NCT01403987

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

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

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, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 31, 2012

Completed
Last Updated

October 31, 2012

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

July 26, 2011

Results QC Date

July 9, 2012

Last Update Submit

September 30, 2012

Conditions

Keywords

EducationAscitesLiverGuidelines

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 COMPARATOR

Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.

Behavioral: Residency Program Teaching

Intermediate Education Arm

EXPERIMENTAL

In 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.

Behavioral: Residency Program TeachingBehavioral: LectureOther: Pocket Card Reference

Intensive Education Arm ("Pager" Arm)

EXPERIMENTAL

This 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.

Behavioral: Residency Program TeachingBehavioral: LectureOther: Pocket Card ReferenceBehavioral: Pager

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.

Also known as: Standard therapy
Control ArmIntensive Education Arm ("Pager" Arm)Intermediate Education Arm
LectureBEHAVIORAL

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.

Also known as: Didactic session
Intensive Education Arm ("Pager" Arm)Intermediate Education Arm

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.

Also known as: Visual aid
Intensive Education Arm ("Pager" Arm)Intermediate Education Arm
PagerBEHAVIORAL

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.

Also known as: One-on-one teaching
Intensive Education Arm ("Pager" Arm)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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: 19475696BACKGROUND
  • Kashner 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: 20592508BACKGROUND
  • Chahla 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: 20165697BACKGROUND
  • Tomolo 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: 16050891BACKGROUND
  • Walton 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

AscitesFibrosis

Interventions

Standard of CareAudiovisual Aids

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationEducational TechnologyTechnologyTechnology, Industry, and Agriculture

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

  • Brian Jacobson, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations