Striving to recruit: the difficulties of conducting clinical research on elderly care home residents

Elderly care home residents are a distinct group of over 440 000 people in over 18 000 homes in England. 1 Their mortality, 2 health status and needs 3,4 are different from those of people of the same age living in their own homes.Indeed, their physical and/or mental frailty and multiple pathology is usually the reason why they live in a residential setting.They are so different in almost every way from people of the same age in their own homes that research outcomes on the latter are simply not valid for them and it is important to conduct research specifically on care home residents.Conducting research on care home residents is beset with constraints and complexities that can impair progress.Careful planning and an extraordinary amount of time and resources are needed to overcome them.We recently completed a large randomized controlled trial of clinical medication review by a pharmacist of elderly residents of care homes.5 In the process we encountered and struggled with many these problems.We hope that, by highlighting the issues and pitfalls, we can help future researchers plan projects involving care home residents. SAMPLING AND CONSENTA representative population requires sampling a large number of homes.Care homes vary in size, in our study from those with only six residents to one with over 200.They are unevenly distributed geographically.Some are purely nursing, some residential and some mixed.They vary in management type from large national groups like BUPA, through local authority owned, to individually owned and run.There is little evidence as to how these differences affect either the care of residents or their therapeutic needs.It is therefore important in designing a study to include multiple homes and consider stratifying by type and size.Unfortunately this increases sample size and the overall cost and workload of the project.The larger the number of homes studied, the greater the organizational and logistical workload.A large number of participants in one home, on the other hand, creates economies of scale but undermines external validity.Cluster randomization would assume a degree of uniformity between homes of the same type/size that cannot be justified.Any clinical study of care home residents needs three 'layers' of cooperation.This is because the collaboration of the home and each resident's doctor is required as well as the consent of the resident.It is unusual for all residents of a home to share the same doctor or even practice.The agreement of several doctors may be needed for one home.Whilst it can be argued that refusal to participate by a care manager or the doctor for a consented patient is an infringement of the patient's rights, in reality it would be impossible to conduct research without their active involvement.It is impossible and impolitic to work with residents without the collaboration of the manager and care staff.Identifying residents and gaining access to them requires their involvement.In the case of residents with cognitive or communication difficulties, care staff will help explain the project to the resident, and be on hand at interview.In homes belonging to larger organizations, the researcher may need approval from a more senior manager.Seeking agreement of the home manager is seldom achievable just by letter.They need to understand the project and the implications for their residents (for whom they have a quasiparental responsibility).They must be satisfied with the researcher's credentials and understand what is required of themselves and their staff.They may need an incentive to participate, which might be a fee for their time, or perhaps a benefit for the residents or the home itself.In our project we reviewed the medication of intervention patients.Many home managers saw this as valuable and agreed to participate for this reason.To achieve this level of understanding requires a personal approach, and a face-toface meeting is useful.It is essential to discover whether each resident can give informed consent.For those who cannot give informed consent, Department of Health guidance 6 states that assent should be sought, usually from a near relative.The Local Ethics Committee must be satisfied that the exclusion of people with cognitive impairment would be to the disadvantage of people with cognitive impairment generally, and that participants would not be 'exposed to tangible