Computer Assisted Symptom Evaluation of Complex Patients (CASE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by John H. Stroger Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT01391026
First received: July 7, 2011
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

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 Intervention
Multiple Co-morbidities
Behavioral: Enhanced patient-centered care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Computer Assisted Quality of Life and Symptom Assessment of Complex Patients

Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • NIH PROMIS 10-item short form quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will assess the physical and mental components of the quality of life instrument


Secondary Outcome Measures:
  • MSAS physical symptom score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Healthcare utilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will monitor healthcare utilization within our system. To include visits to the emergency room, clinics, and hospitalizations.


Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care Behavioral: Enhanced patient-centered care
The experimental arm will be referred to a multi-disciplinary clinic
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391026

Locations
United States, Illinois
Stroger Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Lynda Brodsky, MPH    312-864-0716    researchaffairs@yahoo.com   
Principal Investigator: William E Trick, MD         
Sponsors and Collaborators
John H. Stroger Hospital
Investigators
Principal Investigator: William E Trick, MD Cook County Health and Hospitals System
  More Information

No publications provided

Responsible Party: William E Trick, Cook County Health and Hospitals System
ClinicalTrials.gov Identifier: NCT01391026     History of Changes
Other Study ID Numbers: 10-143, 1R24HS019481-01
Study First Received: July 7, 2011
Last Updated: July 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by John H. Stroger Hospital:
Medical informatics
Health services accessibility

ClinicalTrials.gov processed this record on September 22, 2014