Trial Outcomes & Findings for Improving Performance of Paracentesis in Medical Residency Training (NCT NCT01403987)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

136 participants

Primary outcome timeframe

6 months

Results posted on

2012-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Control Arm Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.	Intermediate Education Arm 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.	Intensive Education Arm ("Pager" Arm) 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.
Overall Study STARTED	34	34	68
Overall Study COMPLETED	16	17	50
Overall Study NOT COMPLETED	18	17	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Arm Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.	Intermediate Education Arm 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.	Intensive Education Arm ("Pager" Arm) 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.
Overall Study Residents forgot their secret PIN	18	17	18

Baseline Characteristics

Improving Performance of Paracentesis in Medical Residency Training

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Arm n=34 Participants Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.	Intermediate Education Arm n=34 Participants 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.	Intensive Education Arm ("Pager" Arm) n=68 Participants 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.	Total n=136 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants	136 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex/Gender, Customized	NA Number of participants n=5 Participants	NA Number of participants n=7 Participants	NA Number of participants n=5 Participants	0 Number of participants n=4 Participants
Region of Enrollment United States	34 participants n=5 Participants	34 participants n=7 Participants	68 participants n=5 Participants	136 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Those who provided both baseline and follow up surveys

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.

Outcome measures

Outcome measures
Measure	Control Arm n=16 Participants Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.	Intermediate Education Arm n=17 Participants 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.	Intensive Education Arm ("Pager" Arm) n=50 Participants 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.
Score Out of Total Possible 25 on a Likert Scale.	21 units on a Likert scale (maximum is 25) Standard Deviation 5	21 units on a Likert scale (maximum is 25) Standard Deviation 5	20 units on a Likert scale (maximum is 25) Standard Deviation 5

SECONDARY outcome

Timeframe: 18 months

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.

Outcome measures

Outcome measures
Measure	Control Arm n=16 Participants Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.	Intermediate Education Arm n=17 Participants 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.	Intensive Education Arm ("Pager" Arm) n=50 Participants 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.
Improvement in Guideline Adherence	44 percentage of participants	53 percentage of participants	80 percentage of participants

SECONDARY outcome

Timeframe: 18 months

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)

Outcome measures

Outcome measures
Measure	Control Arm n=16 Participants Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.	Intermediate Education Arm n=17 Participants 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.	Intensive Education Arm ("Pager" Arm) n=50 Participants 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.
Readmission and Mortality Rates	60 percentage of patients	60 percentage of patients	60 percentage of patients

Adverse Events

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intermediate Education Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intensive Education Arm ("Pager" Arm)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian Jacobson, MD, Principal Investigator

Boston Medical Center

Phone: 617-6386563

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place