Nurse Based Care ManagementPhase 3TOPMEDNCT02106221
Transforming Outcomes for Patients Through Medical Home Evaluation & reDesign
A Phase 3 study testing Intervention in people with Nurse Based Care Management and Health Information Technology, run by Care Management Plus at 1 site in United States.
Trial summary
The purpose of this study is to support enhancement, implementation, and evaluation of an improved model for delivering improved primary care to high-risk older adults through the use of health IT tools, focusing on issues related to the patient-centered primary care home (PCPCH) and other similar high-value elements… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse Based Care Management, Health Information Technology
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65,500 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Feb 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinics must be from the Oregon Rural Practice-based Research Network (ORPRN)
- Primary care clinic meeting one of the following health care setting descriptions: 1) small clinics in rural area, 2) medium-sized clinics in rural area, 3) clinics in moderate-sized health system, or 4) clinic within an academic medical center;
- Clinic will or has attested for PCPCH, achieving Tier 2 or 3 (of 3 tiers);
- Clinic is willing to contract to be a PCPCH with payers;
- Clinic has stable electronic health record (EHR) system with no plans to change systems during study duration;
- Clinic has willingness to receive practice facilitation and participate in study activities, including completion of assessments;
- Clinic has willingness to engage with research team members as defined in the study.
Who cannot join
- patients less then 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The purpose of this study is to support enhancement, implementation, and evaluation of an improved model for delivering improved primary care to high-risk older adults through the use of health IT tools, focusing on issues related to the patient-centered primary care home (PCPCH) and other similar high-value elements that are proposed to improve patient outcomes. During this study, participating clinics will utilize the already-implemented Integrated Care Coordination Information System (ICCIS). Clinic staff will meet with a practice facilitator (monthly and as needed), and will track study activities and submit invoices via ICCIS reporting. These invoices will be used to simulate a shared savings model where clinics will be reimbursed based on their progress and effort towards their goals.
Clinics will set and work towards goals that they have chosen. Goals for the control arm are self-selected by the clinics themselves; goals for the invention arm are related to high-value elements (HVE) that have been identified as areas that can improve patient outcomes. These HVE are:
- Evidence-based Care Management Based on Need
- Identification of At-Risk Populations
- Patient Engagement and Alerts Based on Goals
- Integrated Information for Care Management, especially around Utilization
- Population Management Tools
- Being tested
- Intervention, Control
- Keywords
- Care coordination, nurse care management, practice facilitation, health information technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Will receive payments based on achievement in meeting goals based on specified high value elements as well as effort.
ControlOther
Will receive payments based on achievement in meeting goals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Financial incentives will be provided based on performance in areas determined to be of high-value. Receives: Other: Intervention |
| Control | Active comparator | Financial incentives are a flat rate which can be reduced if an appropriate amount of effort or improvement is not met Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventable utilization
Reduce by 15% ED visits and hospitalizations related to ambulatory care
Measured: 12 months
Quality Measures Improvement
Select 3 standard measures related to the patient population and improve each by 20%. (An example of such a measure might be fall risk assessment. There are several quality measures that are included as part of the HIT tool that is provided to clinics.)
Measured: 12 months
Patient Satisfaction
Improve patient experience with clinic and satisfaction with care coordination by 10% Patient satisfaction will be determined by a CAHPS patient satisfaction survey that is sent out at the start and end of the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startJul 2011
- Primary completionJun 2014
- Study completionFeb 2015
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 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
- 65,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Care Management Plus
- Sponsor type
- University, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Responsible party
- Sponsor
- Investigators
- David A Dorr, MD, MS, Principal investigator, Oregon Health and Science UniversityMarsha Pierre-Jacques Williams, BA, Study chair, Oregon Health and Science UniversityKimberley Gray, BSN, Study chair, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106221
- Sponsor's protocol ID
- GBMF2908
- Acronym
- TOPMED
- Status last verified
- Jul 2015
- First submitted
- 21 Mar 2014
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dorr DA, McConnell KJ, Williams MP, Gray KA, Wagner J, Fagnan LJ, Malcolm E. Study protocol: transforming outcomes for patients through medical home evaluation and redesign: a cluster randomized controlled trial to test high value elements for patient-centered medical homes versus quality improvement. Implement Sci. 2015 Jan 22;10:13. doi: 10.1186/s13012-015-0204-6.
PubMed 25609501
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Outcomes for Patients Through Medical Home Evaluation & reDesign
- ClinicalTrials.gov ID
- NCT02106221
- Acronym / sponsor ID
- TOPMED / GBMF2908
- Keywords
- Care coordination, nurse care management, practice facilitation, health information technology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65,500 participants (actual)
- Lead sponsor
- Care Management PlusUniversity, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Study start
- Jul 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Apr 2014 (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 support enhancement, implementation, and evaluation of an improved model for delivering improved primary care to high-risk older adults through the use of health IT tools, focusing on issues related to the patient-centered primary care home (PCPCH) and other similar high-value elements that are proposed to improve patient outcomes. During this study, participating clinics will utilize the already-implemented Integrated Care Coordination Information System (ICCIS). Clinic staff will meet with a practice facilitator (monthly and as needed), and will track study activities and submit invoices via ICCIS reporting. These invoices will be used to simulate a shared savings model where clinics will be reimbursed based on their progress and effort towards their goals.
Clinics will set and work towards goals that they have chosen. Goals for the control arm are self-selected by the clinics themselves; goals for the invention arm are related to high-value elements (HVE) that have been identified as areas that can improve patient outcomes. These HVE are:
- Evidence-based Care Management Based on Need
- Identification of At-Risk Populations
- Patient Engagement and Alerts Based on Goals
- Integrated Information for Care Management, especially around Utilization
- Population Management Tools
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: InterventionFinancial incentives will be provided based on performance in areas determined to be of high-value. |
| Control | Active comparator | Other: ControlFinancial incentives are a flat rate which can be reduced if an appropriate amount of effort or improvement is not met |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- clinics must be from the Oregon Rural Practice-based Research Network (ORPRN)
- Primary care clinic meeting one of the following health care setting descriptions: 1) small clinics in rural area, 2) medium-sized clinics in rural area, 3) clinics in moderate-sized health system, or 4) clinic within an academic medical center;
- Clinic will or has attested for PCPCH, achieving Tier 2 or 3 (of 3 tiers);
- Clinic is willing to contract to be a PCPCH with payers;
- Clinic has stable electronic health record (EHR) system with no plans to change systems during study duration;
Key exclusion criteria (1 listed)
- patients less then 18
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 |
|---|---|---|
| InterventionWill receive payments based on achievement in meeting goals based on specified high value elements as well as effort. | Other | Intervention |
| ControlWill receive payments based on achievement in meeting goals. | Other | Control |
Primary outcome
Preventable utilization
Time frame: 12 months
Reduce by 15% ED visits and hospitalizations related to ambulatory care
Quality Measures Improvement
Time frame: 12 months
Select 3 standard measures related to the patient population and improve each by 20%. (An example of such a measure might be fall risk assessment. There are several quality measures that are included as part of the HIT tool that is provided to clinics.)
Patient Satisfaction
Time frame: 12 months
Improve patient experience with clinic and satisfaction with care coordination by 10% Patient satisfaction will be determined by a CAHPS patient satisfaction survey that is sent out at the start and end of the study.
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 29 Jul 2015.
- Background: PubMed 25609501Dorr DA, McConnell KJ, Williams MP, Gray KA, Wagner J, Fagnan LJ, Malcolm E. Study protocol: transforming outcomes for patients through medical home evaluation and redesign: a cluster randomized controlled trial to test high value elements for patient-centered medical homes versus quality improvement. Implement Sci. 2015 Jan 22;10:13. doi: 10.1186/s13012-015-0204-6.
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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 A Dorr, MD, MS principal investigator
Oregon Health and Science University
Marsha Pierre-Jacques Williams, BA study chair
Oregon Health and Science University
Kimberley Gray, BSN 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 Intervention 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 7 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 29 Jul 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.
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?
Preventable utilization (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT02106221, 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 29 Jul 2015.