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| Tracking Information | |||||
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| First Received Date ICMJE | March 14, 2001 | ||||
| Last Updated Date | October 31, 2008 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00013117 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Computer-Assisted Access to Specialist Expertise | ||||
| Official Title ICMJE | Computer-Assisted Access to Specialist Expertise | ||||
| Brief 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. |
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| Detailed 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Diabetes Mellitus | ||||
| Intervention ICMJE | Behavioral: Telephone specialist consultation | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 10000 | ||||
| Completion Date | December 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Primary Care Providers in VA community-based outpatient clinics; patients receiving primary care in VA community-based outpatient clinics. Exclusion Criteria: |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00013117 | ||||
| Responsible Party | Aron, David - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | VCR 99-008 | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | January 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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