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

Evaluating CommunityRx, a Self-Care Innovation for Older Adults, Using Agent-Based Modeling: Collecting and Analyzing Data to Build the Agent Based Model

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02435511
Enrollment
411
Registered
2015-05-06
Start date
2015-12-31
Completion date
2017-12-31
Last updated
2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

Keywords

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

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.

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.

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.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 74 Years
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

* Recollection of previous receipt of a HealtheRx

Design outcomes

Primary

MeasureTime frameDescription
Mental Health-related Quality of Life at 3 MonthsAssessed at Baseline, 1 Week, 1 Month and 3 Months; score at 3 months reportedHealth-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.

Secondary

MeasureTime frameDescription
Change From Baseline in Cost Effectiveness at 3 MonthsBaseline, 3 monthsUsing 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.
Patient Satisfaction at 3 MonthsAssessed at baseline, 1 week, 1 month and 3 months; 3 months reported herePatient satisfaction will be measures using the domain of general satisfaction from the Patient Satisfaction Questionnaire (PSQ-18)
Physical Health-related Quality of Life at 3 MonthsAssessed at baseline, 1 week, 1 month and 3 months; 3 months reportedHealth-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.
Self-efficacy - Finding Places and Services in Community to Manage Health as Measured by QuestionnaireAssessed at baseline, 1 week, 1 month and 3 months; score at 3 months reportedMeasure confidence in ability to find services to take care of health

Other

MeasureTime frameDescription
Access to Resources - Rent/Mortgage as Measured by Questionnaire Developed for This StudyBaseline, 1 week, 1 month and 3 monthsMeasure perceived and self-reported access to help paying rent or mortgage
Self-efficacy - Smoking Cessation as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert ScaleBaseline, 1 week, 1 month and 3 monthsMeasure confidence in ability to quit smoking
Access to Resources - Weight Loss Class or Support Group as Measured by Questionnaire Developed for This StudyBaseline, 1 week, 1 month and 3 monthsMeasure perceived and self-reported access to weight loss classes or support groups
Self-efficacy - Eating Healthy as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert ScaleBaseline, 1 week, 1 month and 3 monthsMeasure confidence in ability to eat healthy
Self-efficacy - Exercise as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert ScaleBaseline, 1 week, 1 month and 3 monthsMeasure confidence in ability to exercise
Self-efficacy - Weight as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert ScaleBaseline, 1 week, 1 month and 3 monthsMeasure confidence in ability to manage weight
Access to Resources - Healthy Eating Classes as Measured by Questionnaire Developed for This StudyBaseline, 1 week, 1 month and 3 monthsMeasure perceived and self-reported access to health eating classes
Access to Resources - Counseling as Measured by Questionnaire Developed for This StudyBaseline, 1 week, 1 month and 3 monthsMeasure perceived and self-reported access to counseling
Access to Resources - Smoking Cessation Classes as Measured by Questionnaire Developed for This StudyBaseline, 1 week, 1 month and 3 monthsMeasure perceived and self-reported access to smoking cessation classes
Access to Resources - Stress Management Classes as Measured by Questionnaire Developed for This StudyBaseline, 1 week, 1 month and 3 monthsMeasure perceived and self-reported access to stress management classes

Countries

United States

Participant flow

Pre-assignment details

No participants were excluded after enrollment, prior to randomization.

Participants by arm

ArmCount
Control Arm
The control group will receive usual care, no HealtheRx.
202
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. HealtheRx: 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.
209
Total411

Baseline characteristics

CharacteristicTotalIntervention ArmControl Arm
Age, Continuous60.2 Years
STANDARD_DEVIATION 8.4
60.3 Years
STANDARD_DEVIATION 8.3
60.1 Years
STANDARD_DEVIATION 8.4
Confidence in finding resources
Completely confident
134 Participants68 Participants66 Participants
Confidence in finding resources
Not at all confident
47 Participants22 Participants25 Participants
Confidence in finding resources
Not very confident
48 Participants22 Participants26 Participants
Confidence in finding resources
Somewhat confident
132 Participants70 Participants62 Participants
Confidence in finding resources
Uncertain
50 Participants27 Participants23 Participants
Race/Ethnicity, Customized
Hispanic/Latino
6 Participants3 Participants3 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
370 Participants187 Participants183 Participants
Race/Ethnicity, Customized
Non-Hispanic White
23 Participants11 Participants12 Participants
Race/Ethnicity, Customized
Other
12 Participants8 Participants4 Participants
Region of Enrollment
United States
411 Participants209 Participants202 Participants
Self-reported health
Good
128 Participants68 Participants60 Participants
Self-reported health
Poor or fair
208 Participants104 Participants104 Participants
Self-reported health
Very good or excellent
75 Participants37 Participants38 Participants
Sex: Female, Male
Female
281 Participants152 Participants129 Participants
Sex: Female, Male
Male
130 Participants57 Participants73 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 2020 / 209
serious
Total, serious adverse events
0 / 2020 / 209

Outcome results

Primary

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

Population: The below mean includes only those who completed the 3 month follow-up survey; 1 control and 2 cases participated in the 3 months survey but did not complete the SF-12 needed for this data point

ArmMeasureValue (MEAN)Dispersion
Control ArmMental Health-related Quality of Life at 3 Months50.0 score on a scaleStandard Deviation 11.8
Intervention ArmMental Health-related Quality of Life at 3 Months48.3 score on a scaleStandard Deviation 12.3
Secondary

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

Population: We were unable to obtain the claims data necessary to conduct the cost effectiveness analysis.

Secondary

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

Population: Includes participates who completed 3 month survey; 1 control and 3 cases did not complete the PSQ.

ArmMeasureValue (MEAN)Dispersion
Control ArmPatient Satisfaction at 3 Months4.4 units on a scaleStandard Deviation 1
Intervention ArmPatient Satisfaction at 3 Months4.4 units on a scaleStandard Deviation 0.9
Secondary

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

Population: The below mean includes only participants with completed 3 month follow-up surveys; 1 control and 2 cases did not complete the SF-12 items needed to calculate this measure.

ArmMeasureValue (MEAN)Dispersion
Control ArmPhysical Health-related Quality of Life at 3 Months38.1 score on a scaleStandard Deviation 10.4
Intervention ArmPhysical Health-related Quality of Life at 3 Months38.7 score on a scaleStandard Deviation 10.5
Secondary

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

Population: The below results include only those with 3 month follow-up data; 1 control and 3 cases did not complete this survey item during the 3 month follow up.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Control ArmSelf-efficacy - Finding Places and Services in Community to Manage Health as Measured by QuestionnaireNot very confident17 Participants
Control ArmSelf-efficacy - Finding Places and Services in Community to Manage Health as Measured by QuestionnaireSomewhat confident57 Participants
Control ArmSelf-efficacy - Finding Places and Services in Community to Manage Health as Measured by QuestionnaireUncertain5 Participants
Control ArmSelf-efficacy - Finding Places and Services in Community to Manage Health as Measured by QuestionnaireCompletely confident51 Participants
Control ArmSelf-efficacy - Finding Places and Services in Community to Manage Health as Measured by QuestionnaireNot at all confident27 Participants
Intervention ArmSelf-efficacy - Finding Places and Services in Community to Manage Health as Measured by QuestionnaireCompletely confident65 Participants
Intervention ArmSelf-efficacy - Finding Places and Services in Community to Manage Health as Measured by QuestionnaireNot at all confident15 Participants
Intervention ArmSelf-efficacy - Finding Places and Services in Community to Manage Health as Measured by QuestionnaireNot very confident15 Participants
Intervention ArmSelf-efficacy - Finding Places and Services in Community to Manage Health as Measured by QuestionnaireUncertain4 Participants
Intervention ArmSelf-efficacy - Finding Places and Services in Community to Manage Health as Measured by QuestionnaireSomewhat confident72 Participants
Other Pre-specified

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

Other Pre-specified

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

Other Pre-specified

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

Other Pre-specified

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

Other Pre-specified

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

Other Pre-specified

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

Other Pre-specified

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

Other Pre-specified

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

Other Pre-specified

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

Other Pre-specified

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

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026