MedDataX Logo

Simulated Diabetes Training for Resident Physicians

NCT ID: NCT00979823

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Early SimCare Diabetes Group

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Delayed SimCare Diabetes Group

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

JoAnn M Sperl-Hillen, MD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HealthPartners Research Foundation

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Sperl-Hillen JM, O'Connor PJ, Rush WA, Johnson PE, Gilmer T, Biltz G, Asche SE, Ekstrom HL. Simulated physician learning program improves glucose control in adults with diabetes. Diabetes Care. 2010 Aug;33(8):1727-33. doi: 10.2337/dc10-0439.

Reference Type DERIVED
PMID: 20668151 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R18DK079861

Identifier Type: NIH

Identifier Source: secondary_id

View Link

X0710100 Resident SimCare

Identifier Type: -

Identifier Source: org_study_id