Improving Medical Training for the Care of Chronic Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00676208
First received: May 7, 2008
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

While medical training has increasingly included chronic care management, quality care necessitates education approaches that go farther. In April 2005, the Louis Stokes Cleveland VAMC implemented a weekly Diabetes Shared Medical Appointment (SMA). Our recently published initial results and updated information for 334 patients documented improved results that have been sustained. As such, SMAs offer an important opportunity to improve chronic care and a unique setting for training physicians. In order to equip physicians with needed resources to manage chronic care, the ways in which SMA experiences are processed and integrated into learning about interdisciplinary approaches and expanding trainees' understanding of chronic care issues need to be examined. Building on previous pilot work, the proposed pilot project includes using a think-aloud protocol to evaluate and validate new items and scales assessing interdisciplinary team and chronic care/diabetes beliefs, and evaluating and adjusting direct observation coding tools for chronic condition care.


Condition Intervention Phase
Diabetes Mellitus
Behavioral: Barriers to self-care
Behavioral: Diabetes Attitude Scale-3
Behavioral: Challenges
Behavioral: Interdisciplinary teamwork scale
Behavioral: Advantages of SMA
Behavioral: Direct Observation
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Medical Training for the Care of Chronic Conditions

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Evaluate the impact of SMAs on residents' and medical students' confidence, attitudes, comfort and beliefs regarding chronic care issues and management of diabetes compared to other ambulatory training experiences. [ Time Frame: 4 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the feasibility of using direct observation to accurately measure and compare time utilization patterns and diabetes management issues covered by trainees during patient encounters, and to identify how traditional encounters with patients with [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: April 2008
Study Completion Date: February 2012
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Three groups of trainees (12 in each group) will be asked to complete structured questionnaires. All participants will complete the following questionnaires (20-minutes; self-administered) at baseline and then four weeks later after experiencing 4 SMAs for the first two groups (post-assessment): 1) beliefs about how easily patients can overcome barriers to self-care 2) Diabetes Attitude Scale-3 3) an 8-item scale about how often challenges are experienced by patients with diabetes 4) interdisciplinary teamwork scale and 5) 2 open-ended items about advantages SMAs have compared to traditional appointments, and concerns about SMAs as a way to treat patients with diabetes.
Behavioral: Barriers to self-care
16-items from Glasgow's instrument will be reworded, beliefs about how easily patients can overcome barriers to self-care
Behavioral: Diabetes Attitude Scale-3
33-ite,s, UM Diabetes Research and Training Center, which measures health care professionals' attitude toward diabetes and its treatment
Behavioral: Challenges
8-item scale about how often challenges are experienced by patients with diabetes (developed based on previous pilot work to assess changes in awareness and sensitivity to challenges faced by patients with chronic conditions.
Behavioral: Interdisciplinary teamwork scale
8-item Partnerships for Quality Education CITE survey
Behavioral: Advantages of SMA
2 Open ended items about advantages SMAs have compared to traditional appointments, and outcomes about SMAs as a way to treat patients with diabetes.
Active Comparator: Arm 2
Direct observation coding will be used to accurately measure process and content of patient-resident encounters, both traditional encounters and SMA-one-on-one encounters.
Behavioral: Direct Observation
Accurately measure process and content of patient-resident encounters.

Detailed Description:

: Most physicians receive training in and about an acute care-oriented health care system that cannot adequately address the challenges of chronic care management. While medical training has increasingly included chronic care management, quality care necessitates education approaches that go farther. In April 2005, the Louis Stokes Cleveland VAMC implemented a weekly Diabetes Shared Medical Appointment (SMA). Our recently published initial results (based on 44 SMA participants and 35 comparison patients) indicated that SMAs based on the chronic care model are effective in improving glycemic and blood pressure control in patients who are at high risk for cardiovascular morbidity including those previously labeled "non-compliant" or "non-adherent." (1) Updated information for 334 patients documented a mean change in A1c of -.9 (+/- 1.9), p<.001. The pre-SMA mean for this group was 9 (+/- 2.1) and the post-SMA was 8.4 (+/- 1.7). Thus, results from the SMAs are sustained and, as such, SMAs offer an important opportunity to improve chronic care and a unique setting for training physicians. SMAs offer the potential to provide training in crucial skills that have to date remained less amendable to traditional educational practices. In order to equip physicians with resources to effectively and efficiently manage chronic care, the ways in which SMA experiences are processed and integrated into learning about interdisciplinary approaches and expanding trainees' understanding of chronic care issues need to be examined. Without addressing this gap, it is not possible to develop a comprehensive care model that links education and patient outcomes for chronic conditions, such as diabetes. Our aims will help define relevant parameters to assess ways SMAs impact on beliefs, attitudes, and the processes and content of encounters regarding chronic condition and interdisciplinary care for patients with diabetes. Building on previous pilot work, we will continue to address evaluating and validating instruments to inform a larger grant application. The proposed pilot project includes using a think-aloud protocol to evaluate and validate new items and scales assessing interdisciplinary team and chronic care/diabetes beliefs, and evaluating and adjusting direct observation coding tools for chronic condition care.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

AIM and AIM 2 - Residents and Medical Students:

Inclusion:

- All residents and medical students participating in diabetes Shared Medical Appointment sessions or other training experiences during the course of the study.

Aim 2 Inclusion:

  • Attendings and other providers that the resident meets with during clinic (regular or diabetes SMAs) to discuss patient management issues.
  • Patients who the randomly selected residents see when being observed (shadowed).

Exclusion Criteria:

Aim 1 Exclusion:

- Residents and medical students who have participated in SMAs for patients with diabetes at the Cleveland VAMC in the past.

Aim 2 Exclusion:

  • Other attendings and providers.
  • Patients that the observed residents do not meet with during their scheduled clinic times
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676208

Locations
United States, Ohio
Louis Stokes VA Medical Center
Cleveland, Ohio, United States, 44106-3800
Sponsors and Collaborators
Investigators
Principal Investigator: David C Aron, MD MS Louis Stokes VA Medical Center
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00676208     History of Changes
Other Study ID Numbers: SHP 08-141
Study First Received: May 7, 2008
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Shared Medical Appointments
Diabetes
Education

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014