Research studies funded by the NIHR or one of its research partners may be eligible to be considered for inclusion on the NIHR Clinical Research Network (CRN) portfolio. Inclusion on the portfolio does not automatically lead to an entitlement to NHS Clinical Network Service Support. Studies funded by the NIHR are automatically eligible, to be considered, for inclusion on to the CRN portfolio, however they must still meet the eligibility criteria, and that includes a requirement to involve the NHS.
To be included on the CRN portfolio, and to receive network support from the NIHR CRN and full support from the ENRICH Research Ready Care Home Network, the study has to meet the criteria set out in the document Eligibility Criteria for NIHR Clinical Research Network Support.
Through the NIHR ENRICH Research Ready Care Home network some ‘pre-application' support is available to help input to feasibility, and ensure future studies are well designed and able to work within the care home setting. This improves future ‘deliverability’. For further information contact your local network or email email@example.com. The study must also involve activities that are classified as ‘support’ activities as defined by the Department of Health (see AcoRD).
- Recruitment of NHS patients in an NHS ward, clinic or GP surgery, by staff employed by the NHS, would qualify as a NHS support activity as would reviewing NHS patient records to identify appropriate people to approach for recruitment.
- Seeking consent from NHS patients residing in a care home to take part in an NHS clinical research study is a NHS support activity; who performs this function will determine how it is resourced. ‘Consenting’ care home residents to take part in a research study that does not involve the NHS is not a NHS support activity. The prevailing view is that it is a research cost, which needs to be confirmed with the research funders. However, this is a complex issue – it is not always easy to work out who is funding a care home resident and this can often not be known until someone is recruited to the study and has given consent for information of this kind to be accessed.
It is important to remember that NHS Clinical Network Service Support activities are defined as additional patient care activities that end once the study ends. If residents in care homes require additional NHS patient care as a result of taking part in an NHS clinical research study, the costs of that additional NHS care will need to be met by the NHS either through NHS Clinical Network funding or through normal commissioning arrangements, depending on how the cost is attributed. If the additional care provided to care home residents as a result of participating in a study were to become standard and the cost of the care would not be met directly by the NHS, the cost of the activity during the study cannot be defined as a NHS cost.
Where researchers request care home staff to undertake some form of research related activity, it is important to agree in advance if and how this work will be compensated. Ideally this should take place in the study development phase to allow those costs to be accounted and planned for. If staff time is to be paid, researchers should enquire with the individual care homes what the likely charges / rates will be, as this may vary across the country.
Below are two examples to act as a guide to what is and is not eligible for service support:
- A research team at a University has developed an online training tool aimed at improving the quality of care provided by care home staff for people with dementia in care homes.
- A study of the tool’s effectiveness compared with existing training has been funded by the NIHR Health Technology Assessment (HTA) programme. The hypothesis is that the new training tool will improve care in care homes, improve quality of life for people with dementia living in care homes, reduce use of antipsychotic medication and reduce admissions to acute hospitals and other NHS inpatient facilities.
- The study will recruit both people with dementia and the care home staff providing their care, and randomise them to two groups in which the staff either receive training with the new tool or continue with normal training.
- Staff and residents will be identified by care home managers using care home records. Participants’ consent will be sought by the University research team, who will also provide the training and collect the research data.
Q. Is the study on the NIHR CRN Portfolio?
Yes. It meets the criteria set out.
Q. Which elements of this study are eligible for NHS support costs through the Clinical Research Network?
None. Although the study is on the portfolio, there are no elements that are classified as NHS Support as defined by the DH (see AcoRD).
Q. Why isn’t the identification of patients for NIHR Portfolio research a NHS support activity?
Recruitment of NHS patients in an NHS ward, clinic or GP surgery by staff employed by the NHS would qualify as a NHS Service Support activity as would reviewing NHS patient records to identify appropriate people to approach for recruitment. Reviewing care home data to identify staff or residents who could take part in a study would not be classified as an NHS Service Support cost as it does not involve the NHS.
- Research published in Italy suggests that nutrition may play an important role in reducing the use of antipsychotic medication in people with dementia. The NIHR PGfAR programme has funded a programme to investigate this further in care home settings in the UK.
- The last part of this programme is a large randomised control trial involving people with dementia living in care homes. Participants will be randomised in one of two groups: to receive a particular food supplement or a placebo. The hypothesis is that there will be a reduced use of antipsychotic medication and reduced hospital admissions in people receiving the supplement.
- The inclusion criteria require that participants have a diagnosis of dementia and are receiving an acetylcholine inhibitor (ACI). During the study period participants will have their blood pressure monitored regularly by care home staff as a safety precaution as the extent of any interaction between the supplement and the ACI is not fully understood in this patient group.
- Participants will be identified by screening the NHS records of people with dementia living in care homes. Participants will be ‘consented’ by the registered nurses in the care homes who will be trained to explain the study to the participants and their carers. Where the family/carer have POA it is possible that the consenting will be done by them. The intervention/placebo will be given as a powder added to a hot drink once a day. Blood pressure monitoring will be done by a member of the care home team.
Q. Who should pick up the cost of identifying patients?
As the identification is being done by reviewing NHS records this is an NHS service support activity that should be met by the NIHR Clinical Research Network, provided the activity is being performed by staff employed by the NHS
Q. What if the patients were being identified by care home managers screening care home records, for example if the inclusion criteria were patients with behavioural problems?
This would not be a NHS service support activity as it is being carried out by care home staff using care home records.
Q. The participants’ consent will be sought in the care home, so is this a cost that the care home needs to meet?
No. These NHS patients are being consented to participate in a NHS Clinical Research study that involves an intervention that would, if adopted as normal care, be funded by the NHS. Registered nursing care for some people living in care homes is directly funded by the NHS through the Registered Nurse Care Contribution (RNCC) therefore this is an eligible NHS Service Support activity if performed by staff employed by the NHS.
Q. What about the additional blood pressure monitoring? This is being done by care home staff but is required by the GP for patient safety. Is this an NHS cost?
Yes, as this is an activity funded by the NHS through the Registered Nursing Care Contribution (RNCC) although carried out by care home staff. This is an NHS support cost because the activity relates to patient care but would stop when the research stops even if the intervention continued. If the blood pressure measurement was required routinely, or if the intervention was to become normal practice, then it would be an NHS treatment cost and have to be met by the normal commissioning systems. However, it is not possible for service support costs to be transferred to the care home provider, funding could be sought in the grant application or NHS staff could deliver the service, but this may not be practicable depending on the frequency of the monitoring.
Q. Who should pay for the intervention – the food supplement?
This is an NHS treatment (or excess treatment) cost as dietary supplements for people living in care homes are typically funded through GPs.
"From the pilot phase of the Newcastle 85+ study, it became very obvious that additional funding, in terms of researcher time, was needed to recruit people from care homes above that needed for community recruitment from other sources. Additional layers of stakeholder discussion and negotiation were needed and this has also been accounted for in our recent MRC application for a follow-on programme grant".
Louise Robinson, University of Newcastle
The rules governing support costs are complex. We encourage researchers planning studies in care homes to discuss their costs with their local Research Development Service, or with their local Clinical Research Network, at an early stage.