Functional Decline and Complications of Frail Older Patients Admitted to HospitalCWSInHospNCT01273116
In Hospital Care and Welfare Standard
A study testing CWS in Hospital in people with Functional Decline and Complications of Frail Older Patients Admitted to Hospital, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Functional Decline and Complications of Frail Older Patients Admitted to Hospital
- What is being tested?
- CWS in Hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Jan 2013
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Towards an In Hospital CARE AND WELFARE STANDARD for Frail Elderly
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.
Read the 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.
- Being tested
- CWS in Hospital
- Keywords
- frailty, integrated care, hospital, geriatrics, hospital-wide intervention
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CWS in HospitalOther
Every patient aged ≥70 years will be screened for frailty. (For) every frail patient:
- will have a comprehensive (geriatric) assessment using an adapted version of the EasyCare instrument;
- a geriatric consultation team will propose/recommend a tailored care and welfare plan, which will be updated at the moment of discharge;
- will be discussed at least once in a multidisciplinary meeting;
- a structured medication review will be carried out by a geriatrician;
- is offered an activation programme by volunteers focusing on improvement of orientation, mobility, social activities or nutrition;
- may receive a consult of a geriatrician, if judged necessary;
- will receive extra attention on discharge arrangements.
Hospital staff will be educated, disease-specific guidelines will be adapted to frail older patients.
| Study group | Role | What they receive |
|---|---|---|
| CWS in Hospital | Experimental | CWS in Hospital in addition to usual care Receives: Other: CWS in Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient safety
cumulative incidence in delirium, falls, functional decline (GARS), and loss of cognition (MMSE)
Measured: during hospital stay
Secondary outcomes (8)
Maintenance or improvement of functional status (patient safety)
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
Measured: 2 weeks before admission, discharge, 3 months after discharge
Incidence delirium (patient safety)
incidence delirium (as judged by an independent physician, structured by daily application of the Confusion Assessment Method (CAM) and Delirium Observation Scale (DOS))
Measured: during hospital stay
Autonomy of patient (quality of care)
Consumer Quality Indicator CWS In Hospital: to address autonomy of patients, developed by own researchers
Measured: before implementation and one year after implementation of CWS InHospital
OPROCS (quality of care)
OPROCS = cumulative outcome measure functional ability and quality of life etc. as determined by the elderly (Minimum Data Set)
Measured: discharge and 3 months follow-up
Validity of delirium diagnoses by the medical specialty involved (quality of care)
recognition of delirium by medical staff (nurses and doctors) compared to diagnoses by independent physician using CAM and DRS-r-98
Measured: before and one year after implementation CWS InHospital
Readmissions (quality of care)
readmissions within 1 month after discharge (Minimum Data Set, electronic health record)
Measured: within 1 month after discharge
Objective burden of care among informal caregivers (quality of care)
objective burden of care among informal caregivers (Minimum Data Set)
Measured: from admission to 3 months after discharge patient
Cost-effectiveness
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
Measured: from admission to 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Decline and Complications of Frail Older Patients Admitted to HospitalStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Marcel Olde Rikkert, Radboud University Medical Center
- Investigators
- Marcel GM Olde Rikkert, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273116
- Sponsor's protocol ID
- Nr. 60-61900-98-272, NPO
- Acronym
- CWSInHosp
- Status last verified
- Jan 2013
- First submitted
- 28 Dec 2010
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bakker FC, Persoon A, Bredie SJH, van Haren-Willems J, Leferink VJ, Noyez L, Schoon Y, Olde Rikkert MGM. The CareWell in Hospital program to improve the quality of care for frail elderly inpatients: results of a before-after study with focus on surgical patients. Am J Surg. 2014 Nov;208(5):735-746. doi: 10.1016/j.amjsurg.2014.04.009. Epub 2014 Jun 27.
PubMed 25085385
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards an In Hospital CARE AND WELFARE STANDARD for Frail Elderly
- ClinicalTrials.gov ID
- NCT01273116
- Acronym / sponsor ID
- CWSInHosp / Nr. 60-61900-98-272, NPO
- Keywords
- frailty, integrated care, hospital, geriatrics, hospital-wide intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Jan 2011 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CWS in Hospital | Experimental | Other: CWS in HospitalCWS in Hospital in addition to usual care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| CWS in HospitalEvery patient aged ≥70 years will be screened for frailty. (For) every frail patient: * will have a comprehensive (geriatric) assessment using an adapted version of the EasyCare instrument; * a geriatric consultation team will propose/recommend a tailored care and welfare plan, which will be updated at the moment of discharge; * will be discussed at least once in a multidisciplinary meeting; * a structured medication review will be carried out by a geriatrician; * is offered an activation programme by volunteers focusing on improvement of orientation, mobility, social activities or nutrition; * may receive a consult of a geriatrician, if judged necessary; * will receive extra attention on discharge arrangements. Hospital staff will be educated, disease-specific guidelines will be adapted to frail older patients. | Other | CWS in Hospital |
Primary outcome
Patient safety
Time frame: during hospital stay
cumulative incidence in delirium, falls, functional decline (GARS), and loss of cognition (MMSE)
8 secondary outcomes
Maintenance or improvement of functional status (patient safety)
Time frame: 2 weeks before admission, discharge, 3 months after discharge
Incidence delirium (patient safety)
Time frame: during hospital stay
Autonomy of patient (quality of care)
Time frame: before implementation and one year after implementation of CWS InHospital
OPROCS (quality of care)
Time frame: 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
Readmissions (quality of care)
Time frame: 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
Cost-effectiveness
Time frame: from admission to 3 months after 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 23 Jan 2013.
- Derived from this study: PubMed 25085385Bakker FC, Persoon A, Bredie SJH, van Haren-Willems J, Leferink VJ, Noyez L, Schoon Y, Olde Rikkert MGM. The CareWell in Hospital program to improve the quality of care for frail elderly inpatients: results of a before-after study with focus on surgical patients. Am J Surg. 2014 Nov;208(5):735-746. doi: 10.1016/j.amjsurg.2014.04.009. Epub 2014 Jun 27.
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.
Marcel GM Olde Rikkert, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CWS in Hospital in people with Functional Decline and Complications of Frail Older Patients Admitted to Hospital, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 inclusion and 4 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 23 Jan 2013. 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 Netherlands. 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?
Patient safety (time frame: during hospital stay). 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 NCT01273116, which also lists 1 linked publication.
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 23 Jan 2013.