Connecting Patients to Self-care ResourcesNCT02411409
Impact of the CommunityRx Program on Health, Service Utilization and Costs
A study testing HealtheRx in people with Connecting Patients to Self-care Resources, run by University of Chicago at 1 site in United States.
Trial summary
The CommunityRx system generates patient-centered e-prescriptions for community services (HealtheRx) via an interface between the electronic health records (EHR) and a comprehensive community resource database. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Connecting Patients to Self-care Resources
- What is being tested?
- HealtheRx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113,295 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Intervention group eligibility: Patients receiving ambulatory care at a clinical site connected to CommunityRx who live in the CommunityRx geography. Control group eligibility: Patients receiving care at a clinical site connected to CommunityRx who live outside the CommunityRx geography.
Who cannot join
- Patients receiving care at a clinical site not connected to CommunityRx.
Trial locations and contacts
1 site in 1 country.
About this study
The CommunityRx system generates patient-centered e-prescriptions for community services (HealtheRx) via an interface between the electronic health records (EHR) and a comprehensive community resource database. Based on a patient's diagnoses, a HealtheRx will be printed automatically at the end of the ambulatory care visit and will provide patients with a customized map and/or list of places in their community that provide health and social services as well as contact information for a local community health worker who can provide limited case management support. The CommunityRx program aims to promote: 1) better healthcare, 2) better health, and 3) lower cost. The purpose of this research is to systematically evaluate the impact of CommunityRx on health outcomes as well as health care service utilization and total cost of care for Medicaid, Medicare and other beneficiaries. The investigators hypothesize that beneficiaries who participate in the CommunityRx intervention will experience better healthcare, better health and lower total cost of care.
- Being tested
- HealtheRx
- Keywords
- Health Information Technology (HIT), self-care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealtheRxBehavioural
The HealtheRx is a prescription for community self-care resources. It includes a printed list of self-care resources provided to the patient at an ambulatory visit and tailored based on data from the electronic medical record.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group of patients receives the HealtheRx. Receives: Behavioral: HealtheRx |
| Control group | No intervention | This group of patients does not receive the HealtheRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cost per beneficiary per year
Cost per beneficiary per year
Measured: Annual, up to 6 years
Secondary outcomes (15)
Change in emergency department visit rate
Hospital emergency department visit rate, overall and for patients diagnosed with a) diabetes, b) hypertension, and c) asthma
Measured: Every 3 months, up to 72 months
Change in HbA1c control
Percentage of patients 18-75 years of age with diabetes (type 1 or type 2) who had hemoglobin A1c > 9.0 %.
Measured: Every 3 months, up to 72 months
Change in controlling high blood pressure
% of patients >=18 years old with hypertension diagnosis and a most recent BP measure <140/90mg
Measured: Every 3 months, up to 72 months
Change in body mass index
Percentage of patients overweight or obese (BMI >=25.0 and <30, BMI >=30)
Measured: Every 3 months, up to 72 months
Change in inpatient admission rate
Average number of in patient admissions per person
Measured: Every 3 months, up to 72 months
Change in participant satisfaction (percentage of participants reporting they are satisfied with the HealtheRx)
Program participant satisfaction survey, percentage of participants reporting they are satisfied with the HealtheRx
Measured: Every 3 months, up to 60 months
Change in provider satisfaction ( percent of providers reporting they are satisfied with the HealtheRx system)
Provider satisfaction survey, percent of providers reporting they are satisfied with the HealtheRx system
Measured: Every 6 months, up to 60 months
Change in rate of participant use of community-based service providers listed on HealtheRx
Program participant survey, percent of participants who report using at least 1 service listed on their HealtheRx
Measured: Every 3 months, up to 60 months
Change in HealtheRx reach (proportion of the population in the geography who receive at least 1 HealtheRx)
The proportion of the population in the geography who receive at least 1 HealtheRx
Measured: Every 3 months, up to 60 months
Change in HealtheRx delivery (providers communicate to patients about the HealtheRx)
providers communicate to patients about the HealtheRx
Measured: Every 3 months, up to 60 months
Change in HealtheRx usefulness (participant survey, the percent of program participants who report that their HealtheRx is useful)
Program participant survey, the percent of program participants who report that their HealtheRx is useful
Measured: Every 3 months, up to 60 months
Change in HealtheRx Understandability (participant survey, the percent of program participants who report that their HealtheRx is easy to understand)
Program participant survey, the percent of program participants who report that their HealtheRx is easy to understand
Measured: Every 3 months, up to 60 months
Change in information sharing (participant survey, the percent of program participants who report that they shared information about the HealtheRx with someone else)
Program participant survey, the percent of program participants who report that they shared information about the HealtheRx with someone else
Measured: Every 3 months, up to 60 months
Change in knowledge about resources (participant survey, the percent of program participants who report that they did not know about some of the places listed on their HealtheRx)
Program participant survey, the percent of program participants who report that they did not know about some of the places listed on their HealtheRx
Measured: Every 3 months, up to 60 months
Change in provider confidence in serving social needs (Provider satisfaction survey,)
Provider satisfaction survey, the proportion of providers reporting they are confident in their ability to serve their patients social needs
Measured: Every 6 months, up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connecting Patients to Self-care ResourcesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113,295 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy Lindau, MD, MAPP, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411409
- Sponsor's protocol ID
- IRB13-0771
- Status last verified
- May 2024
- First submitted
- 25 Jul 2014
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the CommunityRx Program on Health, Service Utilization and Costs
- ClinicalTrials.gov ID
- NCT02411409
- Acronym / sponsor ID
- IRB13-0771
- Keywords
- Health Information Technology (HIT), self-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113,295 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CommunityRx system generates patient-centered e-prescriptions for community services (HealtheRx) via an interface between the electronic health records (EHR) and a comprehensive community resource database. Based on a patient's diagnoses, a HealtheRx will be printed automatically at the end of the ambulatory care visit and will provide patients with a customized map and/or list of places in their community that provide health and social services as well as contact information for a local community health worker who can provide limited case management support. The CommunityRx program aims to promote: 1) better healthcare, 2) better health, and 3) lower cost. The purpose of this research is to systematically evaluate the impact of CommunityRx on health outcomes as well as health care service utilization and total cost of care for Medicaid, Medicare and other beneficiaries. The investigators hypothesize that beneficiaries who participate in the CommunityRx intervention will experience better healthcare, better health and lower total cost of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: HealtheRxThis group of patients receives the HealtheRx. |
| Control group | No intervention | –This group of patients does not receive the HealtheRx |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Intervention group eligibility: Patients receiving ambulatory care at a clinical site connected to CommunityRx who live in the CommunityRx geography. Control group eligibility: Patients receiving care at a clinical site connected to CommunityRx who live outside the CommunityRx geography.
Key exclusion criteria (1 listed)
- Patients receiving care at a clinical site not connected to CommunityRx.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealtheRxThe HealtheRx is a prescription for community self-care resources. It includes a printed list of self-care resources provided to the patient at an ambulatory visit and tailored based on data from the electronic medical record. | Behavioural | Intervention group |
Primary outcome
Change in cost per beneficiary per year
Time frame: Annual, up to 6 years
Cost per beneficiary per year
15 secondary outcomes
Change in emergency department visit rate
Time frame: Every 3 months, up to 72 months
Change in HbA1c control
Time frame: Every 3 months, up to 72 months
Change in controlling high blood pressure
Time frame: Every 3 months, up to 72 months
Change in body mass index
Time frame: Every 3 months, up to 72 months
Change in inpatient admission rate
Time frame: Every 3 months, up to 72 months
Change in participant satisfaction (percentage of participants reporting they are satisfied with the HealtheRx)
Time frame: Every 3 months, up to 60 months
Change in provider satisfaction ( percent of providers reporting they are satisfied with the HealtheRx system)
Time frame: Every 6 months, up to 60 months
Change in rate of participant use of community-based service providers listed on HealtheRx
Time frame: Every 3 months, up to 60 months
Change in HealtheRx reach (proportion of the population in the geography who receive at least 1 HealtheRx)
Time frame: Every 3 months, up to 60 months
Change in HealtheRx delivery (providers communicate to patients about the HealtheRx)
Time frame: Every 3 months, up to 60 months
Change in HealtheRx usefulness (participant survey, the percent of program participants who report that their HealtheRx is useful)
Time frame: Every 3 months, up to 60 months
Change in HealtheRx Understandability (participant survey, the percent of program participants who report that their HealtheRx is easy to understand)
Time frame: Every 3 months, up to 60 months
Change in information sharing (participant survey, the percent of program participants who report that they shared information about the HealtheRx with someone else)
Time frame: Every 3 months, up to 60 months
Change in knowledge about resources (participant survey, the percent of program participants who report that they did not know about some of the places listed on their HealtheRx)
Time frame: Every 3 months, up to 60 months
Change in provider confidence in serving social needs (Provider satisfaction survey,)
Time frame: Every 6 months, up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy Lindau, MD, MAPP principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealtheRx in people with Connecting Patients to Self-care Resources, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cost per beneficiary per year (time frame: Annual, up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.