Healthcare UtilizationTHRIVE+NCT03919084
THRIVE+ Pharmacy Liaison-Patient Navigation Intervention
A study testing THRIVE screening and referral, Pharmacy Care Program services and Patient Navigation Services in people with Healthcare Utilization, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthcare Utilization
- What is being tested?
- THRIVE screening and referral, Pharmacy Care Program services and Patient Navigation Services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2019to 5 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- -Patients who are receiving services from the BACO complex care management program.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthcare Utilization
- Being tested
- THRIVE screening and referral, Pharmacy Care Program services, Patient Navigation Services, Motivational Interviewing, Linkage to Community Partner Organization
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE screening and referralOther
Also called THRIVE-Basic
The THRIVE screening tool includes questions to identify eight potentially unmet health-related social needs associated with health outcomes and healthcare utilization: housing and food insecurity, inability to afford medications, need for transportation, trouble paying for heat and electricity, need for employment or education, and difficulty taking care of children or other family members. The survey is written at a 3rd grade reading level, is available in multiple languages, and requires less than five minutes to complete. The paper screener consists of two parts: part one screens patients for health-related social needs in the eight domains. Part two asks patients to indicate the resources they want help accessing across the eight domains. Patients who request resources in one or more domains receive paper guides that describe available hospital and community resources to address the specific domain(s) indicated.
Pharmacy Care Program servicesOther
Pharmacy services provided by a pharmacy liaison include assessing gaps in obtaining refills, identifying barriers to medication adherence, reviewing the patient's engagement in medical care, and developing an action plan with the patient. Action plans focus on strategies to increase medication adherence and engagement in care. The pharmacy liaison will also link the patient to a clinical pharmacist, when appropriate, and will assist the patient with prescription management. After the initial intake is completed, the pharmacy liaison will call patients monthly (or meet with them prior to or following scheduled appointments) over a twelve-month period to confirm medication adherence and address any new barriers to medication adherence and engagement in medical care. The pharmacy liaison in the control arm does not systematically initiate screening for health-related social needs.
Patient Navigation ServicesOther
In traditional patient navigation programs, a lay person from the community guides individuals through the healthcare system to receive appropriate services. For the present study, the research team will train pharmacy liaisons (pharmacy technicians or pharmacy interns with at least a high school degree and four years of pharmacy experience) to provide patient navigation services, in addition to providing medication adherence support and assistance resolving barriers to accessing medication. In an effort to avoid duplication of services the patient navigation intervention will be delivered via a pharmacy liaison trained in patient navigation, thereby decreasing multiple intervention providers and increasing the potential for sustainability should the intervention prove effective.
Motivational InterviewingOther
Motivational interviewing is a counseling method that encourages patient-centered discussions. Motivational interviewing will be delivered by the intervention arm pharmacy liaison-patient navigators to identify the patient's unmet needs and encourage the patient to adopt behavior change that will promote engagement with resources and services to mitigate or alleviate HRSN.
Linkage to Community Partner OrganizationOther
The pharmacy liaison-patient navigator will partner with a community organization, Action for Boston Community Development (ABCD). ABCD will help connect patients receiving THRIVE+ to community resources including childcare, food, heating, and housing. The pharmacy liaison-patient navigator will interface directly with ABCD to coordinate receipt of resources for their patients.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE-Basic | Active comparator | Screening-and-referral usual care model Receives: Other: THRIVE screening and referral; Other: Pharmacy Care Program services |
| THRIVE+ | Experimental | Enhanced screening-and-referral with motivational interviewing and patient navigation services Receives: Other: THRIVE screening and referral; Other: Pharmacy Care Program services; Other: Patient Navigation Services; Other: Motivational Interviewing; Other: Linkage to Community Partner Organization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute healthcare utilization composite measure
Measure includes all-cause hospital admissions and all-cause emergency department visits.
Measured: 12 months
Secondary outcomes (6)
Number of all-cause emergency department visits
Total number of all-cause emergency department visits.
Measured: 12 months
Number of 30-day emergency department revisits
Total number of all-cause emergency department revisits within thirty (30) days of initial emergency department visit.
Measured: 12 months
Emergency department revisits rate
Total number of all-cause emergency department revisits within thirty (30) days of initial emergency department visit divided by total number of all-cause emergency department visits.
Measured: 12 months
Number of all-cause hospital discharges
Total number of all-cause discharges from inpatient status
Measured: 12 months
Number of 30-day hospital readmissions
Total number of all-cause discharges from inpatient status that had a subsequent admission within thirty (30) days of the initial discharge.
Measured: 12 months
30-day inpatient readmission rate
Total number of all-cause discharges from inpatient status that had a subsequent admission within thirty (30) days of the initial discharge divided by total number of all-cause discharges from inpatient status.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start28 May 2019
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthcare UtilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Health Policy Commission, John Hancock Foundation
- Responsible party
- Sponsor
- Investigators
- Karen Lasser, MD MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919084
- Sponsor's protocol ID
- H-38000
- Acronym
- THRIVE+
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2019
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buitron de la Vega P, Ashe EM, Xuan Z, Gast V, Saint-Phard T, Brody-Fialkin J, Okonkwo F, Power J, Wang N, Lyons C, Silverstein M, Lasser KE. A Pharmacy Liaison-Patient Navigation Intervention to Reduce Inpatient and Emergency Department Utilization Among Primary Care Patients in a Medicaid Accountable Care Organization: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250004. doi: 10.1001/jamanetworkopen.2022.50004.
PubMed 36622674Lasser 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.
PubMed 32485325
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03919084
- Acronym / sponsor ID
- THRIVE+ / H-38000
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Massachusetts Health Policy Commission, John Hancock Foundation
- Study start
- 28 May 2019 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THRIVE-Basic | Active comparator | Other: THRIVE screening and referral, Other: Pharmacy Care Program servicesScreening-and-referral usual care model |
| THRIVE+ | Experimental | Other: THRIVE screening and referral, Other: Pharmacy Care Program services, Other: Patient Navigation Services, Other: Motivational Interviewing, Other: Linkage to Community Partner OrganizationEnhanced screening-and-referral with motivational interviewing and patient navigation services |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -Patients who are receiving services from the BACO complex care management program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THRIVE screening and referralAlso: THRIVE-BasicThe THRIVE screening tool includes questions to identify eight potentially unmet health-related social needs associated with health outcomes and healthcare utilization: housing and food insecurity, inability to afford medications, need for transportation, trouble paying for heat and electricity, need for employment or education, and difficulty taking care of children or other family members. The survey is written at a 3rd grade reading level, is available in multiple languages, and requires less than five minutes to complete. The paper screener consists of two parts: part one screens patients for health-related social needs in the eight domains. Part two asks patients to indicate the resources they want help accessing across the eight domains. Patients who request resources in one or more domains receive paper guides that describe available hospital and community resources to address the specific domain(s) indicated. | Other | THRIVE+, THRIVE-Basic |
| Pharmacy Care Program servicesPharmacy services provided by a pharmacy liaison include assessing gaps in obtaining refills, identifying barriers to medication adherence, reviewing the patient's engagement in medical care, and developing an action plan with the patient. Action plans focus on strategies to increase medication adherence and engagement in care. The pharmacy liaison will also link the patient to a clinical pharmacist, when appropriate, and will assist the patient with prescription management. After the initial intake is completed, the pharmacy liaison will call patients monthly (or meet with them prior to or following scheduled appointments) over a twelve-month period to confirm medication adherence and address any new barriers to medication adherence and engagement in medical care. The pharmacy liaison in the control arm does not systematically initiate screening for health-related social needs. | Other | THRIVE+, THRIVE-Basic |
| Patient Navigation ServicesIn traditional patient navigation programs, a lay person from the community guides individuals through the healthcare system to receive appropriate services. For the present study, the research team will train pharmacy liaisons (pharmacy technicians or pharmacy interns with at least a high school degree and four years of pharmacy experience) to provide patient navigation services, in addition to providing medication adherence support and assistance resolving barriers to accessing medication. In an effort to avoid duplication of services the patient navigation intervention will be delivered via a pharmacy liaison trained in patient navigation, thereby decreasing multiple intervention providers and increasing the potential for sustainability should the intervention prove effective. | Other | THRIVE+ |
| Motivational InterviewingMotivational interviewing is a counseling method that encourages patient-centered discussions. Motivational interviewing will be delivered by the intervention arm pharmacy liaison-patient navigators to identify the patient's unmet needs and encourage the patient to adopt behavior change that will promote engagement with resources and services to mitigate or alleviate HRSN. | Other | THRIVE+ |
| Linkage to Community Partner OrganizationThe pharmacy liaison-patient navigator will partner with a community organization, Action for Boston Community Development (ABCD). ABCD will help connect patients receiving THRIVE+ to community resources including childcare, food, heating, and housing. The pharmacy liaison-patient navigator will interface directly with ABCD to coordinate receipt of resources for their patients. | Other | THRIVE+ |
Primary outcome
Acute healthcare utilization composite measure
Time frame: 12 months
Measure includes all-cause hospital admissions and all-cause emergency department visits.
6 secondary outcomes
Number of all-cause emergency department visits
Time frame: 12 months
Number of 30-day emergency department revisits
Time frame: 12 months
Emergency department revisits rate
Time frame: 12 months
Number of all-cause hospital discharges
Time frame: 12 months
Number of 30-day hospital readmissions
Time frame: 12 months
30-day inpatient readmission rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Derived from this study: PubMed 36622674Buitron de la Vega P, Ashe EM, Xuan Z, Gast V, Saint-Phard T, Brody-Fialkin J, Okonkwo F, Power J, Wang N, Lyons C, Silverstein M, Lasser KE. A Pharmacy Liaison-Patient Navigation Intervention to Reduce Inpatient and Emergency Department Utilization Among Primary Care Patients in a Medicaid Accountable Care Organization: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250004. doi: 10.1001/jamanetworkopen.2022.50004.
- Derived from this study: PubMed 32485325Lasser 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Lasser, MD MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE screening and referral, Pharmacy Care Program services and Patient Navigation Services in people with Healthcare Utilization, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute healthcare utilization composite measure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03919084, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.