The reduction of disability in community-dwelling frail elderly: a randomized controlled trial

Depending on the definition of frailty up to 40% of the Dutch elderly
population is frail and an increase in the number of frail elderly is expected.
Frail elderly are more vulnerable for adverse health outcomes such as acute and
chronic diseases, and disability. Disability is a relevant health problem,
because it is associated with a loss of independency in carrying out essential
tasks and roles needed for self-care and independent living. Participation in
meaningful activities that is related to one*s quality of life is limited. In
addition, disability is associated with a higher risk for mortality,
hospitalization, long-term care and related costs. The number of disabled older
people is expected to triple until 2050. Therefore, an intervention for
delaying or preventing disability is highly relevant in community-dwelling
frail elderly. However, evidence about effective interventions is limited.

We propose a randomized controlled study to investigate the effectiveness of
the intervention. Secondly, a comprehensive process evaluation will be
conducted to validate the effectiveness of the intervention and to facilitate
future implementation. We will study the content of the program, the
performance according to protocol and the compliance with the intervention.
Thirdly, data on health care utilization and consumed goods are collected to
determine the cost-effectiveness of the intervention.

In the study 420 community-dwelling frail elderly (70 years or older) and their
informal caregivers will be included through a screening of 70+ elderly in
twelve GP practices in the region of the Westelijke Mijnstreek. Based on a
randomization on practice level, six practices (=210 participants) receive the
new intervention as part of the NPO transition project (intervention group) and
six practices (=210 participants) receive care as usual (control group).
Assuming that 80% of frail elderly has a central informal caregiver, who will
also be included in the study, 340 informal cargivers will be added resulting
in a total sample size of 760. Data for the effectiveness evaluation will be
measured at 6, 12 and 24 months follow-up. Therefore a combination of
telephone interviews, postal questionnaires and registries from health
insurance, general practitioners and hospitals will be used.

The focus of the intervention is on disability prevention. It is a tailor-made
and multidisciplinary intervention that consists of six steps. After an initial
postal screening (step 1) of frail older people (GFI * 5) a comprehensive
multidimensional assessment (step 2) will be done by a practice nurse in
collaboration with the general practitioner (GP). The assessment phase focuses
on the identification of existing limitations in daily life and on risk factors
for future limitations (e.g. polypharmacy, mobility, falls, lack of social and
productive activities, cognitive impairments). Practice nurse and GP determine
if additional assessment is needed for example by means of the GP,
physiotherapist or other specialist from the first and second echelon. After
the assessment, the practice nurse and GP formulate an interim action plan
(step 3). In case of complex problems clients can be discussed in a
multidisciplinary team (practice nurse, GP, physiotherapist and occupational
therapist). Consequently, a meeting between the practice nurse and the client
(and informal caregiver) takes place to define a definitive action plan,
including goals, strategies and actions (step 4). The action plan can be
related to a toolbox of interventions, which will be executed by the
multidisciplinary team (step 5). During executing and after finishing the
components of the toolbox, the practice nurse and the client evaluate the
achievement of goals, the implementation of strategies into daily life and the
need for support in the following period (step 6).

Intervention participants (n=210) receive in the beginning two home visits by a
practice nurse (2x 60 minutes). Consequently, participants receive a
tailor-made intervention which is related to a toolbox of interventions.
Interventions participants can follow several parts of the toolbox. Each part
takes round about 5-10 hours. The burden of receiving the intervention can vary
a lot among participants, depending on the tailor-made nature of the
intervention. A total length of 4-6 months can be expected.
For research purposes all participants (intervention and control group, n=420)
have to fill in a short screeningslist at the start. For the effect evaluation
a postal questionnaire (ca. 30 minutes) has to be filled in at 4 moments in
time and participants will be called four times for a telephone interview (35
min). Postal questionnaires and telephone interviews will be spread over a
period of two years. At the end of the intervention, intervention participants
will be asked to fill in a short questionnaire for the process evaluation (ca.
10 minutes). In addition several participants will be visited for a short
interview (30 min).
Central informal caregivers (n=340) have to fill in a short questionnaire (ca.
30 minutes) at 4 moments in time spread over a period of two years.