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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00013117
Other study ID # VCR 99-008
Secondary ID
Status Completed
Phase N/A
First received March 14, 2001
Last updated April 6, 2015
Est. completion date December 2002

Study information

Verified date November 2007
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The goal of this research was to determine if providing specialist input to primary care providers (PCPs) by means of informal consultation could improve the process and outcomes of care for diabetes. Several studies support the role for specialists and their specific knowledge and expertise in a variety of disorders including diabetes. A variety of methods have been designed to optimize the use of specialty expertise including practice guidelines and disease management approaches as well as the consultation/referral process. The referral-consultation process is an important mechanism for obtaining clinically useful information. At one end of the spectrum of this process, informal consultation involves discussion about a patient with a colleague without the consultant seeing the patient; at the other end of the spectrum, care of the patient is transferred to another physician and the process is formalized. Because much specialist expertise resides in the specialists themselves, the expansion of primary care sites to include community-based outpatient clinics has implications for access to the specialists located elsewhere. This study was designed to evaluate a computer-assisted voice mail system which is relatively inexpensive and more convenient than video-telemedicine systems, making it more practical and more easily exportable. Diabetes care delivery was chosen as the model in which to assess informal consultation based on its frequency among veterans, management challenges, and the emphasis on improvement in diabetes care in VA. A secondary goal of the project was to better characterize the consultation process.


Description:

Background:

The goal of this research was to determine if providing specialist input to primary care providers (PCPs) by means of informal consultation could improve the process and outcomes of care for diabetes. Several studies support the role for specialists and their specific knowledge and expertise in a variety of disorders including diabetes. A variety of methods have been designed to optimize the use of specialty expertise including practice guidelines and disease management approaches as well as the consultation/referral process. The referral-consultation process is an important mechanism for obtaining clinically useful information. At one end of the spectrum of this process, informal consultation involves discussion about a patient with a colleague without the consultant seeing the patient; at the other end of the spectrum, care of the patient is transferred to another physician and the process is formalized. Because much specialist expertise resides in the specialists themselves, the expansion of primary care sites to include community-based outpatient clinics has implications for access to the specialists located elsewhere. This study was designed to evaluate a computer-assisted voice mail system which is relatively inexpensive and more convenient than video-telemedicine systems, making it more practical and more easily exportable. Diabetes care delivery was chosen as the model in which to assess informal consultation based on its frequency among veterans, management challenges, and the emphasis on improvement in diabetes care in VA. A secondary goal of the project was to better characterize the consultation process.

Objectives:

Patients with diabetes mellitus are complex and may benefit from the input of multiple specialists and PCPs must determine the need for and coordinate the input from those multiple specialists. With that in mind, the three objectives of the study are: 1) To assess the impact of computer-assisted access to specialist expertise (CASE) on process of care for patients with diabetes mellitus; 2) To assess the impact of CASE on outcomes of care at the patient level (clinical outcomes and satisfaction), provider level (satisfaction) and the system level (health services utilization and costs); and 3) To characterize the consultation-referral process in community-based outpatient clinics (CBOCs).

Methods:

Randomized controlled trial with access to the CASE system constituting the intervention and a descriptive study of the consultation process. The major outcome variables will be the consultation type, adherence to diabetes practice guidelines, clinical outcome of diabetes care (glycemic control), patient and provider satisfaction.

Status:

Project work has been completed. The final report has been submitted.


Recruitment information / eligibility

Status Completed
Enrollment 10000
Est. completion date December 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

Primary Care Providers in VA community-based outpatient clinics; patients receiving primary care in VA community-based outpatient clinics.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Telephone specialist consultation


Locations

Country Name City State
United States Louis Stokes VA Medical Center, Cleveland, OH Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

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