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Topical Corticosteroid, Topical, Medication, UtilizationNCT02921503

Topical Corticosteroid App

A study testing mobile topical corticosteroid app in people with Topical Corticosteroid, Topical, Medication, Utilization, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
mobile topical corticosteroid app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
5 Jun 2017to 1 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Primary Care Providers in the Hershey Medical Center network:
  • Attending physicians
  • Physician assistants
  • Nurse practitioners
  • 18 years of age or older
  • English speaking

Who cannot join

  • Those who do not fit the inclusion criteria.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Department of Dermatology, Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: Impact of a Mobile App on Topical Corticosteroid Prescribing by Family Practitioners

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.

Read the 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.

Being tested
mobile topical corticosteroid app
Medical subject headings
Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mobile topical corticosteroid appOther

    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 groups in NCT02921503
Study groupRoleWhat they receive
Topical Corticosteroids App UsersExperimentalPractitioners 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.
Receives: Other: mobile topical corticosteroid app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. topical corticosteroid prescriptions

    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.

    Measured: 3 months

Secondary outcomes (1)
  1. user satisfaction

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2016 (estimated)
  2. Study start5 Jun 2017
  3. Primary completion1 Jun 2018
  4. Study completion1 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02921503
Sponsor's protocol ID
00005201
Status last verified
Aug 2018
First submitted
29 Sep 2016
Last updated
15 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing mobile topical corticosteroid app in people with Topical Corticosteroid, Topical, Medication, Utilization, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

topical corticosteroid prescriptions (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.

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