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Topical Corticosteroid App

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ClinicalTrials.gov Identifier: NCT02921503
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Joslyn S. Kirby, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE September 29, 2016
First Posted Date  ICMJE October 3, 2016
Last Update Posted Date August 15, 2018
Actual Study Start Date  ICMJE June 5, 2017
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
topical corticosteroid prescriptions [ Time Frame: 3 months ]
The primary endpoint of this study to be measured would be topical steroid prescription records (including unit sizes, potencies, and number of prescriptions) from study participants before and during use of this app.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02921503 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
user satisfaction [ Time Frame: 3 months ]
The study participants will also be asked to take surveys to rate user satisfaction and clinical utility.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Corticosteroid App
Official Title  ICMJE Impact of a Mobile App on Topical Corticosteroid Prescribing by Family Practitioners
Brief Summary The study aims to evaluate the effectiveness of a mobile application to assist in the prescription of topical corticosteroids (TCS), focusing on best fit choices of potency, vehicle and volume. The mobile application will be developed from the results obtained in a systematic literature review and quality assessment of clinical practice guidelines for topical corticosteroid use. The quality of the guidelines will be assessed using the AGREE II tool. After the app user enters in information concerning patients' rash location and desired treatment duration, the app will generate a list of recommended topical steroids (focusing on specific quantity and potency) for the patient's particular area of need. The objective of the study is to evaluate whether the use of a standardized application will change prescribing practices for primary care physicians, physician assistants and nurse practitioners.
Detailed Description

Primary Study Endpoints The primary endpoint of this study to be measured would be topical steroid prescription records (including unit sizes, potencies, and number of prescriptions) from study participants before and during use of this app.

Secondary Study Endpoints The study participants will also be asked to take surveys to rate user satisfaction and clinical utility.

2.1 Scientific Background and Gaps The literature has shown that patients with dermatologic conditions may not receive appropriate management by PCPs. Dermatologic conditions are common, affecting 20-36% of patients in PCP offices; however PCPs report diagnostic and management uncertainty.1,2 PCPs have been shown to prescribe either inappropriately high-potency TCS or, conversely, inappropriately low-potency TCS.3 In addition, it was recently found that drug costs may be higher if multiple small tubes are dispensed over the treatment course.4 Thus, there are opportunities to reduce cost by prescribing larger units, when indicated; however PCPs may not have the knowledge to effectively and cost-efficiently prescribe TCS. Teaching this information is not sufficient, since most (71%) medical schools provided nine or fewer hours of instruction in the first two years.5 Importantly, mobile devices and apps provide significantly increased access to point-of-care tools and, with use by providers, demonstrate better clinical decision-making and improved patient outcomes.6,7 Thus, our goal is to develop a point-of-care decision support app to educate PCPs while facilitating evidence-based care and lower health care costs.

The mobile application will be developed by a team at Penn State Hershey from the results obtained in a systematic literature review and quality assessment of clinical practice guidelines for topical corticosteroid use. The quality of the guidelines will be assessed using the AGREE II tool. After the app user enters in information concerning patients' rash location and desired treatment duration, the app will generate a list of recommended topical steroids (focusing on specific quantity and potency) for the patient's particular area of need. It is ultimately up to the physician whether or not to follow or modify the recommended suggestions.

Study Rationale Smartphone applications are rising rapidly in popularity in the healthcare field. 85% of clinicians are reported as owners of smart phones, with 50% of them using apps in their practice.8 Use of smartphone technology and clinical decision support tools may mean improvements in primary care practices by assisting in the standardization of the prescribing practices for TCS while allowing dermatologists more availability for patients with higher need.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Topical Corticosteroid, Topical, Medication, Utilization
Intervention  ICMJE Other: mobile topical corticosteroid app
app used on mobile phones that takes the input of providers and suggests topical corticosteroids with specific information on the ingredient, vehicle, and amount
Study Arms  ICMJE Experimental: Topical Corticosteroids App Users
Practitioners will asked to use a novel application during their patient encounters over the next three months. This application should not modify treatment, it will only act as a vehicle to present evidence based research. Patients will not be subjects of this research, as the app is only presenting best practice which the physicians should be aware of.
Intervention: Other: mobile topical corticosteroid app
Publications * Not Provided

*   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 14, 2018)
13
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2016)
15
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Primary Care Providers in the Hershey Medical Center network:

    1. Attending physicians
    2. Physician assistants
    3. Nurse practitioners
  2. 18 years of age or older
  3. English speaking

Exclusion Criteria:

Those who do not fit the inclusion criteria.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02921503
Other Study ID Numbers  ICMJE 00005201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joslyn S. Kirby, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Milton S. Hershey Medical Center
Verification Date August 2018

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