Intensive Management of At-risk Patients

Intensive Management of At-risk Patients: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Disease
• Intervention / Treatment: Behavioral: Control; Behavioral: Intensive management

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Usual care group	Behavioral: Control; Usual care
Experimental: Intervention; Intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED visits	participants' total emergency department visits	6 months
30-day readmissions	participants' total inpatient readmissions within 30 days	30 days
180-day readmissions	participants' total inpatient readmissions within 180 days	180 days
ACSC admits	participants' inpatient admissions for ambulatory care sensitive conditions	6 months
inpatient plus SNF bed days	number of total days of participants' care in an inpatient or skilled nursing facility setting	6 months
cost	participants' total medical expenditures	6 months
delta MLR	average change in each participant's medical loss ratio	6 months
average percent post-acute contact within 1 week	average percent of participants contacted within 1 week of emergency department visit, hospital or skilled-nursing facility discharge	1 week
average percent of high-priority tasks completed within 1 week	average percent of participant care tasks designated as high-priority that are completed within 1 week of being assigned	1 week
average percent of Gold patients contacted weekly	average percent of participants in Gold tier contacted every week	1 week
average percent of participants contacted monthly	average percent of participants contacted every 4 weeks	1 month
average change in percent of high-priority HEDIS gaps	average change in percent of open Healthcare Effectiveness Data and Information Set (HEDIS) measures that are high-priority, meaning statin use in diabetics and cardiovascular disease; medication adherence for oral diabetes, hypertension and statin; diabetes A1c control; and blood pressure control	6 months
average change in staff satisfaction score	average difference in sum of Likert scale responses to staff satisfaction survey	6 months
average change in participant satisfaction score	average difference in sum of Likert scale responses to participant satisfaction survey	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
average change in RAF	average change in each participant's Risk Adjustment Factor	6 months
average number of high-priority tasks completed per week	average number of participant care tasks designated high-priority completed per week	1 week
average time on high-priority tasks per week	average amount of time in minutes per week spent by staff in attempting to complete high-priority participant care tasks	1 week
number of in-person visits	total number of in-person care visits by participants	6 months

Collaborators and Investigators

• Sponsor: CareMore Health, San Bernardino
• Investigators: Principal Investigator: Paul Bixenstine, MD, CareMore Health

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: primary care; ambulatory care; quality improvement; population health; care management; high need high cost; readmission prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No