Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Interprofessional Training to Improve Diabetes Care: The ReSPECT Trial (ReSPECT)

This study has been completed.
Sponsor:
Collaborators:
Case Western Reserve University
The Cleveland Clinic
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00854594
First received: February 27, 2009
Last updated: September 2, 2015
Last verified: September 2015
Results First Received: June 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Diabetes Mellitus
Intervention: Behavioral: Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Cleveland and Cincinnati CBOCs (excluding Georgetown; n = 18 CBOCs) were the study sites randomized to the two study arms. Providers within site were subject to the intervention to which the site was randomized and the questionnaire responses were collected at the provider level.

Reporting Groups
  Description
Control Providers within sites randomized to the control arm will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
ReSPECT Intervention

Providers within sites randomized to the intervention arm 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.

Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention Community-Based Outpatient Clinics (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.


Participant Flow:   Overall Study
    Control   ReSPECT Intervention
STARTED   48 [1]   69 [2] 
COMPLETED   48   69 
NOT COMPLETED   0   0 
[1] 9 sites randomized to control arm, providers completed surveys before and/or after study period
[2] 9 sites randomized to intervention, providers completed surveys before and/or after study period



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
For providers who completed the survey once, using demographics reported; for providers who completed the survey twice, using demographics from earlier survey completion.

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

Role 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 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.

Total Total of all reporting groups

Baseline Measures
   Control   ReSPECT Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   69   117 
Age, Customized [1] 
[Units: Participants]
     
Missing   0   4   4 
39 years or less   7   12   19 
40 to 59 years   41   48   89 
60 years or greater   0   5   5 
[1] Age categories indicated in provider questionnaire.
Gender, Customized 
[Units: Participants]
     
Male   12   13   25 
Female   36   53   89 
Unknown   0   3   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network   [ Time Frame: Baseline ]

2.  Primary:   Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network   [ Time Frame: 22 months (post-intervention) ]

3.  Secondary:   Attitudes Toward Healthcare Teams Scale and Subscales   [ Time Frame: Baseline ]

4.  Secondary:   Attitudes Toward Healthcare Teams Scale and Subscales   [ Time Frame: 22 months (post-intervention) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeneen Shell-Boyd
Organization: Louis Stokes VA Medical Center
phone: (216) 791-2300 ext 5831
e-mail: Jeneen.shell-boyd@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00854594     History of Changes
Other Study ID Numbers: EDU 08-414
Study First Received: February 27, 2009
Results First Received: June 11, 2015
Last Updated: September 2, 2015
Health Authority: United States: Federal Government