Clinical trial NCT03919084: THRIVE+ Pharmacy Liaison-Patient Navigation Intervention
Official title: A Pharmacy Liaison-Patient Navigation Intervention to Reduce Inpatient and Emergency Department Utilization Among Primary Care Patients in a Medicaid Accountable Care Organization: A Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthcare Utilization
Keywords: THRIVE
Patient navigation
Accountable Care Organization
Pharmacy liaison
Pharmacy services
Social determinants of health
health-related social needs
screening and referral
Medicaid ACO
ACO
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Massachusetts Health Policy Commission
name: John Hancock Foundation
First posted: 2019-04-18
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pragmatic comparative effectiveness trial (n=364) to compare two screening and referral program models to address health-related social needs (HRSN) among the intermediate risk population of Boston Accountable Care Organization (BACO), a Medicaid ACO. The first study arm is THRIVE-Basic, the low-touch usual care model already implemented in all primary care clinics at Boston Medical Center (BMC) where patients are screened for HRSN and receive a printed paper resource referral guide. The second study arm is THRIVE+, which enhances the THRIVE-Basic model by engaging a pharmacy liaison-patient navigator to provide targeted navigation services and motivational interviewing to ensure connection to hospital- and community-based resources. The patient navigators will also interface directly with a partner community organization, Action for Boston Community Development (ABCD), to further help connect patients receiving THRIVE+ to community resources for HRSN. All patients in our study will receive pharmacy services via an existing Pharmacy Care Program. Patients in study arm 1 will be connected to a pharmacy liaison, which is standard clinical practice for intermediate risk ACO members in the BMC General Internal Medicine clinics. Patients in study arm 2 will receive systematic screening for and addressing of HRSN (THRIVE+) via a pharmacy liaison-patient navigator (a pharmacy technician trained as a patient navigator to deploy both pharmacy services and the THRIVE+ intervention), thereby avoiding duplication of services and multiple touches. Assignment to the study arms will be linked to existing Pharmacy Care Program enrollment activities and will be based on medical record number. The investigators' rationale for the study is that if patients' HRSN are addressed, patients will be better positioned to manage chronic conditions, adhere to preventive care plans, and less likely to use the emergency department (a conduit to inpatient care) for ambulatory care-sensitive conditions. The effectiveness of these two models will be compared with respect to alleviating HRSN and reducing acute health care utilization over a 12-month follow-up period.


Eligibility criteria: Inclusion Criteria:

* Identified as within the 3rd to 10th percentile for healthcare utilization and cost among Boston Accountable Care Organization (BACO) Medicaid ACO membership at the time of enrollment in the clinical program; and
* Attend a primary care visit with a primary care provider (PCP-nurse practitioner or physician) in General Internal Medicine at Boston University Medical Center.

Exclusion Criteria:

-Patients who are receiving services from the BACO complex care management program.

Primary outcomes:
measure: Acute healthcare utilization composite measure
timeFrame: 12 months
Secondary outcomes:
measure: Number of all-cause emergency department visits
timeFrame: 12 months
measure: Number of 30-day emergency department revisits
timeFrame: 12 months
measure: Emergency department revisits rate
timeFrame: 12 months
measure: Number of all-cause hospital discharges
timeFrame: 12 months
measure: Number of 30-day hospital readmissions
timeFrame: 12 months
measure: 30-day inpatient readmission rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Karen Lasser, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lasser KE, Buitron de la Vega P, Ashe EM, Xuan Z, Alva S, Battisti L, Losi S, Sieber C, Richards C, Sullivan P, Triscari L, Brody L, Roth MT, LeBlanc A, Silverstein M. A pharmacy liaison-patient navigation intervention to reduce inpatient and emergency department utilization among primary care patients in a Medicaid accountable care organization: A pragmatic trial protocol. Contemp Clin Trials. 2020 Jul;94:106046. doi: 10.1016/j.cct.2020.106046. Epub 2020 May 31.