Improving Performance of Paracentesis in Medical Residency Training
1 other identifier
interventional
136
1 country
1
Brief Summary
The investigators hypothesize that there is significant variability in management of patients with ascites despite guidelines provided by the American Association for the Study of Liver Diseases, the professional organization most involved with management of liver patients. This variability may be attributable to knowledge deficits, skill limitations, or reflect systems-issues that limit the ability of a care provider to implement the clinical guidelines (time constraints, inadequate supervision, availability of appropriate equipment, and obtaining consent for non-emergent procedures). This variability does a disservice to the patients being treated, and results in trainee development of habits that are not evidence based. There are simple teaching tools available that may improve learning and retention of evidence based practice. Using these tools should result in more consistent appropriate patient care, improve patient outcomes, and provide better education to our trainees. The purpose of this study is threefold: 1. To improve medical house-staff's technical performance of and comfort level with paracentesis; 2. To improve adherence to professional organization guidelines and to determine if this in fact improves clinical outcomes; 3. To evaluate efficacy of three teaching interventions in inpatient medicine trainee rotations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 26, 2011
CompletedFirst Posted
Study publicly available on registry
July 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
October 31, 2012
CompletedOctober 31, 2012
September 1, 2012
1.2 years
July 26, 2011
July 9, 2012
September 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score Out of Total Possible 25 on a Likert Scale.
Primary outcome is quantified by summation of Likert scale responses to five questions assessing for comfort level in caring for and managing inpatients with ascites. The scale ranges from "strongly disagree," which is assigned a value of 1, to "strongly agree," assigned a value of 5. The summation scores will therefore range from 5 to 25 points out of a total of 25 possible points. The post-intervention scores will be compared between groups using a multiple regression model with terms for treatment, baseline summary scores, and other baseline demographic variables as needed.
6 months
Secondary Outcomes (2)
Improvement in Guideline Adherence
18 months
Readmission and Mortality Rates
18 months
Study Arms (3)
Control Arm
ACTIVE COMPARATORControl group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
Intermediate Education Arm
EXPERIMENTALIn addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
Intensive Education Arm ("Pager" Arm)
EXPERIMENTALThis group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
Interventions
The residency program provides education surrounding the management of ascites to all house-staff in the training program. This consists of lectures, case-based or bedside discussions, and board review. All arms will receive the standard teaching provided by the residency program.
During resident rotations on inpatient wards there are typically several dedicated, one-hour discussions facilitated by the team's supervising attending, addressing a variety of internal medicine topics. In place of or in addition to one of these discussions, a gastroenterology fellow will meet with the team for one hour to discuss a standardized case of a patient with ascites and the management issues. At this time they will review the consensus guidelines for management, and be provided with a pocket card with key points.
A 4x6 inch laminated card will be administered to both intervention arms at the beginning of the study. The card will contain a brief summary of AASLD guidelines, indications for and contraindications to paracentesis, and key studies to order for fluid analysis. The organization of residency rotations is such that members of one randomization group do not typically work with members of other groups, however in the event that there is crossover, they will be free to share information as they see fit in order to optimize patient care.
The intensive education arm will be given a pager number at their initial meeting that they can use to call for personal assistance with performing paracentesis. Since a paracentesis is frequently referred to by housestaff as a "tap," the pager number will correlate with the letters, "TAPS," or #8277. The goal of the pager is to provide supervision and individual teaching so that the care provider can become proficient in the procedure.
Eligibility Criteria
You may qualify if:
- All house-staff in the Internal Medicine Residency training program at Boston Medical Center; House-staff participating in Internal Medicine inpatient rotations as part of preliminary training for other specialties
You may not qualify if:
- House-staff participating in inpatient rotations not supervised by the Department of Internal Medicine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
Related Publications (5)
Runyon BA; AASLD Practice Guidelines Committee. Management of adult patients with ascites due to cirrhosis: an update. Hepatology. 2009 Jun;49(6):2087-107. doi: 10.1002/hep.22853. No abstract available.
PMID: 19475696BACKGROUNDKashner TM, Henley SS, Golden RM, Byrne JM, Keitz SA, Cannon GW, Chang BK, Holland GJ, Aron DC, Muchmore EA, Wicker A, White H. Studying the effects of ACGME duty hours limits on resident satisfaction: results from VA learners' perceptions survey. Acad Med. 2010 Jul;85(7):1130-9. doi: 10.1097/ACM.0b013e3181e1d7e3.
PMID: 20592508BACKGROUNDChahla M, Eberlein M, Wright S. The effect of providing a USB syllabus on resident reading of landmark articles. Med Educ Online. 2010 Jan 29;15. doi: 10.3402/meo.v15i0.4639.
PMID: 20165697BACKGROUNDTomolo A, Caron A, Perz ML, Fultz T, Aron DC. The outcomes card. Development of a systems-based practice educational tool. J Gen Intern Med. 2005 Aug;20(8):769-71. doi: 10.1111/j.1525-1497.2005.0168.x.
PMID: 16050891BACKGROUNDWalton JM, Steinert Y. Patterns of interaction during rounds: implications for work-based learning. Med Educ. 2010 Jun;44(6):550-8. doi: 10.1111/j.1365-2923.2010.03626.x.
PMID: 20604851BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Large number of participants lost to analysis because they forgot their secret personal ID number. The IRB had required we not have a way to link surveys to particular residents, and so lost power with loss of many residents.
Results Point of Contact
- Title
- Brian Jacobson, MD, Principal Investigator
- Organization
- Boston Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Jacobson, MD
Boston Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
July 26, 2011
First Posted
July 27, 2011
Study Start
January 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
October 31, 2012
Results First Posted
October 31, 2012
Record last verified: 2012-09