Evaluating Success and Challenges of a Primary Care Youth Mental Health Programme Using Complexity, Implementation Science, and Appreciative Inquiry.

Background Using an innovative framework of complexity and implementation science, with underpinning core values of appreciative inquiry (CIS-A), this paper describes the evaluation of a pilot service in New Zealand aiming to deliver integrated psychological therapy services within primary care, to young people (aged 18-24) experiencing mild to moderate mental distress. Method Using mixed quantitative and qualitative methods and multiple data sources, there was a strong focus on local innovation and co-design with service users, young people and multiple care providers. Data is drawn from service users, stakeholders and providers of the service in three areas of the lower North Island of New Zealand.  Results The Piki pilot provided a significant and innovative enhancement of mental health care to this population. The service supported 5307 individuals with a range of therapy options, with the majority having between one and three therapy sessions. From 730 service users who completed a survey, 591 (81%) were 'very satisfied' with the service provided. The CIS-A framework was used successfully to provide rapid feedback and encourage adaptation to evolving issues. These included unexpected workload pressures, changes to therapy delivery, the integration of co-design and prioritising the needs of vulnerable groups. There was a successful incorporation of youth/service user input to co-design the programme, introduction of a peer-to-peer support service, and integration of a digital resource platform. The framework was also used to address challenges encountered and to support necessary adaptations in response to the COVID-19 pandemic.  Conclusions We describe the use of an embedded evaluation to support and inform the implementation of a novel and innovative youth mental health programme. Complexity and implementation science, underpinned by the core values of appreciative inquiry (CIS-A), were successfully utilised providing potential learning that can be applied locally, nationally and internationally. This study has a focus on youth mental health but the principles and utility of applying a complexity and implementation science approach have application in many different health care settings. The use of a framework such as CIS-A can support complex innovation and implementation and can be used to enable rapid course correction and turn 'hindsight to foresight'.

Therapist Voices on a Youth Mental Health Pilot: Responsiveness to Diversity and Therapy Modality.

This article explores therapists' views on a large youth mental health pilot project (for 18-25-year-olds), which included an individual cognitive behavior therapy (CBT)-informed individual therapy component. Therapists' views on cultural responsiveness, therapy (delivery, modality and duration) and working with LGBTQIA+ youth were explored using two surveys, individual interviews and focus groups at various stages of the life of the pilot. Some therapists saw the CBT approach as imposed on them, preferring familiar therapy modalities. Many therapists were positive toward CBT for its client-centered approach and reported using CBT-informed approaches with many of their clients to good effect. Some therapists felt pressured by their workplace to see clients for fewer sessions than they needed. Therapists wanted to see a more culturally diverse workforce, to increase their cultural competence through training and to have more easily available cultural supervision. There was some acknowledgement of the importance of training therapists to work competently with LGBTQIA+ young people. Involving therapists in co-design of services from the outset will likely benefit future service development.

Work-place cancer and palliative care interprofessional education: experiences of students and staff.

Workplace-based interprofessional education (IPE) offers opportunities for pre-registration students to interact with patients in authentic settings. Senior dietetic, medical, nursing, physiotherapy and radiation therapy students took part in a workplace IPE initiative on cancer and palliative care informed by experiential learning theory and run by clinical tutors. Research was undertaken to gauge students and tutors' experiences of the initiative. The mixed methods approach included: Pre and post-administration of the University of West England Interprofessional questionnaire 'Communication and Teamwork Scale, 'Interprofessional Learning Scale,' 'Interprofessional Interaction Scale.' Two questions were added relating to cancer and palliative care. Separate focus group interviews were held with students and tutors. There was a positive shift in the Communication and Teamwork scale based on students' pre and post questionnaires, but no change in the other two scales. Analysis of student and tutor focus group data showed that both affirmed the IPE initiative for a range of reasons. A brief experiential, theory-informed IPE initiative with a focus on cancer and palliative care was well received by both students and clinical tutors. The mixed method approach highlighted some discrepancies between quantitative and qualitative results but when synthesized were explicable, demonstrating the value of using a mixed methods approach to research.

A Guideline-Implementation Intervention to Improve the Management of Low Back Pain in Primary Care: A Difference-in-Difference-in-Differences Analysis.

BACKGROUND: Real-world adherence to clinical practice guidelines is often poor, resulting in sub-standard patient care and unnecessary healthcare costs. This study evaluates the effect of a guideline-implementation intervention for the management of low back pain (LBP) in general practice-the Fear Reduction Exercised Early (FREE) approach-on LBP-related injury insurance claims, healthcare utilisation, and costs of treatment. DESIGN: Data were extracted from comprehensive nationwide New Zealand injury insurance claims records. Data were analysed using a 'triple-difference' (difference-in-difference-in-differences) method to isolate the causal effect of FREE training on LBP claims activity, comparing the difference in general practitioner (GP) LBP claims and associated activity before and after training with their non-musculoskeletal injury claims for the same periods (assumed to be unaffected by training), relative to the same comparisons for GPs not trained in the FREE approach. RESULTS: Training GPs in the FREE approach resulted in significant reductions in the number of LBP injury claims lodged (- 19%, 95% CI -34 to -5), the use of physiotherapy (-30%, 95% CI - 42 to - 18) and imaging (- 27%, 95% CI - 46 to - 8%), and the healthcare costs (- 21%, 95% CI - 41 to - 1) of LBP injury. Changes in claims for earnings' compensation (- 10%, 95% CI - 34 to 13) were not significant. CONCLUSIONS: A brief guideline-implementation intervention following best-practice LBP management and guideline-implementation strategies achieved significant reductions, persisting over at least 6 to18 months, in healthcare utilisation consistent with improved delivery of guideline-concordant care.

Young peoples' perspectives about care in a youth-friendly general practice.

INTRODUCTION Youth health outcomes are poor in New Zealand and have a life-long impact on individuals, whanau (family) and society. Little is known about how young people view their experiences of general practice care despite it being the most common place to access health care. AIM This study sought to explore young peoples' experiences of care in a selected, youth-friendly general practice. METHODS In-depth individual interviews with six young people. RESULTS Four themes were identified from young peoples' narratives in relation to their experiences of general practice care: going to the doctor is not easy for a young person; the attributes of staff make all the difference; specific youth-friendly consultation practices help young people; and a youth-friendly physical environment can help young people access services and feel safe. DISCUSSION Even though the study general practice had explicitly instituted youth-friendly initiatives, including offering no-charge consultations and specialist staff members, young people still described considerable barriers to attendance. Many barriers are practice-based and could be modified by staff training, provision of further youth care staff roles and consideration of environmental changes. Other barriers such as waiving prescription costs need government funding.

Refugee-like migrants have similar health needs to refugees: a New Zealand post-settlement cohort study.

BACKGROUND: Refugees and asylum seekers have specific health and social care needs on arrival in a resettlement country. A third group - migrants with a refugee-like background (refugee-like migrants) - are less well defined or understood. AIM: Using routinely collected data, this study compared demographics, interpreter need, and healthcare utilisation for cohorts of refugee-like migrants and refugees. DESIGN & SETTING: A retrospective cohort study was undertaken in Wellington, New Zealand. METHOD: Data were obtained for refugee-like migrants and refugees accepted under the national quota system (quota refugees), who enrolled in a New Zealand primary care practice between 2011 and 2015. Data from the primary care practice and nationally held hospital and outpatient service databases, were analysed. Age and sex standardisation adjusted for possible differences in cohort demographic profiles. RESULTS: The cohorts were similar in age, sex, deprivation, and interpreter need. Refugee-like migrants were found to have similar, but not identical, health and social care utilisation to quota refugees. Primary care nurse utilisation was higher for refugee-like migrants. Clinical entries in the primary care patient record were similar in rate for the cohorts. Emergency department utilisation and hospital admissions were similar. Hospital outpatient utilisation was lower for refugee-like migrants. CONCLUSION: This research suggests that health, social care, and other resettlement services should be aligned for refugee-like migrants and quota refugees. This would mean that countries accepting quota refugees should plan for health and social care needs of subsequent refugee-like migrant family migration. Further research should investigate matched larger-scale national health and immigration datasets, and qualitatively explore factors influencing health-seeking behaviour of refugee-like migrants.

The Fear Reduction Exercised Early (FREE) approach to management of low back pain in general practice: A pragmatic cluster-randomised controlled trial.

BACKGROUND: Effective and cost-effective primary care treatments for low back pain (LBP) are required to reduce the burden of the world's most disabling condition. This study aimed to compare the clinical effectiveness and cost-effectiveness of the Fear Reduction Exercised Early (FREE) approach to LBP (intervention) with usual general practitioner (GP) care (control). METHODS AND FINDINGS: This pragmatic, cluster-randomised controlled trial with process evaluation and parallel economic evaluation was conducted in the Hutt Valley, New Zealand. Eight general practices were randomly assigned (stratified by practice size) with a 1:1 ratio to intervention (4 practices; 34 GPs) or control group (4 practices; 29 GPs). Adults presenting to these GPs with LBP as their primary complaint were recruited. GPs in the intervention practices were trained in the FREE approach, and patients presenting to these practices received care based on the FREE approach. The FREE approach restructures LBP consultations to prioritise early identification and management of barriers to recovery. GPs in control practices did not receive specific training for this study, and patients presenting to these practices received usual care. Between 23 September 2016 and 31 July 2017, 140 eligible patients presented to intervention practices (126 enrolled) and 110 eligible patients presented to control practices (100 enrolled). Patient mean age was 46.1 years (SD 14.4), and 46% were female. The duration of LBP was less than 6 weeks in 88% of patients. Primary outcome was change from baseline in patient participant Roland Morris Disability Questionnaire (RMDQ) score at 6 months. Secondary patient outcomes included pain, satisfaction, and psychosocial indices. GP outcomes included attitudes, knowledge, confidence, and GP LBP management behaviour. There was active and passive surveillance of potential harms. Patients and outcome assessors were blind to group assignment. Analysis followed intention-to-treat principles. A total of 122 (97%) patients from 32 GPs in the intervention group and 99 (99%) patients from 25 GPs in the control group were included in the primary outcome analysis. At 6 months, the groups did not significantly differ on the primary outcome (adjusted mean RMDQ score difference 0.57, 95% CI -0.64 to 1.78; p = 0.354) or secondary patient outcomes. The RMDQ difference met the predefined criterion to indicate noninferiority. One control group participant experienced an activity-related gluteal tear, with no other adverse events recorded. Intervention group GPs had improvements in attitudes, knowledge, and confidence compared with control group GPs. Intervention group GP LBP management behaviour became more guideline concordant than the control group. In cost-effectiveness, the intervention dominated control with lower costs and higher Quality-Adjusted Life Year (QALY) gains. Limitations of this study were that although adequately powered for primary outcome assessment, the study was not powered for evaluating some employment, healthcare use, and economic outcomes. It was also not possible for research nurses (responsible for patient recruitment) to be masked on group allocation for practices. CONCLUSIONS: Findings from this study suggest that the FREE approach improves GP concordance with LBP guideline recommendations but does not improve patient recovery outcomes compared with usual care. The FREE approach may reduce unnecessary healthcare use and produce economic benefits. Work participation or health resource use should be considered for primary outcome assessment in future trials of undifferentiated LBP. TRIAL REGISTRATION: ACTRN12616000888460.

The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.

BACKGROUND: Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psychosocial barriers to recovery and provision of evidence-based care and information. The aim of the Low Back Pain in General Practice (LBPinGP) trial is to explore whether patients with LBP who receive care from GPs trained in the FREE approach have better outcomes than those who receive usual care. METHODS/DESIGN: This is a cluster randomised controlled superiority trial comparing the FREE approach with usual care for LBP management with investigator-blinded assessment of outcomes. GPs will be recruited and then cluster randomised (in practice groups) to the intervention or control arm. Intervention arm GPs will receive training in the FREE approach, and control arm GPs will continue to practice as usual. Patients presenting to their GP with a primary complaint of LBP will be allocated on the basis of allocation of the GP they consult. We aim to recruit 60 GPs and 275 patients (assuming patients are recruited from 75% of GPs and an average of 5 patients per GP complete the study, accounting for 20% patient participant dropout). Patient participants and the trial statistician will be blind to group allocation throughout the study. Analyses will be undertaken on an intention-to-treat basis. The primary outcome will be back-related functional impairment 6 months post-initial LBP consultation (interim data at 2 weeks, 6 weeks and 3 months), measured with the Roland-Morris Disability Questionnaire. Secondary patient outcomes include pain, satisfaction, quality of life, days off from work and costs of care. Secondary GP outcomes include beliefs about pain and impairment, GP confidence, and actual and reported clinical behaviour. Health economic and process evaluations will be conducted. DISCUSSION: In the LBPinGP trial, we will investigate providing an intervention during the first interaction a person with back pain has with their GP. Because the FREE approach is used within a normal GP consultation, if effective, it may be a cost-effective means of improving LBP care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616000888460 . Registered on 6 July 2016.

Genital examination training: assessing the effectiveness of an integrated female and male teaching programme.

BACKGROUND: Learning to undertake intimate female and male examinations is an important part of medical student training but opportunities to participate in practical, supervised learning in a safe environment can be limited. A collaborative, integrated training programme to provide such learning was developed by two university teaching departments and a specialist sexual health service, utilising teaching associates trained for intimate examinations in a simulated clinical educational setting. The objective of this research was to determine changes in senior medical students' self- reported experience and confidence in performing male and female genital examinations, before and after participating in a new clinical teaching programme. METHODS: A quasi-experimental mixed methods design, using pre and post programme questionnaires and focus groups, was used to assess the effectiveness of the programme. RESULTS: The students reported greatly improved skill, confidence and comfort levels for both male and female genital examination following the teaching programme. Skill, confidence and comfort regarding male examinations were rated particularly low on the pre-teaching programme self- assessment, but post-programme was rated at similar levels to the female examination. CONCLUSIONS: This integrated female-male teaching programme (utilising trained teaching associates as simulated patients in a supervised clinical teaching environment) was successful in increasing senior medical students' skills and levels of confidence in performing genital examinations. There were differences between female and male medical students in their learning. Suggestions for improvement included providing more detailed instruction to some clinical supervisors about their facilitation role in the session.

Exploring the maternal and infant continuum - ethnic disparities in infant hospital admissions for respiratory disease.

OBJECTIVE: To investigate maternal and birth-related risk factors associated with infant respiratory hospitalisations in New Zealand. METHODS: A Kaupapa Maori-framed retrospective cohort analysis of public hospital maternal data linked to infant data (54,980 births 1995-2009). Primary outcome was rate of hospitalisation for respiratory disease in the first year of life. Risk variables examined included socioeconomic status (SES), age, smoking, parity, gestation, time to hospital discharge, breastfeeding and maternal ethnicity as a potential marker of differential exposure to risk factors. RESULTS: Independent risk factors for hospitalisation included low maternal SES (rate ratio: 1.33 [95% CI 1.19-1.49]); smoking (1.3 [1.19-1.41]); parity (2.77 [2.37-3.24]); preterm birth (3.14 [2.58-3.83]; 30 compared with 40 weeks); but not breastfeeding (0.99 [0.87-1.11]). After adjustment for risk factors, respiratory hospitalisations remained highest among infants of young Maori women (rate ratio 1.93 [1.46-2.55] at age 22.5 years) and Pacific women across all maternal age groups (rate ratios 2.43 to 2.55), compared with infants of European women. CONCLUSIONS: Maternal and birth factors are strongly associated with ethnic disparities in infant hospital admissions for respiratory disease. IMPLICATIONS: Interventions that begin in pregnancy and address risk factors and social determinants of health are needed to address these disparities.

A retrospective cohort study of the association between midwifery experience and perinatal mortality.

OBJECTIVE: To determine whether experience of midwife-only and nurse-midwife lead maternity carers (LMCs) is related to perinatal mortality. METHODS: In a retrospective analysis, routinely collected data were obtained for all pregnancies resulting in live births (or stillbirth at ≥20weeks or weighing >400g) in New Zealand in 2005-2009. An anonymized dataset of date of midwife registration was used. The main outcome measure was perinatal mortality (fetal deaths and neonatal deaths ≤27days). RESULTS: Among 233215 eligible births, 84043 were linked to a midwife-only LMC and 150172 to a nurse-midwife LMC. Among pregnancies with midwife-only LMCs, perinatal mortality was higher when the midwife had less than 1year of experience than when the midwife had 5-9years' experience (rate ratio 1.33; 95% confidence interval 1.02-1.73), an absolute difference of two additional deaths per 1000 births. There was a decreasing rate of perinatal mortality with increasing experience (P=0.031). Perinatal mortality rates did not differ by experience in the nurse-midwife group. CONCLUSION: Pregnancies cared for by early-career (<1year) midwife-only LMCs were associated with a 33% increase in perinatal mortality. No association between experience and perinatal mortality was found for nurse-midwives. Midwife-only trained LMCs could require additional training and/or supervision in their first year of practice.

Uterine cancer: exploring access to services in the public health system.

BACKGROUND: Maori are the indigenous peoples of New Zealand and experience higher rates of uterine cancer and poorer survival rates. Postmenopausal bleeding (PMB) is the most common presenting symptom for uterine cancer. Prompt investigation is essential with 28 days being viewed as an appropriate time from first medical contact (FMC) to first specialist appointment (FSA). AIMS: To compare access to services for the investigation of PMB between Maori and non-Maori women. MATERIALS AND METHODS: The time interval between FMC to FSA was obtained from medical records for women presenting to gynaecology clinics for PMB. Dates of first bleeding symptoms, knowledge and access issues were collected in a nurse-administered questionnaire. RESULTS: A total of 154 women (n = 27 Maori and 127 non-Maori) participated in the study. 23% of women had their FSA from FMC within 28 days and 67% waited more than six weeks. The 75th percentile was approximately two weeks longer for Maori women. 25% (n = 37) of women were not aware that they needed to see a doctor about PMB, and this was significantly more common for Maori women (44%; 95% CI 25-65) than non-Maori women (20%; 95% CI 13-28; P = 0.011). CONCLUSIONS: The majority of women were not seen for FSA within 28 days of their FMC. Maori women were more likely to experience lengthy delays and to report that they did not know they should see a doctor about PMB. Further investigation into reasons for delays and initiatives to improve access to services and health information appears warranted.

Poor compliance with standard precautions against infections during minor gynaecological procedures.

BACKGROUND: Splash injuries occurring during minor surgical procedures are associated with a significant infective risk to the operator. It is a common misconception that minor operations carry low risks. AIM: To determine the prevalence of the practice of Standard Precautions by medical staff in the obstetric and gynaecology (O & G) units of two hospitals in New Zealand, and to assess self-observed splash injury rates. METHOD: A cross-sectional survey of all doctors working in the O & G units of two public hospitals servicing a population of 435 000. A self-administered questionnaire was provided to 43 doctors with questions related to the use of Standard Precautions, perceived likelihood of infection from a splash and splash injuries sustained during procedures. RESULTS: The response rate was 76.6% (n = 33/43). Of the respondents, only 30.3% (n = 10) used Standard Precautions during minor procedures. Sixty-four per cent (n = 21) routinely used goggles/visor for eye protection. Forty-five per cent (n = 15) thought they were likely to get an infection from a splash, and 55% (n = 18) of clinicians had experienced a splash injury. Of the minor procedures during which splash injuries had occurred, repair of episiotomy 45.8% (n = 11) was the commonest. CONCLUSIONS: This survey shows poor compliance with guidelines for Standard Precautions to protect from infection despite self-reported rates of splash injury being high at 55%. Effective interventions are needed to increase compliance and prevent infection.

Are physical activity interventions in primary care and the community cost-effective? A systematic review of the evidence.

BACKGROUND: The health and economic burden of physical inactivity is well documented. A wide range of primary care and community-based interventions are available to increase physical activity. It is important to identify which components of these interventions provide the best value for money. AIM: To assess the cost-effectiveness of physical activity interventions in primary care and the community. DESIGN OF STUDY: Systematic review of cost-effectiveness studies based on randomised controlled trials of interventions to increase adult physical activity that were based in primary health care or the community, completed between 2002 and 2009. METHOD: Electronic databases were searched to identify relevant literature. Results and study quality were assessed by two researchers, using Drummond's checklist for economic evaluations. Cost-effectiveness ratios for moving one person from inactive to active, and cost-utility ratios (cost per quality-adjusted life-year [QALY]) were compared between interventions. RESULTS: Thirteen studies fulfilled the inclusion criteria. Eight studies were of good or excellent quality. Interventions, study populations, and study designs were heterogeneous, making comparisons difficult. The cost to move one person to the 'active' category at 12 months was estimated for four interventions ranging from €331 to €3673. The cost-utility was estimated in nine studies, and varied from €348 to €86,877 per QALY. CONCLUSION: Most interventions to increase physical activity were cost-effective, especially where direct supervision or instruction was not required. Walking, exercise groups, or brief exercise advice on prescription delivered in person, or by phone or mail appeared to be more cost-effective than supervised gym-based exercise classes or instructor-led walking programmes. Many physical activity interventions had similar cost-utility estimates to funded pharmaceutical interventions and should be considered for funding at a similar level.

Cost-effectiveness of exercise on prescription with telephone support among women in general practice over 2 years.

AIM: To assess the cost-effectiveness of exercise on prescription with ongoing support in general practice. METHODS: Prospective cost-effectiveness study undertaken as part of the 2-year Women's lifestyle study randomised controlled trial involving 1089 'less-active' women aged 40-74. The 'enhanced Green Prescription' intervention included written exercise prescription and brief advice from a primary care nurse, face-to-face follow-up at 6 months, and 9 months of telephone support. The primary outcome was incremental cost of moving one 'less-active' person into the 'active' category over 24 months. Direct costs of programme delivery were recorded. Other (indirect) costs covered in the analyses included participant costs of exercise, costs of primary and secondary healthcare utilisation, allied health therapies and time off work (lost productivity). Cost-effectiveness ratios were calculated with and without including indirect costs. RESULTS: Follow-up rates were 93% at 12 months and 89% at 24 months. Significant improvements in physical activity were found at 12 and 24 months (p<0.01). The exercise programme cost was New Zealand dollars (NZ$) 93.68 (€45.90) per participant. There was no significant difference in indirect costs over the course of the trial between the two groups (rate ratios: 0.99 (95% CI 0.81 to 1.2) at 12 months and 1.01 (95% CI 0.83 to 1.23) at 24 months, p=0.9). Cost-effectiveness ratios using programme costs were NZ$687 (€331) per person made 'active' and sustained at 12 months and NZ$1407 (€678) per person made 'active' and sustained at 24 months. CONCLUSIONS: This nurse-delivered programme with ongoing support is very cost-effective and compares favourably with other primary care and community-based physical activity interventions internationally.

Effectiveness of a falls-and-fracture nurse coordinator to reduce falls: a randomized, controlled trial of at-risk older adults.

OBJECTIVES: To assess the effectiveness of a community-based falls-and-fracture nurse coordinator and multifactorial intervention in reducing falls in older people. DESIGN: Randomized, controlled trial. SETTING: Screening for previous falls in family practice followed by community-based intervention. PARTICIPANTS: Three hundred twelve community-living people aged 75 and older who had fallen in the previous year. INTERVENTION: Home-based nurse assessment of falls-and-fracture risk factors and home hazards, referral to appropriate community interventions, and strength and balance exercise program. Control group received usual care and social visits. MEASUREMENTS: Primary outcome was rate of falls over 12 months. Secondary outcomes were muscle strength and balance, falls efficacy, activities of daily living, self-reported physical activity level, and quality of life (Medical Outcomes Study 36-item Short Form Questionnaire). RESULTS: Of the 3,434 older adults screened for falls, 312 (9%) from 19 family practices were enrolled and randomized. The average age was 81+/-5, and 69% (215/312) were women. The incidence rate ratio for falls for the intervention group compared with the control group was 0.96 (95% confidence interval=0.70-1.34). There were no significant differences in secondary outcomes between the two groups. CONCLUSION: This nurse-led intervention was not effective in reducing falls in older people who had fallen previously. Implementation and adherence to the fall-prevention measures was dependent on referral to other health professionals working in their usual clinical practice. This may have limited the effectiveness of the interventions.

Falls Assessment Clinical Trial (FACT): design, interventions, recruitment strategies and participant characteristics.

BACKGROUND: Guidelines recommend multifactorial intervention programmes to prevent falls in older adults but there are few randomised controlled trials in a real life health care setting. We describe the rationale, intervention, study design, recruitment strategies and baseline characteristics of participants in a randomised controlled trial of a multifactorial falls prevention programme in primary health care. METHODS: Participants are patients from 19 primary care practices in Hutt Valley, New Zealand aged 75 years and over who have fallen in the past year and live independently. Two recruitment strategies were used - waiting room screening and practice mail-out. Intervention participants receive a community based nurse assessment of falls and fracture risk factors, home hazards, referral to appropriate community interventions, and strength and balance exercise programme. Control participants receive usual care and social visits. Outcome measures include number of falls and injuries over 12 months, balance, strength, falls efficacy, activities of daily living, quality of life, and physical activity levels. RESULTS: 312 participants were recruited (69% women). Of those who had fallen, 58% of people screened in the practice waiting rooms and 40% when screened by practice letter were willing to participate. Characteristics of participants recruited using the two methods are similar (p > 0.05). Mean age of all participants was 81 years (SD 5). On average participants have 7 medical conditions, take 5.5 medications (29% on psychotropics) with a median of 2 falls (interquartile range 1, 3) in the previous year. CONCLUSION: The two recruitment strategies and the community based intervention delivery were feasible and successful, identifying a high risk group with multiple falls. Recruitment in the waiting room gave higher response rates but was less efficient than practice mail-out. Testing the effectiveness of an evidence based intervention in a 'real life' setting is important.