physical Disability
- Keywords
- Disability, Activity of Daily Living, Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
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 |
|---|---|---|
| Second Life: People with disabilities | People with disabilities recruited from the virtual world, Second life. | |
| Second Life: People without disabilities | People without disabilities recruited from the virtual world, Second life. | |
| Second Life: Clinicians | Clinicians recruited from the virtual world, Second life. | |
| Urban group | People with and without disabilities recruited from an Urban setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction With Medical Care Survey
Multinomial logistic regression models will be used to determine the degree to which people with disabilities and without have satisfaction with medical care obtained from the survey. The scale ranges from 1 (not satisfied) to 4 (very satisfied) with their medical care. Higher scores represent more satisfaction with medical care. Unit of measurement is units on a scale.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start1 Aug 2013
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hillary R Bogner, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626910
- Sponsor's protocol ID
- AD-12-11-4567
- Status last verified
- Oct 2017
- First submitted
- 30 Nov 2015
- Last updated
- 15 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
de Vries McClintock HF, Barg FK, Katz SP, Stineman MG, Krueger A, Colletti PM, Boellstorff T, Bogner HR. Health care experiences and perceptions among people with and without disabilities. Disabil Health J. 2016 Jan;9(1):74-82. doi: 10.1016/j.dhjo.2015.08.007. Epub 2015 Sep 5.
PubMed 26482010Bogner HR, de Vries McClintock HF, Hennessy S, Kurichi JE, Streim JE, Xie D, Pezzin LE, Kwong PL, Stineman MG. Patient Satisfaction and Perceived Quality of Care Among Older Adults According to Activity Limitation Stages. Arch Phys Med Rehabil. 2015 Oct;96(10):1810-9. doi: 10.1016/j.apmr.2015.06.005. Epub 2015 Jun 26.
PubMed 26119464
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Outcomes Research Institute: Mrs. A and Mr. B
- ClinicalTrials.gov ID
- NCT02626910
- Acronym / sponsor ID
- AD-12-11-4567
- Conditions
- Physical Disability
- Keywords
- Disability, Activity of Daily Living, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Posted 15 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project proposes to fill gaps in the understanding of disparities in healthcare and primary care provider (PCP) quality from the perspectives of adult Medicare beneficiaries with disabilities compared to those without disabilities. Studies document racial/ethnic, economic, and education-related disparities, but little is known about healthcare disparities related to disability.
Detailed description
BACKGROUND: The project proposes to fill gaps in the understanding of disparities in healthcare and primary care provider (PCP) quality from the perspectives of adult Medicare beneficiaries with disabilities compared to those without disabilities. Studies document racial/ethnic, economic, and education-related disparities, but little is known about healthcare disparities related to disability.
OBJECTIVE: The investigators' goal is to engage stakeholders as peers and partners in the development of an evidence-based Patient-Inspired Surveillance Tool for documenting variations in healthcare and PCP quality and any outcome consequences associated with these variations among people with disabilities (PWD) and people without disabilities (PWOD). The tool is intended to provide guidance on programs and policies to ameliorate disparities, improve function, and enhance autonomy in populations of people.
METHODS: The investigators will explore perceptions about the determinants of healthcare and PCP quality in partnership with stakeholders including PWD, PWOD, family of PWD, and healthcare providers in efforts to better understand underlying determinants of healthcare disparities that might be accelerating clinical deterioration. Applying population weighted data and multi-variable methods to patient information included in the Medicare Current Beneficiary Survey (MCBS), the investigators will determine the presence or absence of perceived problems across 5 healthcare and PCP quality "comparators" and (if present) the magnitude of impact on likelihood of patients' functional improvement, functional decline, institutionalization, or death referenced to no status change by 1, 2, and 3 years. A decade of data from the MCBS (on about 40,000 working age and elderly patients) will be applied to ensure adequate statistical power for comparisons. Stakeholders will help interpret the implications of findings and partner with clinician researchers in building the Tool.
PATIENT OUTCOMES: For aim 2, the outcome will be healthcare and PCP quality across 5 "quality comparators" including patients' perceptions about care coordination and quality, access barriers, technical skills of PCP, interpersonal skills of PCP, and the quality of information provided by PCP. Comparisons will be cross sectional contrasting the proportions of people at each stage of disability referenced to PWOD perceiving lower verses higher quality on each comparator. These 5 comparators will become the exposure for aims 3 and 4.
For aims 3 and 4, the outcome will include "no change" (individual remains at the same Activity of Daily Living (ADL)/Instrumental Activity of Daily Living (IADL) stage), "functional improvement" (recovery to a lower ADL/IADL stage), "functional decline" (deterioration to a higher stage of ADL/IADL limitation), "institutionalization" (long-term nursing home), or "death." Comparison will be longitudinal prediction at 1, 2, and 3 years in contrast to no change according to each comparator.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Second Life: People with disabilities | – | –People with disabilities recruited from the virtual world, Second life. |
| Second Life: People without disabilities | – | –People without disabilities recruited from the virtual world, Second life. |
| Second Life: Clinicians | – | –Clinicians recruited from the virtual world, Second life. |
| Urban group | – | –People with and without disabilities recruited from an Urban setting. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Both: both female and male participants are being studied
Key inclusion criteria (4 listed)
- Second Life: People with disabilities - only those with disabilities from Second Life.
- Second Life: People without disabilities - only those without disabilities from Second Life.
- Second Life: clinicians - only clinicians from Second Life.
- Urban: either those with or without disabilities
Key exclusion criteria (4 listed)
- Second Life: People with disabilities - does not include those without disabilities or clinicians from Second Life.
- Second Life: People without disabilities - does not include those with disabilities or clinicians from Second Life.
- Second Life: clinicians - does not include those with or without disabilities from Second Life.
- Urban: does not include clinicians
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
Satisfaction With Medical Care Survey
Time frame: One year
Multinomial logistic regression models will be used to determine the degree to which people with disabilities and without have satisfaction with medical care obtained from the survey. The scale ranges from 1 (not satisfied) to 4 (very satisfied) with their medical care. Higher scores represent more satisfaction with medical care. Unit of measurement is units on a scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26482010de Vries McClintock HF, Barg FK, Katz SP, Stineman MG, Krueger A, Colletti PM, Boellstorff T, Bogner HR. Health care experiences and perceptions among people with and without disabilities. Disabil Health J. 2016 Jan;9(1):74-82. doi: 10.1016/j.dhjo.2015.08.007. Epub 2015 Sep 5.
- Results publication: PubMed 26119464Bogner HR, de Vries McClintock HF, Hennessy S, Kurichi JE, Streim JE, Xie D, Pezzin LE, Kwong PL, Stineman MG. Patient Satisfaction and Perceived Quality of Care Among Older Adults According to Activity Limitation Stages. Arch Phys Med Rehabil. 2015 Oct;96(10):1810-9. doi: 10.1016/j.apmr.2015.06.005. Epub 2015 Jun 26.
- Individual participant dataSharing planned: No
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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.
Hillary R Bogner, MD principal investigator
University of Pennsylvania
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 Physical Disability, run by University of Pennsylvania 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 4 inclusion and 4 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 15 Dec 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?
Yes. Results are posted in the registry (first posted 15 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Satisfaction With Medical Care Survey (time frame: One year). 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 NCT02626910, which also lists 2 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 15 Dec 2017.