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

July 29, 2019 updated by: Marianne Burke, University of Vermont

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research design is a cluster randomized controlled trial of a computerized dermatology information source. This is a two-level design in which primary care providers (PCPs) who see patients for skin problems are the subjects of randomization. Their patients are the subjects of the data collection and analysis. The cluster design examines how much variation in the outcomes is attributable to the providers, how much to patients within the clusters, and how much to the intervention information source itself.

Provider Level:

After completing a baseline questionnaire, providers are randomized to intervention or control groups. Intervention group providers have an orientation to the study protocol that includes how to access and use VisualDx. Control providers receive the protocol overview, but no orientation to the intervention.

Intervention providers agree to refer to VisualDx content when they have a patient with a skin complaint. Control group providers agree not use VisualDx as a reference but may use another medical information source or none.

Patient Level:

To identify eligible patients, authorized investigators reviewed information from the patient record sufficient to send a letter to them over the provider's signature to notify them about the study. The letter gives the option to refuse any contact.

At 30 days after the primary care visit, a study team investigator phones each eligible patients, explains the study, and obtains verbal consent. The investigators are blinded to the randomized group status of the patients.

The investigator proceeds with the interview questionnaire on consent. Age, sex is collected. Patients are asked whether the skin problem is resolved ("Is it all better?"). For every resolved problem, we ask when (date or days since visit) it was resolved. We also ask how many return visits the patient has had with any provider for that problem.

If not resolved, the patient is called again at 60 days and asked the same questions. If not resolved then, we call the patient again at 90 days. The last call to any patient is at 90 days from the index visit for the problem.

Data Analysis and Statistical Measures

The primary predictor variable for both aims is the use of the VisualDx information source by the primary care provider.

For the "days to resolution" outcome variable, the time unit (days) and the status of the problem after 90 days (resolved or not resolved) will be evaluated for each group with Kaplan-Meier survival analysis and the non-parametric log rank test of significance.

For the "number of follow-up visits" outcome variable, the binary predictor (intervention group) and discrete outcome variable (number of visits) will be evaluated with Wilcoxon-rank sum test for non-normal data. The first visit of a patient to a participating provider for a skin problem is considered the index visit and that provider considered the index provider regardless of the provider seen on any subsequent appointment. Analysis will adhere to the intention-to-treat principle with group assignment determined by randomization regardless of whether VisualDx was deployed for care or not. Problems unresolved at the last contact will be censored as unresolved for the Kaplan-Meier analysis.

For aim 1, the estimated sample size to detect an average difference of 8 days in time to resolution with a standard deviation of 20 and an intra-cluster correlation (ICC) of 0.025. With alpha .05 and beta .80, the study would need a minimum 26 providers enrolled with an average 10 patient participants in each provider's cluster for a total of 286 participants completing the study. We planned to enroll at least 30 providers and up to 500 patients to insure against loss to follow-up of, increased standard deviation, or larger than anticipated Intra-Cluster Correlation.

Study Type

Interventional

Enrollment (Actual)

465

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Period of assessment was up to 3 months (90 days) after index visit.
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.
Period of Assessment is up to 90 days after index visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

University of Vermont Medical Center

Investigators

  • Principal Investigator: Marianne D Burke, PhD, University of Vermont
  • Study Chair: Benjamin Littenberg, MD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 15, 2016

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

October 1, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRMS 15-413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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