Physical DisabilityNCT02390557
Persons With Disabilities Generating Quality Metrics
A study testing Survey and YESHealth in people with Physical Disability and Chronic Mental Disorder, run by Massachusetts General Hospital.
Trial summary
No standard way exists to measure the quality of medical care or independent living long-term services and supports provided to persons with disabilities. This project will: provide a broader picture of how consumers with disabilities define care and care quality; measure the value of using consumers' expertise in… Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Physical Disability, Chronic Mental Disorder
- What is being tested?
- Survey and YESHealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 7 Oct 2016
- Phase
- Interventional
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- One Care enrollee
- Permanent physical disability and/or serious mental illness
- Seen at designated practice site
- English or Spanish speaking
Who cannot join
- Persons with an intellectual or a developmental disability
About this study
Official title: Persons With Disabilities Generating Quality Metrics to Inform Integrated Care
No standard way exists to measure the quality of medical care or independent living long-term services and supports provided to persons with disabilities. This project will: provide a broader picture of how consumers with disabilities define care and care quality; measure the value of using consumers' expertise in developing, collecting, and assessing quality measures; and use this information to assist One Care providers in improving care delivered to their enrollees
Read the detailed description
The aims of the project are as follows:
- To work with persons with significant physical disabilities and serious and persistent mental illness to develop two new approaches to assess quality of care: Approach #1: We will survey enrollees about their experiences in One Care and their thoughts about the care they receive. This survey will also ask One Care enrollees about how they manage their care and what self-direction means to them. The survey will be called the Persons with Disabilities Quality Survey (PDQ-S), and it will be available in English and Spanish versions. Approach #2: Enrollees in One Care will provide information about their perceptions of care quality to a trained team of persons with disabilities who will report the information to One Care care teams. The goal of the activity is to support quality improvement in One Care through hearing the consumer's voice. This is called YES Health - Your Experience: Speak up for better health care.
- We want to test how providing consumer informed and consumer directed quality information to One Care providers affects One Care quality.
- We want to improve the ability of One Care enrollees to manage their own health care and to recognize and report quality problems
- Conditions
- Physical Disability, Chronic Mental Disorder
- Being tested
- Survey, YESHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
PDQS survey reports only
YESHealthOther
Arm 3: YESHealth and PDQS survey reports to providers
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard Practice | No intervention | Standard measures of quality at baseline. No intervention reports sent to providers |
| Survey | Experimental | Persons with Disabilities Quality Survey.PDQS Survey Reports Intervention.reports sent to providers of OneCare enrollees Receives: Other: Survey |
| YESHealth | Experimental | Arm 3: YESHealth Reports and PDQS Survey Reports sent to providers of OneCare enrollees Receives: Other: Survey; Other: YESHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Quality of Care
% who agree that their quality of care Is better, the same or worse than before
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start1 Jul 2015
- Primary completion7 Oct 2016
- Study completion7 Oct 2016
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.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control v Survey v YESHealth
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Lisa Iezzoni, Massachusetts General Hospital
- Investigators
- Lisa I Iezzoni, MD, MSc, Principal investigator, Mongan Institute Health Policy Center, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390557
- Sponsor's protocol ID
- 2014000899
- Status last verified
- Apr 2018
- First submitted
- 24 Feb 2015
- Last updated
- 21 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persons With Disabilities Generating Quality Metrics to Inform Integrated Care
- ClinicalTrials.gov ID
- NCT02390557
- Acronym / sponsor ID
- 2014000899
- Conditions
- Physical Disability, Chronic Mental Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 7 Oct 2016 (actual)
- Study completion
- 7 Oct 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 21 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
No standard way exists to measure the quality of medical care or independent living long-term services and supports provided to persons with disabilities. This project will: provide a broader picture of how consumers with disabilities define care and care quality; measure the value of using consumers' expertise in developing, collecting, and assessing quality measures; and use this information to assist One Care providers in improving care delivered to their enrollees
Detailed description
The aims of the project are as follows:
- To work with persons with significant physical disabilities and serious and persistent mental illness to develop two new approaches to assess quality of care: Approach #1: We will survey enrollees about their experiences in One Care and their thoughts about the care they receive. This survey will also ask One Care enrollees about how they manage their care and what self-direction means to them. The survey will be called the Persons with Disabilities Quality Survey (PDQ-S), and it will be available in English and Spanish versions. Approach #2: Enrollees in One Care will provide information about their perceptions of care quality to a trained team of persons with disabilities who will report the information to One Care care teams. The goal of the activity is to support quality improvement in One Care through hearing the consumer's voice. This is called YES Health - Your Experience: Speak up for better health care.
- We want to test how providing consumer informed and consumer directed quality information to One Care providers affects One Care quality.
- We want to improve the ability of One Care enrollees to manage their own health care and to recognize and report quality problems
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- control v Survey v YESHealth
| Arm | Type | Receives |
|---|---|---|
| Control - Standard Practice | No intervention | –Standard measures of quality at baseline. No intervention reports sent to providers |
| Survey | Experimental | Other: SurveyPersons with Disabilities Quality Survey.PDQS Survey Reports Intervention.reports sent to providers of OneCare enrollees |
| YESHealth | Experimental | Other: Survey, Other: YESHealthArm 3: YESHealth Reports and PDQS Survey Reports sent to providers of OneCare enrollees |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- One Care enrollee
- Permanent physical disability and/or serious mental illness
- Seen at designated practice site
- English or Spanish speaking
Key exclusion criteria (1 listed)
- Persons with an intellectual or a developmental disability
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 |
|---|---|---|
| SurveyPDQS survey reports only | Other | Survey, YESHealth |
| YESHealthArm 3: YESHealth and PDQS survey reports to providers | Other | YESHealth |
Primary outcome
Improved Quality of Care
Time frame: 12 months
% who agree that their quality of care Is better, the same or worse than before
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Lisa I Iezzoni, MD, MSc principal investigator
Mongan Institute Health Policy Center, Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Survey and YESHealth in people with Physical Disability and Chronic Mental Disorder, run by Massachusetts General Hospital.
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 1 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 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 21 Nov 2018). 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?
Improved Quality of Care (time frame: 12 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 21 Nov 2018.