Simulated Diabetes Training for Resident Physicians

Type 2 Diabetes Clinical Trial

— SDT  

Official title:

Simulated Diabetes Training for Resident Physicians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979823
• Other study ID #: X0710100 Resident SimCare
• Secondary ID: R18DK079861
• Status: Completed
• Phase: N/A
• First received: September 16, 2009
• Last updated: December 1, 2014
• Start date: September 2010
• Est. completion date: July 2013

Study information

• Verified date: December 2014
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Other:
• Early SimCare Diabetes Group
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.
• Delayed SimCare Diabetes Group
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

Locations

Country	Name	City	State
United States	HealthPartners Research Foundation	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment according to evidence-based diabetes goals		September 2010 - July 2013	No
Primary	Drug intensification		September 2010 - July 2013	No
Primary	Number of risky prescribing events		September 2010 - July 2013	No
Secondary	Secondary analyses will evaluate the actual use of the tool by residents, direct costs of the program, and resident satisfaction.		July 2011 - January 2013	No