Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Diffusion of Use of Low Molecular Weight Heparin for Thrombosis on the Medicine Services

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Chicago.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00203970
First received: September 12, 2005
Last updated: September 4, 2013
Last verified: August 2010
  Purpose

The purpose of this research is to gain insight into the way in which physicians adopt new practice techniques. In particular, we are interested in how medical innovations diffuse throughout social networks. We wish to examine the diffusion of Low Molecular Weight Heparin (LMWH) use for Deep Vein Thrombosis (DVT) throughout the social network of general internal medicine interns, residents, and attendings at the University of Chicago Hospital. In numerous clinical trials, LMWH has been demonstrated to be as effective as unfractionated heparin as a bridge to long-term anticoagulation therapy with Coumadin, with the added benefit of early discharge from the hospital with easy dosing, no need for monitoring, and home therapy. A DVT critical pathway was established at the U of C in 1998, and LMWH was used off-label for that purpose beginning in 1997. However, it is unclear how quickly the use of LMWH was adopted by the physicians on the general medicine services, or whether there exists a pattern for this adoption.


Condition Intervention
Thrombosis
Behavioral: Observation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Diffusion of Use of Low Molecular Weight Heparin for Thrombosis on the Medicine Services

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • retrospective chart review to determine how patients with deep venous thromboses or pulmonary emboli were treated when hospitalized on the medicine services [ Time Frame: June 1997 to December 2000 ] [ Designated as safety issue: No ]
    Using the data abstraction form, we gathered the following information: 1) patient demographics, 2) the identity of the attending, resident, and intern caring for the patient, 3) whether the patient had any absolute or relative contraindications for receiving LMWH, as delineated by the DVT critical pathway, including insurance status and 4) how the patient was treated for his/her condition.


Enrollment: 645
Study Start Date: February 2001
Estimated Study Completion Date: January 2014
Primary Completion Date: March 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Observation
    Using a data abstraction form, we wish to gather the following information: 1) Patient demographics 2) identity of the attending, residents, and interns caring for the patient 3)whether the patient had any absolute or relative contraindications for receiving LMWH 4) how the patient was treated for his/her condition
Detailed Description:

The design of our study is retrospective in nature. We are interested primarily in the use of LMWH in patients admitted to the general medicine services between January 1, 1997 and February 1, 2001 with a primary and secondary diagnosis related to Venous Thromboembolism, including specific ICD-9 codes.

Using a data abstraction form, we gather the following information: 1) patient demographics, 2) identity of the attending, resident, and interns caring for the patient, 3) whether the patient had any absolute or relative contraindications for receiving LMWH, as delineated by the DVT critical pathway, including insurance status and 4)how the patient was treated for his/her condition. To examine whether the identity of the primary care physician affects whether LMWH is given, we also collect the name of the primary care physician if it is listed on the chart.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients admitted into the general medicine services with a primary or secondary diagnosis related to Venous Thromboembolism.

Criteria

Inclusion Criteria:

  • Patients admitted to General Medicine Services with a primary or secondary diagnosis related to venous thromboembolism

Exclusion Criteria:

  • Non-General Medicine Services patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203970

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: David Meltzer, M.D., Ph.D. University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00203970     History of Changes
Other Study ID Numbers: 10895A
Study First Received: September 12, 2005
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Thrombosis
Low Molecular Weight Heparin

Additional relevant MeSH terms:
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Dalteparin
Heparin
Heparin, Low-Molecular-Weight
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014