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Improving Pediatric Safety and Quality With Health Care Information Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00134823
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : July 21, 2011
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 23, 2005
First Posted Date  ICMJE August 25, 2005
Last Update Posted Date July 21, 2011
Study Start Date  ICMJE March 2005
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2011)
Impact on rates of medication errors [ Time Frame: 1 year ]
difference in weight related medication prescribing errors by drug class
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2005)
  • 1. Impact on rates of medication errors, adverse drug events, and potential adverse drug events.
  • 2. Influence on physician guideline adherence for chronic conditions.
  • 3. Influence on the rate of follow-up procedures, provider satisfaction, and patient satisfaction related to follow-up procedures.
  • 4. Impact of diagnosis-based medication recommendations on generic prescribing and guideline adherence.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Pediatric Safety and Quality With Health Care Information Technology
Official Title  ICMJE Improving Pediatric Safety and Quality With Health Care IT
Brief Summary

This study includes four projects aimed to improve the quality and safety of pediatric care through the implementation of four clinical decision support services in the electronic health record (EHR). The four projects will measure the effect of each clinical decision support feature including: weight-based dosing; smart forms for chronic conditions; guideline reminders; and a results manager to track abnormal lab result follow-up.

Hypothesis: Implementation of the clinical decision support features will decrease medication errors and adverse drug events, assist physicians in adhering to clinical practice guidelines and protocols for certain chronic illnesses, improve physician follow-up for abnormal lab results, and overall improve the safety and quality of pediatric clinical practice.

Detailed Description please see description above
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Medication Errors
  • Medical Records Systems, Computerized
  • Patient Safety
  • Quality Improvement
Intervention  ICMJE Other: weight based dosing decision support
weight based dosing decision support
Study Arms  ICMJE
  • Experimental: dosing decision support
    weight based dosing decision support
    Intervention: Other: weight based dosing decision support
  • No Intervention: no decision support
    no weight based dosing decision support
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2005)
5420
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Partners-affiliated pediatric practice providers utilizing Longitudinal Medical Record (LMR), which is an electronic health record system. Also the parents of the patients of the above noted pediatric providers.

Exclusion Criteria:

  • Non-Partners providers, or Partners providers who do not use LMR. Parents of patients not seen by Partners-affiliated pediatric providers who use LMR.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00134823
Other Study ID Numbers  ICMJE 2004-P-002027
HS015002-01 ( Other Grant/Funding Number: AHRQ )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timothy G Ferris, Mass General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Timothy G Ferris, MD, MPH Massachusetts General Hospital, Partners Healthcare System Inc.
PRS Account Massachusetts General Hospital
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP