- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02435511
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
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago Medicine - Adult Emergency Department and Primary Care Group clinic
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Control arm
The control group will receive usual care, no HealtheRx.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mental Health-related Quality of Life at 3 Months
Periodo de tiempo: Assessed at Baseline, 1 Week, 1 Month and 3 Months; score at 3 months reported
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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.
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Assessed at Baseline, 1 Week, 1 Month and 3 Months; score at 3 months reported
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in Cost Effectiveness at 3 Months
Periodo de tiempo: Baseline, 3 months
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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.
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Baseline, 3 months
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Patient Satisfaction at 3 Months
Periodo de tiempo: Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported here
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Patient satisfaction will be measures using the domain of general satisfaction from the Patient Satisfaction Questionnaire (PSQ-18)
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Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported here
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Physical Health-related Quality of Life at 3 Months
Periodo de tiempo: Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported
|
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.
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Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported
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Self-efficacy - Finding Places and Services in Community to Manage Health as Measured by Questionnaire
Periodo de tiempo: Assessed at baseline, 1 week, 1 month and 3 months; score at 3 months reported
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Measure confidence in ability to find services to take care of health
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Assessed at baseline, 1 week, 1 month and 3 months; score at 3 months reported
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Access to Resources - Weight Loss Class or Support Group as Measured by Questionnaire Developed for This Study
Periodo de tiempo: Baseline, 1 week, 1 month and 3 months
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Measure perceived and self-reported access to weight loss classes or support groups
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Baseline, 1 week, 1 month and 3 months
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Access to Resources - Healthy Eating Classes as Measured by Questionnaire Developed for This Study
Periodo de tiempo: Baseline, 1 week, 1 month and 3 months
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Measure perceived and self-reported access to health eating classes
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Baseline, 1 week, 1 month and 3 months
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Access to Resources - Counseling as Measured by Questionnaire Developed for This Study
Periodo de tiempo: Baseline, 1 week, 1 month and 3 months
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Measure perceived and self-reported access to counseling
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Baseline, 1 week, 1 month and 3 months
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Access to Resources - Smoking Cessation Classes as Measured by Questionnaire Developed for This Study
Periodo de tiempo: Baseline, 1 week, 1 month and 3 months
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Measure perceived and self-reported access to smoking cessation classes
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Baseline, 1 week, 1 month and 3 months
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Access to Resources - Stress Management Classes as Measured by Questionnaire Developed for This Study
Periodo de tiempo: Baseline, 1 week, 1 month and 3 months
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Measure perceived and self-reported access to stress management classes
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Baseline, 1 week, 1 month and 3 months
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Access to Resources - Rent/Mortgage as Measured by Questionnaire Developed for This Study
Periodo de tiempo: Baseline, 1 week, 1 month and 3 months
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Measure perceived and self-reported access to help paying rent or mortgage
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Baseline, 1 week, 1 month and 3 months
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Self-efficacy - Smoking Cessation as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale
Periodo de tiempo: Baseline, 1 week, 1 month and 3 months
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Measure confidence in ability to quit smoking
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Baseline, 1 week, 1 month and 3 months
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Self-efficacy - Weight as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale
Periodo de tiempo: Baseline, 1 week, 1 month and 3 months
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Measure confidence in ability to manage weight
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Baseline, 1 week, 1 month and 3 months
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Self-efficacy - Eating Healthy as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale
Periodo de tiempo: Baseline, 1 week, 1 month and 3 months
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Measure confidence in ability to eat healthy
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Baseline, 1 week, 1 month and 3 months
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Self-efficacy - Exercise as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale
Periodo de tiempo: Baseline, 1 week, 1 month and 3 months
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Measure confidence in ability to exercise
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Baseline, 1 week, 1 month and 3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stacy T Lindau, MD, MAPP, University of Chicago
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IRB14-0589
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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