- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01273116
In Hospital Care and Welfare Standard (CWSInHosp)
Towards an In Hospital CARE AND WELFARE STANDARD for Frail Elderly
Study Overview
Status
Intervention / Treatment
Detailed Description
The long-term objective of this study is to examine the effectiveness and efficiency of an intervention program for frail older patients admitted to hospital. The specific aims are:
- To develop a model of integrated hospital care, according to the principle of the Chronic Care Model, focusing both on optimizing care and wellbeing. Feasibility of such a model of care was first evaluated in a pilot study.
- To conduct a before-after study to evaluate the outcomes associated with the proposed model of hospital care in frail older inpatients. Information on outcome indicators, including autonomy, quality of life, physical and cognitive functioning, and service utilization will be collected and compared before and after implementation of the proposed model of hospital care.
We expect that older patients who participate in the intervention program after one year of implementation, compared to patients who were admitted to hospital before implementation of the intervention program, will:
- have less functional decline during admission and after three months follow-up compared to two weeks before admission;
- have a lower incidence, severity and duration of delirium during admission;
- have less cognitive decline during admission;
- are more likely to be discharged directly to their own homes;
- have less weight loss between admission and discharge;
- experience less falls during admission;
- experience less readmissions within one month after discharge;
- have a shorter length of stay;
- have a significant different pattern of use of health care services after three months follow-up;
- experience more autonomy during hospital admission and better quality of life after three months follow-up.
Additionally, we expect that the knowledge and attitudes toward care for older patients among nurses and physicians will change positively during implementation of the intervention program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Frail patients aged 70 years or older, admitted to one of the participating hospital wards
- Patients aged <70 years, but living in a nursing home or diagnosed with dementia (and therefore also judged as frail)
Exclusion Criteria:
- Patients admitted <48 hours
- Palliative care is main goal of hospital admission
- Patients admitted and treated by physicians from non-participating wards and specialities
- Patients who do not speak or understand the Dutch language
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CWS in Hospital
CWS in Hospital in addition to usual care
|
Every patient aged ≥70 years will be screened for frailty. (For) every frail patient:
Hospital staff will be educated, disease-specific guidelines will be adapted to frail older patients. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient safety
Time Frame: during hospital stay
|
cumulative incidence in delirium, falls, functional decline (GARS), and loss of cognition (MMSE)
|
during hospital stay
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maintenance or improvement of functional status (patient safety)
Time Frame: 2 weeks before admission, discharge, 3 months after discharge
|
maintenance or improvement of functional status (Groningen Activity Restriction Scale GARS)):
|
2 weeks before admission, discharge, 3 months after discharge
|
Incidence delirium (patient safety)
Time Frame: during hospital stay
|
incidence delirium (as judged by an independent physician, structured by daily application of the Confusion Assessment Method (CAM) and Delirium Observation Scale (DOS))
|
during hospital stay
|
Autonomy of patient (quality of care)
Time Frame: before implementation and one year after implementation of CWS InHospital
|
Consumer Quality Indicator CWS In Hospital: to address autonomy of patients, developed by own researchers
|
before implementation and one year after implementation of CWS InHospital
|
OPROCS (quality of care)
Time Frame: discharge and 3 months follow-up
|
OPROCS = cumulative outcome measure functional ability and quality of life etc. as determined by the elderly (Minimum Data Set)
|
discharge and 3 months follow-up
|
Validity of delirium diagnoses by the medical specialty involved (quality of care)
Time Frame: before and one year after implementation CWS InHospital
|
recognition of delirium by medical staff (nurses and doctors) compared to diagnoses by independent physician using CAM and DRS-r-98
|
before and one year after implementation CWS InHospital
|
Readmissions (quality of care)
Time Frame: within 1 month after discharge
|
readmissions within 1 month after discharge (Minimum Data Set, electronic health record)
|
within 1 month after discharge
|
Objective burden of care among informal caregivers (quality of care)
Time Frame: from admission to 3 months after discharge patient
|
objective burden of care among informal caregivers (Minimum Data Set)
|
from admission to 3 months after discharge patient
|
Cost-effectiveness
Time Frame: from admission to 3 months after discharge
|
expressed in incremental cost-effectiveness ratio (length of stay; use of health care services (MDS), quality of life) primary outcomes as nominator, and expressed in costs per quality adjusted life years, all related to total health care costs from a societal perspective, from admission to three months following discharge
|
from admission to 3 months after discharge
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marcel GM Olde Rikkert, PhD, Radboud University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Nr. 60-61900-98-272, NPO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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