NCT02435511

Brief Summary

CommunityRx is a health information technology-based innovation that, starting with the patient-health care provider encounter, facilitates self-care coordination for patients, caregivers, and providers. The CommunityRx database interfaces with electronic medical records to provide patients with a "HealtheRx." A HealtheRx is a list of community-based self-care resources tailored to the patients health needs (e.g., a person with diabetes receives information about podiatrists, nutrition classes, and other resources need to manage diabetes). CommunityRx aims to measurably improve health and health care while reducing health care costs especially in underserved health care settings. Specifically, the proposed research aims to 1) evaluate the impact of CommunityRx on health care utilization, cost, health, and patient-centered outcomes for program participants compared to controls; 2) examine the flow and spread of information to and through primary agents including: program participants, community health information experts, healthcare providers, and community-based service providers (businesses and organizations providing self-care resources); and 3) build and use an agent-based model to test the distributed impact, including economic effects, of CommunityRx system adoption on the demonstration area and predict performance over time by conducting experiments that vary assumptions about agent, environment, and population-level characteristics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 15, 2019

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

April 17, 2015

Results QC Date

December 19, 2018

Last Update Submit

May 9, 2022

Conditions

Keywords

agent-based modelingcommunity resourcessimulation modelinginformation interventionclinic-to-community linkages

Outcome Measures

Primary Outcomes (1)

  • Mental Health-related Quality of Life at 3 Months

    Health-related quality of life will be measured using the Short Form Health Survey (SF-12) . Minimum value=0, maximum value=100. Higher scores equal better mental health.

    Assessed at Baseline, 1 Week, 1 Month and 3 Months; score at 3 months reported

Secondary Outcomes (4)

  • Change From Baseline in Cost Effectiveness at 3 Months

    Baseline, 3 months

  • Patient Satisfaction at 3 Months

    Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported here

  • Physical Health-related Quality of Life at 3 Months

    Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported

  • Self-efficacy - Finding Places and Services in Community to Manage Health as Measured by Questionnaire

    Assessed at baseline, 1 week, 1 month and 3 months; score at 3 months reported

Other Outcomes (10)

  • Access to Resources - Weight Loss Class or Support Group as Measured by Questionnaire Developed for This Study

    Baseline, 1 week, 1 month and 3 months

  • Access to Resources - Healthy Eating Classes as Measured by Questionnaire Developed for This Study

    Baseline, 1 week, 1 month and 3 months

  • Access to Resources - Counseling as Measured by Questionnaire Developed for This Study

    Baseline, 1 week, 1 month and 3 months

  • +7 more other outcomes

Study Arms (2)

Control arm

NO INTERVENTION

The control group will receive usual care, no HealtheRx.

Intervention arm

EXPERIMENTAL

The intervention arm will receive the intervention, a HealtheRx, which includes a list of resources in their community tailored to their health needs.

Other: HealtheRx

Interventions

The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient.

Intervention arm

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Medicaid and/or Medicare beneficiary
  • Living in 1 of the 16 zip codes served by CommunityRx
  • Seen at University of Chicago primary care or emergency department

You may not qualify if:

  • Recollection of previous receipt of a HealtheRx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medicine - Adult Emergency Department and Primary Care Group clinic

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

  • Tung EL, Abramsohn EM, Boyd K, Makelarski JA, Beiser DG, Chou C, Huang ES, Ozik J, Kaligotla C, Lindau ST. Impact of a Low-Intensity Resource Referral Intervention on Patients' Knowledge, Beliefs, and Use of Community Resources: Results from the CommunityRx Trial. J Gen Intern Med. 2020 Mar;35(3):815-823. doi: 10.1007/s11606-019-05530-5. Epub 2019 Nov 20.

  • Lindau ST, Makelarski JA, Abramsohn EM, Beiser DG, Boyd K, Chou C, Giurcanu M, Huang ES, Liao C, Schumm LP, Tung EL. CommunityRx: A Real-World Controlled Clinical Trial of a Scalable, Low-Intensity Community Resource Referral Intervention. Am J Public Health. 2019 Apr;109(4):600-606. doi: 10.2105/AJPH.2018.304905. Epub 2019 Feb 21.

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Stacy Lindau
Organization
University of Chicago

Study Officials

  • Stacy T Lindau, MD, MAPP

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

May 6, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

May 11, 2022

Results First Posted

May 15, 2019

Record last verified: 2022-05

Locations