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Evaluation of an Outpatient Modified Prescription Form

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ClinicalTrials.gov Identifier: NCT00256594
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : December 15, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if a modified paper prescribing form decreases prescribing errors compared to a traditional or standard paper prescribing form.

Condition or disease Intervention/treatment
Medication Errors Device: prescription form

Detailed Description:

The broad goal of this proposal is to reduce outpatient prescribing errors in rural primary care practices. Although computerized technology is available for prescribing, it has not yet been implemented in most settings. Additionally, rural prescribers will likely be the last to have the means to adopt this technology. Due to the substantial morbidity and mortality in the United States caused by outpatient medication errors, there is an urgent need for low-cost solutions. This research plan will evaluate a modified paper prescription form that may be implemented in rural primary care settings cheaply and quickly with the goal of outpatient prescription error reduction.

The specific aims of this project are:

  1. To determine if a modified paper prescription form decreases overall prescribing errors compared to a standard paper prescription form
  2. To determine if a modified paper prescription form decreases omission errors compared to a standard paper prescription form
  3. To determine prescriber satisfaction with the modified prescription form

Rural prescribers from four states will be randomly recruited to write prescriptions on standard and modified forms. Prescription duplicates of both types will be analyzed for errors. Prescriber satisfaction with the modified form will be evaluated using surveys and focus groups.

Medication errors are a public health problem. Low-cost technology that is shown to reduce medication errors would benefit all rural patients who receive prescriptions.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of an Outpatient Modified Paper Prescription Form in 4 Rural States to Address the Public Health Problem of Prescribing Error
Study Start Date : August 2005
Primary Completion Date : February 2010
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: prescription form
    Two prescription pads contained modified forms and two prescription pads were similar to the prescription pads the prescriber had been using. Providers completed 100 standard and 100 modified prescriptions

Outcome Measures

Primary Outcome Measures :
  1. error rates of standard versus modified prescriptions per prescriber [ Time Frame: 200 prescriptions each ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be a physician, nurse practitioner, or physician assistant with a current license to write outpatient prescriptions
  • Must practice in Family Practice, Internal Medicine, or Pediatrics
  • Must practice in rural Vermont, West Virginia, South Dakota, or Montana
  • Must write outpatient paper prescriptions
  • Must write prescriptions in English

Exclusion Criteria:

  • Not licensed to write prescriptions
  • Practice in a specialty, inpatient, or long term care setting
  • Do not write paper prescriptions
  • Do not write prescriptions in English
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256594


Locations
United States, Vermont
University of Vermont, Division of General Internal Medicine
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Amanda G Kennedy, PharmD University of Vermont