e-CHAMP: Enhancing Care for Hospitalized Older Adults With Memory Problems
Primary Purpose
Cognitive Impairment, Delirium
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment)
Standard Care
Sponsored by

About this trial
This is an interventional prevention trial for Cognitive Impairment focused on measuring Physician Behavior, Hospital Acquired Complications, MCI, Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria: 65 years of age or older Hospitalized in a medical ward Able to speak English Cognitive impairment based on screening at time of hospital admission Exclusion Criteria: Previously enrolled in the study during prior hospitalization (for multiple admissions; only data from the first admission will be used) Enrolled in another clinical trial Does not have cognitive impairment based on screening at time of hospital admission
Sites / Locations
- Wishard Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Use of potentially inappropriate medications, urinary catheter or physical restraints, and length of time in initiating a referral order, as recorded in the electronic medical record
Total number of hospital acquired complications recorded in the medical record that may be related to cognitive impairment (CI)
Secondary Outcome Measures
Length and cost of hospital stay from discharge records and billing system
Full Information
NCT ID
NCT00182832
First Posted
September 9, 2005
Last Updated
April 11, 2016
Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT00182832
Brief Title
e-CHAMP: Enhancing Care for Hospitalized Older Adults With Memory Problems
Official Title
Enhancing Care for Hospitalized Older Adults With Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of a cognitive screening program coupled with a computerized decision support system in improving the quality of care for hospitalized older adults with cognitive impairment.
Detailed Description
A growing body of evidence demonstrates that older patients with cognitive impairment (CI) who are hospitalized for the management of their medical illnesses are especially vulnerable to hospital acquired complications such as falls, injuries, pressure ulcers, restraints, and delirium. These complications contribute to mortality, poorer functional status, limited rehabilitation, prolonged length of stay, increased institutionalization, and higher health care costs. Evidence suggests that interdisciplinary geriatric inpatient services improve care for hospitalized older adults without CI; however, their effectiveness among older adults with CI is less clear. One reason may be the ever-quickening pace of care in the hospital setting. Thus, matching geriatric evaluation and recommendations to the true pace of hospital care may be one mechanism to improve the care of older adults with CI.
A recent report from the Institute of Medicine suggested that integrating information technology (IT) into health care is the best route to improve the overall safety and quality of the health care system. The hypothesis of this study is that missed, delayed, post-hoc, and incomplete implementation of the geriatric service-based recommendations are significant factors explaining the poor outcomes among hospitalized older adults with cognitive impairment (CI). Wishard Memorial Hospital's physicians are already using a Computerized Decision Support System (CDSS), developed by the Regenstrief Institute, to guide their medical services. For this study, the content of this CDSS will be modified to the special needs of older adults with CI. A major advantage of such a system is reducing the time to implementation of geriatric recommendations with a specific focus on preventing the initiation of potentially harmful medications and procedures during the critical first 48 hours of hospitalization.
A total of 400 patients with cognitive impairment who have been hospitalized in a medical ward will be recruited for this study. Patients will be randomized to receive either standard care or the proactive screening program for CI combined with the modified CDSS. The electronic medical record for all patients will be reviewed for prescriptions for potentially inappropriate medications, urinary catheters, or physical restraints during the first 24 hours and the entire hospital stay. Medical records will be used to determine the total number of hospital acquired complications that may be related to CI; these include falls, injuries such as pulling out IV lines or urinary catheters, pressure ulcers, and new-onset delirium episodes that developed during hospitalization. Also, the time elapsed between screening for CI and the physician ordering a geriatric consultation will be calculated using the electronic medical record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Delirium
Keywords
Physician Behavior, Hospital Acquired Complications, MCI, Mild Cognitive Impairment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
424 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment)
Other Intervention Name(s)
CDSS
Intervention Description
Cognitive screening plus Computerized Decision Support System: proactive screening program for cognitive impairment combined with computerized review of the electronic medical record
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Standard care for hospitalized older patients with cognitive impairment
Primary Outcome Measure Information:
Title
Use of potentially inappropriate medications, urinary catheter or physical restraints, and length of time in initiating a referral order, as recorded in the electronic medical record
Time Frame
baseline and at discharge
Title
Total number of hospital acquired complications recorded in the medical record that may be related to cognitive impairment (CI)
Time Frame
baseline and at discharge
Secondary Outcome Measure Information:
Title
Length and cost of hospital stay from discharge records and billing system
Time Frame
baseline, at discharge, 6 months post-discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
65 years of age or older
Hospitalized in a medical ward
Able to speak English
Cognitive impairment based on screening at time of hospital admission
Exclusion Criteria:
Previously enrolled in the study during prior hospitalization (for multiple admissions; only data from the first admission will be used)
Enrolled in another clinical trial
Does not have cognitive impairment based on screening at time of hospital admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malaz Boustani, MD, MPH
Organizational Affiliation
Regenstrief Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15123850
Citation
Saravay SM, Kaplowitz M, Kurek J, Zeman D, Pollack S, Novik S, Knowlton S, Brendel M, Hoffman L. How do delirium and dementia increase length of stay of elderly general medical inpatients? Psychosomatics. 2004 May-Jun;45(3):235-42. doi: 10.1176/appi.psy.45.3.235.
Results Reference
background
PubMed Identifier
8264068
Citation
Marcantonio ER, Goldman L, Mangione CM, Ludwig LE, Muraca B, Haslauer CM, Donaldson MC, Whittemore AD, Sugarbaker DJ, Poss R, et al. A clinical prediction rule for delirium after elective noncardiac surgery. JAMA. 1994 Jan 12;271(2):134-9.
Results Reference
background
PubMed Identifier
7966844
Citation
Marcantonio ER, Juarez G, Goldman L, Mangione CM, Ludwig LE, Lind L, Katz N, Cook EF, Orav EJ, Lee TH. The relationship of postoperative delirium with psychoactive medications. JAMA. 1994 Nov 16;272(19):1518-22.
Results Reference
background
PubMed Identifier
14687382
Citation
McCusker J, Cole MG, Dendukuri N, Belzile E. Does delirium increase hospital stay? J Am Geriatr Soc. 2003 Nov;51(11):1539-46. doi: 10.1046/j.1532-5415.2003.51509.x.
Results Reference
background
PubMed Identifier
10855596
Citation
Marcantonio ER, Flacker JM, Michaels M, Resnick NM. Delirium is independently associated with poor functional recovery after hip fracture. J Am Geriatr Soc. 2000 Jun;48(6):618-24. doi: 10.1111/j.1532-5415.2000.tb04718.x.
Results Reference
background
PubMed Identifier
9143435
Citation
Harwood DM, Hope T, Jacoby R. Cognitive impairment in medical inpatients. I: Screening for dementia--is history better than mental state? Age Ageing. 1997 Jan;26(1):31-5. doi: 10.1093/ageing/26.1.31.
Results Reference
background
Learn more about this trial
e-CHAMP: Enhancing Care for Hospitalized Older Adults With Memory Problems
We'll reach out to this number within 24 hrs