Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00754377
Other study ID # SHP 08-194
Secondary ID
Status Completed
Phase N/A
First received September 16, 2008
Last updated April 27, 2015
Start date January 2008
Est. completion date December 2011

Study information

Verified date April 2015
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date December 2011
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria:

- None, data being used has already been collected from a previous study which the inclusion criteria included all Internal Medicine and Medicine-Pediatrics residents completing a 4 week ambulatory block from 2005-2006 were required to participate in the PBLI curriculum to satisfy an ACGME's core competency.

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
PBLI Curriculum
PBLI curriculum was offered on alternate rotations

Locations

Country Name City State
United States Louis Stokes VA Medical Center, Cleveland, OH Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Change in Knowledge Scores About Quality Improvement Residents' knowledge was assessed using the knowledge scale (e.g., describe change concept, how a cause-effect diagram is created, elements of the improvement model) from the SQI TAT and scores could range from 0 to 54 points. Difference scores were used based on total score of the scale with larger positive values indicating more increase in knowledge. 1 Month No
See also
  Status Clinical Trial Phase
Completed NCT05817253 - Evaluation of Therapeutic Initiative's Cystitis Portrait and Therapeutics Letter N/A
Not yet recruiting NCT03793946 - A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant N/A
Completed NCT02922101 - Evaluation of the Effectiveness of an Audit and Feedback Intervention With Quality Improvement Toolbox in Intensive Care N/A
Completed NCT01931553 - A Pragmatic Cluster Randomized Controlled Trial to Standardize Attending Morning Rounds in Medicine N/A
Completed NCT04037787 - ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery N/A
Recruiting NCT05050266 - Enhancing Mental and Physical Health of Women Veterans N/A
Recruiting NCT06085690 - Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science N/A
Completed NCT05794490 - Learning From Excellence in a Hospital Unit
Active, not recruiting NCT03724695 - Advanced Heart Care at Home N/A
Recruiting NCT04383379 - To Improve the Rate of Mother's Own Milk Feeding of Premature Infants in NICU N/A
Not yet recruiting NCT05852080 - Multilevel System Intervention Based on Information Platform to Reduce Ischemic Stroke Recurrence Rate N/A
Enrolling by invitation NCT03689049 - SPIDER: A Research & QI Collaboration Supporting Practices in Improving Care for Complex Elderly Patients N/A
Enrolling by invitation NCT05133700 - Use and Opinions of Care Home Medicines Audit Tools
Completed NCT02882594 - Testing the Reliability and Validity of the CIBA N/A
Completed NCT00134823 - Improving Pediatric Safety and Quality With Health Care Information Technology N/A
Completed NCT03824990 - Multi-center Clinical Study on Neonatal Hyperbilirubinemia N/A
Completed NCT03775551 - Counter-referral System Improvement Collaborative N/A
Recruiting NCT04886427 - Implementation of a Multidimensional Quality Model
Withdrawn NCT03210116 - Quality Improvement in Palliative Care Consultation in a Medical ICU N/A
Completed NCT03000751 - CT DOSE Collaboratory N/A