Nurse Based Care ManagementPhase 3NCT01890603
Enhancing Complex Care Through an Integrated Care Coordination Information System
A Phase 3 study testing Data collection in people with Nurse Based Care Management and Health Information Technology, run by Care Management Plus at 1 site in United States.
Trial summary
Cluster randomized controlled trial comparing care coordination incentives to pay for performance (quality measure) incentives in clinics on utilization, cost, quality, and patient experience. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nurse Based Care Management, Health Information Technology
- What is being tested?
- Data collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2011
- Phase
- Phase 3
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Six Clinics participating whom Care Management Plus team has worked with before
- Patients belonging to one of these six clinics
- Picked based on an algorithm designed to identify high risk patients.
- Clinic will review potential patients list and issue a survey with consent form
Who cannot join
- Younger than 18
- Older than 90
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Ambulatory Safety and Quality Program: Improving Management of Individuals With Complex Healthcare Needs Through Health It
Cluster randomized controlled trial comparing care coordination incentives to pay for performance (quality measure) incentives in clinics on utilization, cost, quality, and patient experience.
- Being tested
- Data collection
- Keywords
- Care coordination, primary care, nurse care management, practice facilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).
Data CollectionOther
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).
| Study group | Role | What they receive |
|---|---|---|
| Care Coordination Arm | Experimental | Not described Receives: Other: Data collection |
| Quality Measure Improvement | Active comparator | Not described Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Utilization
Utilization includes Emergency Department visits and hospitalizations for this high risk group.
Measured: up to 18 months
Secondary outcomes (3)
Patient Satisfaction/Experience
Patient Assessment of Care for Chronic Conditions (PACIC; Consumer Assessment of Healthcare Providers and Systems
Measured: 0, 18 months
Reduce Costs
Costs will be aggregated and compared across groups
Measured: 0, 12, 18 months
Improve quality of care
5 pre-validated quality measures will be aggregated and compared across groups.
Measured: 0,3,6,9,12,15,18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse Based Care ManagementStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Care Management Plus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Dorr, MD MS, Principal investigator, Oregon Health and Science UniversityGwenivere Olsen, BS, Study chair, Oregon Health and Science UniversityKelli Radican, Study chair, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890603
- Sponsor's protocol ID
- HS17832
- Status last verified
- Jun 2013
- First submitted
- 12 Jan 2012
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Safety and Quality Program: Improving Management of Individuals With Complex Healthcare Needs Through Health It
- ClinicalTrials.gov ID
- NCT01890603
- Acronym / sponsor ID
- HS17832
- Keywords
- Care coordination, primary care, nurse care management, practice facilitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60,000 participants (actual)
- Lead sponsor
- Care Management PlusUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Jul 2013 (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.
Cluster randomized controlled trial comparing care coordination incentives to pay for performance (quality measure) incentives in clinics on utilization, cost, quality, and patient experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care Coordination Arm | Experimental | Other: Data collection |
| Quality Measure Improvement | Active comparator | Other: Data Collection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Six Clinics participating whom Care Management Plus team has worked with before
- Patients belonging to one of these six clinics
- Picked based on an algorithm designed to identify high risk patients.
- Clinic will review potential patients list and issue a survey with consent form
Key exclusion criteria (2 listed)
- Younger than 18
- Older than 90
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 |
|---|---|---|
| Data collectionResearch involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis). | Other | Care Coordination Arm |
| Data CollectionResearch involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis). | Other | Quality Measure Improvement |
Primary outcome
Rate of Utilization
Time frame: up to 18 months
Utilization includes Emergency Department visits and hospitalizations for this high risk group.
3 secondary outcomes
Patient Satisfaction/Experience
Time frame: 0, 18 months
Reduce Costs
Time frame: 0, 12, 18 months
Improve quality of care
Time frame: 0,3,6,9,12,15,18 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 2 Jul 2013.
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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 Dorr, MD MS principal investigator
Oregon Health and Science University
Gwenivere Olsen, BS study chair
Oregon Health and Science University
Kelli Radican study chair
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Data collection in people with Nurse Based Care Management and Health Information Technology, run by Care Management Plus 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 4 inclusion and 2 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 2 Jul 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of Utilization (time frame: up to 18 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 2 Jul 2013.