Diabetes MellitusReSPECTNCT00854594

Interprofessional Training to Improve Diabetes Care: The ReSPECT Trial

A study testing Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) in people with Diabetes Mellitus, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators' study focuses on improving the care of diabetes, a complex chronic illness, by providing important insights into interprofessional training and its potential role in fostering the necessary interdisciplinary management needed for chronic conditions and in addressing the gap between best practice and… Read more about this study

Who is it for?: Ages 25 to 85 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 1 siteUnited States
Study dates: Sep 2010to Sep 2013
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 25 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

CLINICIANS
All clinicians in all of Ohio's CBOCs (except for the Georgetown CBOC) will be eligible for the study (all PCPs have patients with DM in their panel of patients).
PATIENTS
All diabetic patients who are seen in Ohio's CBOCs (except for the Georgetown CBOC) will be eligible for the study.

Who cannot join

CLINICIANS
Any clinician who does not have diabetic patients on their panel, who aren't apart of Ohio's CBOC's, or see patients at the Georgetown CBOC will not be eligible to participate.
PATIENTS
Patients who don't have a diagnosis of diabetes, who aren't seen at one of Ohio's CBOC's, or is seen for their medical care at the Georgetown CBOC will not be eligible to participate.

Trial locations and contacts

1 site in 1 country.

United States1 site

Louis Stokes VA Medical Center
Cleveland, Ohio, 44106-3800

Other trials in United States

About this study

Official title: Interprofessional Training for Improving Diabetes Care

Read the detailed description

The complexity of diabetes management challenges the acute care-oriented healthcare system. Some experts suggest part of the problem is that the healthcare system fosters a separate silos decision making model. While there is increasing recognition that quality diabetes care is best provided in an interdisciplinary manner, interprofessional training models are limited, as is understanding of the links between interprofessional training, actual practice, and patient outcomes. Advancing our understanding of interprofessional training models is critical because most of the complications associated with diabetes (e.g., amputations, renal failure, strokes) can be prevented or delayed with proper management. The investigators' objective is to better understand the processes and mechanisms by which interprofessional training impacts on chronic care management (practice patterns) and the ways it translates into improved patient outcomes.

Conditions: Diabetes Mellitus
Being tested: Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT)
Keywords: Diabetes, Telemedicine, Shared Medical Appointments
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT)Behavioural
Also called ReSPECT
The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for diabetes mellitus (DM) patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans.

Study groups in NCT00854594
Study group	Role	What they receive
Control	No intervention	Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
ReSPECT Intervention	Experimental	Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview. Receives: Behavioral: Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network
Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities:
1. Instruct patients on home glucose monitoring
2. Teach foot care
3. Teach insulin administration
4. Instruct patients about diet
5. Help patients make changes in their diets that you have recommended
6. Instruct patients about regular exercise
7. Help patients make changes in their exercise habits that you have recommended
8. Identify candidates for long-acting insulin
9. Interpret glucose patterns
10. Adjust insulin in insulin-treated patients with poor glycemic control
11. Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin
12. Manage patients with poor glycemic control
13. Initiate insulin therapy (NPH or insulin glargine and aspart)
14. Apply principles of diabetes care in a team setting
Averages of provider efficacy were calculated across all activities.
Measured: Baseline
Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network
Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities:
1. Instruct patients on home glucose monitoring
2. Teach foot care
3. Teach insulin administration
4. Instruct patients about diet
5. Help patients make changes in their diets that you have recommended
6. Instruct patients about regular exercise
7. Help patients make changes in their exercise habits that you have recommended
8. Identify candidates for long-acting insulin
9. Interpret glucose patterns
10. Adjust insulin in insulin-treated patients with poor glycemic control
11. Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin
12. Manage patients with poor glycemic control
13. Initiate insulin therapy (NPH or insulin glargine and aspart)
14. Apply principles of diabetes care in a team setting
Averages of provider efficacy were calculated across all activities.
Measured: 22 months (post-intervention)

Secondary outcomes (2)

Attitudes Toward Healthcare Teams Scale and Subscales
A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.
Measured: Baseline
Attitudes Toward Healthcare Teams Scale and Subscales
A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.
Measured: 22 months (post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Sep 2013

First posted3 Mar 2009 (estimated)
Study startSep 2010
Primary completionMay 2013
Study completionSep 2013

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.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00854594
Sponsor's protocol ID: EDU 08-414
Acronym: ReSPECT
Status last verified: Sep 2015
First submitted: 27 Feb 2009
Last updated: 6 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kirsh SR, Schaub K, Aron DC. Shared medical appointments: a potential venue for education in interprofessional care. Qual Manag Health Care. 2009 Jul-Sep;18(3):217-24. doi: 10.1097/QMH.0b013e3181aea27d.
PubMed 19609192

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interprofessional Training for Improving Diabetes Care
ClinicalTrials.gov ID: NCT00854594
Acronym / sponsor ID: ReSPECT / EDU 08-414
Conditions: Diabetes Mellitus
Keywords: Diabetes, Telemedicine, Shared Medical Appointments
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Collaborators: Case Western Reserve University, The Cleveland Clinic
Study start: Sep 2010
Primary completion: May 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 3 Mar 2009 (estimated)
Results: Posted 6 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
ReSPECT Intervention	Experimental	Behavioral: Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT)Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.

Who may qualify

Ages: 25 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

CLINICIANS
All clinicians in all of Ohio's CBOCs (except for the Georgetown CBOC) will be eligible for the study (all PCPs have patients with DM in their panel of patients).
PATIENTS
All diabetic patients who are seen in Ohio's CBOCs (except for the Georgetown CBOC) will be eligible for the study.

Key exclusion criteria (4 listed)

CLINICIANS
Any clinician who does not have diabetic patients on their panel, who aren't apart of Ohio's CBOC's, or see patients at the Georgetown CBOC will not be eligible to participate.
PATIENTS
Patients who don't have a diagnosis of diabetes, who aren't seen at one of Ohio's CBOC's, or is seen for their medical care at the Georgetown CBOC will not be eligible to participate.

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
Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT)Also: ReSPECTThe intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for diabetes mellitus (DM) patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans.	Behavioural	ReSPECT Intervention

Primary outcome

Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network
Time frame: Baseline
Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities: 1. Instruct patients on home glucose monitoring 2. Teach foot care 3. Teach insulin administration 4. Instruct patients about diet 5. Help patients make changes in their diets that you have recommended 6. Instruct patients about regular exercise 7. Help patients make changes in their exercise habits that you have recommended 8. Identify candidates for long-acting insulin 9. Interpret glucose patterns 10. Adjust insulin in insulin-treated patients with poor glycemic control 11. Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin 12. Manage patients with poor glycemic control 13. Initiate insulin therapy (NPH or insulin glargine and aspart) 14. Apply principles of diabetes care in a team setting Averages of provider efficacy were calculated across all activities.
Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network
Time frame: 22 months (post-intervention)
Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities: 1. Instruct patients on home glucose monitoring 2. Teach foot care 3. Teach insulin administration 4. Instruct patients about diet 5. Help patients make changes in their diets that you have recommended 6. Instruct patients about regular exercise 7. Help patients make changes in their exercise habits that you have recommended 8. Identify candidates for long-acting insulin 9. Interpret glucose patterns 10. Adjust insulin in insulin-treated patients with poor glycemic control 11. Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin 12. Manage patients with poor glycemic control 13. Initiate insulin therapy (NPH or insulin glargine and aspart) 14. Apply principles of diabetes care in a team setting Averages of provider efficacy were calculated across all activities.

2 secondary outcomes

Attitudes Toward Healthcare Teams Scale and Subscales
Time frame: Baseline
Attitudes Toward Healthcare Teams Scale and Subscales
Time frame: 22 months (post-intervention)

Results and safety

Results posted to the registry on 6 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	48	48
ReSPECT Intervention	69	69

Primary outcome: Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Control n = 39	ReSPECT Intervention n = 55
Value	6.89 (2.17)	6.41 (1.90)

Control vs ReSPECT Intervention: p = 0.26, t-test, 2 sided

Population analysed: Providers within sites randomized to control and intervention arms were surveyed at baseline; 39 control arm providers and 55 intervention arm providers completed the ability items of the survey.

Primary outcome: Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network

Time frame: 22 months (post-intervention). Mean (Standard Deviation). Unit: units on a scale

Measure	Control n = 20	ReSPECT Intervention n = 29
Value	7.09 (2.05)	6.88 (2.14)

Control vs ReSPECT Intervention: p = 0.74, t-test, 2 sided

Population analysed: Providers within sites randomized to control and intervention arms were surveyed after the intervention period; 20 control arm providers and 29 intervention arm providers completed the ability items of the survey.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 48 (0%)	0 of 48 (0%)	Not reported
ReSPECT Intervention	0 of 69 (0%)	0 of 69 (0%)	Not reported

Limitations and caveats (from the sponsor): IRB-related delays were so significant that aspects of the research plan could not be completed. Delays have also been experienced in the collection and analysis of clinical endpoints.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19609192Kirsh SR, Schaub K, Aron DC. Shared medical appointments: a potential venue for education in interprofessional care. Qual Manag Health Care. 2009 Jul-Sep;18(3):217-24. doi: 10.1097/QMH.0b013e3181aea27d.

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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.

Susan R Kirsh, MD principal investigator

HSR&D Central Office

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 4 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 6 Oct 2015. 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 6 Oct 2015). 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?

Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT00854594, 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 6 Oct 2015.