Intensive Management of At-risk Patients

NCT04456725 | Unknown

• 1 other identifier: 001
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Disease

Keywords

high need high cost; population health; care management; quality improvement; ambulatory care; primary care; readmission prevention

Outcome Measures

Primary Outcomes (2)

• inpatient bed days

  number of total participants' days of care in an inpatient setting

  6 months

• inpatient admissions

  total number of participants' inpatient admissions

  6 months

Secondary Outcomes (14)

• ED visits

  6 months

• 30-day readmissions

  30 days

• 180-day readmissions

  180 days

• ACSC admits

  6 months

• inpatient plus SNF bed days

  6 months

Other Outcomes (4)

• average change in RAF

  6 months

• average number of high-priority tasks completed per week

  1 week

• average time on high-priority tasks per week

  1 week

Study Arms (2)

Control

ACTIVE COMPARATOR

Usual care group

Behavioral: Control

Intervention

EXPERIMENTAL

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

Behavioral: Intensive management

Interventions

Intensive management 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.

Intervention

Control BEHAVIORAL

Usual care

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• CareMore Health, San Bernardino: lead

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Bixenstine, MD

  CareMore Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul J Bixenstine, MD

CONTACT

909-296-8800; paul.bixenstine@caremore.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed that their care is different than usual care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Care Physician

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: July 2, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share