Research studies cannot reach their recruitment targets if they are unrealistically planned and resourced. We recommend that trials recruiting older people in the community allocate two and a half hours of researcher time per person, on average, for consent, baseline data collection, travel and administration. While the majority of our home visits proceeded as planned and lasted roughly the expected duration, some visits did take longer. This cannot always be predicted and is hard to plan for. However, it should at least be acknowledged in the planning of community-based trials, and accommodated within targets and timescales where possible.
We acknowledge that a variety of different factors will mean that researcher activity will vary between different community-based trials. Our findings give a good starting point for timing calculations to be based upon.
Travel was one of the major factors impacting our total recruitment time and varied considerably even though our recruitment area was limited to two relatively small conurbations in West Yorkshire. Studies recruiting in rural settings or with large catchment areas would have to allocate more time for travelling to and from home visits.
Our baseline data collection was from a clinical trial that included six commonly used assessment measures, alongside demographic information and health and social care resource use data. Although this is likely to be reasonably representative of community-based clinical trials involving older people, baseline data collection depends on the number and type of measures that are included in a trial’s CRF. Careful preparation and role playing early in the planning of the study, ideally with volunteers who are representative of the study population, should give an indication of how long this element of home visits will take.
When planning studies with older people, special consideration should be given to factors that impact on time, such as cognition, hearing and visual impairment and, in particular, the desire for social contact. Davies et al. [9] reported that the older people participating in the Newcastle 85+ Study often made comments such as ‘I look forward to your visit’ and ‘I enjoy the company’. Although only a median of 5 min per visit, we recorded miscellaneous time for every visit. This reflects, in part, the social component of conducting research in older people’s homes. Community-based researchers have to incorporate a certain, appropriate, amount of non-research time into visits, out of respect for the individuals inviting us into their homes. This additional time should not be overlooked in project planning.
Involving personal consultees for participants lacking the capacity to consent is important in research with older people, but can be time-consuming and requires careful planning [4]. A recent review found only a small proportion of clinical trials included adults lacking the capacity to consent, even in trials involving populations characterised by impaired decision-making capacity [13]. The proportion of participants requiring consultees will depend on the target population for a trial, but any research involving older people in the community is likely to encounter a lack of capacity in the sample. These people should be included wherever possible, to reduce the risk of an unrepresentative study population, and additional time for this should be factored in to study planning.
Securing personal consultee involvement made the recruitment process more time-consuming. This often required multiple visits, extra phone calls and arranging visits to fit consultees’ schedules. It is not always clear that an individual lacks capacity when an initial telephone contact is made to arrange a home visit. So, while it may not be possible for individual researchers to anticipate which visits will become extended or repeated, it should be possible for those planning and scheduling trial recruitment periods to incorporate extra time to account for this.
In areas like Bradford, many of the first-generation migrants who settled in the 1950s and 1960s and are now in later life will not be proficient in written and spoken English. Using bilingual researchers who understand the cultural norms means that Black, Asian and Minority Ethnic (BAME) participants can be included in studies, but the process is more time-consuming than with English speakers. This is especially true when dealing with languages or dialects that have no written form, when all written information has to be translated and discussed [14]. The presence at home visits of family members intending to support and/or interpret for the participant, while welcome if that provides reassurance for the participant, can also be time-consuming. Trials recruiting from diverse older populations should be planned accordingly, allowing extra time for translation.
Recruitment is not complete when the researcher leaves the participant’s home; we recorded nearly half an hour of administrative tasks for each participant following the home visit. Many of these tasks were routine but essential, for example, accurate recording of accruals to ensure project funding was appropriately released. Administration time should therefore not be overlooked.
Although visits where the person is not recruited do not involve data collection, they still entail travel and can often lengthier discussions prior to their decision about participation. We found that removing the four visits not resulting in recruitment from our median total activity time calculation had only a small effect, suggesting that the amount of time needed is similar for people who do and do not agree to participate, though we acknowledge the small numbers involved here.
Our findings are important for anyone preparing project protocols, developing funding applications and completing SoECAT forms or similar cost attribution documents for trials involving older people, particularly those with frailty. The results are also likely to be useful for researchers planning trials for wider populations with multimorbidity, who may have similar challenges to the general older population, including physical limitations, sensory impairment and cognitive impairment. An understanding of how long the elements of community-based research with older people take is vital in informing the costs associated with trials. We recommend that similar work undertaken by colleagues recruiting from other settings, such as hospital wards and care homes, and those recruiting vulnerable groups in the community, for example, people with mental health conditions or learning disabilities, would generate useful knowledge for those planning new clinical trials in these important areas.