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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT02411305
Study groupRoleWhat they receive
PCRC Palliative Care CliniciansNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted8 Apr 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionSep 2015

Resources

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)
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

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.

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