Clinical trial NCT04456725: Intensive Management of At-risk Patients
Official title: Intensive Management of At-risk Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Keywords: high need high cost
population health
care management
quality improvement
ambulatory care
primary care
readmission prevention
Lead sponsor: CareMore Health, San Bernardino
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria: At-risk patients, meaning Gold, Silver, or Bronze tier, as identified by our member 360 platform:

* 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

Primary outcomes:
measure: inpatient bed days
timeFrame: 6 months
measure: inpatient admissions
timeFrame: 6 months
Secondary outcomes:
measure: ED visits
timeFrame: 6 months
measure: 30-day readmissions
timeFrame: 30 days
measure: 180-day readmissions
timeFrame: 180 days
measure: ACSC admits
timeFrame: 6 months
measure: inpatient plus SNF bed days
timeFrame: 6 months
measure: cost
timeFrame: 6 months
measure: delta MLR
timeFrame: 6 months
measure: average percent post-acute contact within 1 week
timeFrame: 1 week
measure: average percent of high-priority tasks completed within 1 week
timeFrame: 1 week
measure: average percent of Gold patients contacted weekly
timeFrame: 1 week
measure: average percent of participants contacted monthly
timeFrame: 1 month
measure: average change in percent of high-priority HEDIS gaps
timeFrame: 6 months
measure: average change in staff satisfaction score
timeFrame: 6 months
measure: average change in participant satisfaction score
timeFrame: 6 months
Other outcomes:
measure: average change in RAF
timeFrame: 6 months
measure: average number of high-priority tasks completed per week
timeFrame: 1 week
measure: average time on high-priority tasks per week
timeFrame: 1 week
measure: number of in-person visits
timeFrame: 6 months
Locations:
Study officials:
affiliation: CareMore Health
name: Paul Bixenstine, MD
role: PRINCIPAL_INVESTIGATOR
References: