Cognitive ImpairmentNCT00182832
e-CHAMP: Enhancing Care for Hospitalized Older Adults With Memory Problems
A study testing e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment) in people with Cognitive Impairment and Delirium, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Delirium
- What is being tested?
- e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wishard Memorial Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Enhancing Care for Hospitalized Older Adults With Cognitive Impairment
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.
Read the 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.
- Conditions
- Cognitive Impairment, Delirium
- Being tested
- e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment), Standard Care
- Keywords
- Physician Behavior, Hospital Acquired Complications, MCI, Mild Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment)Behavioural
Also called CDSS
Cognitive screening plus Computerized Decision Support System: proactive screening program for cognitive impairment combined with computerized review of the electronic medical record
Standard CareBehavioural
Standard care for hospitalized older patients with cognitive impairment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment) |
| 2 | Active comparator | Not described Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and at discharge
Total number of hospital acquired complications recorded in the medical record that may be related to cognitive impairment (CI)
Measured: baseline and at discharge
Secondary outcomes (1)
Length and cost of hospital stay from discharge records and billing system
Measured: baseline, at discharge, 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Malaz Boustani, MD, MPH, Regenstrief Institute, Inc.
- Investigators
- Malaz Boustani, MD, MPH, Principal investigator, Regenstrief Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182832
- Sponsor's protocol ID
- IA0077
- Other IDs
- K23AG026770, K23AG026779-01
- Status last verified
- Apr 2016
- First submitted
- 9 Sep 2005
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15123850Marcantonio 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.
PubMed 8264068Marcantonio 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.
PubMed 7966844McCusker 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.
PubMed 14687382Marcantonio 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.
PubMed 10855596Harwood 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.
PubMed 9143435
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Care for Hospitalized Older Adults With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT00182832
- Acronym / sponsor ID
- IA0077
- Conditions
- Cognitive Impairment, Delirium
- Keywords
- Physician Behavior, Hospital Acquired Complications, MCI, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jun 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment) |
| 2 | Active comparator | Behavioral: Standard Care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment)Also: CDSSCognitive screening plus Computerized Decision Support System: proactive screening program for cognitive impairment combined with computerized review of the electronic medical record | Behavioural | 1 |
| Standard CareStandard care for hospitalized older patients with cognitive impairment | Behavioural | 2 |
Primary outcome
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
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
1 secondary outcome
Length and cost of hospital stay from discharge records and billing system
Time frame: baseline, at discharge, 6 months post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Background: PubMed 15123850Saravay 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.
- Background: PubMed 8264068Marcantonio 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.
- Background: PubMed 7966844Marcantonio 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.
- Background: PubMed 14687382McCusker 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.
- Background: PubMed 10855596Marcantonio 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.
- Background: PubMed 9143435Harwood 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malaz Boustani, MD, MPH principal investigator
Regenstrief Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment) in people with Cognitive Impairment and Delirium, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182832, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.