Diabetes MellitusNCT00676208
Improving Medical Training for the Care of Chronic Conditions
A study testing Shared Medical Appointments in people with Diabetes Mellitus, run by VA Office of Research and Development at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Shared Medical Appointments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical Students:
- Inclusion: All medical students participating in diabetes Shared Medical Appointment sessions or other training experiences during the course of the study.
Who cannot join
- medical students who have participated in SMAs for patients with diabetes at the Cleveland VAMC in the past.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Shared Medical Appointments
- Keywords
- Shared Medical Appointments, Diabetes, Education
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Medical AppointmentsBehavioural
Participated in shared appointments for patients as part of interprofessional team providing care for diabetes
| Study group | Role | What they receive |
|---|---|---|
| Shared Medical Appointments | Experimental | Medical students participated in shared medical appointments for patients with diabetes for one month. Receives: Behavioral: Shared Medical Appointments |
| No shared medical appointments | No intervention | Medical students in this arm did not participate in shared medical appointments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Confidence in Ability to Perform Teamwork
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.
Measured: Pre-intervention and Post-Intervention at 1 month
Secondary outcomes (1)
Change in Professionals' Attitudes About Diabetes
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.
Measured: Pre-intervention and Post-intervention at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David C Aron, MD MS, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676208
- Sponsor's protocol ID
- SHP 08-141
- Status last verified
- Aug 2021
- First submitted
- 7 May 2008
- Last updated
- 23 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Watts SA, Gee J, O'Day ME, Schaub K, Lawrence R, Aron D, Kirsh S. Nurse practitioner-led multidisciplinary teams to improve chronic illness care: the unique strengths of nurse practitioners applied to shared medical appointments/group visits. J Am Acad Nurse Pract. 2009 Mar;21(3):167-72. doi: 10.1111/j.1745-7599.2008.00379.x.
PubMed 19302693
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medical Training for the Care of Chronic Conditions
- ClinicalTrials.gov ID
- NCT00676208
- Acronym / sponsor ID
- SHP 08-141
- Conditions
- Diabetes Mellitus
- Keywords
- Shared Medical Appointments, Diabetes, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Posted 4 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Medical Appointments | Experimental | Behavioral: Shared Medical AppointmentsMedical students participated in shared medical appointments for patients with diabetes for one month. |
| No shared medical appointments | No intervention | –Medical students in this arm did not participate in shared medical appointments. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inclusion: All medical students participating in diabetes Shared Medical Appointment sessions or other training experiences during the course of the study.
Key exclusion criteria (1 listed)
- medical students who have participated in SMAs for patients with diabetes at the Cleveland VAMC in the past.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Medical AppointmentsParticipated in shared appointments for patients as part of interprofessional team providing care for diabetes | Behavioural | Shared Medical Appointments |
Primary outcome
Change in Confidence in Ability to Perform Teamwork
Time frame: 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.
1 secondary outcome
Change in Professionals' Attitudes About Diabetes
Time frame: Pre-intervention and Post-intervention at 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19302693Watts SA, Gee J, O'Day ME, Schaub K, Lawrence R, Aron D, Kirsh S. Nurse practitioner-led multidisciplinary teams to improve chronic illness care: the unique strengths of nurse practitioners applied to shared medical appointments/group visits. J Am Acad Nurse Pract. 2009 Mar;21(3):167-72. doi: 10.1111/j.1745-7599.2008.00379.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Aron, MD MS principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Medical Appointments in people with Diabetes Mellitus, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Confidence in Ability to Perform Teamwork (time frame: Pre-intervention and Post-Intervention at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00676208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.