Aims to evaluate different feeding policies for stroke patients:

Are oral supplements effective? When should we start tube feeding? Is PEG better than NG?

The FOOD TrialThe FOOD Trial

Is a “Family” of 3 trials which:

share the same randomisation system share data collection forms share the same follow up system allows co-enrolment into the 3 trials

The FOOD TrialThe FOOD Trial

Feeding policies vary greatly If feeding practices influences outcome Variation in practice is unacceptable We need RCTs to identify best practice

The RCT and systematic review are the “gold standards” for judging whether a treatment does more good than harm.

(NHS R& D Centre for Evidence based Medicine)

Variations in PracticeVariations in Practice

Trial 1

N o rm al D iet N o rm al D ietP LU S

S u p p lem en ts

P atien tS w allo w er

Within 1st month of admission

Trial 1Trial 1

Im m ed iate Tu b e D elay tu b efo r a t leas t a w eek &

h yd rate u s in g p aren teral flu id s

P atien tN o n -sw allo w er

Within 1st week of admission

Trial 2Trial 2

N G tu b e P E G tu b e

P atien tN o n S w allo w er

In 1st month of admission

Trial 3Trial 3

This means patients can be entered into more than one of these 3 trials

Allows randomisation whenever you are uncertain about the best policy

Increases number of eligible patients Increases rate of accrual Mimics everyday clinical practice Provides information on interactions

Co-enrolmentCo-enrolment

Im m ed iate Tu b e

P E G N G

C o n tin u in g d ysp h agia

D elay Tu b e & h yd rate

P atien tN o n -sw allo w er

W ith in 1 st w eek o f a d m iss io n

Sequential Co-enrolment in Trials 2 Then 3Sequential Co-enrolment in Trials 2 Then 3

Sequential Co-enrolment in Trials 2 Then 1Sequential Co-enrolment in Trials 2 Then 1

N o rm al D iet S u p p lem en ts

S w allo w in g im p ro ves

Im m ed iate Tu b e

N o rm al D iet S u p p lem en ts

S w allo w in g im p ro ves

D elay Tu b e & h yd rate

P atien tN o n -sw allo w er

W ith in 1 st w eek o f a d m iss io n

N o rm al D iet S u p p lem en ts

S w allo w in g im p ro vesw ith in 1 s t m o n th

P E G Tu b e

N o rm al D iet S u p p lem en ts

S w allo w in g im p ro vesw ith in 1 s t m o n th

N G Tu b e

P atien tN o n -sw allo w er

w ith in 1 s t m o n th o f a d m iss io n

Sequential Co-enrolment in Trials 3 Then 1Sequential Co-enrolment in Trials 3 Then 1

Delayed Tube Feeding For At Least One Week (Hydrate with Parenteral Fluids)

Delayed Tube Feeding For At Least One Week (Hydrate with Parenteral Fluids)

IV or S/C according to local protocols

Does not preclude oral diet or fluids If oral intake adequate clinician may stop parenteral

fluids If regime becomes impractical or another regime is

definitely indicated clinician may switch.

Immediate Tube FeedingImmediate Tube Feeding

• PEG or NG• Initiate feeding within 72 hours of phone call to

randomisation service• Recommend using a nutritionally complete feed,

according to local policy• Prescribe in consultation with Dietitian • Does not preclude oral diet or fluids• If regime becomes impractical or another regime is

definitely indicated clinician may switch.

The randomisation system

This all might seem complicated but: Our computerised randomisation system sorts it

out You simply fill in a one page randomisation form Telephone our 24 hour freefone number The patient will be allocated to a feeding regime

which reflects your uncertainties

The Randomisation SystemThe Randomisation System

Follow up

Report serious adverse events in hospital using report card

A simple form at hospital discharge or death in hospital

Centralised follow up at 6 months by telephone or postal questionnaire

Follow UpFollow Up

Six months after first randomisation

To establish:

Independence in everyday activities Type of residence

Modified Rankin and EUROQoLScore If patient still being fed via a tube

Follow UpFollow Up

Targets

We currently hope to randomise at least:

6000 in Trial 1 (Normal diet vs. Supps) 2000 in Trial 2 (Early vs. delay tube) 1000 in Trial 3 (NG vs. PEG)

TargetsTargets

Future plans

Expand numbers of centres Accelerate accrual Encourage co-enrolment

Future PlansFuture Plans

Progress

We have already randomised over 2500 patients 129 centres in 18 countries are already taking part We need to randomise over 9000 patients by 2002 We would like your help !

ProgressProgress

The PracticalitiesThe Practicalities

Everything you need is in the FOOD Manual

Freephone number to the randomisation service

24 hour helpline

1. Identify a patient2. Get consent3. Randomise4. Prescribe treatment allocation 5. Complete Hospital Discharge Form

The PracticalitiesThe Practicalities