Developing a Practice-Based Learning and Improvement Quality Improvement (QI) Systems Impact Assessment Questionnaire

NCT ID: NCT00754377

Last Updated: 2015-05-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Accreditation Council for Graduate Medical Education (ACGME) acknowledged the changing needs of physicians in training when it endorsed practice-based learning and improvement (PBLI) -- a competency that is typically omitted from medical curriculum. The goal is to have residents competent to investigate and evaluate their own patient care practices, integrate scientific evidence and be able to improve their practices. Available assessment tools do not adequately address all of the components of PBLI and few assessment tools attempt to capture the residents' ability to develop and implement clinically-based Continuous Quality Improvement (CQI) projects that involve the practice setting. Curriculums without such foci miss the importance of system perspectives and opportunities for interprofessional team development. Our aim is to evaluate preliminary data on the curriculum we developed to address the gaps, to develop an assessment tool, and to provide methods for assessing the sustainability of system projects.

The key component of the curriculum is the integration of system quality improvement projects. PBLI curriculum was offered on alternate rotations. Preliminary data is available from 6 PBLI QI Systems Curriculum blocks (n=50) and 5 comparison blocks (n=42). Data includes closed- and open-ended questions designed to assess resident PBLI application skills, the notes and presentation slides for the residents' presentation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Physicians in training operate in complex healthcare delivery systems but many have not been equipped with the knowledge or skills to analyze clinical environments and continually improve patient care.\[1\] Instead, their training emphasizes the clinical management of individual patients. The Accreditation Council for Graduate Medical Education (ACGME) acknowledged the changing needs of physicians in training when it endorsed one of two novel core competencies that are typically omitted from formal medical curriculum: practice-based learning and improvement (PBLI).\[2,3\] The ACGME's PBLI competency involves six points. The overall objective is to have residents competent to investigate and evaluate their own patient care practices, evaluate and integrate scientific evidence into their clinics and be able to improve their practices. However, the ACGME was not prescriptive about how to successfully implement and evaluate PBLI, and an established curriculum and validated assessment tool did not exist.\[4\] Efforts to date to develop an assessment tool provide a foundation, but none adequately addresses all of the components of PBLI as described by the ACGME. \[3, 5-10\] In particular, few assessment tools attempt to capture the residents' ability to develop and implement clinically-based CQI projects that involve the practice setting and assess impact on the practice setting and/or organization. Curriculums without such foci miss the importance of system perspectives, opportunities for interprofessional team development, and meaningful impacts on patient care at a broader organizational level.

After several iterations, a PBLI QI curriculum that addressed the gaps identified in many other curriculums was instituted. \[11\] The key component was the integration of system quality improvement projects that could evolve over several resident outpatient rotation blocks. Data from 11 blocks of the new curriculum is available for analysis. Data includes closed- and open-ended questions designed to assess resident PBLI application skills and the notes and presentation slides for the residents' presentation at the internal medicine's morbidity and mortality conference (IM MMC) at the end of each block. Funding would make it possible to more quickly evaluate the existing preliminary data. Our overall aim is to evaluate the preliminary data on the new curriculum and develop an assessment tool that addresses the six ACGME points and provides methods for assessing the sustainability of system projects. The next step will be to apply for a grant to more fully evaluate the curriculum and assessment tool.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Quality Improvement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PBLI Curriculum group

To evaluate preliminary data on a PBLI curriculum grounded on QI system projects.

PBLI Curriculum

Intervention Type OTHER

PBLI curriculum was offered on alternate rotations

Comparison group

Received a different curriculum.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PBLI Curriculum

PBLI curriculum was offered on alternate rotations

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* None, the residents from 2004 that did not complete a 4 week ambulatory block and residents participating in ambulatory block 7 and 13 were excluded from the study previously Institutional Review Board (IRB) approved and exempted study. Blocks 7 and 13 are not structured to permit teaching.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David C Aron, MD MS

Role: PRINCIPAL_INVESTIGATOR

Louis Stokes VA Medical Center, Cleveland, OH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA. 2010 Jun 23;303(24):2479-85. doi: 10.1001/jama.2010.841.

Reference Type RESULT
PMID: 20571014 (View on PubMed)

Lawrence RH, Tomolo AM. Development and preliminary evaluation of a practice-based learning and improvement tool for assessing resident competence and guiding curriculum development. J Grad Med Educ. 2011 Mar;3(1):41-8. doi: 10.4300/JGME-D-10-00102.1.

Reference Type RESULT
PMID: 22379522 (View on PubMed)

Tomolo AM, Lawrence RH, Watts B, Augustine S, Aron DC, Singh MK. Pilot study evaluating a practice-based learning and improvement curriculum focusing on the development of system-level quality improvement skills. J Grad Med Educ. 2011 Mar;3(1):49-58. doi: 10.4300/JGME-D-10-00104.1.

Reference Type RESULT
PMID: 22379523 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHP 08-194

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.