The challenges of innovation in the organization of home enteral tube feeding

The challenges of innovation in the organizationof home enteral tube feeding

P. Howard* and N. Bowen *Head of Nutrition and Dietetic Services, United Bristol Healthcare NHS Trust, Bristol; Commercial Director, Nutricia Ltd,

Trowbridge, Wiltshire, UK

Introduction

The number of patients being discharged from

hospital on home enteral tube feeding (HETF)

has been increasing by about 20% year on year

and, at the end of 1998, approximately 12 000

patients in the UK were bene®ting from HETF

(Elia, 1997, 1998, 1999). This has been caused by

a combination of factors including developments

in healthcare technology, changes in clinical

practice and growing numbers of elderly pa-

tients.

The needs of patients on HETF are complex and

can either be relatively short-term, perhaps less

than 6 months, or inde®nite. Some patients also

need additional speciality treatments, for example

for cancer or renal disease. In essence, each

patient requires the following for the successful

management of HETF:

· a regular supply of feeding solutions, the asso-

ciated `consumables' (tubes, sets and ancillary

items) and a pump;

· access to appropriate nursing care for training

in the use of the HETF system. This includes

pump management and simple problem solving;

· access to a dietitian to enable the suitability of

the feeding regimen to be monitored in the

context of nutritional status;

· awareness of emergency arrangements in the

event of problems;

· access to informed medical support to monitor

clinical condition, nutritional care and the need

for continued HETF. This support should

include access to a Speech and Language

Therapist to assess the safety of oral feeding in

the event of improved swallowing function

(Finestone, 2000);

· access to appropriate support to enable the

emotional, social and domestic demands of

HETF to be managed effectively.

Clearly, patients using HETF need a range of

products and services which can be provided in a

variety of ways (Elia, 1995). These have depended

on local circumstances and the organizational

ã Blackwell Science Ltd 2001 J Hum Nutr Dietet, 14, pp. 3±11 3

CorrespondencePat Howard,Head of Nutrition and Dietetic Services,United Bristol Healthcare NHS Trust,Bristol BS2 8HW, UK.Tel.: +44 117 928 2049E-mail: [email protected]

Keywordshome enteral feeding, organizationof home enteral feeding services.

AcceptedOctober 2000

Abstract

The number of patients discharged from hospital who need home

enteral tube feeding has been increasing steadily in the UK.

Arrangements for support of these patients is extremely variable. The

unsatisfactory arrangements for home enteral tube feeding which

existed in Avon in 1996 prompted an innovative reorganization. On

the basis of that experience, this review examines the key issues

involved and the questions to be considered, which may be of bene®t

to other trusts faced with similar challenges.

arrangements have been complex (Silkroski, 1998;

Parver, 1998; Howard, 2000). In some instances,

inadequate service provision has been reported

(McWhirter et al., 1994; Townsley & Robinson,

1997; L'Estrange, 1997; Silkroski, 1998; Mensforth,

1999; McNamara et al., 2000).

Meeting the needs of patients using HETF

The established route for supplying medicines to

patients in the community is by prescription on an

FP10 or GP10 form at the expense of the NHS. The

process has been described in detail (Howard, 2000)

and the essential features are shown in Table 1.

Tariff prices for products prescribed in the

community are, usually, signi®cantly higher than

the hospital price for the same product. One rea-

son for this is that hospitals are able to purchase

much larger quantities on a contractual basis,

thereby realizing economies of scale.

Traditionally, the needs of patients on HETF

have been met by adopting one of three basic

approaches. Each approach is tailored to meet the

requirements of the FP10/GP10 prescribing route

but is governed by local budget arrangements.

Hospital-based service

The budget is usually, but not always, centralized

and is managed either by the Head of Nutrition

and Dietetic Services or by an appropriate Nurse/

General Manager. The dietitian will advise the GP,

either independently or via the discharging con-

sultant, of the required nutritional regimen which

is then prescribed on an FP10/GP10 form. The

product will then, usually, be collected by the

patient from the local community pharmacy.

The feeding equipment is organized and deliv-

ered separately either through the community

nursing service, via the NHS supplies organization

or directly from the manufacturer.

These costs are then charged back to the hos-

pital budget. Ancillary items, e.g. tape and litmus

paper, are generally supplied by the community

nursing service.

Dietetic support may not be routinely available

for HETF patients, even on an outpatient basis,

due to con¯icting service pressures. Any training

which is needed is usually undertaken by ward-

based staff before discharging the patient, and

community nursing support is often limited.

Community-based service

The budget is held within the community where

there may also be a community-based dietetic

service. Arrangements are usually similar to those

described above but there is more likelihood of

appropriate nursing and, maybe, dietetic support.

Commercial hospital ± home service

Such arrangements have been developed by the

private sector in response to identi®ed healthcare

and social needs and the drive to maintain market

representation. From the outset these schemes

have improved delivery arrangements: instead of

consumables arriving from one source and solu-

tions from another, often on different days, it has

become possible for patients to receive both sim-

ultaneously. Furthermore, the companies supply

and maintain feeding pumps as well as providing a

telephone help-line facility.

During recent years these services have been

extended to include varying levels of nursing

support as well as additional features such as the

development of targeted educational resources.

The current situation, nationally, is one in which

most hospitals discharging patients on HETF rely

on services provided by the enteral feeding com-

panies (Russell, 2000; NHS Purchasing and Supplies

Agency ± personal communication 2000). These are

generated by the patient's GP completing an FP10/

GP10 prescription, which means that the GP retains

duty of care for the patient. There is little doubt that

Table 1 FP10/GP10 Prescriptions: Essential features

· GPs are only allowed to prescribe items listed on the DrugTariff if they do not wish to be charged for the cost of theprescription;

· speci®c prescriptions are written for individual patients;· the prescribed items are dispensed by a quali®ed

pharmacist;· the items are collected by the patient unless special delivery

arrangements have been made;· the pharmacist receives a dispensing fee and is reimbursed

according to agreed Drug Tariff prices.

P. Howard and N. Bowen4

ã Blackwell Science Ltd 2001 J Hum Nutr Dietet, 14, pp. 3±11

commercial intervention has greatly improved

HETF service provision in many areas. In addition,

it has enabled any existing, albeit inadequate,

resources to be deployed more effectively within

current ®nancial and organizational frameworks.

The sustained growth in HETF (Elia, 1997, 1998,

1999; Russell, 2000), the increased use of audits

and a better appreciation of the problems have all

stimulated innovative approaches to care provi-

sion (Ireton-Jones et al., 1997; Klein et al., 1998).

These are resulting in easier access to supplies of

equipment and solutions, improved quality of care

and much more patient-centred services.

Innovations are often associated with risks and

these must be identi®ed and carefully considered

at every stage in service development. The Avon

Home Enteral Feeding Scheme was introduced, on

a pilot basis, in August 1997. A number of

important issues had to be addressed to ensure the

provision of a safe, ef®cient and effective service

which involved extensive discussions with the key

stakeholders, including the suppliers of enteral

feeds. This review describes the insights gained

from this experience.

The Avon home enteral tube feedingscheme

This scheme delivers nutritional support to about

320 patients on HETF living within the boundaries

of Avon Health Authority. There is a population

of approximately 1 million people, with HETF

originally being provided by seven healthcare

trusts. Recent mergers have reduced this to ®ve

trusts. There are regional centres for paediatrics,

renal disease, neurosciences, oncology and cardiac

services, among others.

Before the scheme was implemented there was

minimal dietetic and nursing support for most

patients once they were discharged from hospital

± unless they were directly managed by the

regional renal unit. Each trust operated inde-

pendently and most had arrangements with

enteral feed suppliers to provide a delivery service

for nutritional equipment and solutions. This was

initiated on the advice of the dietitian in the

hospital from which the patient was discharged

once an FP10/GP10 prescription had been re-

ceived from the patient's GP.

Clinical care was provided on a fragmented and

ad hoc basis by community nurses and GPs.

Experience was limited because most practices

have only one or two patients and this was com-

pounded by many GPs having little knowledge of

nutrition whilst recognizing that they would

bene®t from training on the subject (MORI Poll,

1998). This was, clearly, suboptimal service pro-

vision with associated clinical risks and was a

concern for all the staff involved.

An opportunity arose in 1996 to review this and

identify a different approach (Liddell, 1994, 1995).

The key factor was the ability to effect virement of

funding from primary to secondary care (cir-

cumventing the use of FP10/GP10 prescriptions),

thereby enabling similar economies of scale to be

realized in the community as were already avail-

able in the hospital. It was, of course, fundamental

that Avon Health Authority were committed to

reinvesting any cost savings in the provision of an

improved HETF service.

This change in ®nancial arrangements has

facilitated the local development of a patient

centred service in which:

· all supplies are delivered by a commercial

HETF service directly to the patient's home at a

previously agreed date and time;

· all patients, and also their carers/nurses, are fully

trained in the use of the equipment by compet-

ent specialist nurses provided by the service;

· there are identi®ed arrangements for `trouble-

shooting' problems;

· GPs and community staff are no longer

responsible for a nutritional service about

which they, usually, have little knowledge.

The scheme has now been running successfully

for 3 years. During this time a number of organ-

izational issues have been revisited to make sure

that there is continuing, safe service provision. The

most signi®cant of these centre around using an

alternative to FP10/GP10 prescriptions, now highly

important in the context of clinical governance.

Other issues are also important but, generally,

in an organizational rather than a clinical frame-

work and these are summarized in Table 2.

Home enteral tube feeding 5


Patient safety

This is paramount when any new approach to care

is considered. In Avon, we have identi®ed several

important aspects.

Arrangements to ensure clinical competence ±

having a centrally managed service means that

expertise is now concentrated within a small

number of professionals (2.5 wte senior dietitians

employed by the trust managing the service and

3.0 wte nutrition nurse specialists employed by

the service provider). Caseload size is such that

experience is quickly acquired and expertise

attained. However, it is essential that this is aug-

mented by a formal programme of continuing

professional development to ensure that practice

remains up to date. Achievement of this is more

dif®cult in the absence of a centralized service.

Scope of service provision ± traditionally a

community-based nutrition support service

includes the GP, the community nurse and, per-

haps, a dietitian. There is the same need for a

co-ordinated approach to nutritional support

provision for patients at home as there is in hos-

pital (Elia, 1994; ASPEN, 1999; Lennard-Jones,

1999). Co-ordinated arrangements around the

discharge process are particularly important

(Mensforth & Spalding, 1998).

Product usage ± nutritional solutions may only

be prescribed by a GP if they are `listed' by the

Advisory Committee on Borderline Substances

(ACBS). This is not the case when feeds are pur-

chased in secondary care. It is important to ensure

that ACBS listing is identi®ed as a criterion in the

contract speci®cation to prevent inappropriate

products being used. This will minimize the like-

lihood of solutions being provided by nonspe-

cialist suppliers or being imported from countries

where stringent quality controls and clinical trials

are not mandatory.

However, removing the requirement to use

ACBS listed products could result in the ability to

use new products sooner, perhaps before clinical

trial data are available. In such a situation it would

be necessary for the supplier to satisfy the pur-

chasing trust that products provided for patient

use are appropriately indemni®ed. A safeguard

may be to involve the NHS Purchasing and Sup-

plies Agency at an early stage in the contracting

process.

Drug nutrient interactions ± the community

pharmacist is well-placed to identify potential

risks, although the responsibility for this rests with

the GP. In reality, this may or may not happen. If

the FP10/GP10 route is not used, it is important

that arrangements are in place to ensure that the

responsibility for potential adverse reactions is

clearly identi®ed so that appropriate action can be

taken. Examples of potential reactions could

include concurrent prescriptions for antibiotics,

anticonvulsants, opiates and anticoagulants

(Strom & Miller, 1990; Gilbar & Kam, 1997;

LourencËo, 2000).

Clinical responsibility

Problem solving ± responsibility for this must be

clearly identi®ed so that the patient knows who to

contact when there are any feeding-related dif®-

culties. Typically these fall into three categories:

Table 2 Issues to be addressed when considering HETFprovision òff FP10'

Essential Important

Patient safetyArrangements to ensureclinical competence

4

Scope of service provision 4

Product usage ± indemnity 4

Drug±nutrient interactions 4

Clinical responsibility 4

Problem solving 4

Indemnity 4

Medical supervision 4

Duty of care 4

Financial issuesReinvestment of savings 4

Primary care led services 4

Budget management 4

Realistic service costs 4

Contracting process 4

Future funding 4

Long-term implications 4

VAT arrangements 4

Community Pharmacists 4

Organizational arrangementsData collection 4

NHS changes 4



equipment related ± for instance a malfunctioning

pump; tube/solution related ± such as a blockage,

adaptor breakage or volume of delivery/presenta-

tion; other such as hydration or an urgent need for

tube replacement.

Arrangements must be in place to ensure that the

patient's needs are met appropriately by suitably

quali®ed personnel. This can have signi®cant im-

plications for dietetic as well as nursing resources.

Indemnity ± this must be clearly addressed so

that arrangements can be clari®ed and agreed.

This must be done at two levels; at the level of the

individual practitioner and at the level of the

management or `host' trust.

Dietitians are, in effect, `dependent prescribers'

(Crown, 1999). This means that competent dieti-

tians can only prescribe identi®ed products in

speci®c circumstances according to agreed proto-

cols (Council for Professions Supplementary to

Medicine, 1996; General Medical Council, 1998).

Such protocols have to be agreed by both the Trust

Board (speci®cally the Medical Director) and the

Trust Solicitors/Insurers. Protocols should be

reconsidered at predetermined intervals but new

legislation should prompt a more fundamental

review. Individual dietitians should check that any

proposed changes in local practice are covered by

their professional insurance through the British

Dietetic Association. This includes the manage-

ment of invasive procedures, such as balloon

gastrostomy replacement and phlebotomy, as well

as prescribing responsibilities.

Medical Supervision ± new European legislation

states that enteral tube feeding solutions, together

with sip feeds and supplements, must be used

under medical supervision. This supervision `may

be applied with the assistance of other competent

health professionals' (European Commission,

1999). Clearly, enteral tube feeds which are not

prescribed under the FP10/GP10 process are not

being used under medical supervision unless an

agreed protocol is in place which preserves the

continuing involvement of a patient's GP or hos-

pital consultant and goes beyond mere delegation

to a dietitian.

Unfortunately, the new legislation does not

de®ne `medical supervision' and, in the absence of

clear guidelines on the issue, it would be prudent

to adopt the recommendation made in the Crown

Report that dependent prescribers practice within

an agreed assessment and treatment plan (Crown,

1999). To conform with both the spirit and the letter

of the legal requirement for medical supervision,

such a plan should also encompass a review process

by a medical practitioner at agreed intervals.

Duty of Care ± the term `Duty of Care' describes

the legal, ethical and clinical responsibilities of

clinical care (Boyd et al., 1997; Montgomery, 1997;

General Medical Council, 1998,). There is no formal

de®nition of this because the concept is enshrined

in case law and each situation is considered on an

individual basis (British Medical Association, per-

sonal communication 2000). Traditionally, duty of

care falls within the medical domain, although there

are examples of the use of other models, for instance

in mental health. In essence, once a doctor accepts

duty of care, the patient can expect to be medically

treated in a safe and appropriate manner. This

includes clinical diagnosis, drug prescription and

clinical monitoring.

In the new context of medical supervision, GPs

and hospital consultants will need to preserve duty

of care even if dietitians are responsible for initi-

ating and maintaining HETF.

If prescribing responsibility changes, all parties

must be satis®ed that the new arrangements are

explicit and that, above all, they continue to pro-

tect patients. `Competent Health Professionals'

must generate ongoing con®dence and accept full

responsibility for this aspect of their practice.

Financial issues

It is important that estimates of any savings that

may be created by the viring of funding from

primary to secondary care are produced by

healthcare professionals and managers who have

access to factual information. Any rationale for

change should be evidence-based and an audit

may be necessary to understand and clarify

current practice, particularly when Trusts have

merged. The over-riding objective must be to

deliver an improvement in the quality of care.

Reinvestment of savings ± most health author-

ities face increasing resource pressures and may



wish to invest any savings from new HETF

arrangements in other areas. This is likely to result

in an HETF service which will not be viable and

where there will be reduced patient facilities cou-

pled with even greater clinical risks. Obviously this

must be avoided and a commitment to reinvest

any savings in the new HETF arrangement should

be agreed.

Primary care led services ± the emergence of

primary care organizations within `the new NHS'

involves the transfer of responsibility and associ-

ated funding from secondary into primary care

(Department of Health, 1997). In the current

climate, some GPs may be reluctant to support an

initiative which reverses this.

Budget management ± arrangements for this

must be clear and any constraints, such as the

ability to overspend and reporting requirements,

should be agreed and the implications fully

understood. The local ®nance department should

be involved in discussions about setting up the

service and there should be a named contact.

Realistic service costs ± At present most enteral

feeding companies provide some level of home

care service but there is no explicit cost attached

to this. Such services are expensive (Russell, 2000)

but are generally regarded as part of the cost of the

product. If new arrangements are introduced,

every aspect of an HETF service needs to be

recognized and Table 3 provides a checklist.

Contracting process ± this is complex and

important aspects can, all too easily, be over-

looked. Guidance about contracting is available

from the NHS Purchasing & Supply Agency

(1999). Many contracts will need to be let

throughout the European Community using the

OJEC process. The constraints introduced by this

process must be understood.

Future funding ± This is an important issue due

to the increasing trend in HETF (Elia, 1997, 1998,

1999, 2000; Elia et al., 2000). In addition to the

factors mentioned earlier which have stimulated

the growth of HETF, a high-pro®le, effective ser-

vice is itself likely to attract more patients.

Arrangements must be in place from the outset to

ensure adequate funding for future years once the

initial ®nancial agreements have been superseded.

This will prevent `crisis' management when the

originally negotiated limits are reached. These

should incorporate allowances for increases in

manpower, including clerical support and `value

added' extras such as training and in¯ation.

Table 3 Costing a home enteral tube feeding service

Many different aspects must be considered when calculatingthe full cost of such a service. These include

1 Feeding solutions and delivery equipmentsolutions (including any òff contract' requirements)delivery systems· giving sets· additional reservoirs· connectors· syringes· gloves· feeding tubes· lubricating jelly· pH paperdressings· tapepumps· initial supply· on-going maintenance· replacement2 Clinical supportdietitians and/or nurses: salaries· travel costs· out-of-hours service costs· study leave· cover for annual/sick leave· uniformsinterview costs3 Clerical supportsecretaries: salaries· cover for leaveinterview costs4 Accommodation/resourcesof®ce spaceof®ce furniturecommunication facilities· telephone ± rental/calls· fax· e-mail· mobile ± rental/calls· bleep5 Information managementcomputer(s)/printer(s)appropriate software with Internet linkfacility for recording activity6 Delivery arrangementsstorage of stockdispensing facilitiesdelivery: transport costsdriver costsuplift of unused stockemergency deliveries7 Miscellaneousresource development



Long-term implications ± although an HETF

scheme can generate savings, these should be

reinvested, as described above. This means that,

overall, any new arrangements should be `cost

neutral' in terms of NHS funding. The need to

identify the clinical governance bene®ts, as well as

®nancial governance arrangements, is essential.

VAT ± Value Added Tax is linked to FP10/GP10

prescriptions but, if this route is not used, VAT

exemption is permitted provided that an alter-

native system is in place which satis®es Customs

and Excise in terms of VAT exemption (HM

Customs and Excise Business Advice Centre ±

personal communication). Essentially, three con-

ditions must be met:

· the patient must be living in their own home

and not in a nursing home or other institution;

· there must be a system of alternative `prescrip-

tion' to identify the patient and the treatment;

· the prescription must be dispensed by a qual-

i®ed pharmacist.

It should also be noted that these regulations

currently apply only to the feeding solutions,

feeding tubes and giving sets and that they are

applied on an individual basis to each enteral

feeding company. In the event of one company

supplying products from another company, the

VAT ruling pertaining to the primary supplier will

apply. National regulations are ambiguous and

local Customs and Excise Of®cers may interpret

them differently ± this should be checked.

Community Pharmacists ± if enteral feeds are

purchased outside the FP10/GP10 route, commu-

nity pharmacists will be denied any involvement

as members of the wider primary care team. This

can include advice to patients/carers as well as, in

some cases, facilitating home deliveries. They will

also forfeit any income from prescription fees so it

is important that they are included in any

discussions about new arrangements for HETF.

Organizational arrangements

Data collection ± As already pointed out, HETF is an

area of care provision which is expanding rapidly

(Elia, 1997, 1998, 1999, 2000; Elia et al., 2000). The

ability to ensure future funding to match growth

needs to be based on the extrapolation of current

data. This is automatically collected through

Prescribing and Cost Trends Data (PACT), which

is dependent on FP10/GP10 prescriptions. If an

alternative route is used, arrangements must be

made to ensure that important data continue to be

available at national level (Elia, 2000). One way of

capturing information on patient numbers,

although not yet on the type or cost of feed, is by

registering with the British Arti®cial Nutrition

Survey (BANS). Further information on BANS is

available in the Appendix. It is possible that such

registration could become a mandatory require-

ment.

NHS Changes ± these are a continuing aspect of

healthcare provision and will impact on any

ìnterface' service developments. There are three

important themes in the current proposals.

Graduated Care: this model emphasizes the

need to use acute hospital beds ef®ciently and is

leading to earlier discharge on a rehabilitative

basis. Changing patient demography is resulting in

more elderly patients being discharged more

quickly ± and this is the group where the largest

proportion of HETF is undertaken (Elia, 1997,

1998, 1999, 2000; Elia et al., 2000).

Primary Care Trusts: there is concern that this

development may lead to fragmented service

delivery although there is, at present, little evi-

dence to support this. As discussed earlier, HETF

services are more effective when there are larger

numbers of patients. One trust, however, could act

on an àgency' basis for others in providing HETF.

Community Dietitians: there may be implica-

tions for those who are employed in the commu-

nity and who manage patients on HETF.

Conclusion

Clearly, a range of issues need to be reviewed by

any health authority contemplating the removal of

enteral feeds from FP10/GP10 as their preferred

option for improving the quality of care for pa-

tients on HETF. Some of these are fundamental

and failure to consider them adequately could

have serious consequences. In addition to this,



experience has shown that effective implementa-

tion of an HETF service which does not utilize the

FP10/GP10 route requires careful planning over

many months. Finally, HETF is, obviously, only

one of several treatments provided in the com-

munity ± the issues and questions considered here

may also be appropriate in other contexts.

Acknowledgment

We would like to thank Mrs G. Williams for typing

the manuscript.

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Appendix

British Arti®cial Nutrition Survey (BANS) was

established in 1996 to record information regard-

ing patients receiving home arti®cial nutrition

support. In addition, BANS collects data on the

organization and provision of nutritional support

services in both hospital and community settings.

BANS is an initiative of the British Association of

Parenteral and Enteral Nutrition (BAPEN) and is

the largest ongoing survey of its kind in the world.

Aims of BANS

The aim is to audit and research nutritional care in

hospitals and in the community in order to

improve the quality of nutritional support for

patients at risk of disease-related malnutrition.

BANS data are therefore needed to:

· Monitor at a national level the growth of arti-

®cial nutritional support in hospitals and in the

community.

· Track treatment outcomes, especially in

patients receiving home arti®cial nutrition.

· Establish the structure of nutrition support

services operating within British hospitals and

in the community.

· Identify the problems associated with the use

(or lack of use) of arti®cial nutritional support

in hospital and the community.

· Assess whether standards of care are adequately

met and provide a framework for improvement

when standards are not met.

Bene®ts of BANS

Through regular feedback of information, the

registering centres may obtain the following

bene®ts:

· Useful management information essential for

establishing funding arrangements.

· A comparison between the local operative

framework of nutrition support services and

that set in national guidelines. This information

can help identify areas that may need improve-

ment.

· Use of the BANS forms for direct comparison of

local and regional audits, e.g. do the local

nutrition support services and the types of

patients treated by these services re¯ect the

national scene?

Trusts may, already, be registered with BANS.

This can usually be ascertained by contacting the

Head of Nutrition and Dietetic Services or the

Nutrition Nurse Specialist.

If the Trust is not registered, information about

doing this is available from

BANS, c/o Streets Heaver Healthcare Computing

FREEPOST

4 Low Moor Road

Lincoln LN6 3BR

Tel.: 01522 872000

Fax: 01522 872255



Documents

The challenges of innovation in the organization of home enteral tube feeding