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Intensive Management of At-risk Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04456725
Enrollment
600
Registered
2020-07-02
Start date
2020-07-01
Completion date
2020-12-31
Last updated
2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease

Keywords

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

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.

Interventions

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.

BEHAVIORALControl

Usual care

Sponsors

CareMore Health, San Bernardino
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will not be informed that their care is different than usual care.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
inpatient bed days6 monthsnumber of total participants' days of care in an inpatient setting
inpatient admissions6 monthstotal number of participants' inpatient admissions

Secondary

MeasureTime frameDescription
inpatient plus SNF bed days6 monthsnumber of total days of participants' care in an inpatient or skilled nursing facility setting
average percent of participants contacted monthly1 monthaverage percent of participants contacted every 4 weeks
average change in percent of high-priority HEDIS gaps6 monthsaverage 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
average change in staff satisfaction score6 monthsaverage difference in sum of Likert scale responses to staff satisfaction survey
average change in participant satisfaction score6 monthsaverage difference in sum of Likert scale responses to participant satisfaction survey
average percent of high-priority tasks completed within 1 week1 weekaverage percent of participant care tasks designated as high-priority that are completed within 1 week of being assigned
average percent post-acute contact within 1 week1 weekaverage percent of participants contacted within 1 week of emergency department visit, hospital or skilled-nursing facility discharge
ED visits6 monthsparticipants' total emergency department visits
30-day readmissions30 daysparticipants' total inpatient readmissions within 30 days
180-day readmissions180 daysparticipants' total inpatient readmissions within 180 days
ACSC admits6 monthsparticipants' inpatient admissions for ambulatory care sensitive conditions
cost6 monthsparticipants' total medical expenditures
delta MLR6 monthsaverage change in each participant's medical loss ratio
average percent of Gold patients contacted weekly1 weekaverage percent of participants in Gold tier contacted every week

Other

MeasureTime frameDescription
number of in-person visits6 monthstotal number of in-person care visits by participants
average change in RAF6 monthsaverage change in each participant's Risk Adjustment Factor
average number of high-priority tasks completed per week1 weekaverage number of participant care tasks designated high-priority completed per week
average time on high-priority tasks per week1 weekaverage amount of time in minutes per week spent by staff in attempting to complete high-priority participant care tasks

Contacts

Primary ContactPaul J Bixenstine, MD
paul.bixenstine@caremore.com909-296-8800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026