CClinicalTrials.gg
CompletedNCT02435511Updated May 11, 2022Results posted

Study the Impact of the CommunityRx Program on Health, Self-care and Cost

An interventional study of HealtheRx in Health Behavior, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 45 Years to 74 Years. Per ClinicalTrials.gov, last updated 2022-05-11.

Sponsored by University of Chicago · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
411
Allocation
Non-randomized
Ages
45 Years to 74 Years
Sex
All
01

Study 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.

Read the detailed description

CommunityRx connects health care to self-care. CommunityRx begins with the medical encounter and functions like an e-prescribing system, modeled after medication e-prescribing.9 Rather than sending a medication prescription to the patient's pharmacy, a HealtheRx "prescription" is automatically generated at the point of care, delivered to the patient in paper (or electronic) form and stored in the Electronic Medical Record (EMR) for future reference. The HealtheRx is ontologically-generated, driven by standard demographic (eg. age, gender, address, language) data fields in the EMR and customized to patient problems/diagnoses like "homelessness," or "obesity." Like e-prescribing medicine, CommunityRx involves prescribing, fulfillment (patient signs up for a Weight Watchers class), and administration (patient participates in the weight loss program) (Fig. 2).10 The HealtheRx prescription is the primary information agent in the system, driven by simple ontologic rules that generate complexity, including iteration of the CommunityRx system itself, as human agents interact with the self-care information.

CommunityRx can be best understood as part of a complex adaptive system. The HealtheRx, in contrast to a drug prescription, is designed specifically to enhance the interpersonal aspect of the patient-physician encounter, informing both agents about self-care resources. A patient receives a HealtheRx and then contacts a Community Health Information Specialist (CHIS) or not. She seeks self-care resources or not.

Data captured by the CommunityRx system about patient referrals and needs are distributed to community-based service providers (CBSPs) in the form of quarterly reports delivered to CBSP contacts cultivated by CHIS. These data efficiently reveal to CBSPs real-time needs and gaps in self-care resources. The investigators hypothesize these data will be used by CBSPs over time to ensure supply. Youth who generate community resource data through employment with MAPSCorps also gain insight to community resources and engage with CBSP personnel and CHIS as they gather their data. Youth spread information to their networks about community resources and increase their use of these resources. MAPSCorps data about community resources are shared publicly (www.healtherx.org, www.southsidehealth.org, www.dondeesta.org). Self-care becomes more efficient. Supply meets demand. Patients and providers have more time and resources to devote to other salubrious activities and CBSPs become stronger. Over time, transparency in the market for self-care resources increases competition and quality.

This hypothetical dynamic is an example of emergent self-organization from a complex adaptive system. The intervention starts with a simple encounter, governed by simple rules, between patient and health care provider. As the number of these encounters grow, previously siloed sectors - health care and self-care - evolve a new kind of formation that is far more efficient for the community than the current state. CommunityRx drives this new formation through multiple agents who are unaware of the complexity they are producing: "...the self-organized structure simply emerges as a result of each individual doing their own thing, independently." In evaluating the economic effects of CommunityRx adoption, agent-based modeling (ABM) can test how close the attractor state, or end-point in a CommunityRx system configuration (set of assumed behaviors and designed interventions), comes to a Pareto efficient point of equilibrium. The effects of the CommunityRx intervention are non-linear, involve interactions and feedback loops, and therefore require a complex system modeling approach for evaluation.

A. Purpose or Hypothesis

Data inputs for agent based modeling (ABM) can come from a range of sources, including empirical quantitative and qualitative data, data from the literature, and expert opinion. Because CommunityRx targets people of all ages (0-99 yrs, to date), a prospective, experimental, community-based design (eg. RCT) to assess outcomes by age strata would be very informative about patient agents (the investigators expect age-group differences in behavior, social networks, and outcomes) but cost-prohibitive. ABM can accommodate assumptions made based on this important, but specific, population subgroup (or "testbed"), includes many agents, and allows for multiple simulations to assess the impact of variations in those assumptions for the much larger and more diverse population that the system-wide model includes. A cost-effectiveness analysis is needed to understand the true economic impact of CommunityRx on the total cost of the burden of disease. In addition, the research team brings clinical and research expertise and specialized interest in middle-age and older adult populations with chronic disease. Focusing on this subgroup builds on this track record and will meaningfully extend our contributions to the gerontology and geriatrics fields.

Specifically, the aims (and associated hypotheses) of this research include:

Aim 1. Evaluate the impact of CommunityRx on health care utilization, cost, health, and patient-centered outcomes for program participants (patients who receive care at the clinical demonstration sites and live in an 16 zip code area) compared to controls (patients who receive health care at the demonstration sites, but live outside the 16 zip code area), with a special focus on middle-age and older adults.

Aim 1a. Evaluate the impact of CommunityRx on health care utilization, health care costs, and on health outcomes for program participants (patients who receive care at the clinical demonstration sites and live in an 16 zip code area) compared to controls (patients who receive health care at the demonstration sites, but live outside the 11 zip code area) of all ages. NOTE: This aim is funded separately and registered on clinicaltrials.gov separately (see ID 1C1CMS330997).

Hypothesis: CommunityRx will decrease emergency/inpatient care utilization, decrease percent per beneficiary per year (%PBPY) costs and improve health.

Aim 1b. Evaluate the impact of the CommunityRx system on patient-centered outcomes in a randomized control trail of 200 program participants ages 45-74 and compared to 200 controls.

Hypothesis: CommunityRx will be associated with clinically meaningful improvements in: a) self-care behavior; b) perceived care quality; and c) quality of life.

Aim 1c. Characterize the economic value of care augmented with the CommunityRx system compared to usual care, based on the prospective participant-control study described in Aim 1b.

Hypothesis: Compared to usual care, care augmented with the CommunityRx system will be as cost-effective as commonly accepted medical devices and treatments.

Aim 2. Examine the flow and spread of information to and through primary agents including: program participants, community health information specialists, healthcare providers, and community-based service providers (businesses and organizations providing self-care resources).

Hypotheses: 1) Among the CBSPs receiving high volumes of CommunityRx referrals for people ≥45 years old (>1000/year), CommunityRx will produce a self-reported increase in: a) knowledge of community resources especially for older adults, b) referrals to other CBSPs, c) older client volume, and d) aging-related goods/services /programs inventory; and 2) Delivery of the CommunityRx intervention at the point of medical care produces knowledge about self-care resources in the community that spreads to secondary agents including members of patient and provider social networks.

Aim 3. Build and use an agent-based model to test the distributed impact, including economic effects, of CommunityRx adoption on the demonstration area and predict performance over time by conducting experiments that vary assumptions about agent, environment, and population-level characteristics.

Hypotheses: 1) The system-level value of CommunityRx is greater than the value quantified as %PBPY health care utilization savings and is projected to increase with population aging; 2) Experiments run on a systems-based model will predict and quantify the impact of strategies to optimize CommunityRx performance for improvements, sustainability, and spread to other settings; and 3) Systems-Based Modeling is an effective and efficient tool for large-scale evaluation of a health information technology-based intervention to improve health and health care.

02

Conditions studied

  • Health Behavior

Keywords

  • agent-based modeling
  • community resources
  • simulation modeling
  • information intervention
  • clinic-to-community linkages
03

In context

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 45-74 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

Exclusion criteria

Exclusion Criteria:

  • Recollection of previous receipt of a HealtheRx
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
411 participants (actual)

Study arms

  • No intervention
    Control arm

    The control group will receive usual care, no HealtheRx.

  • Experimental
    Intervention arm

    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

  • OtherHealtheRx

    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.

06

What researchers measure

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.

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

Secondary outcomes

  1. Change From Baseline in Cost Effectiveness at 3 Months

    Using claims data and self-reported data on heath care utilization, we will use data from intervention baseline and at 3 months following the intervention to assess the cost effectiveness of HealtheRx.

    Time frame: Baseline, 3 months

  2. Patient Satisfaction at 3 Months

    Patient satisfaction will be measures using the domain of general satisfaction from the Patient Satisfaction Questionnaire (PSQ-18)

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

  3. Physical Health-related Quality of Life at 3 Months

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

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

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

    Measure confidence in ability to find services to take care of health

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

Other outcomes

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

    Measure perceived and self-reported access to weight loss classes or support groups

    Time frame: Baseline, 1 week, 1 month and 3 months

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

    Measure perceived and self-reported access to health eating classes

    Time frame: Baseline, 1 week, 1 month and 3 months

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

    Measure perceived and self-reported access to counseling

    Time frame: Baseline, 1 week, 1 month and 3 months

  4. Access to Resources - Smoking Cessation Classes as Measured by Questionnaire Developed for This Study

    Measure perceived and self-reported access to smoking cessation classes

    Time frame: Baseline, 1 week, 1 month and 3 months

  5. Access to Resources - Stress Management Classes as Measured by Questionnaire Developed for This Study

    Measure perceived and self-reported access to stress management classes

    Time frame: Baseline, 1 week, 1 month and 3 months

  6. Access to Resources - Rent/Mortgage as Measured by Questionnaire Developed for This Study

    Measure perceived and self-reported access to help paying rent or mortgage

    Time frame: Baseline, 1 week, 1 month and 3 months

  7. Self-efficacy - Smoking Cessation as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale

    Measure confidence in ability to quit smoking

    Time frame: Baseline, 1 week, 1 month and 3 months

  8. Self-efficacy - Weight as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale

    Measure confidence in ability to manage weight

    Time frame: Baseline, 1 week, 1 month and 3 months

  9. Self-efficacy - Eating Healthy as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale

    Measure confidence in ability to eat healthy

    Time frame: Baseline, 1 week, 1 month and 3 months

  10. Self-efficacy - Exercise as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale

    Measure confidence in ability to exercise

    Time frame: Baseline, 1 week, 1 month and 3 months

07

Results

Posted May 15, 2019

Participant flow

Participant flow — Overall Study
MilestoneControl ArmIntervention Arm
Started202209
Completed158174
Not completed4435

Outcome measures

PrimaryMental 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.

Time frame:
Assessed at Baseline, 1 Week, 1 Month and 3 Months; score at 3 months reported
Reported as:
Mean · score on a scale
Mental Health-related Quality of Life at 3 Months
score on a scaleControl ArmIntervention Arm
Mental Health-related Quality of Life at 3 Months50.0 ± 11.848.3 ± 12.3
SecondaryChange From Baseline in Cost Effectiveness at 3 Months

Using claims data and self-reported data on heath care utilization, we will use data from intervention baseline and at 3 months following the intervention to assess the cost effectiveness of HealtheRx.

Time frame:
Baseline, 3 months

No measurements were reported for this outcome.

SecondaryPatient Satisfaction at 3 Months

Patient satisfaction will be measures using the domain of general satisfaction from the Patient Satisfaction Questionnaire (PSQ-18)

Time frame:
Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported here
Reported as:
Mean · units on a scale
Patient Satisfaction at 3 Months
units on a scaleControl ArmIntervention Arm
Patient Satisfaction at 3 Months4.4 ± 1.04.4 ± 0.9
SecondaryPhysical Health-related Quality of Life at 3 Months

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

Time frame:
Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported
Reported as:
Mean · score on a scale
Physical Health-related Quality of Life at 3 Months
score on a scaleControl ArmIntervention Arm
Physical Health-related Quality of Life at 3 Months38.1 ± 10.438.7 ± 10.5
SecondarySelf-efficacy - Finding Places and Services in Community to Manage Health as Measured by Questionnaire

Measure confidence in ability to find services to take care of health

Time frame:
Assessed at baseline, 1 week, 1 month and 3 months; score at 3 months reported
Reported as:
Count of participants · Participants
Self-efficacy - Finding Places and Services in Community to Manage Health as Measured by Questionnaire
ParticipantsControl ArmIntervention Arm
Not at all confident2715
Not very confident1715
Uncertain54
Somewhat confident5772
Completely confident5165
Other pre-specifiedAccess to Resources - Weight Loss Class or Support Group as Measured by Questionnaire Developed for This Study

Measure perceived and self-reported access to weight loss classes or support groups

Time frame:
Baseline, 1 week, 1 month and 3 months

Results for this outcome have not been posted.

Other pre-specifiedAccess to Resources - Healthy Eating Classes as Measured by Questionnaire Developed for This Study

Measure perceived and self-reported access to health eating classes

Time frame:
Baseline, 1 week, 1 month and 3 months

Results for this outcome have not been posted.

Other pre-specifiedAccess to Resources - Counseling as Measured by Questionnaire Developed for This Study

Measure perceived and self-reported access to counseling

Time frame:
Baseline, 1 week, 1 month and 3 months

Results for this outcome have not been posted.

Other pre-specifiedAccess to Resources - Smoking Cessation Classes as Measured by Questionnaire Developed for This Study

Measure perceived and self-reported access to smoking cessation classes

Time frame:
Baseline, 1 week, 1 month and 3 months

Results for this outcome have not been posted.

Other pre-specifiedAccess to Resources - Stress Management Classes as Measured by Questionnaire Developed for This Study

Measure perceived and self-reported access to stress management classes

Time frame:
Baseline, 1 week, 1 month and 3 months

Results for this outcome have not been posted.

Other pre-specifiedAccess to Resources - Rent/Mortgage as Measured by Questionnaire Developed for This Study

Measure perceived and self-reported access to help paying rent or mortgage

Time frame:
Baseline, 1 week, 1 month and 3 months

Results for this outcome have not been posted.

Other pre-specifiedSelf-efficacy - Smoking Cessation as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale

Measure confidence in ability to quit smoking

Time frame:
Baseline, 1 week, 1 month and 3 months

Results for this outcome have not been posted.

Other pre-specifiedSelf-efficacy - Weight as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale

Measure confidence in ability to manage weight

Time frame:
Baseline, 1 week, 1 month and 3 months

Results for this outcome have not been posted.

Other pre-specifiedSelf-efficacy - Eating Healthy as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale

Measure confidence in ability to eat healthy

Time frame:
Baseline, 1 week, 1 month and 3 months

Results for this outcome have not been posted.

Other pre-specifiedSelf-efficacy - Exercise as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale

Measure confidence in ability to exercise

Time frame:
Baseline, 1 week, 1 month and 3 months

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Arm—0/202 (0%)0/202 (0%)
Intervention Arm—0/209 (0%)0/209 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Control ArmIntervention ArmTotal
Mean60.1 ± 8.460.3 ± 8.360.2 ± 8.4
Sex: Female, Male
Sex: Female, Male(Participants)Control ArmIntervention ArmTotal
Female129152281
Male7357130
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Control ArmIntervention ArmTotal
Non-Hispanic Black183187370
Non-Hispanic White121123
Hispanic/Latino336
Other4812
Region of Enrollment
Region of Enrollment(Participants)Control ArmIntervention ArmTotal
United States202209411
Self-reported health
Self-reported health(Participants)Control ArmIntervention ArmTotal
Poor or fair104104208
Good6068128
Very good or excellent383775
Confidence in finding resources
Confidence in finding resources(Participants)Control ArmIntervention ArmTotal
Not at all confident252247
Not very confident262248
Uncertain232750
Somewhat confident6270132
Completely confident6668134
08

Study locations

1 site
  • University of Chicago Medicine - Adult Emergency Department and Primary Care Group clinic
    Chicago, Illinois 60637, United States
09

References and documents

Publications

  • 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. PubMed 31749028 ↗
  • 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. PubMed 30789775 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02435511
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
May 6, 2015
Start date
Dec 2015
Primary completion
Dec 2016
Completion
Dec 2017
Results posted
May 15, 2019
Last update
May 11, 2022

Study contacts

Stacy T Lindau, MD, MAPP
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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