NCT00754377

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 14, 2014

Completed
Last Updated

May 12, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

September 16, 2008

Results QC Date

August 29, 2014

Last Update Submit

April 27, 2015

Conditions

Keywords

EducationProgram EvaluationQuality of Health CareMedical Residents

Outcome Measures

Primary Outcomes (1)

  • Beliefs About Ability to Implement a CQI Project

    Residents' belief about their ability to implement a CQI project was measured using a single efficacy item (values ranged from 1, strongly disagree, to 5, strongly agree). The item is from the Systems Quality Improvement Training and Assessment Tool. Differences (post minus pre) in this belief item were looked at with positive and higher difference values reflecting more positive change/increase in belief.

    1 month

Secondary Outcomes (1)

  • Change in Knowledge Scores About Quality Improvement

    1 Month

Study Arms (2)

PBLI Curriculum group

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

Other: PBLI Curriculum

Comparison group

Received a different curriculum.

Interventions

PBLI curriculum was offered on alternate rotations

PBLI Curriculum group

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Internal Medicine residents

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Limitations and Caveats

While necessary limitations for initial assessment tool development, concerns will be addressed in the multi-site trial of the curriculum, including assessment of the training manual and codebooks that were developed during this project.

Results Point of Contact

Title
Dr. David Aron
Organization
Louis Stokes VA Medical Center

Study Officials

  • David C Aron, MD MS

    Louis Stokes VA Medical Center, Cleveland, OH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 18, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

December 1, 2011

Last Updated

May 12, 2015

Results First Posted

November 14, 2014

Record last verified: 2015-04

Locations