Chronic Disease (Physical)CHWNCT04028609
Community Health Worker Intervention to Improve Post-Hospital Outcomes
A study testing Healthy at Home and Services as Usual in people with Chronic Disease (Physical) and Mental Disorder, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This study tests an intervention designed to avoid 30-day readmissions following a medical hospitalization by patients who have co-occurring mental illness. The Intervention is delivered by community health workers in the inpatient setting and 30 days following hospital discharge to the community. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Chronic Disease (Physical), Mental Disorder
- What is being tested?
- Healthy at Home and Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2019to 9 Mar 2020
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- receiving inpatient treatment for chronic medical condition
- evidence of a mental health diagnosis
- age 21- 60 years
- expected to return to community residence
- residing within a 30-mile radius of the hospital
- expected to remain in hospital for 2 or more days
- able to provide informed consent
Who cannot join
- terminally ill
- unable to communicate in English
- expected to be discharged to skilled facility or nursing home
- participating in another transitional care intervention
- hospitalized for behavioral health disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago, Department of Psychiatry
Chicago, Illinois, 60612
About this study
Official title: Community Health Worker and Certified Peer Specialist Intervention to Improve Post-Hospital Outcomes
This study tests an intervention designed to avoid 30-day readmissions following a medical hospitalization by patients who have co-occurring mental illness. The Intervention is delivered by community health workers in the inpatient setting and 30 days following hospital discharge to the community.
Read the detailed description
This study will test the efficacy of a brief intervention delivered to adults with co-occurring medical and mental health conditions by community health workers designed to avoid 30-day readmissions following medical hospitalization. Adult inpatients of a university hospital will be randomly assigned to the intervention plus services as usual versus services as usual alone, and assessed at baseline and 30 days following discharge. Chi square will be used to assess the primary outcome of admission within 30 days of discharge and changes in patient activation, mental health symptoms, medication adherence, and perceived competence for health maintenance. Also examined will be study condition differences in post-discharge inpatient service utilization and cost.
- Conditions
- Chronic Disease (Physical), Mental Disorder
- Being tested
- Healthy at Home, Services as Usual
- Keywords
- 30-day readmission, primary care, community health worker, health education
- Medical subject headings
- Chronic Disease, Mental Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy at HomeBehavioural
In addition to receiving medical services as usual, subjects receive services from Community Healthy Workers during the transition from the hospital to their community residence.
Services as UsualOther
Routine medical services
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects receive an intervention with 4 components: development of a personal health plan; review and support for medication adherence; connection with primary care provider within 30 days; and education about clinical indicators that call for immediate intervention. Receives: Behavioral: Healthy at Home |
| Services as Usual | Active comparator | Subjects receive medical services as usual. Receives: Other: Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Federal Center for Medicare and Medicaid Services' measure of unplanned readmissions that occur within 30 days of discharge from an initial admission
This is a dichotomous indicator variable that reports the occurrence of an inpatient admission to the hospital within 30 days of discharge from a previous hospitalization. Score ranges from 0 (no readmission) to 1 (readmission).
Measured: 30 days post discharge
Federal Center for Medicare and Medicaid Services' measure of completion of a outpatient visit with primary care provider
This is a dichotomous indicator variable that reports the completion of a patient's visit to an outpatient primary care provider
Measured: during the 30 days period following discharge
Secondary outcomes (8)
Patient Activation Measure
This scale measures the construct of a person's self-perceived ability to engage in health care. Items assess patients' self-perceived level of knowledge, skill, and confidence in their ability to manage their own health. Total score ranges from 13 to 52 with higher values indicating greater activation. Total score is calculated by summing items to create a raw score which is then divided by the number of items answered and multiplied by 13 and transformed to a Z score based on calibration tables.
Measured: study entry (pre-intervention), 30 days post discharge (post intervention)
Perceived Competence for Health Maintenance Questionnaire
This scale measures the construct of self rated ability to manage one's health condition, engage in routine health care, and recover from a medical condition. Total score ranges from 1 to 7 with higher values indicating greater competence. Total score is calculated by averaging scores of the 4 items.
Measured: study entry (pre-intervention), 30 days post discharge (post intervention)
Short Form Health Survey
This scale measures the construct of self-reported physical and emotional health by asking about functioning (e.g., climbing stairs, doing housework) and emotional well-being (e.g., feeling calm and peaceful, being downhearted or blue). Total score ranges from 12 to 44 with higher values indicating better health. Total score is the sum of all item responses.
Measured: study entry (pre-intervention), 30 days post discharge (post intervention)
Health Care Climate Questionnaire
This scale measures the construct of a patients' perception of their medical care as as providing needed information, acknowledging their feelings, and supporting their autonomy. Total score ranges from 1 to 7 with higher values indicating greater autonomy. Total score is calculated by averaging the item scores.
Measured: study entry (pre-intervention), 30 days post discharge (post intervention)
Center for Disease Control and Prevention's National Health and Nutrition Examination Survey of Usual Source of Medical Care
These items from a national household survey ask respondents about their access to and type of usual source of medical care. Both items are categorical self-report questions designed to yield descriptive information with no scoring.
Measured: study entry (pre-intervention), 30 days post discharge (post intervention)
Patient Satisfaction Questionnaire
This a questionnaire that measures the construct of patients' satisfaction with their medical provider by asking them to rate their doctor's communication, time spent, and overall satisfaction. Total score ranges from 6 to 30 with higher values indicating greater satisfaction. Total score is calculated by adding the item scores.
Measured: study entry (pre-intervention), 30 days post discharge (post intervention)
Patient Health Questionnaire-2
This is a screening questionnaire for depression and anhedonia that measures the extent to which respondents report that they are sad, hopeless, and have little interest in doing things. Total score ranges from 0 to 6 with higher values indicating greater likelihood of depressive disorder. Total score is calculated by adding the 2 item scores.
Measured: study entry (pre-intervention), 30 days post discharge (post intervention)
Generalized Anxiety Disorder 2-item Questionnaire
This is a screening questionnaire for generalized anxiety disorder that measures the extent to which respondents report that they are nervous, anxious, or continually worried. Total score ranges from 0 to 6 with higher values indicating greater likelihood of generalized anxiety disorder. Total score is calculated by adding the 2 item scores.
Measured: study entry (pre-intervention), 30 days post discharge (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start12 Sep 2019
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Why it stopped: COVID-19 prevented further enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Disease (Physical)Studies of the same condition, open and under way.
- More trials run by University of Illinois 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention includes 4 components: development of a personal health plan; review and support for medication adherence; connection with primary care provider within 30 days; and education about clinical indicators that call for immediate intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Principal investigator, Judith A. Cook, University of Illinois Chicago
- Investigators
- Judith Cook, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028609
- Sponsor's protocol ID
- 2018-0715
- Other IDs
- 90RT5038a
- Acronym
- CHW
- Status last verified
- Apr 2023
- First submitted
- 11 Jul 2019
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cook JA, Mueser KT. Community health workers: Potential allies for the field of psychiatric rehabilitation? Psychiatr Rehabil J. 2015 Sep;38(3):207-9. doi: 10.1037/prj0000164.
PubMed 26348316
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Worker and Certified Peer Specialist Intervention to Improve Post-Hospital Outcomes
- ClinicalTrials.gov ID
- NCT04028609
- Acronym / sponsor ID
- CHW / 2018-0715
- Conditions
- Chronic Disease (Physical), Mental Disorder
- Keywords
- 30-day readmission, primary care, community health worker, health education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 prevented further enrollment
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 22 Jul 2019 (actual)
- 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.
This study tests an intervention designed to avoid 30-day readmissions following a medical hospitalization by patients who have co-occurring mental illness. The Intervention is delivered by community health workers in the inpatient setting and 30 days following hospital discharge to the community.
Detailed description
This study will test the efficacy of a brief intervention delivered to adults with co-occurring medical and mental health conditions by community health workers designed to avoid 30-day readmissions following medical hospitalization. Adult inpatients of a university hospital will be randomly assigned to the intervention plus services as usual versus services as usual alone, and assessed at baseline and 30 days following discharge. Chi square will be used to assess the primary outcome of admission within 30 days of discharge and changes in patient activation, mental health symptoms, medication adherence, and perceived competence for health maintenance. Also examined will be study condition differences in post-discharge inpatient service utilization and cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention includes 4 components: development of a personal health plan; review and support for medication adherence; connection with primary care provider within 30 days; and education about clinical indicators that call for immediate intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Healthy at HomeSubjects receive an intervention with 4 components: development of a personal health plan; review and support for medication adherence; connection with primary care provider within 30 days; and education about clinical indicators that call for immediate intervention. |
| Services as Usual | Active comparator | Other: Services as UsualSubjects receive medical services as usual. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- receiving inpatient treatment for chronic medical condition
- evidence of a mental health diagnosis
- age 21- 60 years
- expected to return to community residence
- residing within a 30-mile radius of the hospital
Key exclusion criteria (5 listed)
- terminally ill
- unable to communicate in English
- expected to be discharged to skilled facility or nursing home
- participating in another transitional care intervention
- hospitalized for behavioral health disorder
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 |
|---|---|---|
| Healthy at HomeIn addition to receiving medical services as usual, subjects receive services from Community Healthy Workers during the transition from the hospital to their community residence. | Behavioural | Intervention |
| Services as UsualRoutine medical services | Other | Services as Usual |
Primary outcome
Federal Center for Medicare and Medicaid Services' measure of unplanned readmissions that occur within 30 days of discharge from an initial admission
Time frame: 30 days post discharge
This is a dichotomous indicator variable that reports the occurrence of an inpatient admission to the hospital within 30 days of discharge from a previous hospitalization. Score ranges from 0 (no readmission) to 1 (readmission).
Federal Center for Medicare and Medicaid Services' measure of completion of a outpatient visit with primary care provider
Time frame: during the 30 days period following discharge
This is a dichotomous indicator variable that reports the completion of a patient's visit to an outpatient primary care provider
8 secondary outcomes
Patient Activation Measure
Time frame: study entry (pre-intervention), 30 days post discharge (post intervention)
Perceived Competence for Health Maintenance Questionnaire
Time frame: study entry (pre-intervention), 30 days post discharge (post intervention)
Short Form Health Survey
Time frame: study entry (pre-intervention), 30 days post discharge (post intervention)
Health Care Climate Questionnaire
Time frame: study entry (pre-intervention), 30 days post discharge (post intervention)
Center for Disease Control and Prevention's National Health and Nutrition Examination Survey of Usual Source of Medical Care
Time frame: study entry (pre-intervention), 30 days post discharge (post intervention)
Patient Satisfaction Questionnaire
Time frame: study entry (pre-intervention), 30 days post discharge (post intervention)
Patient Health Questionnaire-2
Time frame: study entry (pre-intervention), 30 days post discharge (post intervention)
Generalized Anxiety Disorder 2-item Questionnaire
Time frame: study entry (pre-intervention), 30 days post discharge (post intervention)
Results and safety
The study was stopped early (reason given: COVID-19 prevented further enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Background: PubMed 26348316Cook JA, Mueser KT. Community health workers: Potential allies for the field of psychiatric rehabilitation? Psychiatr Rehabil J. 2015 Sep;38(3):207-9. doi: 10.1037/prj0000164.
- Individual participant dataSharing planned: No
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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.
Judith Cook, PhD principal investigator
University of Illinois 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 Healthy at Home and Services as Usual in people with Chronic Disease (Physical) and Mental Disorder, run by University of Illinois 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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Apr 2023. 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 was stopped early (reason given: COVID-19 prevented further enrollment). Results are not available in the source record.
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?
Federal Center for Medicare and Medicaid Services' measure of unplanned readmissions that occur within 30 days of discharge from an initial admission (time frame: 30 days post discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04028609, which also lists 1 linked publication.
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 28 Apr 2023.