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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT01039324
Study groupRoleWhat they receive
Intermediate Intervention (arm #1)ExperimentalCare 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)ExperimentalE-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)ExperimentalSubjects 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.

  1. Emergency department encounter rates among patients in the study population.

    Measured: 6 months

Secondary outcomes (22)
  1. Emergency department encounter rates for low severity diagnoses among all patients.

    Measured: 6 months

  2. Total emergency department encounter rates among patients for whom intervention was appropriate.

    Measured: 6 months

  3. Total emergency department encounter rates among all patients.

    Measured: 6 months

  4. Hospitalization rates among patients for whom intervention was appropriate.

    Measured: 6 months

  5. Hospitalization rates among all patients.

    Measured: 6 months

  6. Hospital readmission rates within 30 days after hospitalization among patients for whom intervention was appropriate.

    Measured: 6 months

  7. Hospital readmission rates within 30 days after hospitalization among all patients.

    Measured: 6 months

  8. Primary care visit rates among patients following an emergency department encounter or hospitalization for whom intervention was appropriate.

    Measured: 6 months

  9. Primary care visit rates among all patients following an emergency department encounter or hospitalization.

    Measured: 6 months

  10. Rates of completion of medically-indicated post hospitalization studies or procedures among patients for whom intervention was appropriate.

    Measured: 6 months

  11. Rates of completion of medically-indicated post hospitalization studies or procedures among all patients.

    Measured: 6 months

  12. Total medical costs among patients for whom intervention was appropriate.

    Measured: 6 months

  13. Total medical costs among all patients.

    Measured: 6 months

  14. Emergency department costs among patients for whom intervention was appropriate.

    Measured: 6 months

  15. Emergency department costs among all patients.

    Measured: 6 months

  16. Hospitalization costs among patients for whom intervention was appropriate.

    Measured: 6 months

  17. Hospitalization costs among all patients.

    Measured: 6 months

  18. Outpatient costs among patients for whom intervention was appropriate.

    Measured: 6 months

  19. Outpatient costs among all patients.

    Measured: 6 months

  20. Patient satisfaction among patients for whom intervention was appropriate.

    Measured: 6 months

  21. Patient-reported quality of life among patients for whom intervention was appropriate.

    Measured: 6 months

  22. 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.

  1. First posted24 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionMar 2012
  4. Study completionSep 2012

Resources

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)
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

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.

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