An interventional study of Residency Program Teaching and Lecture in Ascites and Cirrhosis, sponsored by Boston Medical Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2012-10-31.
Sponsored by Boston Medical Center · Not applicable and Interventional
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.
Since 2004 the American Association for the Study of Liver Disease (AASLD) has well-established guidelines for management of liver failure patients that is based on expert review of current literature. These guidelines address the initial evaluation of patients admitted to the hospital with complications of their liver disease, including patients with abdominal distention from fluid accumulation. In many cases, evaluation of this intraabdominal fluid, or ascites, performed using paracentesis, a procedure in which fluid is withdrawn from the abdomen and sent for laboratory analysis, is indicated, and the results of which will guide further treatment. Despite these guidelines, there remains significant variability in practice among inpatient providers.
The study will begin with a chart review to identify compliance with, and barriers to, evidence-based recommendations. A baseline survey of house-staff in the internal medicine department will be used to identify knowledge base and perceived barriers to implementation of best practices as defined by AASLD. The house-staff will subsequently be divided into three intervention groups for administration and evaluation of different teaching tools. A control group will have internet access to AASLD guidelines and undergo teaching that is already provided by the residency program. The second group will receive the baseline teaching, but also receive a pocket-card outlining recommendations and participate in a short, dedicated lecture to reinforce the guidelines. The third group will receive the pocket card, lecture, and a pager number to call for individual education at the time that cases arise. The groups will be followed for a period of six months, after which they will participate in an exit survey for reassessment of knowledge and perceived barriers, and a chart review will be conducted for comparison of data.
The primary outcome will be subjective improvement in practice based on survey results. Secondary outcomes will be measurement of actual and perceived benefit of pocket card, lecture, and individual education, determined by knowledge based questions on the survey, and improvement in patient clinical outcomes based on chart review noting particularly 30-day readmission rate and 90-day mortality.
259 studies on the registry are indexed under Ascites; 52 are open to participants now.
This study's enrollment of 136 is above the median of 55 across 181 interventional studies indexed under Ascites.
Browse Ascites studies →Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
Behavioral: Residency Program Teaching
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 Teaching · Behavioral: Lecture · Other: Pocket Card Reference
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 Teaching · Behavioral: Lecture · Other: Pocket Card Reference · Behavioral: Pager
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
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
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
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
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.
Time frame: 6 months
Improvement in Guideline Adherence
Improvement in adherence to AASLD guidelines is summarized as yes or no improvement based on investigator chart review performed prior to and after the intervention. This is not a measure of resident reporting adherence but rather investigator interpretation of patient care and whether care was in line with published guidelines.
Time frame: 18 months
Readmission and Mortality Rates
Percentage of patients in each arm that were either readmitted within 30 days or died within 90 days (ie a combined endpoint of either/or readmission or death)
Time frame: 18 months
| Milestone | Control Arm | Intermediate Education Arm | Intensive Education Arm ("Pager" Arm) |
|---|---|---|---|
| Started | 34 | 34 | 68 |
| Completed | 16 | 17 | 50 |
| Not completed | 18 | 17 | 18 |
| Withdrew: Residents forgot their secret pin | 18 | 17 | 18 |
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.
| units on a Likert scale (maximum is 25) | Control Arm | Intermediate Education Arm | Intensive Education Arm ("Pager" Arm) |
|---|---|---|---|
| Score Out of Total Possible 25 on a Likert Scale. | 21 ± 5 | 21 ± 5 | 20 ± 5 |
Improvement in adherence to AASLD guidelines is summarized as yes or no improvement based on investigator chart review performed prior to and after the intervention. This is not a measure of resident reporting adherence but rather investigator interpretation of patient care and whether care was in line with published guidelines.
| percentage of participants | Control Arm | Intermediate Education Arm | Intensive Education Arm ("Pager" Arm) |
|---|---|---|---|
| Improvement in Guideline Adherence | 44 | 53 | 80 |
Percentage of patients in each arm that were either readmitted within 30 days or died within 90 days (ie a combined endpoint of either/or readmission or death)
| percentage of patients | Control Arm | Intermediate Education Arm | Intensive Education Arm ("Pager" Arm) |
|---|---|---|---|
| Readmission and Mortality Rates | 60 | 60 | 60 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Arm | — | 0/34 (0%) | 0/34 (0%) |
| Intermediate Education Arm | — | 0/34 (0%) | 0/34 (0%) |
| Intensive Education Arm ("Pager" Arm) | — | 0/68 (0%) | 0/68 (0%) |
| Age, Categorical(Participants) | Control Arm | Intermediate Education Arm | Intensive Education Arm ("Pager" Arm) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 34 | 34 | 68 | 136 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex/Gender, Customized(Number of participants) | Control Arm | Intermediate Education Arm | Intensive Education Arm ("Pager" Arm) | Total |
|---|---|---|---|---|
| Number | NA | NA | NA | 0 |
| Region of Enrollment(participants) | Control Arm | Intermediate Education Arm | Intensive Education Arm ("Pager" Arm) | Total |
|---|---|---|---|---|
| United States | 34 | 34 | 68 | 136 |
The record gives a start of Jan 2011, a primary completion of Mar 2012 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2012, 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.