Trial Outcomes & Findings for Health Care Hotspotting: A Randomized Controlled Trial (NCT NCT02090426)

NCT ID: NCT02090426

Last Updated: 2020-11-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 800 participants
• Primary outcome timeframe: 180-day from indexed hospital discharge
• Results posted on: 2020-11-19

Participant Flow

Participant milestones

Measure	Standard Care Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including Temporary Assistance for Needy Families (TANF), Supplemental Nutrition Assistance Program (SNAP), and programs that promote housing stability. Link2Care
Overall Study STARTED	401	399
Overall Study Analysis Population	389	393
Overall Study COMPLETED	389	393
Overall Study NOT COMPLETED	12	6

Reasons for withdrawal

Measure	Standard Care Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including Temporary Assistance for Needy Families (TANF), Supplemental Nutrition Assistance Program (SNAP), and programs that promote housing stability. Link2Care
Overall Study Lost to Follow-up	12	6

Baseline Characteristics

Health Care Hotspotting: A Randomized Controlled Trial

Baseline characteristics by cohort

Measure	Standard Care n=389 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=393 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care	Total n=782 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	288 Participants n=5 Participants	279 Participants n=7 Participants	567 Participants n=5 Participants
Age, Categorical >=65 years	101 Participants n=5 Participants	114 Participants n=7 Participants	215 Participants n=5 Participants
Sex: Female, Male Female	204 Participants n=5 Participants	187 Participants n=7 Participants	391 Participants n=5 Participants
Sex: Female, Male Male	185 Participants n=5 Participants	206 Participants n=7 Participants	391 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	202 Participants n=5 Participants	227 Participants n=7 Participants	429 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	126 Participants n=5 Participants	105 Participants n=7 Participants	231 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic white	60 Participants n=5 Participants	58 Participants n=7 Participants	118 Participants n=5 Participants
Race/Ethnicity, Customized Asian, multiracial, or other	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Prior Hospital Utilization 2 admissions in prior year	165 Participants n=5 Participants	171 Participants n=7 Participants	336 Participants n=5 Participants
Prior Hospital Utilization 3+ admissions in prior year	224 Participants n=5 Participants	222 Participants n=7 Participants	446 Participants n=5 Participants
Preferred Language English	309 Participants n=5 Participants	329 Participants n=7 Participants	638 Participants n=5 Participants
Preferred Language Non-English	80 Participants n=5 Participants	64 Participants n=7 Participants	144 Participants n=5 Participants

PRIMARY outcome

Timeframe: 180-day from indexed hospital discharge

Outcome measures

Measure	Standard Care n=389 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=393 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Any Hospital Readmission	240 Participants	245 Participants

SECONDARY outcome

Timeframe: 180-day from indexed hospital discharge

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 180-day from indexed hospital discharge

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 180-day from indexed hospital discharge

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 180-day from indexed hospital discharge

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 180-day from indexed hospital discharge

Outcome measures

Measure	Standard Care n=389 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=393 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Number of Readmissions	1.54 readmissions Standard Deviation 1.98	1.52 readmissions Standard Deviation 1.98

SECONDARY outcome

Timeframe: 180-day from indexed hospital discharge

Outcome measures

Measure	Standard Care n=389 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=393 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Had 2+ Readmissions	141 Participants	143 Participants

SECONDARY outcome

Timeframe: 180-day from indexed hospital discharge

Outcome measures

Measure	Standard Care n=389 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=393 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Number of Days in the Hospital	9.95 days in hospital Standard Deviation 14.10	9.36 days in hospital Standard Deviation 13.01

SECONDARY outcome

Timeframe: 180-day from indexed hospital discharge

Outcome measures

Measure	Standard Care n=389 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=393 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Hospital Charges	114,768 hospital charges ($) Standard Deviation 187,084	116,422 hospital charges ($) Standard Deviation 200,490

SECONDARY outcome

Timeframe: 180-day from indexed hospital discharge

Outcome measures

Measure	Standard Care n=389 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=393 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Hospital Receipts	17,650 Hospital Receipts ($) Standard Deviation 29,099	18,130 Hospital Receipts ($) Standard Deviation 29,302

OTHER_PRE_SPECIFIED outcome

Timeframe: 30-day from indexed hospital discharge

Outcome measures

Measure	Standard Care n=389 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=393 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Number of Readmissions	0.39 readmissions Standard Deviation 0.68	0.38 readmissions Standard Deviation 0.73

OTHER_PRE_SPECIFIED outcome

Timeframe: 90-day from indexed hospital discharge

Outcome measures

Measure	Standard Care n=389 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=393 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Number of Readmissions	0.92 readmissions Standard Deviation 1.28	0.94 readmissions Standard Deviation 1.41

OTHER_PRE_SPECIFIED outcome

Timeframe: 365-day from indexed hospital discharge

Outcome is the number of hospital readmissions within 365-days from index hospital discharge and is reported for the subset of participants for which sufficient time has passed that 365-day outcomes can be observed in hospital claims data.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 365-day from indexed hospital discharge

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 365 days from indexed hospital discharge

Outcome is the number of days until readmission for the subset of participants for which sufficient time has passed that 365-day outcomes can be observed in hospital claims data and who had a readmission within 365 days.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 180-day from indexed hospital discharge

Population: Pre-specified subset of patients with 3+ readmissions in the prior year who completed the 180-day primary outcome period.

Outcome measures

Measure	Standard Care n=224 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=222 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Number of Readmissions (for Patients With 3+ Readmissions in the Prior Year)	1.95 readmissions Standard Deviation 2.24	1.86 readmissions Standard Deviation 2.12

OTHER_PRE_SPECIFIED outcome

Timeframe: 180-day from indexed hospital discharge

Population: Pre-specified subset of patients with 2 readmissions in the prior year who completed the 180-day primary outcome period.

Outcome measures

Measure	Standard Care n=165 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=171 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Number of Readmissions (for Patients With 2 Readmissions in the Prior Year)	0.99 readmissions Standard Deviation 1.38	1.09 readmissions Standard Deviation 1.68

OTHER_PRE_SPECIFIED outcome

Timeframe: 180-day from indexed hospital discharge

Population: Pre-specified subset of English-speaking patients who completed the 180-day primary outcome period.

Outcome measures

Measure	Standard Care n=309 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=329 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Number of Readmissions (for English Speaking Patients)	1.53 readmissions Standard Deviation 1.85	1.53 readmissions Standard Deviation 2.01

OTHER_PRE_SPECIFIED outcome

Timeframe: 180-day from indexed hospital discharge

Population: Pre-specified subset of non-English speaking patients who completed the 180-day primary outcome period.

Outcome measures

Measure	Standard Care n=80 Participants Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=64 Participants Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Number of Readmissions (for Non-English Speaking Patients)	1.58 readmissions Standard Deviation 2.44	1.48 readmissions Standard Deviation 1.81

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 240 other events

Deaths: 49 deaths

Link2Care

Serious events: 0 serious events

Other events: 245 other events

Deaths: 45 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard Care n=389 participants at risk Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.	Link2Care n=393 participants at risk Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability. Link2Care
Social circumstances Hospital Admission	61.7% 240/389 • Number of events 599 • Adverse event data were collected for 365 days post discharge from the index hospital admission. Because we measure outcomes through administrative records rather than clinical visits, records of adverse events also come from administrative records, such as the National Death Index. Some data are not yet available because of time lags from when events occur to when data is available to researchers. We report all known adverse events, with additional future data analysis planned. Serious adverse events are either death or the release of private health information (PHI) to parties external to the study team. Study targets high-risk population with expected mortality, unrelated to the study. Adverse Events are events that lead to readmission to the hospital for a study participant. The Camden Coalition conducted root-cause analysis to ascertain an AE's relatedness to the intervention, but had no contact with control group. AE are reported from hospital administrative data.	62.3% 245/393 • Number of events 599 • Adverse event data were collected for 365 days post discharge from the index hospital admission. Because we measure outcomes through administrative records rather than clinical visits, records of adverse events also come from administrative records, such as the National Death Index. Some data are not yet available because of time lags from when events occur to when data is available to researchers. We report all known adverse events, with additional future data analysis planned. Serious adverse events are either death or the release of private health information (PHI) to parties external to the study team. Study targets high-risk population with expected mortality, unrelated to the study. Adverse Events are events that lead to readmission to the hospital for a study participant. The Camden Coalition conducted root-cause analysis to ascertain an AE's relatedness to the intervention, but had no contact with control group. AE are reported from hospital administrative data.

Additional Information

Amy Finkelstein, PhD

Massachusetts Institute of Technology

Phone: 6173246995

Email: jgubb@mit.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place