Computer Assisted Symptom Evaluation of Complex Patients (CASE)
| Tracking Information | |||||
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| First Received Date ICMJE | July 7, 2011 | ||||
| Last Updated Date | July 11, 2011 | ||||
| Start Date ICMJE | June 2011 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01391026 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Computer Assisted Symptom Evaluation of Complex Patients | ||||
| Official Title ICMJE | Computer Assisted Quality of Life and Symptom Assessment of Complex Patients | ||||
| 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. |
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| Detailed Description | Outcome measures:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Multiple Co-morbidities | ||||
| Intervention ICMJE | Behavioral: Enhanced patient-centered care
The experimental arm will be referred to a multi-disciplinary clinic |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01391026 | ||||
| Other Study ID Numbers ICMJE | 10-143, 1R24HS019481-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | William E Trick, Cook County Health and Hospitals System | ||||
| Study Sponsor ICMJE | John H. Stroger Hospital | ||||
| Collaborators ICMJE | Agency for Healthcare Research and Quality (AHRQ) | ||||
| Investigators ICMJE |
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| Information Provided By | John H. Stroger Hospital | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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