The efficacy of a multifactorial falls-prevention programme,implemented in primary health care

Abstract

Introduction

A major threat to healthy ageing is accidental falls causing individual suffering as well as increasing costs for society. The aim of this study was to compare and evaluate a multifactorial falls-prevention programme, with ordinary falls prevention in primary healthcare.

Method

Eligible patients were community-dwelling older adults (+65) who had fallen within the last 6 months or were concerned about falling. Participants (n = 131) were randomized to an intervention or control group. The primary outcome was measure of falls and the secondary was fear of falling.

Results

There was a significant decrease in the risk of falls and fear of falling at 12 months in favour of the intervention group. When comparing groups over time, including baseline measures, only fear of falling remained significant.

Conclusion

Small-group learning environments in combination with learning by doing, could be an effective approach for the translation of knowledge into everyday life and valued activities leading to a decrease in falls and fear of falling. Multifactorial and multi-disciplinary approaches against falls in a small-group learning environment could be effective in preventing falls and reducing fear of falling among older adults at risk.

Keywords

Accidental falls health promotion multi-disciplinary occupational therapy adult learning

Introduction

The World Health Organization (WHO) (WHO, 2004) states that the encouragement of the individual’s participation and involvement in all dimensions of society should be secured. A major threat to healthy ageing is accidental falls, as falls are the second leading cause of unintentional injury or deaths worldwide. The prevalence of falls among the population of older adults varies between 20–33% (Peel, 2011). An accidental fall is defined as an event that results in a person coming to rest unintentionally on the ground or floor or other lower level (Hauer et al., 2006; Lamb et al., 2005; WHO, 2007). Falls often occur when doing everyday occupations: for example, falling from a ladder while changing a light bulb (Hägvide et al., 2013; Lord et al., 2007).

Multifactorial preventive programmes that are able to address several risk factors, for example, malnutrition, polypharmacy or home hazards, and programmes that involve several different professional groups, for instance, physiotherapists, occupational therapists or nurses, have shown efficacy in rehabilitation work (Clemson, 2010; Clemson et al., 2012; Gillespie et al., 2012). Although multifactorial falls-prevention interventions have been shown to reduce falls (Gillespie, et al., 2012), the translation of the research into practice, for example, among the clinicians in primary health care, has been limited (Close, 2005; Shubert et al., 2014). Multifactorial and multi-disciplinary programmes combined are still considered as novel in primary health care, but are important to implement and evaluate through the demand for more evidence-based practice. Considering the increase in the Western world’s ageing population, as well as the increased requirement for regionalisation of preventive care and rehabilitation from hospitals into primary health care, the ongoing work of translating research into practice is important.

Community-based care in Sweden is organized in primary health care units or centres providing non-acute care for all citizens in the community. The large majority of visitors are older adults over the age of 65 years. Clinical guidelines and policy documents have given priority to the development of prevention programmes targeting the older population and their health issues and needs.

The present study is a pilot study evaluating the programme ‘Active lifestyle all your life’, a new, standardized multifactorial, multi-disciplinary falls-prevention programme implemented in primary health care. The programme uses a small-group learning environment and peer learning to engage the participants in the programme. The uniqueness of the programme is its base in occupational science (Clark et al., 1997; Clark et al., 2001) in combination with evidence regarding prevention of falls and reduction of fear of falling. The programme targets falls prevention from a positive non-patronising and occupational-science approach including the experiences and needs of the individual as being the experts on their lives. This study defines the occupational science approach as the recognition that, despite being elderly and possibly frail, a person can continue to live an active lifestyle, participating in valued and engaging occupations. However, the individual needs to have knowledge about the risks and possibilities in order to adapt their valued occupations and their environment in their continuing life as an older person. Studies have shown that the elderly often see themselves as competent in their daily life and that advice from health care professionals can be perceived as insulting (Child et al., 2012). Continuing engagement in valued occupations is a unique approach for a falls-prevention programme, in contrast to a patronising approach that has been identified as a significant barrier to elderly participating in falls-prevention programmes (Bunn et al., 2008; Jang et al., 2015). To our knowledge, no previous falls-prevention programme, specifically based in occupational science, has been implemented and evaluated (as indicated in results from a scoping review (Leland et al., 2012)). Qualitative studies of participants’ and group leaders’ experiences of a programme have been conducted (Johansson and Jonsson, 2013; Johansson et al., 2014). Results from these studies indicated that the small-group format was recognised as a facilitator for knowledge translation and behavioural change (Johansson and Jonsson, 2013). Further, the role of the professionals was transformed from being an expert to also becoming a facilitator for change (Johansson et al., 2014). An evaluation of the programme in relation to participation and autonomy indicated a trend of increased perceived participation and a decrease in perceived difficulties in the intervention group (Johansson et al., 2015).

The aim for this present study was to evaluate the efficacy of the programme, in measures of falls and fear of falling, in comparison with control groups receiving standard care.

Method

Design

This study was a pilot randomized controlled single-blind two-armed trial (ClinicalTrials.gov Identifier: NCT01391728), which followed the design presented in CONSORT (Boutron et al., 2008).

Study participants, recruitment, randomization and blinding

Invited to participate, using convenience sampling, were community-dwelling older adults over 65 years of age, who met the inclusion criteria: one or more accidental falls during the last 6 months and/or one or more fall incidents (trip, slip or stumble) and/or reported concerns about falling, and without known cognitive impairment. Exclusion criteria were: documented psychiatric problems that make participation in organized group activities impossible and considerable difficulties in understanding and speaking the Swedish language.

After receiving informed consent and conducting baseline measures, the sample was, as a first step, randomly allocated by a blinded research assistant. Allocation was done to ensure equal sizes of the two groups at every primary health care unit, using blocks of four. Group size was set to eight in each group to facilitate the group dynamic, as this provides opportunities for learning through discussions and reflections (McKimm and Morris, 2009). Thus, a total of 16 patients were to be enrolled at each primary health care unit. However, due to lack of eligible patients in some of the primary health care units, an additional randomization procedure had to be performed. This was done by relocating some of the participants in the control groups to the intervention groups, to ensure that a group intervention was feasible. The reallocation of the patients from control to intervention group meant that the reallocated participants received the intervention directly and at the same clinic where initially recruited.

Finally, the procedure of randomization resulted in 74 in the intervention group, and 57 participants in the control group, see Figure 1. The enrolment of the participants continued between February and September 2011.

Figure 1.

The flow chart of the participants.

Baseline measures

The baseline measures comprised a background questionnaire of demographics combined with measures of falls efficacy through the use of the instrument The Falls-Efficacy Scale-Swedish version (FES-S, Hellström et al., 2002), engagement in valued occupations, the Occupational Gaps Questionnaire (OGQ, Eriksson et al., 2013) and self-rated physical (Physical Health Scale, PHS) and emotional (Mental Health Scale, MSC) quality of life through the use of the instrument Short Form Health Survey (SF-12, Gandek et al., 1998). To measure both accidental falls and fear of falling, the questions: Have you fallen within the last 6 months? (Primary outcome), and: Are you afraid of falling? (Secondary outcome) were used.

The programme

Intervention

The programme, ‘Active lifestyle all your life', was implemented with older adults, over the age of 65, at nine different primary health care units in Stockholm, Sweden, during 2011. Staff at the unit (physician, nurses, occupational therapists and physiotherapists) recruited participants based on the inclusion criteria, through written information in the waiting room and/or face-to-face contact with older clients visiting the unit, for instance, renewing their prescriptions. The groups were each led by two therapists employed at the primary care unit (an occupational therapist and a physiotherapist). A workshop lasting 4 hours prepared the group leaders for the intervention. A binder with detailed information about the structure, content and focus of each part of the intervention was provided to the group leaders to ensure treatment fidelity across the groups; in addition, in each session there was room for flexibility in relation to the discussions initiated by the participants about their needs and valued occupations. Throughout the intervention the researcher (first author) and an assistant had regular contact with the group leaders to ensure they were running the intervention according to the programme. Each intervention group met for 2 hours biweekly at the primary health care units. In total, all the groups met 12 times over 9 months.

Standardized material was developed for this programme. The material was used throughout the programme and every participant was given the complete material in a binder. The standardized material was developed based on recommendations of a synthesis of systematic reviews and a meta-analysis of earlier falls-prevention programmes (Chang et al., 2004; Gillespie et al., 2012). These recommendations include the use of a multifactorial and multi-disciplinary person-centred educational approach. In addition, a small-group environment was used to facilitate the participants’ engagement in tasks and processes (McKimm and Morris, 2009) and the learning by doing and practising in everyday life situations. At each group meeting predetermined themes were addressed in a fixed order, all related to the prevention of falls from multifactorial perspectives, that is, physical exercise, engagement in occupations, physical balance, home safety, nutrition, and resources in the community. The purpose of the programme was that the participants should be able to integrate the knowledge required to motivate them to take the initiative themselves to make the necessary changes in their home, their immediate environment and in society (that is, lifestyle change). The format of the group meetings included a theoretical part with a predetermined theme, time for coffee and refreshments, round-table discussions and ended with balance exercises. The balance training was individually tailored to each participant, although performed in a group format to optimise the potential effect (Nelson et al., 2007). The intervention also included a field visit chosen by the group in the community (that is, going bowling or visiting a senior gym) and two individually tailored home visits. The experiences of participating in and delivering the intervention are described in more depth in two qualitative studies (Johansson and Jonsson, 2013; Johansson et al., 2014). The controls were offered standard care from their primary health care unit and when asked every third month, none had been receiving falls prevention.

Follow-up measures

The intervention groups as well as the controls were monitored every 3 months between baseline and follow-up at 12 months. The same measures were used for all the participants in the study. In order to capture possible accidental falls following completion of the intervention, follow-up was set to 12 months after baseline assessment, hence 3 months post ending the programme. The primary outcome variable in this study was accidental falls, measured with the question Have you fallen during the last three months? The second outcome was a repetition of the baseline measure of fear of falling by the use of the same question (Are you afraid of falling?). Both outcomes were completed by 88% of the participants at 12 months.

Data analysis

All data were analysed using the intention-to-treat approach. P-values of less than or equal to 0.05 were considered statistically significant in all analyses. The baseline characteristics and measures of the participants were compared using bivariate analysis to investigate differences between the samples. The Mann–Whitney U test was used for the ordinal level variables, and the t-test was used for the continuous variables. Data from baseline and follow-up at 12 months were used. The software package IBM® SPSS® v. 21.0 was used for descriptive statistics and baseline comparison of the two groups. For the primary outcome as well as for the secondary outcome, analyses with descriptive statistics were performed in order to investigate relationships between the variables and to decide on what data to use as independent variables for the models investigating the odds of an event. In addition, data from falls and fear of falling were analysed in relation to risk using multiple logistic regression models for repeated measures, all performed in Statistical Analysis Software (SAS). Mixed models for repeated measures, the risks as well as the change in risk over time, were calculated in General Estimated Equation (GEE), comparing the measures from the two groups over time and then presented as odds ratios (OR). The odds of an event, in this study falls or fear of falling, is defined as the ratio of the probability of event occurrence to the probability of non-occurrence, that is, the prediction of binary outcomes (Campbell et al., 2007). The calculation of trend as the interaction between group and time was also included in the analysis. By using the interaction effect, the models were able to demonstrate whether there were any non-parallel changes between the intervention and the control group. The variables included in the final models – besides the dependent variables (falls or fear of falling) – were group allocation, age, gender, time, group x time (and the mental component score (MCS) from the SF-12, from baseline, in the model for fear of falling). The choice to include the MCS score from baseline was taken since it showed correlation to fear of falling when modelling.

Results

There were no statistically significant differences between the two groups with respect to the characteristics of the participants at baseline, see Table 1. The mean age was 76.4 years in the intervention group and 75.9 years in the control group. About two-thirds of the participants used some kind of walking support and one-third in each group used a walker. No correlation was found between fear of falling and accidental falls at baseline.

Table 1.

Characteristics of participants at baseline.

	Intervention group (n = 74)	Control group (n = 57)
Gender Female/Male (Male %)	59/15 (20)	51/6 (11)
Mean age (SD)	76.4 years (6.10)	75.9 years (6.89)
Falls (%)	42 (56.8)	34 (59.6)
Fear of falling Q: Are you afraid of falling? (yes %)	49 (66.0)	34 (59.6)
Living alone (%)	47 (64)	29 (51)
Help with cleaning (%)	10 (14)	2 (4)
Level difference (for example, stairs) to get in or out of home (%)	43 (58)	40 (70)
User of walker (%)	23 (31)	19 (33)
User of any walking support (%)	44 (59)	29 (51)
Frail, more than three diagnoses (%)	34 (46)	26 (46)
Occupational Gaps Questionnaire^a, median (SD)	3 (3.2)	3 (2.5)
Falls efficacy Scale FES-S^b, mean (SD)	102 (24.96)	104 (21.69)
Self-rated quality of life, SF-12^c physical component score (SD)	36.53 (5.50)	38.36 (7.47)
Self-rated quality of life, SF-12^c mental component score (SD)	49.08 (6.63)	48.19 (6.80)

Occupational Gaps Questionnaire measures to what extent a person experiences discrepancies between occupations he or she wants to perform and actually performs.

Falls Efficacy Scale measures to what extent a person experiences confidence in their own ability to perform 13 activities without falling. A higher score indicates a higher confidence, max = 130.

The 12-Item Short Form Health Survey (SF-12) measures the individual’s subjective experiences of their health and produces two scores, a physical scale score and mental scale score. Higher scores represent more positive experiences of own health.

Accidental falls

At baseline, 57% in the intervention group and 60% in the control group had fallen. At follow-up, the falls rate in the intervention group was 12% compared with 36% in the control group. The risk of having an accidental fall at 12 months was statistically significantly lower for the participants in the intervention group in comparison to the risk in the control group (p < 0.005). However, both groups showed a decrease in falls over time and the result between groups over time was non-significant (p = 0.059), see Table 2 for detailed information. Within the intervention group at follow-up the remaining risk of having a fall was only 11% in comparison with the risk at baseline. In the control group the remaining risk was 34% in comparison with the measurement at baseline. By investigating factors predicting an accidental fall at 12 months, the only significance was found in relation to being allocated to the control group. In addition, a higher rating on the MCS of the SF-12 at baseline indicated a decrease in the risk of a fall at follow-up (OR = 0.95) in the total sample.

Table 2.

The risk of falls at follow-up: Between the intervention and the control group, over time and within each group.

Odds ratio estimates and profile-likelihood confidence intervals (CI) for the risk of accidental falls	OR	OR Lower CI	OR Upper CI	p-value
Falls at 12 months: intervention versus controls	0.248	0.092	0.665	0.005*
Falls at 12 months in comparison with baseline measures: intervention versus controls	0.332	0.105	1.046	0.059
Change of risk of falls within the intervention group at 12 months in comparison with baseline measures	0.113	0.046	0.276	0.001*
Change in risk of falls within the control group at 12 months in comparison with baseline measures	0.339	0.166	0.693	0.003*

Significant p < 0.05

Fear of falling

At baseline, 72% in the intervention group stated that they experienced fear of falling compared with 60% in the control group. At follow-up, a significant decrease in the fear of falling was measured in the intervention group, both regarding measures at 12 months (p = 0.003) and over time considering the baseline measures (p < 0.001). The control group showed instead an increase in the odds of fear of falling over time (OR = 1.314), however this was not statistically significant, see Table 3. The statistics furthermore indicated that a presence of fear of falling at baseline was likely to remain at follow-up (OR = 2.9). As such, the predicting factors for fear of falling at follow-up were: fear of falling at baseline, being in the control group, and lower rating on the MCS scale in the SF-12.

Table 3.

The fear of falling measured at follow-up: in comparison between the groups, over time and within each group.

Odds ratio estimates and profile-likelihood confidence intervals (CI) for the risk of fear of falling	OR	Lower CI	Upper CI	p-value
Fear of falling at 12 months: intervention versus controls	0.123	0.128	0.667	0.003*
Risk of fear of falling at 12 months in comparison with baseline measures: intervention versus controls	0.117	0.040	0.342	0.001*
Change of fear of falling within the intervention group at 12 months in comparison with baseline measures	0.154	0.070	0.337	0.001*
Change in fear of falling within the control group at 12 months in comparison with baseline measures	1.314	0.633	2.277	0.464

Significant p < 0.05

Discussion and implications

The programme has the potential to reduce falls as well as the fear of falling. The efficacy of the intervention was satisfactory according to the decrease in fear of falling and in the risk of falls, which demonstrated the potential of a multifactorial occupational science-based approach, when implemented in primary health care. These results generate benefits for the individual who is able to remain active and engaged in older age.

The concept of fear of falling and its association with falls has been widely examined in falls-prevention research (Clemson, et al., 2015; Zijlstra, et al., 2013). Fear of falling as well as falls need to be examined and addressed in a person-centred way, as the impact from the concepts is individually experienced and interpreted in everyday life by the individuals, as demonstrated in this study. Fear of falling might lead to activity curtailment, which in itself might increase the risk of falls (Peterson, 2010).

The importance of the interventions fitting into the individuals’ context is recognized as an active agent in successful interventions (Clark et al., 2001; Kielhofner, 2008). In the present study, fear of falling and falls risk were approached from a person-centred perspective including tailored activities developed from the needs and wishes of the participants, which included individual home visits and sharing in a group and led to personal adaptations (Johansson and Jonsson, 2013; Johansson et al., 2014). Further, from an occupational perspective, the breadth and occupational focus of the programme gave the informants knowledge of how and why an active lifestyle contributes to health benefits. An active lifestyle approach is also supported in other research literature as being beneficial for healthy ageing (Jackson et al., 1998; Mountain and Craig, 2010).

In this study, all the informants completed the programme over 9 months and no adherence issues were reported. Problems with adherence to falls programmes have been stressed in earlier studies (Gibson et al., 2010; Pohl, 2015). Older adults’ perceptions of contributors to adherence to falls-prevention interventions are: social support, low intensity exercises, support for autonomy and interpretation of the programme as relevant, with a focus on active ageing (Bunn et al., 2008); these were all factors included in the present programme and could explain the high adherence. Thus, the results also suggest a high potential for the programme to be implemented into primary health care, as the participants in this study were interested in and had a need for a falls-prevention programme and therefore completed the programme.

Methodological limitations

There was no registration of how many of the persons invited declined to participate. This might have led to selection bias in the overall sample of participants. There was a disparity in gender distribution, with only 20% male participants. This is not surprising as women more commonly seek primary health care in relation to fall incidences (Socialstyrelsen, 2016) and men are known to be under-represented in falls-prevention research (Liddle et al., 2016). The small amount of men participating limits generalization across gender. No monitoring of the flow of patients through the primary health care centres during the time of the study were performed, which also has to be seen as a limitation in connection to the disparity in gender.

The risk factors for falls are numerous and for the present pilot the regression analysis concerning falls and fear of falling had to prioritise factors of high importance: age, gender, and self-rated quality of life. Factors such as environmental characteristics, frailty and engagement in valued occupations were removed from the final regression model due to the limited sample size and weak correlations with the primary and secondary outcomes. The final regression model used might be seen as a limitation of the study.

Furthermore, the choice to randomize the participants into an intervention group and a control group at every primary health care unit could have generated bias in the form of contamination between the two groups (Hoffmann et al., 2013), and if the same care providers administered the treatments being compared, this might also have introduced bias into the trial (Boutron et al., 2008), however when monitoring the control group’s involvement in falls prevention none was reported. The decision to move some of the participants in the control groups into the intervention groups should not be ignored as it interfered with the original randomization procedure.

In the present study, falls and fear of falling were investigated using single questions (items). Single-item scales have been critiqued for their lack of predictive validity, however if a multi-item scale with redundant items is used, content validity could be negatively affected and single items are advised (Diamantopoulos et al., 2012) motivating the use of single questions for measuring occurrence of falls and fear of falling. The choice to measure occurrence of falls at baseline and follow-up might have benefitted from an approach using prospective falls calendars (Hauer et al., 2006; Lamb et al., 2005), as the administration of a falls calendar could have minimised the risk of recollection bias. Additionally, a core set of outcome measures regarding falls has been formulated aiming to increase the comparability of study results (Hauer et al., 2006; Lamb et al., 2005). As such, falls, fallers, fall rate, and time of first fall should be included and reported. Despite some methodological shortcomings of this pilot study, valuable information about falls and the prevention of falls is presented, showing how the programme impacted on falls and fear of falling.

Conclusion

The results showed the efficacy of the programme by the decreased falls and fear of falling in comparison with usual care. This pilot study indicated that falls and fear of falling could be positively impacted by using multifactorial and multi-disciplinary methods in primary health care. A small-group learning environment in combination with learning by doing, could be an effective approach for the translation of knowledge into everyday life, leading to a decrease in falls and fear of falling.

Key findings

Small-group learning environments combined with learning by doing, could be an effective approach in falls prevention.

Occupation-based interventions in primary health care can decrease falls and fear of falling in older adults at risk.

What the study has added

Falls and fear of falling could be reduced with an occupation-based group intervention, creating opportunities for behavioural change in older adults at risk.

Footnotes

Acknowledgements

We thank all participants that participated on our study. We also acknowledge the primary health care centres in Stockholm City Council that hosted the intervention study.

Research ethics

Ethical approval was obtained from the General Board of Ethics Stockholm, reference number: 2009/1518-31/4 on 3 December 2009. The database created for this study at Karolinska Institutet is registered as KI-2500/11-631. All participants provided written informed consent.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

This study was supported by the Doctoral School in Health Care Sciences, Karolinska Institutet, the foundation of Promobilia and the Gun and Bertil Stohnes Foundation.

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