NCT00854594

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

October 6, 2015

Completed
Last Updated

October 6, 2015

Status Verified

September 1, 2015

Enrollment Period

2.7 years

First QC Date

February 27, 2009

Results QC Date

June 11, 2015

Last Update Submit

September 2, 2015

Conditions

Diabetes Mellitus

Keywords

DiabetesTelemedicineShared Medical Appointments

Outcome Measures

Primary Outcomes (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.

    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.

    22 months (post-intervention)

Secondary Outcomes (2)

  • Attitudes Toward Healthcare Teams Scale and Subscales

    Baseline

  • Attitudes Toward Healthcare Teams Scale and Subscales

    22 months (post-intervention)

Study Arms (2)

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.

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

Interventions

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

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
ReSPECT Intervention

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Stokes VA Medical Center

Cleveland, Ohio, 44106-3800, United States

Location

Related Publications (1)

  • 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.

    PMID: 19609192RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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.

Results Point of Contact

Title
Jeneen Shell-Boyd
Organization
Louis Stokes VA Medical Center
Jeneen.shell-boyd@va.gov
(216) 791-2300

Study Officials

  • Susan R Kirsh, MD

    HSR&D Central Office

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 3, 2009

Study Start

September 1, 2010

Primary Completion

May 1, 2013

Study Completion

September 1, 2013

Last Updated

October 6, 2015

Results First Posted

October 6, 2015

Record last verified: 2015-09

Locations

US(1)