Transforming Outcomes for Patients Through Medical Home Evaluation & reDesign (TOPMED)

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

Study Overview

• Status: Completed
• Conditions: Health Information Technology; Nurse Based Care Management
• Intervention / Treatment: Other: Intervention; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 65500
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• patients less then 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Financial incentives will be provided based on performance in areas determined to be of high-value.	Other: Intervention; Will receive payments based on achievement in meeting goals based on specified high value elements as well as effort.
Active Comparator: Control; Financial incentives are a flat rate which can be reduced if an appropriate amount of effort or improvement is not met	Other: Control; Will receive payments based on achievement in meeting goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Care Management Plus
• Collaborators: Gordon and Betty Moore Foundation
• Investigators: Principal Investigator: David A Dorr, MD, MS, Oregon Health and Science University; Study Chair: Marsha Pierre-Jacques Williams, BA, Oregon Health and Science University; Study Chair: Kimberley Gray, BSN, Oregon Health and Science University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: health information technology; practice facilitation; Care coordination; nurse care management
• Other Study ID Numbers: GBMF2908