Intensive Management of At-risk Patients

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04456725
• Other study ID #: 001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2020
• Source: CareMore Health, San Bernardino
• Contact: Paul J Bixenstine, MD
• Phone: 909-296-8800
• Email: paul.bixenstine[@]caremore.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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.
• Control
Usual care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CareMore Health, San Bernardino

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	average change in RAF	average change in each participant's Risk Adjustment Factor	6 months
Other	average number of high-priority tasks completed per week	average number of participant care tasks designated high-priority completed per week	1 week
Other	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
Other	number of in-person visits	total number of in-person care visits by participants	6 months
Primary	inpatient bed days	number of total participants' days of care in an inpatient setting	6 months
Primary	inpatient admissions	total number of participants' inpatient admissions	6 months
Secondary	ED visits	participants' total emergency department visits	6 months
Secondary	30-day readmissions	participants' total inpatient readmissions within 30 days	30 days
Secondary	180-day readmissions	participants' total inpatient readmissions within 180 days	180 days
Secondary	ACSC admits	participants' inpatient admissions for ambulatory care sensitive conditions	6 months
Secondary	inpatient plus SNF bed days	number of total days of participants' care in an inpatient or skilled nursing facility setting	6 months
Secondary	cost	participants' total medical expenditures	6 months
Secondary	delta MLR	average change in each participant's medical loss ratio	6 months
Secondary	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
Secondary	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
Secondary	average percent of Gold patients contacted weekly	average percent of participants in Gold tier contacted every week	1 week
Secondary	average percent of participants contacted monthly	average percent of participants contacted every 4 weeks	1 month
Secondary	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
Secondary	average change in staff satisfaction score	average difference in sum of Likert scale responses to staff satisfaction survey	6 months
Secondary	average change in participant satisfaction score	average difference in sum of Likert scale responses to participant satisfaction survey	6 months