The design and development of a complex multifactorial falls assessment intervention for falls prevention: The Prevention of Falls Injury Trial (PreFIT)

A comprehensive falls history interview is undertaken with every participant invited for assessment. The purpose of a falls history interview is to identify any predisposing factors leading to a fall, to explore context and consequences of any previous falls or near misses to provide clues about causation. The PreFIT assessor is trained in systematic enquiry about falls, including symptoms and contextual factors before, during and after any fall-related ‘event’ including trips and stumbles. Taking a good falls history is an important skill which can be honed over time although there is no single question or validated algorithm to follow. Clinical guidelines do recommend that detailed falls history interviews should be undertaken [16, 21], however we found no templates or guidance for the types of questions to include. We therefore generated a template list of PreFIT prompt questions based upon observations of experienced clinical staff conducting during falls interviews with hospitalised older adults. The prompt questions were produced as an easy-to-use laminate for PreFIT assessors (Table 3). The aim of a falls history interview is to identify intrinsic risk factors, relevant activities and environmental challenges, any of which may be amenable to modification. Participants may have a combination or mosaic of risk characteristics, which requires careful exploration and the ability to link different risk factors e.g. visual problems leading to repeated trips and stumbles within the home. “Red flags” are warning signs that referral to a GP or medical specialist is warranted e.g. cardiac abnormalities, history of syncope, evidence of seizure activity such as aura or tongue biting etc.

The Timed Up-and-Go (TUGT) was developed as a basic test for functional mobility [22]. It consists of observation and measurement of the time taken for participants to stand up from a standard chair with arms of seat height 40-50 cm, walk forwards a distance of three metres at a normal walking pace, turn and walk back to sit down to the original sitting position. Time taken is recorded in seconds. Participants can push off using the chair arms if they need to [23]. Shoes are worn and the person’s usual walking aid can be used during the test. The exact distance is measured and marked on the floor using tape. Assessors are trained to observe for any gait-related problems on entry to the assessment room and during the TUGT. Observations are made whilst the participant is standing and walking e.g. noting stride length, foot clearance, veering to one side, grabbing or lunging for room furniture. A 14-s cut-point on the TUGT is predictive of falls in community-dwelling, frail older adults [23], therefore this threshold is used to generate onward referral to PreFIT physiotherapy for strength and balance retraining (the Otago Exercise Programme). For the purpose of the trial, we defined deficits as taking longer than 14 s on the TUGT, evidence of gait or balance problems or fear of falling (identified during the falls history interview).

A standard definition for postural hypotension, agreed by a multidisciplinary consensus conference [24] is used: “postural or orthostatic hypotension, defined as a sustained reduction of systolic blood pressure of at least 20 mmHg or a drop in systolic blood pressure to below 100 mmHg, or a reduction of diastolic blood pressure of 10 mmHg within 3 min of standing”. PreFIT participants are screened by asking if they ever feel dizzy or light-headed if they stand up too quickly or first thing in the morning getting out of bed (Table 2). Lying and standing blood pressure is taken on all trial participants, regardless of history of dizziness, using a calibrated manual or electronic sphygmomanometer. The radial pulse is taken for 1 min and electrocardiogram (ECG) taken if the participant has an irregular pulse, bradycardia or tachycardia. Participants are asked to report the presence of dizziness or light-headedness during the standing phase. Symptomatic patients only are given a PreFIT postural hypotension leaflet that provides advice about changing position, fluid intake, tightening calves when getting up from a lying position etc. Onward referral is made to the GP or consultant-led falls clinic if any cardiac problem is suspected (Table 2).

Polypharmacy is very common in older adults [7]. The UK Department of Health defines a medication review as “a structured, critical examination of a patient’s medicines with the objective of reaching an agreement with the patient about treatment, optimising the impact of medicines, minimising the number of medication related problems and reducing waste” [25]. This policy document described different levels of medication review (Level 0 to Level 3), relating to intensity of review, skill of assessor and whether or not conducted in the presence of the patient.

High-risk or ‘culprit’ medications that may contribute to risk of falls include drugs targeting the central nervous system, such as the psychotropics, benzodiazepines, antidepressants antipsychotics [26]. Other drugs, although the evidence base for the causal relationship with falls is slightly weaker, include antiepileptics, antiarrhythmics, urinary anti-cholinergics and alpha-blockers [26, 27]. For PreFIT, two types of medication reviews are conducted; firstly, a visual medication screen of all prescribed drugs combined with a face-to-face discussion with the patient about the use of prescribed and over the counter drugs (DoH Level 1). This initial screen searches for specific classes of high-risk medications based on a PreFIT listing of (a) psychotropics and (b) culprit medications (Table 2). Data are also recorded on prescribed bisphosphonate drugs. Psychotropic medications include any antidepressant, psychotropic, sedative/anxiolytic or antimania drugs. Any “culprit” medication includes antihypertensives, antiarrhythmics, diuretics, vestibular suppressants, analgesics, anticonvulsants, anti-Parkinsonians or vasodilators. Any patient prescribed one or more of these drugs is then referred for a Level 3 comprehensive GP-led clinical medication review [25]. This involves a separate appointment between the patient and GP, either face to face or by telephone if any medication revision is considered minor. One or more nominated GPs from each practice are given brief training on high-risk medications and how to conduct a falls-related medication review.

Impaired visual acuity (sharpness or fine detail of vision), has been identified as a risk factor for falls in some, but not all, studies of older adults. The UK NICE concluded that there was insufficient evidence that single interventions targeting vision impairment alone were effective, but that referral for visual correction within a multifactorial intervention could contribute to falls reduction [8]. Bifocal glasses can add to the risk of falls because near-vision lenses impair distance vision and affect depth perception, affecting the ability of an older person to detect environmental hazards [28]. The wearing of multifocal/bifocal glasses should be restricted in older adults prone to falls. Given this evidence, we included a simple visual acuity screener using a standard 3-m Snellen chart test [29]. For PreFIT, the Snellen chart screening tool is used in conjunction with questions about last eye check, any changes in eyesight or any visual problems. Participants are asked to bring their spectacles to the appointment - distance vision glasses can be worn during the sight test. The person can stand or sit three metres from the chart; the distance is clearly marked on the floor using tape. Any visual screening test scoring less than 6/6 on either eye requires referral to an optician for a full eye test. Eye tests are free in the UK for anyone aged 70 years and older. PreFIT participants are therefore encouraged to attend their one free eye check per annum.

Up to a third of older people suffer from foot problems, such as foot pain, toe deformity, weakness or restricted range of motion [30, 31]. These problems are common reasons for attending primary care services. Other UK surveys suggest that the main foot conditions affecting older people requiring core podiatry include nail problems, corns, calluses and toe deformities [32]. PreFIT participants are screened for any foot problems including pain, numbness, diabetes and regular attendance at chiropody/podiatry. A visual examination is made to check for bunions, hammertoes, calluses or nails that may cause pain or gait disturbances. Tests are undertaken for proprioception (big toe positioning with eyes closed) and sensation, by brushing a cotton wool ball lightly across both feet (with the sternum used as normative reference). Assessment of footwear is undertaken and advice is given on proper fitting shoes e.g. wide fitting, low heel height, slightly bevelled heel, good supportive heel-collar, a thin firm midsole to allow sensory input and slip resistant sole [33].

UK NICE guidance reports on different studies of domestic hazards, home hazard modification and safety interventions but concluded that in older adults without a history of falls in the previous year, there was no evidence of effectiveness [1, 8]. There is one good quality trial demonstrating that home hazard assessment with a supervised modification programme is effective in reducing falls in those discharged from hospital [34, 17]. The evidence suggests that home hazard removal and advice about functional activities is most effective in reducing falls in individuals with visual impairment [9]. It is not a prerequisite that a home assessment is conducted for every PreFIT participant, but if there are concerns about the home environment or safety whilst performing activities, or if suspicions are raised during the falls interview e.g. someone reporting repeated trips or stumbles at home. Onward referral is then made to occupational therapy or social services. In some instances, UK social services can cover the cost of home adaptations or equipment. Screening questions include asking about the use of furniture whilst walking, difficulty getting out of a chair or rising from the toilet, any stairs or steps at home, coping with stairs, use of walking aids. A PreFIT Home Safety Tip Sheet is given to anyone who may benefit from simple advice on home safety.

A detailed PreFIT Intervention Manual was given to every member of staff responsible for MFFP assessment. This comprehensive 115-page manual describes the scientific rationale and evidence-base for each risk factor, trial process and procedures, with flowcharts for treatment pathways for onward referral. Laminated easy-to-use instruction sheets were produced e.g. how to conduct the TUGT, vision check etc. Figure 2 is an example of a quick reference guide to the PreFIT falls assessment. Healthcare staff participating in the MFFP intervention received a 5-h structured training session in how to conduct the PreFIT falls assessment. Training was delivered during regular working hours, with time approved by relevant employers. Staff training could take place at any suitable location, such as a GP surgery, community venue or hospital setting, depending upon availability. Staff ranged from experienced falls team personnel (medical doctors, nurses, occupational therapists or physiotherapists) to general practice staff e.g. advanced nurse practitioners/practice nurses. Staff were required to have either a nursing or an allied healthcare background with professional registration. A medical geriatrician (RS/KW/SR) and senior researcher from the trial team provided training (JB). Additional training on ‘how to conduct a falls-related medication review’ was undertaken with one or more nominated GPs from each participating general practice. Modest reimbursement was given to practices willing to undertake PreFIT MFFP assessments, as per excess treatment costs agreed and approved by the funder.

A pilot study was undertaken to determine acceptability of the MFFP intervention to participants and clinicians, and to assess the feasibility of delivering the intervention in the NHS setting. A number of clinical teams and primary care staff from different regions had expressed interest in the trial, however staff from the Devon Region had the capacity to support the pilot study and support training of primary care staff. Twelve general practices in Devon were identified with support from the Comprehensive Local Research Network (now Clinical Research Networks) and regulatory approvals were obtained. Participant recruitment ran from July 2010 to March 2012. A total of 1801 participants were recruited from the 12 practices, of which four practices were randomised to deliver the MFFP intervention. Completed balance screeners were received from 492/575 (86%) participants within these four practices. Of responding participants, 190 were eligible for MFFP falls assessment. Findings from the balance screener revealed that n = 55 (29%) had fallen more than once in the previous year, n = 111 (58%) reported a single fall with or without balance problems, and n = 24 (13%) reported balance problems only. Of the 190 participants invited for assessment, 148 attended (78%). The draft MFFP intervention was administered to participants within one general practice; after minor revisions and improvements to data collection forms, the modified intervention was then rolled out to the remaining three practices. After external independent review of pilot study data and approval from the funder, the main trial was launched. Full data on assessments and effectiveness of interventions will be reported in the main trial results. A pragmatic approach was taken to ensure that MFFP delivery was matched to fit with usual NHS practice for each region (either primary or secondary care-led).

Throughout the pilot study, regular contact was maintained with healthcare staff to provide clinical and research support. Quality control visits were undertaken with every trained healthcare professional within a short period after training (Table 1). The independent quality control monitor observed at least one falls assessment to assess whether the healthcare professional conducted the MFFP assessment and followed the referral pathway according to protocol. A five-page quality control assessment form was completed for each visit to record issues relating to room set up, risk factor assessment, conduct of tests and onward referrals (Table 1, Intervention Fidelity). A password-protected online forum was created to allow healthcare professionals to post comments or share experiences with the research team.