Validation study of a two step screening procedure for older persons with complex problems

The Dutch Nationaal Programma Ouderenzorg (NPO) (Dutch National Care for the
Elderly Programme), and the Zorg voor Ouderen en Welzijn Netwerk Nijmegen
(ZOWEL NN) (Nijmegen Network for Elderly Care and Welfare), which was
established in this context, are aimed at older people with complex problems in
the broadest sense of the term: health problems, functional limitations, and
also psychosocial problems such as loneliness.
So far, however, there is no screening tool available that general
practitioners (GPs) and primary care nurses can use to recognize these complex
problems among older people in a simple, sound (valid and reliable) and
effective way. A valid and feasible screening method to identify frail older
people and the complexity of their care situation is important because this is
the key to tailor-made interventions.
From both a practical and scientific perspective, it is therefore very
important to assess whether a pragmatic two-step screening is able to provide a
valid tool to identify frail older people that at the same time can be
implemented easily in usual care.

In addition to the aim of validating a tool to identify frailty and complexity
in a primary care setting, we specifically aim on one particularly disabling
geriatric problem; falling. Although there are many screening tools available
aiming to identify people at a high risk of falling, so far no reliable and
easy tool for primary care professionals is available. Using the data collected
through the two-step screening, we aim to develop a prediction rule for the
identification of future falls.

The main objective of the study is to develop a valid and efficient screening
procedure to identify frail older subjects who find themselves in a complex
care situation. The study basically addresses three research questions,
concerning:
1) The feasibility, reliability, and concurrent validity against comprehensive
geriatric assessment of a simple and pragmatic, two-step screening procedure
for complex health problems and problems related to wellbeing in older subjects
in primary care.
2) The predictive validity the two-step screening for the identification of
functional decline.
3) The costs of the two-step screening procedure
4) To develop a prediction rule for the identification of future falls using
information collected in primary care.

cohort study design

TWO STEP SCREENING METHOD
The first step is performed by the GP and uses all information readily
available in the GP practice (e.g. electronic medical record) to divide all
persons aged 70 years and over who are registered as a patient in this practice
in three groups: older people who are 1) definitely, 2) possibly, or 3)
definitely not frail.
The second step consists of collecting additional data of the persons who are
identified as possibly or definitely frail according to step 1. In order to
collect this additional information, a practice nurse assesses these persons
with a questionnaire that includes all domains that are relevant for the health
and welfare of older people
After this information has been collected, the GP and the practice nurse
together divide this group into a group of persons who are considered frail and
a group of person who considered not to be frail after all.
Subsequently, from all frail patients an evaluation will be made of the
complexity of the care situation. A patient has a complex care situation when
the problems of the patient leads to uncertainty or lack of agreement about the
present problems and how they should be handled.

RESEARCH SET UP
560 elderly subjects will be screened with the two-step method and the gold
standard method (comprehensive geriatric assessment) and the diagnostic results
will be compared.
For this purpose all persons of 70 and above from 10 full time equivalents of
GPs in the area of Nijmegen will be screened with the two-step screening and
will subsequently be asked to participate with the gold standard.
In addition, there will be prospective validation to find out what is the
predictive value of the two-step screening for the
occurrence of functional deterioration within a year.

All patients will also be asked to give separate informed consent for the
follow-up of fall incidents with the falls telephone. The participants will get
weekly automated calls from this telephone.

All patients will get a complete geriatric assessment :
- medical history, physical, functional and psychiatric examination by a
geriatrician (90 minutes)
- Routine clinimetric screening by a geriatric nurse (75 min): MMSE, Geriatric
depression scale, Timed up and go test, modified Katz-scale, Fried frailty
assessment and the gaitrite protocol.
- routine blood test

Since the screening itself (baseline and follow-up) is part of innovative
health care that will be implemented anyway, it is not part of the study.

The patients who gave adjacent informed consent for follow up through the falls
telephone, get weekly automated calls from this service during 12 months of
follow up.

No harms are expected to result from the participations of the people in the
study.