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The Impact of a Dermatology Information Source on Skin Problem Outcomes in Primary Care

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ClinicalTrials.gov Identifier: NCT02922738
Recruitment Status : Completed
First Posted : October 4, 2016
Results First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
University of Vermont Medical Center
Information provided by (Responsible Party):
Marianne Burke, University of Vermont

Brief Summary:

Health care providers use a variety of computerized medical information sources to reduce knowledge gaps and support patient care decisions. Few studies have evaluated the impact of medical information sources on patient outcomes. Skin problems are the reason for many visits to primary care providers and result in a high percentage of referrals to dermatologists and return visits to primary care for the same skin problem.

The objective is to evaluate the impact of primary care providers' use of a dermatology information source, VisualDx, on skin problems outcomes.

The study design is a cluster-randomized controlled trial. Participants include primary care providers as clusters and their patients with skin problems. Providers are randomized to intervention group that refers to VisualDx when seeing a patient with a skin problem, or to the control group who does not. Patients have the randomized group status of the doctor they saw for the problem.

Patients are interviewed to determine the problem status and how many follow-up visits they had for the problem at intervals after the index visit.


Condition or disease Intervention/treatment Phase
Decision Support Systems,Clinical Skin Diseases Other: VisualDx Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: The Impact of a Dermatology Information Source on Skin Problem Outcomes in Primary Care
Study Start Date : June 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Arm Intervention/treatment
Experimental: Intervention - VisualDx Arm
Arm had 2 levels: provider (cluster) level and patient level. Providers, randomly assigned to the intervention arm, refer to VisualDx when they saw a patient who presented with a skin problem. Their patients were assigned to the intervention group and interviewed about the outcomes of their treatment.
Other: VisualDx
VisualDx is a computerized clinical information technology with medical image and text content in dermatology.

No Intervention: Control - Usual Care Arm
Arm had 2 levels: provider (cluster) level and patient level. Providers, randomly assigned to control, did not refer to VisualDx but could refer to other information sources or none per usual care. Their patients were assigned to the control group and interviewed about the outcomes of their treatment



Primary Outcome Measures :
  1. Number of Patients With Resolved Skin Problems [ Time Frame: Period of assessment was up to 3 months (90 days) after index visit. ]
    Resolved skin disease status was assessed by phone interview. Patient reported status. Patients were censored if "unresolved" at 90 days.

  2. Number of Follow-Up Visits to Any Provider for the Same Problem [ Time Frame: Period of Assessment is up to 90 days after index visit ]
    Follow-up visits count is assessed at each phone interview. Patients report return visits.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients seen by a participating Primary Care Provider for a chronic or acute skin problem

Exclusion Criteria:

  • Skin problems due to burns or lacerations
  • Cognitively impaired, mentally ill, prisoners, non-English speaking

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): NCT02922738


Sponsors and Collaborators
University of Vermont
University of Vermont Medical Center
Investigators
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Principal Investigator: Marianne D Burke, PhD University of Vermont
Study Chair: Benjamin Littenberg, MD University of Vermont

Additional Information:
Publications:
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Responsible Party: Marianne Burke, Associate Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT02922738    
Other Study ID Numbers: CHRMS 15-413
First Posted: October 4, 2016    Key Record Dates
Results First Posted: July 30, 2019
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marianne Burke, University of Vermont:
Clinical Knowledge Systems, Decision support, Dermatology
Technology Assessment
Additional relevant MeSH terms:
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Skin Diseases