NCT01391026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

July 7, 2011

Last Update Submit

June 19, 2023

Conditions

Keywords

Medical informaticsHealth services accessibility

Outcome Measures

Primary Outcomes (1)

  • NIH PROMIS 10-item short form quality of life

    We will assess the physical and mental components of the quality of life instrument

    6 months

Secondary Outcomes (2)

  • MSAS physical symptom score

    6 months

  • Healthcare utilization

    6 months

Study Arms (2)

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

Behavioral: Enhanced patient-centered care

Interventions

The experimental arm will be referred to a multi-disciplinary clinic

Enhanced patient-centered care

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Visual or cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Study Officials

  • William E Trick, MD

    Cook County Health & Hospitals System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations