Improving Medical Training for the Care of Chronic Conditions

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00676208
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

While medical training has increasingly included chronic care management, quality care necessitates education approaches that go farther. In April 2005, the Louis Stokes Cleveland Veterans Affairs Medical Center (VAMC) implemented a weekly Diabetes Shared Medical Appointment (SMA). 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Behavioral: Shared Medical Appointments	N/A

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). Results indicate that 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. Building on previous pilot work, we continued to address evaluating and validating instruments. The proposed pilot project included 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving Medical Training for the Care of Chronic Conditions
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Shared Medical Appointments Medical students participated in shared medical appointments for patients with diabetes for one month.	Behavioral: Shared Medical Appointments; Participated in shared appointments for patients as part of interprofessional team providing care for diabetes
No Intervention: No shared medical appointments Medical students in this arm did not participate in shared medical appointments.

Outcome Measures

Primary Outcome Measures

1. Change in Confidence in Ability to Perform Teamwork [Pre-intervention and Post-Intervention at 1 month]

   A three item scale was used to assess confidence in ability to convey logic of recommendations to other providers, explain one's distinctive perspective, and be accountable to patients for a decision made by a colleague from another discipline. The responses for each item ranged from 'not at all confident' (0) to 'very confident' (4), with higher values indicating more confidence. The total scale ranged from 0 to 16 with higher being more confident. Difference scores were analyzed (post-pre) with positive and higher values indicating more favorable change.

Secondary Outcome Measures

1. Change in Professionals' Attitudes About Diabetes [Pre-intervention and Post-intervention at 1 month]

   The University of Michigan's Research and Training Center's Diabetes Attitude Scale was used. There are 33 items and the response format is a 5 point Likert Scale ranging from 'strongly disagree'(1) to 'strongly agree'(5). A higher score means more positive attitudes toward diabetes and its treatment (e.g., psychosocial impact of diabetes; value of tight glucose control).The total score is computed by summing individual items and ranges from 0 to 165. Post-pre total scores were used with positive and higher values indicating greater favorable change.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Medical Students:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: David C Aron, MD MS, Louis Stokes VA Medical Center, Cleveland, OH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00676208
• Other Study ID Numbers: SHP 08-141
• First Posted: May 12, 2008
• Last Update Posted: Sep 23, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by VA Office of Research and Development: Shared Medical Appointments; Diabetes; Education

Study Results

Participant Flow

Arm/Group Title	Intervention	Comparison
Arm/Group Description	Medical Students who are assigned to observe Shared Medical Appointments.	Medical students who do not experience Shared Medical Appointments during the study period April to August 2008.
Period Title: Overall Study
STARTED	14	19
COMPLETED	12	13
NOT COMPLETED	2	6

Baseline Characteristics

Arm/Group Title	SMA Participants	Comparison	Total
Arm/Group Description	Medical Students who were assigned to observe Shared Medical Appointments (SMA).	Medical students who do not experience Shared Medical Appointments.	Total of all reporting groups
Overall Participants	14	19	33
Age (Count of Participants)
<=18 years	NA NaN	NA NaN	NA NaN
Between 18 and 65 years	NA NaN	NA NaN	NA NaN
>=65 years	NA NaN	NA NaN	NA NaN
Sex/Gender, Customized (participants) [Number]
Not collected	NA NaN	NA NaN	NA NaN
Region of Enrollment (participants) [Number]
United States	14 100%	19 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	Change in Confidence in Ability to Perform Teamwork
Description	A three item scale was used to assess confidence in ability to convey logic of recommendations to other providers, explain one's distinctive perspective, and be accountable to patients for a decision made by a colleague from another discipline. The responses for each item ranged from 'not at all confident' (0) to 'very confident' (4), with higher values indicating more confidence. The total scale ranged from 0 to 16 with higher being more confident. Difference scores were analyzed (post-pre) with positive and higher values indicating more favorable change.
Time Frame	Pre-intervention and Post-Intervention at 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SMA Participants	Comparison
Arm/Group Description	Medical students who are assigned to observe Shared Medical Appointments (SMA).	Medical Students who do not experience Shared Medical Appointments.
Measure Participants	12	13
Mean (Standard Deviation) [units of a scale]	1.40 (0.65)	-0.12 (0.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SMA Participants, Comparison
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Change in Professionals' Attitudes About Diabetes
Description	The University of Michigan's Research and Training Center's Diabetes Attitude Scale was used. There are 33 items and the response format is a 5 point Likert Scale ranging from 'strongly disagree'(1) to 'strongly agree'(5). A higher score means more positive attitudes toward diabetes and its treatment (e.g., psychosocial impact of diabetes; value of tight glucose control).The total score is computed by summing individual items and ranges from 0 to 165. Post-pre total scores were used with positive and higher values indicating greater favorable change.
Time Frame	Pre-intervention and Post-intervention at 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SMA Particiants	Comparison
Arm/Group Description	Medical students who were assigned to observe Shared Medical Appointments (SMA).	Medical students who do not experience Shared Medical Appointments (SMA).
Measure Participants	12	13
Mean (Standard Deviation) [units on a scale]	0.88 (1.51)	-1.12 (2.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SMA Participants, Comparison
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	SMA Participants		Comparison
Arm/Group Description	Medical students who were assigned to observe Shared Medical Appointments (SMA).		Medical students who do not experience Shared Medical Appointments.
All Cause Mortality
	SMA Participants		Comparison
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SMA Participants		Comparison
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	SMA Participants		Comparison
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/19 (0%)

Limitations/Caveats

The small sample sizes and the reliance on one site for the data. This was a pilot study, both limitations were recognized from the outset and indeed seen as an advantage given the focus on trying to identify measures to include in a larger study.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.