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CompletedNCT00854594ReSPECTUpdated Oct 6, 2015Results posted

Interprofessional Training to Improve Diabetes Care: The ReSPECT Trial

An interventional study of Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) in Diabetes Mellitus, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 25 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-10-06.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
117
Allocation
Randomized
Ages
25 Years to 85 Years
Sex
All
01

Study 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 actual care provided.

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.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Diabetes
  • Telemedicine
  • Shared Medical Appointments
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 117 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
117 participants (actual)

Study arms

  • No intervention
    Control

    Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.

  • Experimental
    ReSPECT Intervention

    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.

    Behavioral: Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT)

Interventions

  • BehavioralRole modeling in Shared medical appointments to Promote Establishing Collaborative Teams (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.

    Also known as: ReSPECT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: 22 months (post-intervention)

Secondary outcomes

  1. 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.

    Time frame: Baseline

  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.

    Time frame: 22 months (post-intervention)

07

Results

Posted Oct 6, 2015
Limitations and caveats
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.

Participant flow

Participant flow — Overall Study
MilestoneControlReSPECT Intervention
Started4869
Completed4869
Not completed00

Outcome measures

SecondaryAttitudes 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.

Time frame:
Baseline
Reported as:
Mean · units on a scale
Attitudes Toward Healthcare Teams Scale and Subscales
units on a scaleControlReSPECT Intervention
Attitudes Toward Healthcare Teams Scale and Subscales4.42 ± .524.29 ± .55
PrimaryProvider 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.

Time frame:
Baseline
Reported as:
Mean · units on a scale
Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network
units on a scaleControlReSPECT Intervention
Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network6.89 ± 2.176.41 ± 1.90
Statistical analysis
  • Control vs ReSPECT Intervention · t-test, 2 sided · p = 0.26
PrimaryProvider 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.

Time frame:
22 months (post-intervention)
Reported as:
Mean · units on a scale
Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network
units on a scaleControlReSPECT Intervention
Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network7.09 ± 2.056.88 ± 2.14
Statistical analysis
  • Control vs ReSPECT Intervention · t-test, 2 sided · p = 0.74
SecondaryAttitudes 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.

Time frame:
22 months (post-intervention)
Reported as:
Mean · units on a scale
Attitudes Toward Healthcare Teams Scale and Subscales
units on a scaleControlReSPECT Intervention
Attitudes Toward Healthcare Teams Scale and Subscales4.44 ± 0.524.24 ± 0.59

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control—0/48 (0%)0/48 (0%)
ReSPECT Intervention—0/69 (0%)0/69 (0%)

Baseline characteristics

For providers who completed the survey once, using demographics reported; for providers who completed the survey twice, using demographics from earlier survey completion.

Age, Customized
Age, Customized(participants)ControlReSPECT InterventionTotal
Missing044
39 years or less71219
40 to 59 years414889
60 years or greater055
Sex/Gender, Customized
Sex/Gender, Customized(participants)ControlReSPECT InterventionTotal
Male121325
Female365389
Unknown033
08

Study locations

1 site
  • Louis Stokes VA Medical Center
    Cleveland, Ohio 44106-3800, United States
09

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00854594
Lead sponsor
US Department of Veterans Affairs
Collaborators
Case Western Reserve University, The Cleveland Clinic
Responsible party
Sponsor
First posted
Mar 3, 2009
Start date
Sep 2010
Primary completion
May 2013
Completion
Sep 2013
Results posted
Oct 6, 2015
Last update
Oct 6, 2015

Study contacts

Susan R Kirsh, MD
principal investigator · HSR&D Central Office

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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