|- candidate number||6303|
|- NTR Number||NTR1946|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-aug-2009|
|- Secondary IDs||60-61900-98-126 ZON-MW|
|- Public Title||Integrated Systematic Care for Older PEople.|
|- Scientific Title||Pro-active care for older people at risk for functional decline: Screening for vulnerability and effectiveness of a subsequent guided care plan in primary care.|
|- hypothesis||A slow and unpredictable deterioration of the capabilities of the older patient can lead to a vulnerable situation, often unnoticed by the caregiver. As a consequence, care is delayed and acute problems will arise that will need an immediate solution. The actions taken in these situations, such as hospital or nursing home admissions, are not always beneficial for the older patients. The provided care is expensive and of less quality, and the older patient and the caregiver are often dissatisfied with the provided care. These urgent solutions will probably not be necessary when vulnerable situations are detected in time and adequate help is being organized. Further deterioration is then likely to be prevented. |
|- Healt Condition(s) or Problem(s) studied||Frailty, Older people with multiple problems|
|- Inclusion criteria||Inclusion criteria for screening: |
1. People aged 75 years and over;
2. Enlisted in general practices.
Inclusion criteria for GP care plan in intervention practices:
1. Poor performance on >3 out of 4 domains on screening questionnaire.
|- Exclusion criteria||Exclusion criteria for screening:|
1. Terminal illness (life expectancy < 3 months).
Exclusion criteria for GP care plan: None.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2009|
|- planned closingdate||1-sep-2012|
|- Target number of participants||10000|
|- Interventions||The GP's formulate a care action plan for frail elderly.|
|- Primary outcome||Difference in quality of life, functional status of the participants in the intervention group versus the control group after 12 months. |
|- Secondary outcome||1. Satisfaction of older persons, caretakers and caregivers with delivered care;|
2. Indicators for proactive, coherent care;
3. Costs per quality adjusted life years (QALY).
|- Timepoints||1. Start 1-9-2009;|
2. M1-12 execution of the intervention;
3. Baseline measurements;
4. M13-24 outcome measurements and evaluation.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.W. Blom|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.W. Blom|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Public Health and Primary Care|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||RATIONALE:|
The number of older people with a combination of somatic, functional, mental or social problems is rising. The problems these older people are facing are not always known to care-providers. The general practitioner (GP) may sometimes suspect the presence of some of these problems, but usually only acts on demand. For vulnerable elders a screening/monitoring and proactive way of working is important, although this is not yet common in primary care.
The aim of this project is to assess the value/efficacy/cost-benefit of a simple structural monitoring system to detect the deterioration in somatic, functional, mental or social health of individuals aged 75 years and over followed by the execution of a care plan for those people with a combination of somatic, functional, mental and social problems.
Randomisation: This study employs a randomised design. Seventy general practices (clusters) will be randomized in a 1:1 ratio to the experimental monitoring system or usual care.
MONITORING AND SCREENING PHASE:
From all 70 general practices a short screening questionnaire with questions about somatic, functional, mental and social health will be sent to all people of 75 years and older. Older persons who do not return the screening questionnaire will be contacted through the GP and will be offered help with the questionnaire.
In the intervention group (35 practices), results of the screening questionnaire will be sent back to the GP and registered in the Electronic Patient Records (EPR). The GP, in cooperation with practice staff (e.g. practice nurse, GP’s assistant), will make a care plan for older people with problems in three or four of the four domains in the screening questionnaire, involving preferences and capabilities of the patient and his/her caretakers. This care plan will incorporate treatment goals and actions to be taken, such as indicated diagnostic strategies and interventions, medication review, referral to home care or social work or consultation with other caregivers involved. For patients with problems in 1 or 2 domains the GP will initiate individual or programmatic interventions. GP and practice staff will be trained to implement this monitoring and pro-active way of working. In the control group (usual care, 35 practices), the GPs will not receive feedback information from the screening questionnaire, patients will be provided usual care.
MAIN STUDY PARAMETERS AND ENDPOINTS:
The primary outcome of the study is the difference in functional status of the participants in the intervention group versus the usual care group after 12 months measured with the ADL (Acivities of Daily Living) items of the Groningen Activities Restriction scale.
Other outcomes are quality of life of participants, percentage of unplanned admission in nursing homes or hospitals, percentage home visits during evenings, nights and weekends and outcomes related to quality of care such as satisfaction of participants, caretakers and caregivers with delivered care and indicators for proactive, coherent care. Outcomes will be measured by means of an interview with structured questionnaires.
The economic evaluation will compare incremental societal costs (screening, intervention, other health care consumption, (in) formal home care) to the difference in functional status (primary outcome measure) and in quality of life (cost-effectiveness analysis). For cost-utility analysis (costs per quality adjusted life years [QALY]), a Visual Analogue Scale for perceived health status and the EQ-5D+c (EQ-5D extended with a cognitive dimension) will be added. Both the cost-effectiveness analysis and cost-utility analysis will use a one-year time horizon, without discounting.
NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS:
It will take the participants a maximum of 15 minutes to fill in the screening questionnaire. Older persons not returning the screening questionnaire will be contacted by telephone through the GP and offered help to fill in the questionnaire. A representative sample of older people will be visited at home to administer additional questionnaires (home visit of 60-90 minutes).
In the intervention group, the GP may ask the older patient with multiple problems to pay him/her a visit at the practice or the GP visits the older patient at home to discuss a care plan tailored to the individual patient. In both intervention and usual care practices, the screening questionnaire and outcome measurements will be repeated after 12 and 24 months. After 6 months all participants receive the screening questionnaire and two questionnaires for the economic evaluation.
RISK OF PARTICIPATION:
No additional risks are involved in this project compared to standard care. The interventions that will be used in the care plans or as programmatic intervention are commonly used or prescribed in General Practice. All standard care is according to current treatment guidelines.
|- Main changes (audit trail)|
|- RECORD||10-aug-2009 - 11-okt-2009|