Randomized Clinical Trial on peri-operative interventions for fragile older patients undergoing surgery. The Profyd trial.

Hospital admission can be a major life event for fragile older people,
associated with increased morbidity and mortality. Especially, large invasive
surgical interventions are in elderly patients increasingly accompanied with
complications, delirium, loss of function and mortality. To decease
post-surgical complications in fragile older patients indicated for elective
surgery small pilot studies have been conducted, which were mainly
monodisciplinary interventions. The effectiveness of a combination of
pre-surgical screening for multiple risk factors, followed by pre- and
post-surgical interventions in the 1st and 2nd line adjusted to the patient*s
status has rarely been investigated.

The objective of the study is to improve the peri-operative care for fragile
older patients who have been indicated for elective surgery of thorax and
abdomen.

A single blinded Randomized Controlled Trial (RCT) investigating the effects of
two interventions. The patients undergoing one of the two interventions are
unaware of the intervention given to them.

The intervention group starts immediately with pre-surgical interventions
adjusted to the patients* status. Daily activities and the patient*s fitness
level are trained by a physiotherapist, the patients nutritional status will be
improved by a dietitian, risk factors for a delirium are minimized and
medication will be minimized as much as possible by a geriatrician. These
interventions will be continued when needed (clinical and post-clinical in the
1st or 3rd line). Patients in the control group will receive the usual
peri-operative care.

A screening takes place to determine whether participants are suitable for the
study. By means of the VMS it is checked whether the elderly person meets the
four criteria for fragile elderly people: delirium, falls, malnutrition and
physical constrains.

Measurements during the investigation
There will be four measurements; a baseline measurement after the screening
when the patient agrees to participate in this study, shortly before surgery
when the patient is hospitalized, 1 month and 6 months after surgery.
The participants will be asked to complete questionnaires and two physical
tests will be carried out. An extensive description of the questionnaires and
the tests is given in chapter 6 of the research protocol, the C1 document.

Intervention group
Participants in the intervention group will be visited by a physiotherapist and
a dietitian conform the course that was given. Patients will also meet with a
geriatrician who will try to diminish the risk factors for a delirium and will
try to minimize the amount of medication used. Treatment by the
physiotherapist, dietarian and geriatrician will be continued in the hospital
during hospitalization. After the patient*s discharge from the hospital and
when needed, treatment by a physiotherapist and dietitian will be continued for
a maximum of four weeks. Treatment by a geriatrician will be continued, when
needed, for a maximum of four weeks as well.

Control group
The participants in the control group receive the care as usual.