In Hospital Care and Welfare Standard

Not Applicable

Completed

• Conditions: Functional Decline and Complications of Frail Older Patients Admitted to Hospital
• Interventions: Other: CWS in Hospital

• Registration Number: NCT01273116
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The current organization of hospital care for older patients with complex healthcare needs is of insufficient quality, safety and efficiency. Frail older patients have a higher risk for development of complications and consequently a higher length of hospital stay, a higher risk of functional decline, and higher care needs after discharge. As nearly half of the patients admitted to Dutch hospitals is over 65 years, it is highly necessary to adapt the organization of hospital care to their needs. Besides having introduced the medical specialty geriatrics, hospital management has not started to provide hospital wide healthcare tailored to frail older patients. Therefore, the purpose of this study is to develop and examine the effectiveness of an intervention program for frail older patients admitted to hospital aimed at preventing functional decline and other hospital related negative outcomes.

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 Timeline

• Study First Submitted: 2010-12-28
• Study Start: 2011-01
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2012-07
• Status Verified: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-21
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CWS in Hospital	CWS in Hospital	CWS in Hospital in addition to usual care

Primary Outcome Measures

Name	Time	Method
Patient safety	during hospital stay	cumulative incidence in delirium, falls, functional decline (GARS), and loss of cognition (MMSE)

Secondary Outcome Measures

Name	Time	Method
Maintenance or improvement of functional status (patient safety)	2 weeks before admission, discharge, 3 months after discharge	maintenance or improvement of functional status (Groningen Activity Restriction Scale GARS)): * difference between 2 weeks before admission and discharge; * difference between discharge and 3 months after discharge; * difference between 2 weeks before admission and 3 months after discharge
Incidence delirium (patient safety)	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))
Autonomy of patient (quality of care)	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
OPROCS (quality of care)	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)
Validity of delirium diagnoses by the medical specialty involved (quality of care)	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
Readmissions (quality of care)	within 1 month after discharge	readmissions within 1 month after discharge (Minimum Data Set, electronic health record)
Objective burden of care among informal caregivers (quality of care)	from admission to 3 months after discharge patient	objective burden of care among informal caregivers (Minimum Data Set)
Cost-effectiveness	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

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands