AsthmaNCT01039324
Care Transitions for Complex Patient - Cycle 1 and Cycle 2
A study testing Reports and Reports and Notices in people with Asthma and Coronary Artery Disease, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to improve patient care and safety while decreasing ED visit rates by sending specific information about care transitions related to hospital admission and discharge and emergency department and specialty care visits to primary care practices, care managers and patients with the use of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma, Coronary Artery Disease, Diabetes
- What is being tested?
- Reports and Reports and Notices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,422 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Sep 2012
- 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
- North Carolina Medicaid beneficiary enrolled in the Northern Piedmont Community Care Network (NPCCN)
- Has complex healthcare needs as defined by having two or more IOM (Institute of Medicine) priority conditions (hypertension, coronary artery disease, congestive heart failure, stroke, asthma, diabetes) OR one of the following: moderate to severe mental health diagnosis (schizophrenic disorder, episodic mood disorder, delusional disorder, non-organic psychosis, anxiety, dissociative-somatoform disorder, personality disorder), end-stage renal disease, sickle cell disease
- Continuous enrollment in NPCCN for 10 of the previous 12 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center (Division of Clinical Informatics)
Durham, North Carolina, 27710
About this study
Official title: Improving Care Transitions for Complex Patients Through Decision Support
The purpose of this study is to improve patient care and safety while decreasing ED visit rates by sending specific information about care transitions related to hospital admission and discharge and emergency department and specialty care visits to primary care practices, care managers and patients with the use of health information technology (HIT) shared across a community-based network of providers.
Cycle 1 focuses on the impact of notices about ED encounters and hospitalizations derived from billing data that are sent to care managers for all 47,000 patients in the Northern Piedmont Community Care Network (NPCCN). Cycle 2 explores the impact of letters sent to patients, and care event reports sent to a patient's medical home in addition to notices sent to care managers about ED encounters, hospitalization and specialty care based on ADT (Admission Discharge Transfer) and billing data on 4,600 patients with complex health needs.
Read the detailed description
This three-year project seeks to improve outcomes, quality and coordination of care for patients with complex healthcare needs by facilitating the availability of information following three types of care transitions into the ambulatory care setting. Specific information regarding care transitions will be made available to patients, primary care practitioners and care managers following hospitalizations, emergency department (ED) encounters, and specialty clinic evaluations.
This project will build upon a regional Health Information Exchange (HIE) network created to connect providers serving 47,000 Medicaid beneficiaries across traditional institutional boundaries from both rural and urban settings in a 6-county region in the Northern Piedmont of North Carolina. This network includes 25 ambulatory care practices, 3 federally qualified health centers, 4 rural health clinics, 3 urgent care facilities, 11 government agencies, 5 hospitals and 2 cross-disciplinary care management teams. Within this HIE network, 4,600 patients with complex healthcare needs have been identified.
For this project, a standards-based clinical decision support tool will be utilized in order to ensure that the proposed approach is generalized, portable, and scalable; and routinely available claims and scheduling data will be used as the primary data source. This approach will support both traditional clinic-based models of care as well as new care models including population health management and the use of cross-disciplinary teams.
Under Aim 1, the existing HIE network and decision support tool will be enhanced to enable detection of transitions in care and delivery of timely, patient-specific information regarding these care transitions to patients, primary care clinicians and multidisciplinary care management team members. Under Aim 2, the impact of the proposed approach will be evaluated in a two-cycle randomized controlled trial primarily involving approximately 47000 Medicaid beneficiaries with a special focus on 4600 patients with complex health needs, 309 primary care clinicians, and 31 care management workers. Cycle 1 will assess only daily notices sent to care managers and will use only billing data. Cycle 2 will evaluate all components of the proposed intervention and us both billing and ADT data (see below). For Cycle 1, patients will be randomly assigned by family unit to either receive or not receive email notices sent to their care managers. For Cycle 2 patients will be randomly assigned to one of three groups: 1) information on care transitions sent to patients and their clinic-based caregivers; 2) information sent to patients, their clinic-based caregivers and their care managers; and 3) no information sent. The primary outcome measure will be the overall rate of ED utilization for each study group. Under Aim 3, the economic attractiveness of the proposed approach will be determined. Under Aim 4, the technology and results of this study will be disseminated through public media, publications and presentations. Information-augmented care transitions between sites should result in improved care coordination, higher quality of care, and more appropriate care.
This trial will be deployed in two cycles in order to support the needs of the care management network while the full intervention is developed. Cycle 1 will run from December, 2009 through December, 2010. It will assess the impact of notices about hospital admissions and ED encounters derived from billing data and sent daily to care managers for the 47,000 patients enrolled in NPCCN on the study outcomes. Cycle 2 will run from December, 2010 through December, 2011 and will address AIM 2 of the original grant proposal. For Cycle 2, events detected from ADT and billing data will be generated daily. The events will include hospital admissions, hospital discharges, ED encounters, and specialty care visits. The responses to events will include event summary reports sent to patients' assigned medical homes, letters sent to patients or their guardians, and release of information requests on behalf of a patient's medical home. The response will be generated for 4,600 patients identified as having complex health needs. In addition, notices will be sent to care managers for detected hospital and ED events for all 47,000 patients enrolled in NPCCN. Special priority will be given to patients with complex heath needs.
- Being tested
- Reports, Reports and Notices, Usual care
- Keywords
- Complex patients, Care transitions, Patient safety, Patient care, Health Information Technology, Health Information Exchange, Clinical Decision Support, Care coordination, Data sharing
- Medical subject headings
- Asthma, Coronary Artery Disease, Diabetes Mellitus, Hypertension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReportsOther
Primary care event reports and patient letters
Reports and NoticesOther
Primary care event reports, patient letters and care manager notices
Usual careOther
This is the study's control group
| Study group | Role | What they receive |
|---|---|---|
| Intermediate Intervention (arm #1) | Experimental | Care transition reports sent to primary care clinics, care transition letters sent to patients, release of information requests about care transitions sent on behalf of primary care clinics. Receives: Other: Reports |
| Full Intervention (arm #2) | Experimental | E-mail notices sent to care managers about care transitions plus care transition reports sent to primary care clinics, care transition reports sent to patients, release of information requests about care transitions sent on behalf of primary care clinics. Receives: Other: Reports and Notices |
| Control (arm #3) | Experimental | Subjects assigned to the control group will receive "usual care" which is the standard of care coordination currently existent between patients, providers and care managers. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency department encounter rates among patients in the study population.
Measured: 6 months
Secondary outcomes (22)
Emergency department encounter rates for low severity diagnoses among all patients.
Measured: 6 months
Total emergency department encounter rates among patients for whom intervention was appropriate.
Measured: 6 months
Total emergency department encounter rates among all patients.
Measured: 6 months
Hospitalization rates among patients for whom intervention was appropriate.
Measured: 6 months
Hospitalization rates among all patients.
Measured: 6 months
Hospital readmission rates within 30 days after hospitalization among patients for whom intervention was appropriate.
Measured: 6 months
Hospital readmission rates within 30 days after hospitalization among all patients.
Measured: 6 months
Primary care visit rates among patients following an emergency department encounter or hospitalization for whom intervention was appropriate.
Measured: 6 months
Primary care visit rates among all patients following an emergency department encounter or hospitalization.
Measured: 6 months
Rates of completion of medically-indicated post hospitalization studies or procedures among patients for whom intervention was appropriate.
Measured: 6 months
Rates of completion of medically-indicated post hospitalization studies or procedures among all patients.
Measured: 6 months
Total medical costs among patients for whom intervention was appropriate.
Measured: 6 months
Total medical costs among all patients.
Measured: 6 months
Emergency department costs among patients for whom intervention was appropriate.
Measured: 6 months
Emergency department costs among all patients.
Measured: 6 months
Hospitalization costs among patients for whom intervention was appropriate.
Measured: 6 months
Hospitalization costs among all patients.
Measured: 6 months
Outpatient costs among patients for whom intervention was appropriate.
Measured: 6 months
Outpatient costs among all patients.
Measured: 6 months
Patient satisfaction among patients for whom intervention was appropriate.
Measured: 6 months
Patient-reported quality of life among patients for whom intervention was appropriate.
Measured: 6 months
Provider satisfaction among providers with contact with patients for whom intervention was appropriate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Piedmont Carolina Community Care Partners, North Carolina Division of Medical Assistance
- Responsible party
- Sponsor
- Investigators
- Eric Eisenstein, DBA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039324
- Sponsor's protocol ID
- Pro00010738
- Other IDs
- R18HS017795
- Status last verified
- Feb 2014
- First submitted
- 23 Dec 2009
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care Transitions for Complex Patients Through Decision Support
- ClinicalTrials.gov ID
- NCT01039324
- Acronym / sponsor ID
- Pro00010738
- Keywords
- Complex patients, Care transitions, Patient safety, Patient care, Health Information Technology, Health Information Exchange, Clinical Decision Support, Care coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,422 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Northern Piedmont Carolina Community Care Partners, North Carolina Division of Medical Assistance
- Study start
- Dec 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 24 Dec 2009 (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 improve patient care and safety while decreasing ED visit rates by sending specific information about care transitions related to hospital admission and discharge and emergency department and specialty care visits to primary care practices, care managers and patients with the use of health information technology (HIT) shared across a community-based network of providers.
Cycle 1 focuses on the impact of notices about ED encounters and hospitalizations derived from billing data that are sent to care managers for all 47,000 patients in the Northern Piedmont Community Care Network (NPCCN). Cycle 2 explores the impact of letters sent to patients, and care event reports sent to a patient's medical home in addition to notices sent to care managers about ED encounters, hospitalization and specialty care based on ADT (Admission Discharge Transfer) and billing data on 4,600 patients with complex health needs.
Detailed description
This three-year project seeks to improve outcomes, quality and coordination of care for patients with complex healthcare needs by facilitating the availability of information following three types of care transitions into the ambulatory care setting. Specific information regarding care transitions will be made available to patients, primary care practitioners and care managers following hospitalizations, emergency department (ED) encounters, and specialty clinic evaluations.
This project will build upon a regional Health Information Exchange (HIE) network created to connect providers serving 47,000 Medicaid beneficiaries across traditional institutional boundaries from both rural and urban settings in a 6-county region in the Northern Piedmont of North Carolina. This network includes 25 ambulatory care practices, 3 federally qualified health centers, 4 rural health clinics, 3 urgent care facilities, 11 government agencies, 5 hospitals and 2 cross-disciplinary care management teams. Within this HIE network, 4,600 patients with complex healthcare needs have been identified.
For this project, a standards-based clinical decision support tool will be utilized in order to ensure that the proposed approach is generalized, portable, and scalable; and routinely available claims and scheduling data will be used as the primary data source. This approach will support both traditional clinic-based models of care as well as new care models including population health management and the use of cross-disciplinary teams.
Under Aim 1, the existing HIE network and decision support tool will be enhanced to enable detection of transitions in care and delivery of timely, patient-specific information regarding these care transitions to patients, primary care clinicians and multidisciplinary care management team members. Under Aim 2, the impact of the proposed approach will be evaluated in a two-cycle randomized controlled trial primarily involving approximately 47000 Medicaid beneficiaries with a special focus on 4600 patients with complex health needs, 309 primary care clinicians, and 31 care management workers. Cycle 1 will assess only daily notices sent to care managers and will use only billing data. Cycle 2 will evaluate all components of the proposed intervention and us both billing and ADT data (see below). For Cycle 1, patients will be randomly assigned by family unit to either receive or not receive email notices sent to their care managers. For Cycle 2 patients will be randomly assigned to one of three groups: 1) information on care transitions sent to patients and their clinic-based caregivers; 2) information sent to patients, their clinic-based caregivers and their care managers; and 3) no information sent. The primary outcome measure will be the overall rate of ED utilization for each study group. Under Aim 3, the economic attractiveness of the proposed approach will be determined. Under Aim 4, the technology and results of this study will be disseminated through public media, publications and presentations. Information-augmented care transitions between sites should result in improved care coordination, higher quality of care, and more appropriate care.
This trial will be deployed in two cycles in order to support the needs of the care management network while the full intervention is developed. Cycle 1 will run from December, 2009 through December, 2010. It will assess the impact of notices about hospital admissions and ED encounters derived from billing data and sent daily to care managers for the 47,000 patients enrolled in NPCCN on the study outcomes. Cycle 2 will run from December, 2010 through December, 2011 and will address AIM 2 of the original grant proposal. For Cycle 2, events detected from ADT and billing data will be generated daily. The events will include hospital admissions, hospital discharges, ED encounters, and specialty care visits. The responses to events will include event summary reports sent to patients' assigned medical homes, letters sent to patients or their guardians, and release of information requests on behalf of a patient's medical home. The response will be generated for 4,600 patients identified as having complex health needs. In addition, notices will be sent to care managers for detected hospital and ED events for all 47,000 patients enrolled in NPCCN. Special priority will be given to patients with complex heath needs.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermediate Intervention (arm #1) | Experimental | Other: ReportsCare transition reports sent to primary care clinics, care transition letters sent to patients, release of information requests about care transitions sent on behalf of primary care clinics. |
| Full Intervention (arm #2) | Experimental | Other: Reports and NoticesE-mail notices sent to care managers about care transitions plus care transition reports sent to primary care clinics, care transition reports sent to patients, release of information requests about care transitions sent on behalf of primary care clinics. |
| Control (arm #3) | Experimental | Other: Usual careSubjects assigned to the control group will receive "usual care" which is the standard of care coordination currently existent between patients, providers and care managers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- North Carolina Medicaid beneficiary enrolled in the Northern Piedmont Community Care Network (NPCCN)
- Has complex healthcare needs as defined by having two or more IOM (Institute of Medicine) priority conditions (hypertension, coronary artery disease, congestive heart failure, stroke, asthma, diabetes) OR one of the following: moderate to severe mental health diagnosis (schizophrenic disorder, episodic mood disorder, delusional disorder, non-organic psychosis, anxiety, dissociative-somatoform disorder, personality disorder), end-stage renal disease, sickle cell disease
- Continuous enrollment in NPCCN for 10 of the previous 12 months
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 |
|---|---|---|
| ReportsPrimary care event reports and patient letters | Other | Intermediate Intervention (arm #1) |
| Reports and NoticesPrimary care event reports, patient letters and care manager notices | Other | Full Intervention (arm #2) |
| Usual careThis is the study's control group | Other | Control (arm #3) |
Primary outcome
Emergency department encounter rates among patients in the study population.
Time frame: 6 months
22 secondary outcomes
Emergency department encounter rates for low severity diagnoses among all patients.
Time frame: 6 months
Total emergency department encounter rates among patients for whom intervention was appropriate.
Time frame: 6 months
Total emergency department encounter rates among all patients.
Time frame: 6 months
Hospitalization rates among patients for whom intervention was appropriate.
Time frame: 6 months
Hospitalization rates among all patients.
Time frame: 6 months
Hospital readmission rates within 30 days after hospitalization among patients for whom intervention was appropriate.
Time frame: 6 months
Hospital readmission rates within 30 days after hospitalization among all patients.
Time frame: 6 months
Primary care visit rates among patients following an emergency department encounter or hospitalization for whom intervention was appropriate.
Time frame: 6 months
Primary care visit rates among all patients following an emergency department encounter or hospitalization.
Time frame: 6 months
Rates of completion of medically-indicated post hospitalization studies or procedures among patients for whom intervention was appropriate.
Time frame: 6 months
Rates of completion of medically-indicated post hospitalization studies or procedures among all patients.
Time frame: 6 months
Total medical costs among patients for whom intervention was appropriate.
Time frame: 6 months
Total medical costs among all patients.
Time frame: 6 months
Emergency department costs among patients for whom intervention was appropriate.
Time frame: 6 months
Emergency department costs among all patients.
Time frame: 6 months
Hospitalization costs among patients for whom intervention was appropriate.
Time frame: 6 months
Hospitalization costs among all patients.
Time frame: 6 months
Outpatient costs among patients for whom intervention was appropriate.
Time frame: 6 months
Outpatient costs among all patients.
Time frame: 6 months
Patient satisfaction among patients for whom intervention was appropriate.
Time frame: 6 months
Patient-reported quality of life among patients for whom intervention was appropriate.
Time frame: 6 months
Provider satisfaction among providers with contact with patients for whom intervention was appropriate.
Time frame: 6 months
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 15 May 2014.
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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.
Eric Eisenstein, DBA 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 Reports and Reports and Notices in people with Asthma and Coronary Artery Disease, 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 3 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 15 May 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 encounter rates among patients in the study population. (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 15 May 2014.