Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigating Trends in Compliance With Quality Assurance Metrics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119532
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Nirav Shah, University of Michigan

Brief Summary:

Over 40 million major operative procedures are performed in the US annually and comprise about 40% of healthcare expenditures. Despite decades of research, perioperative mortality and morbidity remain a major healthcare system cost and detriment to long-term quality of life. More than ten percent of patients experience a significant event such as surgical site infection, reoperation, myocardial infarction, pulmonary embolus, or death. Nearly 100,000 patients die after surgery each year. National data demonstrate a 3-fold variation in risk adjusted surgical morbidity and mortality, suggesting many opportunities for improvement in perioperative care.

Anesthesiology care demonstrates wide variation in practice. Sometimes, this variation is appropriate because the anesthesiologist is responding to patient comorbidities or procedure specific events. However, even after controlling for patient specific factors, there is a substantial amount of unexplained variation in fundamental elements of anesthesiology care. The same procedure and patient can be performed using completely different anesthetic techniques, hemodynamic management strategies, and medications. This variation in care can lead to a variation in outcome.

The use of electronic health records (EHR) with detailed preoperative and intraoperative data allows an automated system to be developed to notify clinicians their compliance to both process of care metrics and outcome metrics. The Multicenter Perioperative Outcomes Group (MPOG) quality improvement arm is known as Anesthesiology Performance Improvement Reporting Exchange (ASPIRE). Like other Collaborative Quality Initiatives, the primary goal of ASPIRE is to provide hospitals with risk-adjusted feedback on outcome and process of care variation. In addition, ASPIRE creates an active best-practice sharing environment to enable data to spur action. Recent literature has demonstrated that hospital-level feedback may not be adequate to improve performance and clinical outcomes. In addition to hospital level data and feedback, ASPIRE can disseminate provider-specific electronic feedback that may decrease variation in care known to impact complications and cost.

The primary aim for this research study on ASPIRE's QI program is to determine if the investigators can change behavior as measured by a provider's compliance to specific performance metrics. The investigators believe that the start of individual provider performance feedback reports to ASPIRE members presents a unique opportunity to research the efficacy of these novel tools. The investigators propose to test the hypothesis that monthly provider specific feedback emails on ASPIRE quality metrics over a period of 9 months improves provider compliance as measured by a either a 10% improvement in the Total Performance Score or by moving from below to above the 90% performance threshold in the Total Performance Score Index.

Each provider type (faculty, CRNA, resident/fellow) within a hospital participating in ASPIRE will be individually randomized to either receiving the electronic performance improvement email or not for a total of nine months. No individual at the participating site will see the individualized email compliance reports except for the specific provider. Only an aggregate of the compliance across the entire hospital will be supplied to the chairperson and the quality assurance directors. After the completion of the nine month randomization period, all providers will receive monthly ASPIRE performance improvement emails.

The University of Michigan is the coordinating center but also participating in this research on QI project. De-identified patient data will be pulled in aggregate for each provider using the MPOG database. The provider performance for each measure will then be sent from ASPIRE to the randomized care provider via an email. The chairperson and quality assurance directors will only see aggregate data on compliance rates and can NOT identify individual compliance rates. Each participating site will obtain their own institutional IRB to participate in this study.


Condition or disease Intervention/treatment Phase
Postoperative Morbidity Other: Receive metric feedback email Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 672 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigating Trends in Compliance With Quality Assurance Metrics
Study Start Date : July 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Receive feedback email
Anesthesia care providers who receive monthly feedback emails on the participants specific quality measures
Other: Receive metric feedback email
If the provider received an email about the participants performance metrics

No Intervention: Did not receive feedback email
Anesthesia care providers who did NOT receive monthly feedback emails on the participants specific quality measures



Primary Outcome Measures :
  1. Number of providers with improved compliance (for all clinical providers) with Anesthesia Quality Measures using an email based provider specific feedback system [ Time Frame: 9 months ]
    Investigating improved bundle compliance for all providers where all anesthesia care providers at the given institution were randomized to receive emails (attending/residents/CRNAs).


Other Outcome Measures:
  1. Number of providers with improved compliance (where only one set of clinical providers) with Anesthesia Quality Measures using an email based provider specific feedback system [ Time Frame: 9 months ]
    Investigating improved bundle compliance for all providers where only one anesthesia care provider group at the given institution were randomized to receive emails (attending/residents/CRNAs).

  2. Number of providers with improved compliance for providers that already met the threshold compliance with Anesthesia Quality Measures using an email based provider specific feedback system [ Time Frame: 9 months ]
    For all providers at baseline that already met bundle threshold compliance, we will investigate to determine if improved their performance during the study period.

  3. Number of providers with improved compliance for all sites except the coordinating center with Anesthesia Quality Measures using an email based provider specific feedback system [ Time Frame: 9 months ]
    Investigating improved bundle compliance for all providers expect those in the coordinating center to determine if they performance metrics have improved.

  4. Number of patients with postoperative morbidity assigned to providers that did and did not receive quality metric emails. [ Time Frame: 9 months ]
    Determine if patient postoperative morbidity are affected by a provider receiving metric emails for all cases,

  5. Number of patients with postoperative morbidity assigned to only CRNA or Residents that did and did not receive quality metric emails. [ Time Frame: 9 months ]
    Determine if patient postoperative morbidity are affected by a provider receiving metric emails but only for CRNAs, fellows and anesthesiology residents.

  6. Number of patients with postoperative morbidity assigned to providers at all sites except the coordinating center that did and did not receive quality metric emails. [ Time Frame: 9 months ]
    Determine if patient postoperative morbidity are affected by a provider receiving metric emails for cases done outside the coordinating center.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hospitals currently participating in ASPIRE (https://www.aspirecqi.org/)
  • Quality assurance champion and chairperson have decided to participate in this quality assurance project.

Exclusion Criteria:

  • Hospitals not currently participating in ASPIRE

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119532


Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Study Director: Sachin Kheterpal, MD, MBA University of Michigan
Additional Information:
Layout table for additonal information
Responsible Party: Nirav Shah, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03119532    
Other Study ID Numbers: Compliance metrics
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents