Palliative CareQFTNCT02411305
Feasibility Testing of the Quality-monitoring Tool, Qdact, for the Palliative Care Research Cooperative
An observational study of Palliative Care, run by Duke University at 5 sites in United States.
Trial summary
Few formal mechanisms for collecting, analyzing, and reporting data on quality in palliative care exist. Such infrastructure is needed to understand current clinical practices, inform quality improvement projects, and research which links adherence to specific quality measures and improved patient-centered outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Palliative Care
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2015to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Palliative care clinicians from sites of the Palliative Care Research Cooperative.
Who may be able to join
- Palliative care clinicians employed by Palliative Care Research Cooperative sites.
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado
Aurora, Colorado, 80045
University of North Carolina
Chapel Hill, North Carolina, 27559
Duke University Medical Center
Durham, North Carolina, 27710
Four Seasons Compassion for Life
Flat Rock, North Carolina, 28731
UCSF
San Francisco, California, 94143
About this study
Official title: Testing the Feasibility of a Point-of-care Quality Monitoring Infrastructure for the PCRC
Few formal mechanisms for collecting, analyzing, and reporting data on quality in palliative care exist. Such infrastructure is needed to understand current clinical practices, inform quality improvement projects, and research which links adherence to specific quality measures and improved patient-centered outcomes. This infrastructure, if proven feasible, can then become integrated into usual palliative care delivery across the PCRC. Then, palliative care can conduct the same types of collaborative quality improvement activities, based on data collected at point of care, as other medical disciplines like general surgery and cardiology.
Read the detailed description
Healthcare processes are measured, evaluated, and characterized through the use of healthcare quality measures. Healthcare quality measures are tools that quantify the consistency of care delivery within a population eligible for the process. Containing a numerator (those with successful delivery of a care process) and a denominator (eligible patients for that care process), quality measures produce a frequency or adherence rate to which a care process was performed. Adherence rates can then be compared to evaluate quality of care across clinicians, organizations, or collaborations to compare data, establish benchmarks, and spur quality improvement projects.
In palliative care, for example, it is usually considered best practice to prescribe opioids for moderate/severe pain. Imagine that a palliative care program's calculated adherence rate reveals that their clinicians prescribe opioids for moderate-to-severe pain only 50% of the time. Armed with this information, the program can now develop a directed quality improvement project with the intention of improving this performance towards a more ideal goal (e.g. 75%). Further, it can provide feedback to clinicians in real-time regarding how they are performing against the quality measures of interest. In this example, clinicians may receive an electronic alert reminding them to prescribe an opioid when directed by an accepted best practice. This real-time approach, combined with a system that promotes culture of data collection, sharing, benchmarking, and reporting, are effective methods to improve healthcare quality. Lastly, and the focus of this proposal, is to build and test such an infrastructure that performs such real-time quality monitoring of healthcare measures in the Palliative Care Research Cooperative group (PCRC).
The investigators have previously identified the three major components needed for an effective and usable quality-monitoring infrastructure. Together, these three components answer the "what", "how", and "for why" questions that must be addressed within a quality assessment and improvement system.
First, is the ability to perform collaborative and integrated data collection across several sites. Successful multi-site data collection requires a centrally governed set of data collection processes, which are guided by a data dictionary. A data dictionary is a set of agreed-upon data elements, answer choices, rules, and branching logic. The data dictionary informs the development of a data collection platform for use by clinicians. Together, the data dictionary and software for use by clinicians guide "what" data is collected, and ensure that the intended collaborative analyses can be performed with the data set created.
Second, is the process for data collection - the "how" characteristic within the system. Data is collected, transmitted and recorded through the use of a data collection platform, transmission processes, and registry, respectively. The data collection platform is the interface in which real-time data is captured and recorded. This can involve paper-based or electronic forms using patient, caregiver, or clinician reporters. Data is then transmitted to the registry, either through electronic or manual means. Lastly, data is collected and securely stored in a prospective registry, so quality reports can be generated and research analyses completed. These steps are recommended standards for development of health information technology by the Agency for Healthcare Research and Quality (AHRQ).
Third, is the component of the infrastructure that answers the question, "for why?" Several reports have highlighted the need to translate raw data from quality monitoring efforts into continuous feedback on quality to clinicians and other end-users to motivate the delivery of best practices. This allows for changes in clinician performance during usual clinical care delivery, thus meeting the Institute of Medicine's aim for a rapid learning healthcare system. Generally, feedback is provided through system-generated reports that target specific end-users (e.g. clinicians, administrators) delivered during pre-specified time periods (e.g. weekly, quarterly).
At Duke University, investigators recently built the information technology infrastructure needed for prospective quality measure adherence and outcomes monitoring in palliative care. This system was developed and deployed in the Carolinas Consortium for Palliative Care, a four-site collaboration between Duke University and three community palliative care organizations. Recently, this Consortium has expanded to include organizations outside the Carolinas; eleven sites now comprise the Global Palliative Care Quality Alliance (GPCQA). The rapid expansion of qdact users and subsequent data collected have supported several research-level analysis published in the literature.
In using qdact.pc, clinicians record data on processes of care and patient-reported outcomes on personal iPads® during face-to-face clinical encounters with patients. During patient interviews, clinicians record patient-reported areas of distress, clinical management decisions, and patient-reported outcomes using validated instruments. These instruments include those common to the field, including the Edmonton Symptom Assessment Scale (ESAS), Palliative Performance Scale, and FACT-G. Longitudinal changes in these scales are captured through repeat use of qdact.pc during subsequent encounters. Further, qdact.pc calculates length of stay from admission and discharge dates, changes in symptom severity by calculating the difference between two dates, and readmission rates by analyzing whether patients in the registry had previously been admitted. Then, care processes and outcomes can be linked using these data.
- Conditions
- Palliative Care
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 |
|---|---|---|
| PCRC Palliative Care Clinicians | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of qdact.pcrc as measured by number of issues/comments on qualitative surveys
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 posted8 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Duke 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Palliative Care Research Cooperative Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411305
- Sponsor's protocol ID
- Pro00060336
- Acronym
- QFT
- Status last verified
- Dec 2015
- First submitted
- 3 Apr 2015
- Last updated
- 4 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of a Point-of-care Quality Monitoring Infrastructure for the PCRC
- ClinicalTrials.gov ID
- NCT02411305
- Acronym / sponsor ID
- QFT / Pro00060336
- Conditions
- Palliative Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Palliative Care Research Cooperative Group
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- First posted
- 8 Apr 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.
Few formal mechanisms for collecting, analyzing, and reporting data on quality in palliative care exist. Such infrastructure is needed to understand current clinical practices, inform quality improvement projects, and research which links adherence to specific quality measures and improved patient-centered outcomes. This infrastructure, if proven feasible, can then become integrated into usual palliative care delivery across the PCRC. Then, palliative care can conduct the same types of collaborative quality improvement activities, based on data collected at point of care, as other medical disciplines like general surgery and cardiology.
Detailed description
Healthcare processes are measured, evaluated, and characterized through the use of healthcare quality measures. Healthcare quality measures are tools that quantify the consistency of care delivery within a population eligible for the process. Containing a numerator (those with successful delivery of a care process) and a denominator (eligible patients for that care process), quality measures produce a frequency or adherence rate to which a care process was performed. Adherence rates can then be compared to evaluate quality of care across clinicians, organizations, or collaborations to compare data, establish benchmarks, and spur quality improvement projects.
In palliative care, for example, it is usually considered best practice to prescribe opioids for moderate/severe pain. Imagine that a palliative care program's calculated adherence rate reveals that their clinicians prescribe opioids for moderate-to-severe pain only 50% of the time. Armed with this information, the program can now develop a directed quality improvement project with the intention of improving this performance towards a more ideal goal (e.g. 75%). Further, it can provide feedback to clinicians in real-time regarding how they are performing against the quality measures of interest. In this example, clinicians may receive an electronic alert reminding them to prescribe an opioid when directed by an accepted best practice. This real-time approach, combined with a system that promotes culture of data collection, sharing, benchmarking, and reporting, are effective methods to improve healthcare quality. Lastly, and the focus of this proposal, is to build and test such an infrastructure that performs such real-time quality monitoring of healthcare measures in the Palliative Care Research Cooperative group (PCRC).
The investigators have previously identified the three major components needed for an effective and usable quality-monitoring infrastructure. Together, these three components answer the "what", "how", and "for why" questions that must be addressed within a quality assessment and improvement system.
First, is the ability to perform collaborative and integrated data collection across several sites. Successful multi-site data collection requires a centrally governed set of data collection processes, which are guided by a data dictionary. A data dictionary is a set of agreed-upon data elements, answer choices, rules, and branching logic. The data dictionary informs the development of a data collection platform for use by clinicians. Together, the data dictionary and software for use by clinicians guide "what" data is collected, and ensure that the intended collaborative analyses can be performed with the data set created.
Second, is the process for data collection - the "how" characteristic within the system. Data is collected, transmitted and recorded through the use of a data collection platform, transmission processes, and registry, respectively. The data collection platform is the interface in which real-time data is captured and recorded. This can involve paper-based or electronic forms using patient, caregiver, or clinician reporters. Data is then transmitted to the registry, either through electronic or manual means. Lastly, data is collected and securely stored in a prospective registry, so quality reports can be generated and research analyses completed. These steps are recommended standards for development of health information technology by the Agency for Healthcare Research and Quality (AHRQ).
Third, is the component of the infrastructure that answers the question, "for why?" Several reports have highlighted the need to translate raw data from quality monitoring efforts into continuous feedback on quality to clinicians and other end-users to motivate the delivery of best practices. This allows for changes in clinician performance during usual clinical care delivery, thus meeting the Institute of Medicine's aim for a rapid learning healthcare system. Generally, feedback is provided through system-generated reports that target specific end-users (e.g. clinicians, administrators) delivered during pre-specified time periods (e.g. weekly, quarterly).
At Duke University, investigators recently built the information technology infrastructure needed for prospective quality measure adherence and outcomes monitoring in palliative care. This system was developed and deployed in the Carolinas Consortium for Palliative Care, a four-site collaboration between Duke University and three community palliative care organizations. Recently, this Consortium has expanded to include organizations outside the Carolinas; eleven sites now comprise the Global Palliative Care Quality Alliance (GPCQA). The rapid expansion of qdact users and subsequent data collected have supported several research-level analysis published in the literature.
In using qdact.pc, clinicians record data on processes of care and patient-reported outcomes on personal iPads® during face-to-face clinical encounters with patients. During patient interviews, clinicians record patient-reported areas of distress, clinical management decisions, and patient-reported outcomes using validated instruments. These instruments include those common to the field, including the Edmonton Symptom Assessment Scale (ESAS), Palliative Performance Scale, and FACT-G. Longitudinal changes in these scales are captured through repeat use of qdact.pc during subsequent encounters. Further, qdact.pc calculates length of stay from admission and discharge dates, changes in symptom severity by calculating the difference between two dates, and readmission rates by analyzing whether patients in the registry had previously been admitted. Then, care processes and outcomes can be linked using these data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCRC Palliative Care Clinicians | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Palliative care clinicians from sites of the Palliative Care Research Cooperative.
Key inclusion criteria (1 listed)
- Palliative care clinicians employed by Palliative Care Research Cooperative sites.
Key exclusion criteria (1 listed)
- None
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
Feasibility of qdact.pcrc as measured by number of issues/comments on qualitative surveys
Time frame: 6 months
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 4 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care, run by Duke University at 5 sites 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 1 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Feasibility of qdact.pcrc as measured by number of issues/comments on qualitative surveys (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 4 Feb 2016.