Computer Assisted Symptom Evaluation of Complex Patients (CASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01391026
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : September 2, 2015
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
William E Trick, John H. Stroger Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Multiple Co-morbidities Behavioral: Enhanced patient-centered care Not Applicable

Detailed Description:

Outcome measures:

  1. Quality of life as measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) short form
  2. Physical symptom burden as measured by the Memorial Symptom Assessment Scale (MSAS), short form

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Computer Assisted Quality of Life and Symptom Assessment of Complex Patients
Study Start Date : June 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
No Intervention: Usual care
Experimental: Enhanced patient-centered care
Patients will be evaluated and treated in the advanced illness management clinic
Behavioral: Enhanced patient-centered care
The experimental arm will be referred to a multi-disciplinary clinic

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. MSAS physical symptom score [ Time Frame: 6 months ]
  2. Healthcare utilization [ Time Frame: 6 months ]
    We will monitor healthcare utilization within our system. To include visits to the emergency room, clinics, and hospitalizations.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01391026

United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: William E Trick, MD Cook County Health & Hospitals System

Responsible Party: William E Trick, Principal Investigator, John H. Stroger Hospital Identifier: NCT01391026     History of Changes
Other Study ID Numbers: 10-143
1R24HS019481-01 ( U.S. AHRQ Grant/Contract )
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015

Keywords provided by William E Trick, John H. Stroger Hospital:
Medical informatics
Health services accessibility