NCT02106221

Brief 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 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:

  1. 1.Evidence-based Care Management Based on Need
  2. 2.Identification of At-Risk Populations
  3. 3.Patient Engagement and Alerts Based on Goals
  4. 4.Integrated Information for Care Management, especially around Utilization
  5. 5.Population Management Tools

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65,500

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

2.9 years

First QC Date

March 21, 2014

Last Update Submit

July 28, 2015

Conditions

Keywords

Care coordinationnurse care managementpractice facilitationhealth information technology

Outcome Measures

Primary Outcomes (3)

  • Preventable utilization

    Reduce by 15% ED visits and hospitalizations related to ambulatory care

    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.)

    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.

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Financial incentives will be provided based on performance in areas determined to be of high-value.

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

Other: Control

Interventions

Will receive payments based on achievement in meeting goals based on specified high value elements as well as effort.

Intervention
ControlOTHER

Will receive payments based on achievement in meeting goals.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • patients less then 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

    PMID: 25609501BACKGROUND

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • David A Dorr, MD, MS

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR
  • Marsha Pierre-Jacques Williams, BA

    Oregon Health and Science University

    STUDY CHAIR
  • Kimberley Gray, BSN

    Oregon Health and Science University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2014

First Posted

April 8, 2014

Study Start

July 1, 2011

Primary Completion

June 1, 2014

Study Completion

February 1, 2015

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations