- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01391026
Computer Assisted Symptom Evaluation of Complex Patients (CASE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Stroger Hospital of Cook County
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Visual or cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Enhanced patient-centered care
Patients will be evaluated and treated in the advanced illness management clinic
|
The experimental arm will be referred to a multi-disciplinary clinic
|
|
No Intervention: Usual care
Patients will receive usual care by their primary care physicians without automated referral to specialized providers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MSAS physical symptom score
Time Frame: 6 months
|
6 months
|
|
|
Healthcare utilization
Time Frame: 6 months
|
We will monitor healthcare utilization within our system.
To include visits to the emergency room, clinics, and hospitalizations.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William E Trick, MD, Cook County Health & Hospitals System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 10-143
- 1R24HS019481-01 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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