Pre-post Intervention Pilot Study Research Articles

Charting Wellness in India: Piloting the iTHRIVE's Functional Nutrition Approach to Improve Glycaemic and Inflammatory Parameters in Prediabetes and Type 2 Diabetes Mellitus.

Introduction Type 2 diabetes mellitus (T2DM) is characterized by elevation of blood glucose levels due to underlying insulin resistance and inflammation. Multiple modifiable risk factors such as unhealthy dietary habits, physical inactivity, obesity, smoking and psychological stress contribute toT2DM. Weinvestigated the efficacy of a comprehensive functional nutrition approach aimed at mitigating T2DMusing the iTHRIVE approach which encompassed anti-inflammatory and elimination diets, micronutrient supplements, physical activity, stress managementand environmental modifications through a pre-post study design. The research assessed changes in blood glucose and inflammatory markers following the implementation of thefunctional nutrition program. Methods A prospective pre-post intervention pilot study was conducted at ThriveTribe Wellness Solutions Pvt Ltd. (iTHRIVE), where 50 study participants from urban areas of Pune city, India(n=25 each group) were recruited voluntarily in the age group of 20-60 years. The participants were subjected to 90 days of the iTHRIVE functional nutrition approach which consisted of eliminating certain inflammatory foods and adding a combination of nutritious organic foods, adding dietary supplements like magnesium, vitamin D, alpha lipoic acid, chromium picolinate, berberine and biogymnema, physical activities like resistance training, stress reduction techniques like meditation and deep breathing exercises along with environmental changes. The blood parameters like fasting blood glucose, postprandial blood glucose, glycated haemoglobin (HbA1C), fasting serum insulin, post-prandial serum insulin, high sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), vitamin D, body weight and waist circumference were measured before and after the intervention. The changes were statistically analyzed using a paired t-test. Results The mean age of the participants was found to be 43.76±10.58 years. Around 68%of the participants were prediabetic (HbA1c: 5.7-6.4%) and 32% had T2DM (HbA1c ≥6.5%). A significant reduction was observed in the average HbA1c (13.75% reduction, p<0.0001), average post-prandial blood glucose levels (14.51% reduction, p<0.048), average post-prandial serum insulin (34.31% reduction, p<0.017) and average ESR levels (34.51% reduction, p<0.006). The hs-CRP levels were reduced by 6.6%, but not statistically significant. The average body weight of the participants dropped from 78.59±15.18 kg to 75.20±14.20 kg with a mean loss of 2.91 kg (p<0.05) whereas the waist circumference decreased from 37.54±5.09 to 35.97±4.74 inches with an average loss of 1.19 inches (p<0.0004). Conclusions Following the intervention, several health indicators indicated significant improvements. Particularly, there was a significant drop in HbA1c levels, suggesting better long-term blood glucose control. Blood glucose and serum insulin levels after a meal dropped significantly, indicating enhanced insulin sensitivity. There was a decrease in systemic inflammation as evidenced by the decreasein ESR levels. These results imply that the iTHRIVE functional nutrition approach used in this investigation might be beneficial for enhancing glycemic controland insulin sensitivity, along with reducing inflammatory markers in people with prediabetes and T2DM. Larger sample sizes and longer periods of monitoring would be useful in subsequent research to validate and build on these encouraging findings.

Blended intervention based on acceptance and commitment therapy for informal caregivers of people with dementia (ACT-IC): protocol of a mixed-methods feasibility study

IntroductionNumerous caregiver support programmes have shown promise in promoting the mental health of informal caregivers of people with dementia (PwD). However, there is still a lack of evidence-based interventions tailored...

Evaluating Human Papillomavirus eHealth in Hmong Adolescents to Promote Vaccinations: Pilot Feasibility Study.

Human papillomavirus (HPV) is a common sexually transmitted infection, causing multiple cancers, including cervical, penile, and anal. Infection and subsequent health risks caused by HPV can be diminished by HPV vaccination. Unfortunately, vaccination rates among Hmong Americans are substantially lower than those among other racial and ethnic groups, despite having higher cervical cancer rates than non-Hispanic White women. Such disparities and sparse literature highlight the need for innovative and culturally appropriate educational interventions to improve HPV vaccine rates in Hmong Americans. We aimed to develop and evaluate the effectiveness and usability of an innovative web-based eHealth educational website, the Hmong Promoting Vaccines website (HmongHPV website), for Hmong-American parents and adolescents to improve their knowledge, self-efficacy, and decision-making capacities to obtain HPV vaccinations. Through social cognitive theory and community-based participatory action research process, we created a theory-driven and culturally and linguistically appropriate website for Hmong parents and adolescents. We conducted a pre-post intervention pilot study to assess the website's effectiveness and usability. Overall, 30 Hmong-American parent and adolescent dyads responded to questions about HPV and HPV vaccine knowledge, self-efficacy, and decision-making at preintervention, 1 week after intervention, and at the 5-week follow-up. Participants responded to survey questions about website content and processes at 1 and 5 weeks, and a subset of 20 dyad participants participated in telephone interviews 6 weeks later. We used paired t tests (2-tailed) to measure the change in knowledge, self-efficacy, and decision-making processes, and used template analysis to identify a priori themes for website usability. Participants' HPV and HPV vaccine knowledge improved significantly from pre- to postintervention stage and follow-up. Knowledge scores increased from preintervention to 1 week after intervention for both parents (HPV knowledge, P=.01; vaccine knowledge, P=.01) and children (HPV knowledge, P=.01; vaccine knowledge, P<.001), which were sustained at the 5-week follow-up. Parents' average self-efficacy score increased from 21.6 at baseline to 23.9 (P=.007) at post intervention and 23.5 (P=.054) at follow-up. Similar improvements were observed in the teenagers' self-efficacy scores (from 30.3 at baseline to 35.6, P=.009, at post intervention and 35.9, P=.006, at follow-up). Collaborative decision-making between parents and adolescents improved immediately after using the website (P=.002) and at follow-up (P=.02). The interview data also revealed that the website's content was informative and engaging; in particular, participants enjoyed the web-based quizzes and vaccine reminders. This theory-driven, community-based participatory action research-designed and culturally and linguistically appropriate educational website was well received. It improved Hmong parents' and adolescents' knowledge, self-efficacy, and decision-making processes regarding HPV vaccination. Future studies should examine the website's impact on HPV vaccine uptake and its potential for broader use across various settings (eg, clinics and schools).

MHealth Intervention for Promoting Hypertension Self-management Among African American Patients Receiving Care at a Community Health Center: Formative Evaluation of the FAITH! Hypertension App

African Americans (AAs) are at a higher risk of premature death from cardiovascular diseases compared to White Americans, with disproportionate attributable risk from uncontrolled hypertension. These health disparities are rooted in structural racism with resultant adverse social determinants of health (SDOH) including limited access to quality healthcare. Given their high usage among AAs, mobile technologies, including smartphones, show promise in increasing access to reliable health information. Thus, culturally tailored mobile health (mHealth) interventions may promote hypertension self-management among this population. This formative study assessed the feasibility of integrating an innovative mHealth intervention into clinical and community settings to improve blood pressure (BP) control among AAs. A mixed methods study of AA patients with uncontrolled hypertension was implemented over two consecutive phases. In Phase 1, patients and clinicians from two federally qualified health centers (FQHCs) in the Minneapolis-St. Paul, Minnesota metropolitan area provided input through a focus group series to refine an existing culturally tailored mHealth app (FAITH! [Fostering African-American Improvement in Total Health!] App) to promote hypertension self-management among AA patients with uncontrolled hypertension. Phase 2 was a single-arm pre-post intervention pilot study to assess feasibility and patient satisfaction. Patients receiving care at an FQHC participated in a 10-week intervention utilizing the refined FAITH! Hypertension App synchronized with a wireless BP monitor and support from a community health worker (CHW) to address SDOH-related social needs. The multimedia app consisted of a 10-module educational series focused on hypertension and cardiovascular risk factors with interactive self-assessments, medication/BP self-monitoring and social networking. Primary outcomes were feasibility (app engagement/satisfaction) and preliminary efficacy (change in BP) at immediate post-intervention. In Phase 1, 13 AA patients (69% age ≥50, 77% female) and 16 clinicians (69% age ≥50, 88% female, 63% AA) participated in focus groups. Based on their feedback, app modifications included addition of: BP/medications-tracking, BP self-care task reminders, and culturally sensitive contexts. In Phase 2, 16 AA patients were enrolled (mean age 52.6 years [SD 12.3], 75% female). Of the 16, 38% completed at least half of 10 education modules. Seven of the 16 completed the post-intervention assessment. These patients rated the intervention a 9 (out of 10) as helpful in hypertension self-management. Qualitative data revealed that these patients viewed the app as user-friendly, engaging, and informative, and CHWs were perceived as providing accountability and support. Of the 7 patients, mean systolic and diastolic BPs decreased by 6.4 mmHg (p=.15) and 2.8 mmHg (p=.78) at immediate post-intervention, respectively. A culturally tailored mHealth app, with reinforcement by CHW support, may improve hypertension self-management among under-resourced AAs receiving care at FQHCs. A future randomized efficacy trial of the intervention is warranted. Registration: ClinicalTrials.gov Identifier: NCT03777709.

Change in care hours, cost, and functional independence following continence and assistive technology intervention in an acquired brain injury population

Purpose After acquired brain injury (ABI) dependence on intervention for continence management is common. This preliminary investigation aimed to (i) quantify toileting care hours and costs in a community-based ABI rehabilitation and disability setting, and (ii) measure change in care needs, costs, and functional independence after intervention with assistive technologies (ATs). Method Pragmatic pre-post intervention pilot study of 14 adults with ABI and toileting disability accessing community-based neurorehabilitation or disability support in Western Australia. Toileting and functional independence were assessed monthly from baseline (T 0) to 3-month follow-up (T 3). Basic and nursing care hours (Northwick Park Dependency Score), cost of care estimates (Northwick Park Care Needs Assessment), functional independence (Functional Independence and Assessment Measure), and cost of consumables were examined pre- and post-intervention with ATs. Multilevel mixed-effects models with bootstrap estimation were conducted. Results Cost of consumables significantly declined (AU$69/week), and functional independence significantly improved following intervention (+23.5 points). There was a non-significant reduction in care needs for toileting (4 h/week) and in the cost of toileting care (AU$633/week). Conclusion Toileting disability substantially impacts care hours and costs. This study provides preliminary evidence that comprehensive continence management is beneficial in reducing costs and supporting people with an ABI to increase their independence. IMPLICATIONS FOR REHABILITATION A comprehensive continence assessment and management plan reduces the number of care hours, cost of care, and cost of continence products in a neurorehabilitation and disability support sample for people with acquired brain injury (ABI). Assistive technologies for continence management are beneficial in supporting people with ABI to increase independence, and reduce costs. Providing comprehensive continence assessment and management plan reduces reliance on staff for continence care, and improves functional independence.

Nurses and midwives' experiences with peer-group clinical supervision intervention: A pilot study.

This study aimed to evaluate differences in supervisees' understanding of clinical supervision and their perceptions of organisational functioning before and after engaging in peer-group clinical supervision. Protected reflective time allows discussion of complex issues affecting health care. Peer-group clinical supervision is one model of clinical supervision that could facilitate this, but it is poorly understood. A pre-post intervention pilot study was performed. The intervention was delivered over a 12-month period. Data were collected using surveys on demographic and work-related factors and experience of clinical supervision pre- and post intervention. Adaptability increased significantly between the pre- and post surveys. The post survey data showed finding time for clinical supervision scoring lowest with open-ended comments reinforcing this. The supervisees found the sessions to offer a safe place despite initial concerns. The peer-group model of clinical supervision allowed supervisees to build a rapport and trust with their colleagues and share experiences. The benefits to participating in peer-group clinical supervision traversed the individual and organisation. These data support the implementation of such sessions while addressing workload and time pressures to aid participation.

Effects of Mindfulness-Based Stress Reduction Training on Healthcare Professionals' Mental Health: Results from a Pilot Study Testing Its Predictive Validity in a Specialized Hospital Setting.

This pilot study aimed to evaluate the feasibility and acceptability of a Mindfulness-Based Stress Reduction (MBSR) training and to examine positive and negative symptom-focused mental health variables. The mental health variables were used to test the predictive validity of the training among healthcare professionals. Thirty healthcare professionals participated in this non-randomized pre-post intervention pilot study. The questionnaire on mental health was filled in twice. Baseline and post-intervention differences were tested with paired samples t-tests and Wilcoxon signed-rank tests. The participants’ evaluation of the training was assessed with a five-item questionnaire. The recruitment and retention were successful, and participants’ evaluation of the training itself was positive but the influence on daily life was rated only moderately positive. In comparison with baseline at post-intervention participants showed significant improvements in general mindfulness, the burnout dimension personal accomplishment, quality of sleep, positive emotions, and self-efficacy. A significant decrease was found in the burnout dimension emotional exhaustion, stress level, negative emotions at work, and worrying. No significant changes were found for the burnout dimension mental distance, and work engagement. The measures showed ample within-person differences and low, medium, or high effect sizes. The current trial approach of the MBSR training seems feasible and acceptable. Our results suggest that mindfulness, burnout, stress level, quality of sleep, positive emotions at work, negative emotions at work, self-efficacy, and worrying are meaningful mental health variables for inclusion in a larger-scale Randomized Controlled Trial on the effects of MBSR.

A mixed-methods pilot study of ‘LIFEView’ audiovisual technology: Virtual travel to support well-being and quality of life in palliative and end-of-life care patients

Background: There is evidence that psychosocial and spiritual interventions of short duration, such as reminiscence therapy, provide positive impacts on quality of life and emotional and existential well-being in adults receiving palliative care. Aim: To determine (1) the feasibility of integrating ‘LIFEView’, a video-based software with >1600 videos of world destinations, in palliative care settings, and (2) positive, neutral or harmful effects of using ‘LIFEView’ videos. Design: A mixed-methods pre–post intervention pilot study was conducted to collect feasibility and preliminary data on physical and psychological symptoms, physiological indicators, spiritual well-being and aspects of quality of life. Setting/participants: Adult patients on an inpatient palliative care unit or receiving care from a community palliative care consultation team who were capable of providing consent and completing the outcome measures were eligible participants. Results: Overall, 27/41 (66%) participants took part in the study. Feasibility criteria, including participant acceptability, low participant burden, tool completion rate and retention rate, were fulfilled, though challenges were experienced with recruitment. Modest improvements, though non-significant, were shown on preliminary data collected on physical and psychological symptoms using the Edmonton Symptom Assessment System–revised, spiritual well-being assessed by the 12-item Functional Assessment of Chronic Illness Therapy – Spiritual Well-Being scale and physiological measurements. Qualitative analysis revealed five themes: motivations for using ‘LIFEView’, perceptions of the technology, reminiscence, ‘LIFEView’ as an adaptable technology and ongoing or future use. Conclusion: A future adequately powered study to investigate the impacts of ‘LIFEView’ on patient well-being and quality of life appears to be feasible.

1037. A Pharmacist-Driven 48 Hour Antibiotic Time Out Pilot at a Large Academic Medical Center

BackgroundThe Centers for Disease Control and Prevention published The Core Elements of Hospital Antibiotic Stewardship Programs in 2014, which recommended that all clinicians perform an antibiotic time out (ATO) after 48 hours. The best methods to operationalize these recommendations remain unclear. Given our information technology barriers, we developed a targeted, pharmacist-driven, 48 hour ATO pilot.MethodsThis pre-post intervention pilot study included hospitalized adults admitted to one of the four wards between 5/1/18 and 6/30/18. Patients who received ≥48 hours of broad-spectrum intravenous antibiotics (vancomycin, piperacillin–tazobactam, cefepime, a carbapenem, or a fluoroquinolone) were prospectively identified via TheraDoc (Premier Inc., Charlotte, NC). An infectious diseases (ID) trained pharmacist reviewed patients on a daily basis during June. The primary outcome was days of therapy (DOT), which was assessed with Spearman’s rank-order correlation. All P-values were from 2-sided tests, and results were deemed statistically significant at P < 0.05.ResultsA total of 151 unique patients were identified during the study period. The most common antibiotic indications were skin and soft-tissue infection (31.1%), urinary tract infection (22.5%), and intraabdominal infection (22.5%). An ID physician was consulted on 59% of patients. The pharmacist reviewed an average of 7 patients (3 unique) each day during the intervention month. A total of 27 recommendations were made with 15 (56%) being accepted. The most common recommendations were to de-escalate therapy (n = 8), stop antibiotics (n = 6), and add a stop date to the antibiotic order (n = 4). DOT in the pre- and post-intervention period did not differ (P = 0.28).ConclusionA month-long, targeted, pharmacist-driven, 48 hour ATO pilot was unable to demonstrate a reduction in DOT. Furthermore, only 56% of pharmacist recommendations were accepted despite targeting low-acuity infections, which may have limited our ability to observe a reduction in DOT. Larger studies are warranted to further evaluate how ATOs influence DOT over time.Disclosures All authors: No reported disclosures.

Sleep Pattern and Sports Performance of Adolescent Archers: A Pre–Post-intervention Pilot Study

Sleep is an important factor for sports performance. Physiological delay in sleep–wake phase and sports training pose adolescent athletes at increased risk of sleep problems. The aim of the study was to observe the sleep pattern and effect of non-pharmacological sleep strategies in adolescent archers. Fifteen male adolescent archers participated. Sleep measures were recorded using ‘School Sleep Habits Survey’ questionnaire. Awareness of benefits of good sleep on recovery in sports was done for coaches, staff and players. Institution of a sleep consultation and practice of non-pharmacological strategies to improve sleep for players was carried out for a year. Sleep measures and archery scores were analysed. Sleep pattern showed delayed sleep onset and decreased sleep duration. Post-intervention, total sleep duration increased during weekdays and weekends and sleep onset latency significantly reduced during weekdays (p = 0.008). Archery practice shooting score over the year significantly improved (p = 0.018). Sleep in adolescent archers showed altered sleep parameters. Self-awareness and sleep hygiene education of coaches and players along with non-pharmacological interventions showed a significant improvement in sleep and archery performance. CTRI/2017/05/008676.

Attitudes Towards Adapted Lifestyle-Integrated Functional Exercise Developed for 60–70-Year-Olds: Perceptions of Participants and Trainers

Background: Time commitments, limited access, or unwillingness to join a group are some of the many reasons for low adherence to structured exercise in older adults. A promising alternative approach is integrating exercise into daily routines. Objective: This study tested whether an adapted Lifestyle-integrated Functional Exercise (aLiFE) programme is suitable for adults aged 60–70 years. Methods: The aLiFE approach was evaluated by interviews and focus-groups with participants and trainers following 4-week pre-post intervention pilot study. For data analyses, Framework Approach was used. Coding was managed using NVivo, and subsequently organised into overarching themes. Results: Twenty women and 11 men (mean age 66.4 ± 2.7 years) and 6 trainers (30.0 ± 6.2 years; 5 women) participated. Both participants and trainers were positive about the programme. Participants understood the concept of integrating balance, strength and physical activities into daily lives and valued the individual tailoring in the programme, the preventive approach, and the support of trainers. Trainers valued the flexible approach and peer support between trainers. However, both participants and trainers disliked the extensive study paperwork and reported some challenges to integrate activities into daily routines during the compressed intervention: busy and varied lifestyles, embarrassment performing activities in public, pain, difficulty of specific activities. Participants noted habitualisation of some activities within the short intervention period, even without continuous self-monitoring. Conclusions: aLiFE is a highly acceptable intervention amongst adults aged 60–70 years. Trainers are especially relevant as motivators and support providers. The effectiveness of the aLiFE approach should be tested in a randomised controlled trial.

Improving the attitudes of primary care practitioners toward adolescent care: a pre-post intervention pilot study.

Background Investing in adolescent health is among the most cost-effective health measures. Primary care practitioners are ideally positioned to deliver such interventions. However, several barriers hinder them from engaging with adolescents. Objective To pilot test the impact of a 1-day training session on adolescent health on the attitudes of primary care practitioners toward adolescent care. Subjects Participants were family physicians and nurses enrolled in a 1-day training session on adolescent health. Methods A non-randomized, pre-post intervention study with no control group. Data on barriers for providing care to adolescents, preferred pediatric age group and attitudes toward adolescent care were collected immediately prior. Participants' attitudes were measured again immediately after training. Results Most participants reported they preferred to attend pediatric groups other than adolescents. The most frequently reported barriers were: excessive amount of time needed and lack of training. Participants reported positive pre-training attitudes, with mean scores above the midpoint of the scale in all dimensions. Significant positive improvements were observed after training in Adequacy, Self-esteem and Satisfaction. Subgroup analysis showed that at baseline, professionals who preferred to work with adolescents had significantly more positive attitudes in Adequacy, Self-esteem and Satisfaction. After training there was a general improvement in attitudes in both groups, with attenuation of the differences between them. Conclusion Participation in a 1-day tailored educational intervention on adolescent health had a positive impact on the attitudes of primary care practitioners, regardless of their preferred age group. This improvement may lead to more active engagement with adolescents and substantial health gains.

Feasibility of parent-mediated behavioural intervention for behavioural problems in children with Autism Spectrum Disorder in Nigeria: a pilot study.

BackgroundAutism Spectrum Disorders (ASD) is a disabling and lifelong neuro-developmental disorder. Challenging behaviours such as aggression and self injury are common maladaptive behaviours in ASD which adversely affect the mental health of both the affected children and their caregivers. Although there is evidence-base for parent-delivered behavioural intervention for children with ASD and challenging behaviours, there is no published research on the feasibility of such an intervention in sub-Saharan Africa. This study assessed the feasibility of parent-mediated behavioural intervention for challenging behaviour in children with ASD in Nigeria.MethodsThis was a pre-post intervention pilot study involving 20 mothers of children with DSM-5 diagnosis of ASD recruited from a Child and Adolescent Mental Health Service out-patient Unit. All the mothers completed five sessions of weekly manualised group-based intervention from March to April, 2015. The intervention included Functional Behavioural Analysis for each child followed by an individualised behaviour management plan. The primary outcome measure was the Aggression and Self Injury Questionnaire, which assessed both Aggression towards a Person and Property (APP) and Self Injurious Behaviour (SIB). The mothers’ knowledge of the intervention content was the secondary outcome. All outcome measures were completed at baseline and after the intervention. The mothers’ level of satisfaction with the programme was also assessed. Treatment effect was evaluated with Wilcoxon Signed Rank Tests of baseline and post-intervention scores on outcome measures.ResultsThe children were aged 3–17 years (mean = 10.7 years, SD 4.6 years), while their mothers’ ages ranged from 32 to 52 years (mean 42.8 years, SD 6.4 years). The post intervention scores in all four domains of the APP and SIB were significantly reduced compared with pre-intervention scores. The mothers’ knowledge of the intervention content significantly increased post-intervention. The intervention was well received with the vast majority (75 %) of participants being very satisfied and all (100 %) were willing to recommend the programme to a friend whose child has similar difficulties.ConclusionsParent-mediated behavioural intervention is a feasible and promising treatment for challenging behaviour in children with ASD in Nigeria. Behavioural intervention should be an integral component in scaling up services for children with ASD in Nigeria.

The Effect of Adherence-Encouraging Interventions on Adherence to Tyrosine Kinase Inhibitor Treatment in Chronic Myeloid Leukemia (TAKE-IT): A Pre-Post Intervention Pilot Study

Introduction: Medication non-adherence (MNA) to tyrosine kinase inhibitors TKIs occurs in around 30% of chronic myeloid leukemia (CML) patients and is associated with adverse outcomes (Noens, 2009; Marin, 2010). Data on adherence-enhancing interventions (AEIs) in CML are scarce and an improvement in dose implementation has yet to be shown.Objective: To evaluate the efficacy of a multilevel AEI in improving MNA to TKIs in CML.Methods: We initiated a prospective multicenter (N=4) pre-post adherence intervention pilot study in CML (NCT01768689). Patients were eligible if they had received at least 3 months of imatinib, nilotinib or dasatinib for CML, irrespective of treatment line or subsequent duration. TKI adherence was assessed for 7.5 months using electronic monitoring (EM) with MEMS (Medical Events Monitoring System 6) and BAASIS. The MEMS bottle cap contains a micro-electronic circuit that registers dates and times of cap opening. The BAASIS is a 4-item patient reported outcome used to assess adherence in solid organ transplants and CML (Cleemput, 2007; Noens, 2009).We designed an investigational AEI to address known barriers to TKI adherence in CML (Figures 1 & 2), using components with proven efficacy in improving MNA in chronic diseases. The key elements were: behavioral change techniques (BCT); motivational interviewing (MI; Figure 2); and multilevel including patient (Figure 1), peer group and health care provider levels (not shown). The BCT taxonomy developed by Michie et al (Ann Behav Med, 2013) was used in Figures 1 & 2 to describe the intervention and to facilitate its reproducibility.During the first 4.5 months of adherence monitoring, MNA was managed as per local practice. The intervention phase was then initiated (Figure 1) and adherence measured for a further 3 months. The pre and post-intervention periods were defined as the 3 months before and after the initiation of the AEI, respectively. The primary outcome measure was EM adherence using MEMS, and primary analysis was the comparison between pre and post-intervention adherence, expressed as the percentage of days with drug taken as prescribed. Generalized Estimating Equation model was used to adjust for correlation between adherence levels pre and post intervention, measured in the same patient. We also explored the association between adherence according to BAASIS (at 3 different time-points during the pre/post intervention periods) and the corresponding 1-month periods of EM adherence.Results: Between 10/2013 and 7/2014, we enrolled 55 CML patients (median age, 60.5 years; median current TKI duration, 34 months) receiving imatinib (59%), nilotinib (18%) or dasatinib (23%).Median pre-intervention EM adherence was 97.5% (min 48%; 10th percentile: 82.6%; 25th: 92.1%; 75th: 99.3%; 90th: 100%; max 100%) and the mean was 93%. Non-membership in a CML patients group (51%), living alone (18%) and 3rd line treatment (9%) were each risk factors for pre-intervention MNA on multivariate analysis, whereby mean adherence was 7% (p<0.01), 10.2% (p=0.03) and 13.9% (p=0.01) lower than patients without each of these risk factors, respectively. The estimated mean adherence was near perfect (99.7%) with none of the above risk factors (N=21; 38%).The AEI affected a 1.45% improvement in adherence for the whole cohort (95% CI: 0.09-2.8%, p=0.04). The AEI led to an improvement of 2.51% in the non-members of a CML patient group (95% CI: 0.2-4.8%, p=0.03) relative to 0.25% (p=0.71) in the members. By extrapolation, this corresponds to an additional 5.3 days of correct intakes over 1 year for the whole cohort, and 9.5 days for non-members of a CML patient group. Using an exploratory cut-off of EM adherence ≥ 95% as adherent, the BAASIS (N=132) correctly classified 75.5% (74/98) as adherent and 73% (25/34) as non-adherent.Conclusion: The effect of the AEI is modest but statistically significant, and higher in non-members of a CML patients group. At the same time, this study shows the futility and potential resource wasting of trying to improve adherence in the large group of near-perfect adherers without risk factors. Our pilot study provides proof of concept that EM adherence may be improved in CML patients by a multilevel AEI, and that the magnitude of improvement is higher in subgroups at risk. These subgroups should be identified, if possible, by combining patient characteristics with the BAASIS. [Display omitted] [Display omitted] DisclosuresLeader:Novartis: Research Funding. Sharf:Pfizer: Honoraria; BMS: Honoraria, Research Funding; Gilead: Honoraria; Novartis: Honoraria, Research Funding; Ariad: Honoraria, Research Funding. Tousset:MWV Healthcare: Employment. Ellis:Novartis: Other: Advisory Board; Pfizer: Other: Advisory Board. Raanani:BMS: Other: Advisory Board; Pfizer: Other: Advisory Board; Novartis: Other: Advisory Board, Research Funding; Ariad: Other: Advisory Board.

Care planning practices for behavioural and psychological symptoms of dementia in residential aged care: A pilot of an education toolkit informed by the Aged Care Funding Instrument

Aim: To assess the feasibility and the effects of a multi-component education toolkit that used the Aged Care Funding Instrument behaviour (ACFI-BEH) scores to trigger care planning for older people experiencing behavioural and psychological symptoms of dementia (BPSD). Method: Forty-six older people and 209 staff and managers from five Sydney metropolitan residential aged care (RAC) facilities participated in this pre–post intervention pilot study. Results: The face validity and accessibility/acceptability of the toolkit was established, but potential utility of the ACFI-BEH in informing care planning was proven to be negligible. The ACFI-informed education toolkit did not lead to statistically significant improvements in care planning practice or reduce the severity/frequency of the targetted BPSD. Care plan quality remained low post intervention, with between 31% (N = 12/39) and 65% (N = 13/20) of care plans not addressing the persons’ BPSD, nor utilising the ACFI information in relation to BPSD. Conclusion: This study has underscored the problems associated with current care planning practice in RAC settings and the need for developing strategies to ensure quality and safe care through individualised care planning practices. Our study processes, results and lessons discussed in this paper could assist future research on this type of research in RAC settings.