Multiple Co-morbiditiesCASENCT01391026
Computer Assisted Symptom Evaluation of Complex Patients
A study testing Enhanced patient-centered care in people with Multiple Co-morbidities, run by Cook County Health at 1 site in United States.
Trial summary
Patients who have advanced or multiple chronic illnesses present management difficulties for primary care providers. Acute medical issues and limited time for patient evaluation can complicate complete assessment of physical symptoms that directly impact a patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Multiple Co-morbidities
- What is being tested?
- Enhanced patient-centered care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Oct 2012
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish speaker
- Must be a general medicine clinic patient
- Must have a physical symptom score on MSAS above threshold (i.e., 1.0 or higher)
- Must have a phone number for contact
Who cannot join
- Visual or cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Stroger Hospital of Cook County
Chicago, Illinois, 60612
About this study
Official title: Computer Assisted Quality of Life and Symptom Assessment of Complex Patients
Patients who have advanced or multiple chronic illnesses present management difficulties for primary care providers. Acute medical issues and limited time for patient evaluation can complicate complete assessment of physical symptoms that directly impact a patient's quality of life. The Cook County Health and Hospitals System (CCHHS) established an Advanced Illness Management Clinic to provide care for complex patients. Patient entry into the Advanced Illness Management Clinic is by referral only, a passive process. After discharge, general medicine clinic patients who do not have a medical provider are given an appointment in the clinic. Since the hospital is the source of many patients, this guarantees that these patients will have at least one illness advanced enough to require hospitalization, and most will have additional chronic illnesses. An outpatient palliative care clinic located in a specialty clinic setting was initiated in 2004. The goal of the clinic was to extend the benefits realized by hospital patients, for whom palliative care consultation has been available for many years, to patients cared for in the outpatient setting. The benefits provided include physical symptom management, spiritual counseling, and support for social issues. Until recently, this outpatient palliative care model has mainly served patients with malignancy. With the addition of the Advanced Illness Management Clinic, palliative care clinicians now can provide care to patients with other chronic and serious illness in the primary care setting.
Hypothesis: Complex patients will have improved quality of life and a reduced symptom burden if seen by a multidisciplinary clinic post-hospitalization, compared to usual care in a general medicine clinic.
Read the detailed description
Outcome measures:
- Quality of life as measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) short form
- Physical symptom burden as measured by the Memorial Symptom Assessment Scale (MSAS), short form
- Conditions
- Multiple Co-morbidities
- Being tested
- Enhanced patient-centered care
- Keywords
- Medical informatics, Health services accessibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced patient-centered careBehavioural
The experimental arm will be referred to a multi-disciplinary clinic
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients will receive usual care by their primary care physicians without automated referral to specialized providers. |
| Enhanced patient-centered care | Experimental | Patients will be evaluated and treated in the advanced illness management clinic Receives: Behavioral: Enhanced patient-centered care |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH PROMIS 10-item short form quality of life
We will assess the physical and mental components of the quality of life instrument
Measured: 6 months
Secondary outcomes (2)
MSAS physical symptom score
Measured: 6 months
Healthcare utilization
We will monitor healthcare utilization within our system. To include visits to the emergency room, clinics, and hospitalizations.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Co-morbiditiesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, William Trick, Cook County Health
- Investigators
- William E Trick, MD, Principal investigator, Cook County Health & Hospitals System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391026
- Sponsor's protocol ID
- 10-143
- Other IDs
- 1R24HS019481-01
- Acronym
- CASE
- Status last verified
- Jun 2023
- First submitted
- 7 Jul 2011
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Quality of Life and Symptom Assessment of Complex Patients
- ClinicalTrials.gov ID
- NCT01391026
- Acronym / sponsor ID
- CASE / 10-143
- Conditions
- Multiple Co-morbidities
- Keywords
- Medical informatics, Health services accessibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Jul 2011 (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.
Patients who have advanced or multiple chronic illnesses present management difficulties for primary care providers. Acute medical issues and limited time for patient evaluation can complicate complete assessment of physical symptoms that directly impact a patient's quality of life. The Cook County Health and Hospitals System (CCHHS) established an Advanced Illness Management Clinic to provide care for complex patients. Patient entry into the Advanced Illness Management Clinic is by referral only, a passive process. After discharge, general medicine clinic patients who do not have a medical provider are given an appointment in the clinic. Since the hospital is the source of many patients, this guarantees that these patients will have at least one illness advanced enough to require hospitalization, and most will have additional chronic illnesses. An outpatient palliative care clinic located in a specialty clinic setting was initiated in 2004. The goal of the clinic was to extend the benefits realized by hospital patients, for whom palliative care consultation has been available for many years, to patients cared for in the outpatient setting. The benefits provided include physical symptom management, spiritual counseling, and support for social issues. Until recently, this outpatient palliative care model has mainly served patients with malignancy. With the addition of the Advanced Illness Management Clinic, palliative care clinicians now can provide care to patients with other chronic and serious illness in the primary care setting.
Hypothesis: Complex patients will have improved quality of life and a reduced symptom burden if seen by a multidisciplinary clinic post-hospitalization, compared to usual care in a general medicine clinic.
Detailed description
Outcome measures:
- Quality of life as measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) short form
- Physical symptom burden as measured by the Memorial Symptom Assessment Scale (MSAS), short form
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients will receive usual care by their primary care physicians without automated referral to specialized providers. |
| Enhanced patient-centered care | Experimental | Behavioral: Enhanced patient-centered carePatients will be evaluated and treated in the advanced illness management clinic |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English or Spanish speaker
- Must be a general medicine clinic patient
- Must have a physical symptom score on MSAS above threshold (i.e., 1.0 or higher)
- Must have a phone number for contact
Key exclusion criteria (1 listed)
- Visual or cognitive impairment
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 |
|---|---|---|
| Enhanced patient-centered careThe experimental arm will be referred to a multi-disciplinary clinic | Behavioural | Enhanced patient-centered care |
Primary outcome
NIH PROMIS 10-item short form quality of life
Time frame: 6 months
We will assess the physical and mental components of the quality of life instrument
2 secondary outcomes
MSAS physical symptom score
Time frame: 6 months
Healthcare utilization
Time frame: 6 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 22 Jun 2023.
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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.
William E Trick, MD principal investigator
Cook County Health & Hospitals System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced patient-centered care in people with Multiple Co-morbidities, run by Cook County Health 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 4 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 22 Jun 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 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?
NIH PROMIS 10-item short form quality of life (time frame: 6 months). 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 22 Jun 2023.