Simulated Diabetes Training for Resident Physicians (SDT)

December 1, 2014 updated by: HealthPartners Institute

The objective of this translational research is to study the effect of implementing an innovative simulated diabetes learning intervention within primary care residency programs. The intervention uses cognitive behavioral learning theory to provide goal-directed feedback to residents after every encounter over a series of virtual patient-physician encounters. Formulas derived from pharmacokinetic data and the experience of clinical experts model simulated physiologic responses to drug changes, health behaviors, and adherence factors. The online intervention is economical, sustainable, and addresses a number of current obstacles to outpatient diabetes training in primary care residency programs.

In this group trial, we randomly assign about 20 primary care residency programs with up to 700 residents total to either an (a) Early learning program group or (b) Delayed learning program group. We will assess the ability of residents to achieve evidence-based diabetes clinical goals and avoid potential medical safety issues for glycemia, blood pressure, and lipids on simulated assessment cases. Secondary analyses will evaluate the actual use of the tool by residents, direct costs of the program, and resident satisfaction.

Study Overview

Detailed Description

Specific aim 1: To examine the impact of a simulated case-based learning intervention on measures of quality of diabetes care delivered by primary care residents to simulated adult patients with diabetes mellitus.

Hypothesis 1: Compared to delayed SimCare Diabetes learning program group residents, those residents in the early SimCare Diabetes learning program group will treat a higher proportion of simulated patients to evidence based diabetes goals including glycemic control (A1c < 7%), blood pressure control (BP < 130/80 mm Hg), and lipid control (evidence-based LDL, Triglyceride, and HDL levels).

Specific aim 2: To examine the impact of a simulated case-based learning intervention on rates of appropriate drug intensification and number of risky prescribing events in the management of simulated adult patients with diabetes mellitus.

Hypothesis 2: Compared to delayed SimCare Diabetes learning program group residents, those residents in the early SimCare Diabetes learning program group will have improved rates of appropriate drug intensification in simulated assessment cases.

Hypothesis 3: Compared to delayed SimCare Diabetes learning program group residents, those residents in the early SimCare Diabetes learning program group will have a lower number of risky prescribing events in simulated assessment cases.

Study Type

Interventional

Enrollment (Actual)

341

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55440
        • HealthPartners Research Foundation

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Study subjects include up to 700 first, second, third, and fourth year primary care residents from a minimum of 20 residency programs across the country. To become a partner in this study, programs must meet the eligibility criteria listed below:

To be eligible for partnership in this study, a program must meet all the following criteria:

a) be an accredited family medicine or internal medicine/med-peds training program within the U.S., (b) have a minimum of 12 residents within the standard 3- to 4-year program, (c) the program director must endorse and be willing to offer SimCare Diabetes to all residents within the program and provide residents (with help from the study staff) with the explanatory and registration materials, (d) the residency program director must sign a letter of agreement with the research team specifying the responsibilities of the research team and of the residency program in addressing the specific needs of this project, (e) the residency program director must agree to complete a residency program director survey, which provides insight into the general characteristics of the residency program, and provide diabetes quality measurement data from at least one resident ambulatory clinic pre-intervention (around October/November 2010) and post-intervention (around June/July 2011), (f) residents within the program must have high speed internet access, and (g) if randomized to the delayed learning program group, the program must be willing to postpone SimCare Diabetes until after the post-intervention assessment cases are completed.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early SimCare Diabetes Group
This group will receive an email web-link to 3 simulated learning cases each month for 6 months. After 6 months (18 total learning cases), they will then complete 4 simulated assessment cases, a diabetes knowledge survey, and a satisfaction survey.
Residents in the early learning program group will participate in the learning cases before undergoing a knowledge and performance assessment. They will complete 18 learning cases, 4 assessment cases, knowledge survey, and a satisfaction survey.
Active Comparator: Delayed SimCare Diabetes Group
Beginning in the spring of 2011, residents in this group will receive an email web-link to complete 4 simulated assessment cases and a diabetes knowledge survey. They will subsequently be sent 3 learning cases a month for 6 months and a satisfaction survey to complete.
Residents in the delayed learning program group will receive their usual diabetes training through their residency program for 8 months before completing the knowledge and performance assessment, and then will subsequently be offered the learning program. They will receive 4 assessment cases, knowledge survey, and satisfaction survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment according to evidence-based diabetes goals
Time Frame: September 2010 - July 2013
September 2010 - July 2013
Drug intensification
Time Frame: September 2010 - July 2013
September 2010 - July 2013
Number of risky prescribing events
Time Frame: September 2010 - July 2013
September 2010 - July 2013

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary analyses will evaluate the actual use of the tool by residents, direct costs of the program, and resident satisfaction.
Time Frame: July 2011 - January 2013
July 2011 - January 2013

Collaborators and Investigators

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

Investigators

  • Principal Investigator: JoAnn M Sperl-Hillen, MD, HealthPartners Institute

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.

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

September 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 16, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (Estimate)

September 18, 2009

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • X0710100 Resident SimCare
  • R18DK079861 (U.S. NIH Grant/Contract)

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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