Evaluation of an Outpatient Modified Prescription Form | NCT00256594

Studies
Evaluation of an Outpatient Modified Prescription Form

NCT00256594

Sponsor

University of Vermont

Status

Completed

Last Update Posted

Dec 15, 2011Estimated

Enrollment

84Actual

Phase

Not Applicable

Conditions

Medication Errors

Interventions

prescription form

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Feb 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Nov 17, 2005

First Submission Date that Met QC Criteria

Nov 17, 2005

First Posted Date

Nov 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2011

Last Update Posted Date

Dec 15, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amanda Kennedy, Assistant Professor of Medicine, University of VermontPrincipal Investigator

Lead Sponsor

University of VermontOTHER

Collaborators

Name	Class
Health Resources and Services Administration (HRSA)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

To determine if a modified paper prescription form decreases overall prescribing errors compared to a standard paper prescription form
To determine if a modified paper prescription form decreases omission errors compared to a standard paper prescription form
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
prescription form	Device	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
error rates of standard versus modified prescriptions per prescriber		200 prescriptions each

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amanda G Kennedy, PharmD	University of Vermont	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Vermont, Division of General Internal Medicine		Burlington	Vermont	05401	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15469125	Background	Kennedy AG, Littenberg B. A modified outpatient prescription form to reduce prescription errors. Jt Comm J Qual Saf. 2004 Sep;30(9):480-7. doi: 10.1016/s1549-3741(04)30056-0.
21200063	Result	Kennedy AG, Littenberg B, Callas PW, Carney JK. Evaluation of a modified prescription form to address prescribing errors. Am J Health Syst Pharm. 2011 Jan 15;68(2):151-7. doi: 10.2146/ajhp100063.

Type	Date	Date Unknown
Release	Dec 9, 2013
Reset	Jan 24, 2014