Diabetes MellitusNCT00013117
Computer-Assisted Access to Specialist Expertise
A study testing Telephone specialist consultation in people with Diabetes Mellitus, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Telephone specialist consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary Care Providers in VA community-based outpatient clinics; patients receiving primary care in VA community-based outpatient clinics.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Telephone specialist consultation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone specialist consultationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Telephone specialist consultation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David C Aron, MD MS, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013117
- Sponsor's protocol ID
- VCR 99-008
- Status last verified
- Nov 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Access to Specialist Expertise
- ClinicalTrials.gov ID
- NCT00013117
- Acronym / sponsor ID
- VCR 99-008
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Dec 2002 (actual)
- First posted
- 16 Mar 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Telephone specialist consultation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary Care Providers in VA community-based outpatient clinics; patients receiving primary care in VA community-based outpatient clinics.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone specialist consultation | Behavioural | Arm 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Aron, MD MS principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone specialist consultation in people with Diabetes Mellitus, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.