Intensive Management of At-risk Patients

NCT ID: NCT04456725

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-12-31

Brief Summary

The purpose of this study is to assess if intensive management of at-risk participants, utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring, will lead to better patient outcomes than usual care.

Detailed Description

At-risk participants will be randomized 1:1 to either usual care or intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring for 6 months. Participants in the intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them with the support of the study team. Staff will focus on contacting all patients within one week of any emergency department visit or hospital discharge, contacting all highest-risk participants weekly and all participants monthly, and completing high-priority tasks for participant care within one week. The primary outcomes of this quality improvement study are inpatient bed days and number of inpatient admissions.

Conditions

Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Usual care group

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Usual care

Intervention

Intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring.

Group Type: EXPERIMENTAL

Intensive management

Intervention Type: BEHAVIORAL

The intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them intensively, with the support of the study team.

Interventions

Intensive management

The intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them intensively, with the support of the study team.

Intervention Type: BEHAVIORAL

Control

Usual care

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Gold tier - 6+ emergency department (ED) visits last year, annual spend >$100,000, 8 or more hierarchical condition category (HCC) diagnoses, readmission <30 days prior, or ambulatory care-sensitive condition (ACSC) hospitalization <30 days prior
• Silver tier - 4+ ED visits last year, annual spend >$75,000, 6 or more HCC diagnoses, readmission <90 days prior, substance abuse HCC diagnosis, behavioral health admit <90 days, 15+ chronic medications prescribed in the last 90 days (and not qualifying for Gold tier)
• Bronze tier - 3+ ED visits last year, annual spend >$50,000, 5 or more HCC diagnoses, 3+ hospitalizations last year, end-stage liver disease, end-stage renal disease, Medicare and Medicaid dual-enrolled, disease-management program patients with ACSC admission or ED visit in the last year, 10+ chronic medications in the last 90 days, 6+ health risk-assessment score, 12+ Edmonton Frail Scale score (and not qualifying for Gold or Silver tiers)

Exclusion Criteria

• enrolled in hospice
• enrolled in Institutional Special Needs Plan
• primary patient of study investigator

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CareMore Health, San Bernardino

OTHER

Sponsor Role: lead

Responsible Party

Paul Bixenstine

Primary Care Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Bixenstine, MD

Role: PRINCIPAL_INVESTIGATOR

CareMore Health

Central Contacts

Paul J Bixenstine, MD

Role: CONTACT

paul.bixenstine@caremore.com

909-296-8800

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id