Clinical Decision SupportNCT00365885
Showing Health Information Value in a Community Network
A study testing Computer-based clinical decision support. in people with Clinical Decision Support and Medical Informatics Interventions, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the value of shared health information on care quality and costs when this information is used to notify care providers about concerning health events for patients cared for by a community-based network of providers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clinical Decision Support, Medical Informatics Interventions, Population Health Management
- What is being tested?
- Computer-based clinical decision support.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,108 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2008
- 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
- Enrollment in the Community Care of North Carolina Medicaid program in Durham County North Carolina
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to determine the value of shared health information on care quality and costs when this information is used to notify care providers about concerning health events for patients cared for by a community-based network of providers.
Read the detailed description
Project Abstract This three-year project will assess the costs and benefits of health information technology (HIT) in an established community-wide network of academic, private and public healthcare facilities created to share clinical information for the purpose of population-based care management of over 16,000 Medicaid beneficiaries in Durham County, North Carolina. The area of interest for this project is the impact of information-driven interventions on care quality, patient safety and healthcare costs across the diverse stakeholders participating in this collaborative partnership. In order to asses HIT value rigorously in the context of a production information system that is under continual development, we propose to conduct a randomized controlled trial. Specifically, we will randomly assign patients by family unit to either a control group or to an intervention group in which they will initially receive one of 3 information-driven interventions. The interventions include clinical alerts sent to care providers, performance feedback reports presented to clinic managers, and care reminders sent directly to patients. The content of the interventions will address "concerning" events (e.g., an emergency room encounter for asthma) and care deficiencies (e.g., delinquency on biannual mammogram) identified from the composite set of clinical data in our information system. To assess the benefits and burdens of the interventions, combinations of the 3 interventions will be sequentially introduced into the study groups over the course of the project. The analysis will compare groups receiving various combinations of interventions as well as those receiving no interventions. At baseline and at six-month intervals throughout the course of the study, we will measure emergency department encounter rates, hospitalization rates, HEDIS (Healthcare Effectiveness Data and Information Set) scores, missed appointment rates, glycated hemoglobin levels in diabetics, and patient satisfaction. Our assessment will look at the societal value of HIT as well as the value for individual stakeholders including patients, providers, payers, purchasers and policy makers. From these measures, we will assess the costs and benefits of this community-wide effort to promote interoperability of clinical data exchange in order to increase the understanding of HIT value in a community setting. In our preliminary studies, we have observed a statistically significant 3-fold reduction in repeat ED (Emergency Department) encounter rates using email alerts alone. The approach used in this project is able to be generalized across geographic areas and healthcare settings and can, therefore, serve to promote the dissemination of HIT to other communities.
- Conditions
- Clinical Decision Support, Medical Informatics Interventions, Population Health Management, Quality of Healthcare
- Being tested
- Computer-based clinical decision support.
- Keywords
- Medical Informatics, Decision Support Systems, Clinical, Community Health Services, Costs and Cost analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based clinical decision support.Other
Also called Decision support engine is called SEBASTIAN
computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | electronic mail notifications to care managers about sentinel health events Receives: Other: Computer-based clinical decision support. |
| 2 | Experimental | feedback reports with notifications to clinic managers about sentinel health events Receives: Other: Computer-based clinical decision support. |
| 3 | Experimental | letters to patients with notifications about sentinel health events Receives: Other: Computer-based clinical decision support. |
| 4 | No intervention | electronic mail notifications to care managers about sentinel health events -- generated but withheld |
| 5 | No intervention | feedback reports with notifications to clinic managers about sentinel health events -- generated but withheld |
| 6 | No intervention | letters to patients with notifications about sentinel health events -- generated but withheld |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency department utilization rates and hospitalization rates
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Secondary outcomes (30)
ED encounter rates for low severity conditions
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
ED encounter rates for asthma
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
ED encounter rates for diabetes
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization rates
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization rates for asthma (also PQI)
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization rates for diabetes (also PQI)
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Glycemic control (hemoglobin A1c)
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Medication contraindications
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
HEDIS - Preventive services
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
HEDIS - # WCC visits
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
AHRQ Prevention Quality Indicators
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
HEDIS - Asthma and diabetes
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
# of messages triggered for health risks
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
# of messages triggered for barriers to care
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Missed appointment rates
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Primary care appointment rates
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
F/U rates post-partum
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Patient satisfaction instruments (CHAPS)
Measured: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
EuroQoL
Measured: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
Provider opinion surveys
Measured: At conclusion of study
Costs of ED utilization for all causes
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Costs of ED use for asthma
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Costs of ED use for diabetes
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Costs of ED use for low severity visits
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization costs for all causes
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization costs for asthma
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization costs for diabetes
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Reimbursement for labs+other ancillary services
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Primary care reimbursement
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
ED rates for recurrent ED encounters
Measured: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical Decision SupportStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David F Lobach, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365885
- Sponsor's protocol ID
- Pro00006833
- Other IDs
- R01HS015057
- Status last verified
- Dec 2012
- First submitted
- 16 Aug 2006
- Last updated
- 11 Jul 2014
- Results posted
- No
Publications
Eisenstein EL, Anstrom KJ, Macri JM, Crosslin DR, Johnson FS, Kawamoto K, Lobach DF. Assessing the potential economic value of health information technology interventions in a community-based health network. AMIA Annu Symp Proc. 2005;2005:221-5.
PubMed 16779034
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Showing Health Information Value in a Community Network
- ClinicalTrials.gov ID
- NCT00365885
- Acronym / sponsor ID
- Pro00006833
- Conditions
- Clinical Decision Support, Medical Informatics Interventions, Population Health Management, Quality of Healthcare
- Keywords
- Medical Informatics, Decision Support Systems, Clinical, Community Health Services, Costs and Cost analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,108 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Aug 2006 (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 purpose of this study is to determine the value of shared health information on care quality and costs when this information is used to notify care providers about concerning health events for patients cared for by a community-based network of providers.
Detailed description
Project Abstract This three-year project will assess the costs and benefits of health information technology (HIT) in an established community-wide network of academic, private and public healthcare facilities created to share clinical information for the purpose of population-based care management of over 16,000 Medicaid beneficiaries in Durham County, North Carolina. The area of interest for this project is the impact of information-driven interventions on care quality, patient safety and healthcare costs across the diverse stakeholders participating in this collaborative partnership. In order to asses HIT value rigorously in the context of a production information system that is under continual development, we propose to conduct a randomized controlled trial. Specifically, we will randomly assign patients by family unit to either a control group or to an intervention group in which they will initially receive one of 3 information-driven interventions. The interventions include clinical alerts sent to care providers, performance feedback reports presented to clinic managers, and care reminders sent directly to patients. The content of the interventions will address "concerning" events (e.g., an emergency room encounter for asthma) and care deficiencies (e.g., delinquency on biannual mammogram) identified from the composite set of clinical data in our information system. To assess the benefits and burdens of the interventions, combinations of the 3 interventions will be sequentially introduced into the study groups over the course of the project. The analysis will compare groups receiving various combinations of interventions as well as those receiving no interventions. At baseline and at six-month intervals throughout the course of the study, we will measure emergency department encounter rates, hospitalization rates, HEDIS (Healthcare Effectiveness Data and Information Set) scores, missed appointment rates, glycated hemoglobin levels in diabetics, and patient satisfaction. Our assessment will look at the societal value of HIT as well as the value for individual stakeholders including patients, providers, payers, purchasers and policy makers. From these measures, we will assess the costs and benefits of this community-wide effort to promote interoperability of clinical data exchange in order to increase the understanding of HIT value in a community setting. In our preliminary studies, we have observed a statistically significant 3-fold reduction in repeat ED (Emergency Department) encounter rates using email alerts alone. The approach used in this project is able to be generalized across geographic areas and healthcare settings and can, therefore, serve to promote the dissemination of HIT to other communities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Computer-based clinical decision support.electronic mail notifications to care managers about sentinel health events |
| 2 | Experimental | Other: Computer-based clinical decision support.feedback reports with notifications to clinic managers about sentinel health events |
| 3 | Experimental | Other: Computer-based clinical decision support.letters to patients with notifications about sentinel health events |
| 4 | No intervention | –electronic mail notifications to care managers about sentinel health events -- generated but withheld |
| 5 | No intervention | –feedback reports with notifications to clinic managers about sentinel health events -- generated but withheld |
| 6 | No intervention | –letters to patients with notifications about sentinel health events -- generated but withheld |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Enrollment in the Community Care of North Carolina Medicaid program in Durham County North Carolina
Key exclusion criteria (1 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 |
|---|---|---|
| Computer-based clinical decision support.Also: Decision support engine is called SEBASTIANcomputer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients | Other | 1, 2, 3 |
Primary outcome
Emergency department utilization rates and hospitalization rates
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
30 secondary outcomes
ED encounter rates for low severity conditions
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
ED encounter rates for asthma
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
ED encounter rates for diabetes
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization rates
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization rates for asthma (also PQI)
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization rates for diabetes (also PQI)
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Glycemic control (hemoglobin A1c)
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Medication contraindications
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
HEDIS - Preventive services
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
HEDIS - # WCC visits
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
AHRQ Prevention Quality Indicators
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
HEDIS - Asthma and diabetes
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
# of messages triggered for health risks
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
# of messages triggered for barriers to care
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Missed appointment rates
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Primary care appointment rates
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
F/U rates post-partum
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Patient satisfaction instruments (CHAPS)
Time frame: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
EuroQoL
Time frame: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
Provider opinion surveys
Time frame: At conclusion of study
Costs of ED utilization for all causes
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Costs of ED use for asthma
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Costs of ED use for diabetes
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Costs of ED use for low severity visits
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization costs for all causes
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization costs for asthma
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Hospitalization costs for diabetes
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Reimbursement for labs+other ancillary services
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
Primary care reimbursement
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
ED rates for recurrent ED encounters
Time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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 11 Jul 2014.
- Background: PubMed 16779034Eisenstein EL, Anstrom KJ, Macri JM, Crosslin DR, Johnson FS, Kawamoto K, Lobach DF. Assessing the potential economic value of health information technology interventions in a community-based health network. AMIA Annu Symp Proc. 2005;2005:221-5.
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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 F Lobach, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based clinical decision support. in people with Clinical Decision Support and Medical Informatics Interventions, run by Duke University 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 1 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 11 Jul 2014. 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.
What does the primary outcome measure?
Emergency department utilization rates and hospitalization rates (time frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00365885, which also lists 1 linked publication.
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 11 Jul 2014.