Self-management support with the Respiratory Adherence Care Enhancer instrument in asthma and chronic obstructive pulmonary disease: An implementation trial.

AIM: Suboptimal self-management with controller inhalation therapy in asthma and COPD is frequently observed with poor treatment outcomes. The developed 'Respiratory Adherence Care Enhancer' (RACE) instrument identifies and addresses individual barriers to self-management with a theoretical underpinning. This study investigates the feasibility of pharmaceutical support with this instrument. METHODS: An implementation trial was conducted with asthma and COPD patients in 5 community pharmacies in the Netherlands. Patients were allocated to standard care or add-on support with the RACE instrument. Patients were invited to complete the RACE questionnaire at baseline, 5-week and 10-week follow-up. Barrier profiles were accessible for the intervention group with subsequent consultations at baseline and 5-weeks. Experiences were collected from patients and consultants with a questionnaire and reported findings. Primary endpoints focused on the acceptability, practicality and implementation process. Secondary endpoints included between-group differences in barrier and disease control outcomes from baseline at 10-weeks follow-up. RESULTS: In total, 84 patients were included; 48 were assigned to intervention and 36 to standard care. Patient satisfaction of support with the RACE instrument was high (71%). Patients felt motivated, reassured and more confident about their disease management. Consultants reported an increase in awareness of patient barriers. Patient recognition of barrier profiles was 83.9% (±12.9%). The barrier inhaler techniques decreased significantly for the intervention group at follow-up with odds ratio 0.30 (95% confidence interval, 0.10-0.91). No significant differences were observed for changes in number of barriers and disease control. CONCLUSION: Self-management support with the RACE instrument is feasible and appreciated, facilitating behaviour change with patient-centred pharmaceutical care in asthma and COPD.

Respiratory Adherence Care Enhancer Questionnaire: Identifying Self-Management Barriers of Inhalation Corticosteroids in Asthma.

Introduction: Suboptimal self-management of inhaled corticosteroids (ICS) in asthma patients is frequently observed in clinical practice and associated with poor asthma control. Driving factors for suboptimal self-management are complex and consist of a range of behavioral barriers (cognitive, affective and practical) with a considerable inter-individual variability. Identification of individual barriers facilitates the use of corresponding behavior change techniques and tailored care to improve asthma treatment outcomes. Objective: This study describes the development and validation of the 'Respiratory Adherence Care Enhancer' (RACE) questionnaire to identify individual barriers to self-management of ICS therapy in asthma patients. Methods: The development included: 1) an inventory of self-management barriers based on a literature review, 2) expert assessment on relevance and completeness of this set, linking these barriers to behavioral domains of the Theoretical Domains Framework (TDF) and 3) the formulation of corresponding questions assessing each of the barriers. A cross-sectional study was performed for validation. Primary care asthma patients were invited to fill out the RACE-questionnaire prior to a semi-structured telephonic interview as golden standard. Barriers detected from the questionnaire were compared to those mentioned in the interview. Results: The developed questionnaire is made up of 6 TDF-domains, covering 10 self-management barriers with 23 questions. For the validation 64 patients completed the questionnaire, of whom 61 patients were interviewed. Cronbach's alpha for the consistency of questions within the barriers ranged from 0.58 to 0.90. Optimal cut-off values for the presence of barriers were determined at a specificity between 67 and 92% with a sensitivity between 41 and 83%. Significant Areas Under the Receiver Operating Curves values were observed for 9 barriers with values between 0.69 and 0.86 (p-value <0.05), except for 'Knowledge of ICS medication' with an insignificant value of 0.53. Conclusion: The RACE-questionnaire yields adequate psychometric characteristics to identify individual barriers to self-management of ICS therapy in asthma patients, facilitating tailored care.

Exploring Patient's Perspectives and Experiences After Start with Inhalation Maintenance Therapy: A Qualitative Theory-Based Study.

BACKGROUND: Treatment of obstructive lung disease with inhalation therapy needs changes in patient behavior. Shortly after the start with inhaled corticosteroids (ICS) maintenance therapy, patients might be in need of additional pharmaceutical care, tailored to their individual needs. This study aimed to provide insight into patient behavior, goals and perceptions regarding their medical treatment at start with ICS therapy, by telephone interviews with ICS starters. Besides, this study investigated pharmacists' and patients' experiences with these interviews and opinions on the utility of this type of consultation for daily practice. METHODS: Semi-structured telephone interviews were conducted by pharmacists with adult patients 2-3 weeks after starting ICS. The Theoretical Domain Framework (TDF) was used for data analysis and coding. Afterward, the patients and pharmacists were questioned about their experiences with the interview. RESULTS: Five pharmacists conducted interviews with 23 ICS starters. Except the domains "environmental context and resources", "optimism", and "reinforcement", the remaining 11 domains in the TDF were addressed in the interviews. The majority of patients defined personal goals, which mainly addressed disease or symptom control (clinical goals). Some patients showed a lack of knowledge regarding the clinical indication or therapy duration. Views on beneficial medication effects differed between patients. Some patients specifically mentioned concerns or anxiety about side effects. The interviewees described different perceptions on the necessity of a personalized routine for regular medication use. Patients and pharmacists both felt positive about an added value of these interviews for daily practice. CONCLUSION: Patient interviews shortly after start with ICS therapy revealed various perceptions and beliefs that might influence medication use and achievement of individual treatment goals. The patients appreciated the opportunity to ask questions and share their perspectives and needs with their pharmacist, and the pharmacists experienced that the interviews had added value.

Adherence to guideline recommendations for asthma care in community pharmacies: actual and needed performance.

Pharmaceutical care guidelines aim to provide recommendations for pharmaceutical care, reduce unwanted pharmacy practice variation and ultimately improve the quality of healthcare. This study evaluated community pharmacists' adherence to recommendations for the provision of care to asthma patients with first dispensing and follow-up refill encounters in The Netherlands. Data were pharmacists' self-assessment of adherence to guideline recommendations, independent observations of dispensing encounters and a nationwide questionnaire on pharmacists' views on the desirable (clinical) necessity of applying guideline recommendations to their patient population. The 21 pharmacists who performed self-assessment judged their adherence concerning inhalation instructions as high. The lowest scores were reported for recommendations to collect additional information on the type of lung disease and for asking patients' expectations, wishes and concerns. Sixty-eight dispensing encounters were observed. In 83% of the 35 first dispensing observations, inhalation instruction was provided. This percentage was lower (62%) at refill dispensings. During all encounters, pharmacy staff seldom explored patients' perceptions or responded to patients' expectations, wishes and concerns. One hundred and four pharmacists completed the feasibility questionnaire. Pharmacists judged that all patients should receive inhalation instruction at first dispensing. They regarded it necessary to check on patients' expectations, wishes and concerns regarding the treatment for only up to 70% of the patients. More efforts on guideline implementation are needed, especially on follow-up dispensings and on gaining relevant information from patients and other healthcare professionals. Pharmacists still have opportunities to grow in applying a patient-tailored approach and exploring patients' individual needs, rather than providing practical information.

Self-Management Maintenance Inhalation Therapy With eHealth (SELFIE): Observational Study on the Use of an Electronic Monitoring Device in Respiratory Patient Care and Research.

BACKGROUND: Electronic inhalation monitoring devices (EIMDs) are available to remind patients with respiratory diseases to take their medication and register inhalations for feedback to patients and health care providers as well as for data collection in research settings. OBJECTIVE: This study aimed to assess the validity as well as the patient-reported usability and acceptability of an EIMD. METHODS: This observational study planned to include 21 community pharmacies in the Netherlands. Patient-reported inhalations were collected and compared to EIMD registrations to evaluate the positive predictive value of these registrations as actual patient inhalations. Patients received questionnaires on their experiences and acceptance. RESULTS: A convenience sample of 32 patients was included from across 18 pharmacies, and 932 medication doses were validated. Of these, 796 registrations matched with patient-reported use (true-positive, 85.4%), and 33 inhalation registrations did not match with patient-reported use (false-positive, 3.5%). The positive predictive value was 96.0%, and 103 patient-reported inhalations were not recorded in the database (false-negative, 11.1%). Overall, patients considered the EIMD to be acceptable and easy to use, but many hesitated to continue its use. Reminders and motivational messages were not appreciated by all users, and more user-tailored features in the app were desired. CONCLUSIONS: Patients' interaction with the device in real-world settings is critical for objective measurement of medication adherence. The positive predictive value of this EIMD was found to be acceptable. However, patients reported false-negative registrations and a desire to include more user-tailored features to increase the usability and acceptability of the EIMD.

Barriers and facilitators for community pharmacists' participation in pharmacy practice research: a survey.

OBJECTIVES: The aim of this study was to explore pharmacists' barriers and facilitators regarding participation in pharmacy practice research. METHODS: We conducted an online cross-sectional survey in 1974 community pharmacies in the Netherlands. KEY FINDINGS: A total of 252 pharmacists completed the questionnaire. The majority agreed that participation in research should be part of daily practice. Efficient time investment and a clear benefit for general professional knowledge, patient care and pharmacy organisation were the most important facilitating factors. CONCLUSIONS: To encourage pharmacists' participation, researchers should offer clear instructions, possibilities for flexible time management, simple patient inclusion, task delegation and no additional contacts with healthcare professionals due to the research.

Considerations of prescribers and pharmacists for the use of non-selective ß-blockers in asthma and COPD patients: An explorative study.

RATIONALE, AIMS, AND OBJECTIVES: Despite recommendations in prevailing guidelines to avoid the use of non-selective (NS) ß-blockers in patients with asthma or COPD, on average, 10 patients per community pharmacy receive NS ß-blockers monthly. The aim of our study was to identify the reasons of prescribers and pharmacists to treat asthma and COPD patients with NS ß-blockers. METHODS: Fifty-three community pharmacists in the Netherlands selected patients with actual concurrent use of inhalation medication and NS ß-blockers. For at least 5 patients, each pharmacist screened all medication surveillance signals and actions taken at first dispensing. Each pharmacist selected 3 different initial prescribers for a short interview to explore their awareness of the co-morbidity and reasons to apply NS ß-blockers. RESULTS: Pharmacists identified 827 asthma/COPD patients with actual use of NS ß-blockers. From these, 153 NS ß-blocker prescribers were selected and interviewed (64 general practitioners, 45 ophthalmologists, 24 cardiologists, and 20 other prescribers). One hundred seven prescribers were aware of the drug-disease interaction of the asthma or COPD co-morbidity when initiating the NS ß-blocker, and 46 were not. From these, 40 prescribers did not consider the contraindication to be relevant. For 299 patients, medication surveillance signals and actions at first dispensing were retrieved. Patients used predominantly ocular timolol (39.8%), and the oral preparations propranolol (30.8%) and carvedilol (15.1%). In 154 cases, the pharmacy system generated a warning alert. CONCLUSIONS: A substantial number of prescribers was unaware of the co-morbidity or did not regard NS ß-blockers contraindicated, despite prevailing clinical guidelines. Improvement programs should target prescribers' awareness and knowledge of NS ß-blockers in patients with asthma or COPD.

Self-management research of asthma and good drug use (SMARAGD study): a pilot trial.

Background Community pharmacists play an important role in supporting patients for optimal drug use. Objective To assess the effectiveness of monitoring in asthma patients with inhaled corticosteroids (ICS) on disease control. Setting Asthma patients using ICS were invited from two intervention (IG) and two control pharmacies (CG). Method Participating patients completed questionnaires at the study start and at 6-month follow-up, including the Control of Allergic Rhinitis and Asthma Test (CARAT) questionnaire. IG patients completed the CARAT questionnaire every 2 weeks and received counselling on disease management, ICS adherence, and inhalation technique when scores were suboptimal, deteriorating, or absent. For Turbuhaler users, additional electronic monitoring (EMI) was available, with daily alerts for ICS intake. Main outcome measure As the primary outcome, CARAT scores at follow-up were compared between IG and CG using linear regression. As secondary outcome, refill adherence was compared using logistic regression. Results From March to July 2015, we enrolled 39 IG and 41 CG patients. At follow-up, CARAT scores did not differ between IG and CG (-0.19; 95% confidence interval [CI], -2.57 to 2.20), neither did patient numbers with ICS adherence >80% (0.82; 95% CI, 0.28-2.37). Among EMI users, CARAT scores did not differ, but ICS adherence >80% showed a 4.52-fold increase (95% CI, 1.56-13.1) compared with EMI nonusers. Conclusion Among community-dwelling asthma patients, pharmacist monitoring did not affect CARAT scores, but EMI use showed improved ICS refill adherence.

The RT-18: a new screening tool to assess young adult risk-taking behavior.

Risk-taking behavior is a major determinant of health and plays a central role in various diseases. Therefore, a brief questionnaire was developed to assess risk taking among young adults with known different levels of risk-taking behavior (social drinkers and recreational drug users). In Study 1, N = 522 university students completed the RT-18 risk taking questionnaire. N = 100 students were retested after 2 to 4 weeks and performed the Cambridge Gambling Task (CGT). Mean RT-18 score was 7.69 and Cronbach's alpha was 0.886. The test-retest reliability was r = 0.94. Significant correlation was found between the RT-18 score and CGT scores of risk taking, bet proportion, and risk adjustment. In Study 2, N = 7834 young adult social drinkers, and recreational drug users, mean RT-18 score was 9.34 and Cronbach's alpha was 0.80. Factor analysis showed that the RT-18 comprises two factors assessing level of risk-taking behavior and risk assessment. Men scored significantly higher than women on the RT-18. Recreational drug users had significantly higher scores when compared to social drinkers. In Study 3 of N = 1000 students, construct validity was confirmed by showing that the RT-18 outcome correlates significantly with scores on the Stimulating-Instrumental Risk Inventory. In conclusion, the RT-18 is a valid and reliable screening tool to differentiate levels of risk-taking behavior. This short scale is quick and practical to administer, imposing minimal demands on participants. The RT-18 is able to differentiate risk taking and risk assessment which can help target appropriate intervention strategies.

Effects of alcohol on highway driving in the STISIM driving simulator.

OBJECTIVE: The STISIM driving simulator is widely used. To enhance its usefulness in pharmacological research, a calibration study was performed to test a standardized highway driving test scenario after administration of three different dosages of alcohol and placebo. METHODS: Twenty-seven healthy young adults (14 men and 13 women; mean age (SD) = 22.8 (1.4)) participated in this randomized, single-blind crossover trial. Subjects received alcohol to gain a blood alcohol concentration (BAC) of 0.05%, 0.08%, and 0.11%, or placebo-alcohol. In each condition, subjects completed a 100-km highway driving simulator test. The standard deviation of lateral position, the weaving of the car, was the primary parameter of the test. RESULTS: Alcohol produced dose-dependent driving impairment. Standard deviation of lateral position and standard deviation of speed were significantly increased relative to placebo (p < 0.05). Subjective driving assessments were in line with the objective driving measurements. CONCLUSION: The STISIM highway driving simulator test is able to differentiate dose-dependent impairment after administration of alcohol. The highway driving test scenario is suitable for future psychopharmacological research.

Identifying metabolic syndrome without blood tests in young adults--the Terneuzen Birth Cohort.

BACKGROUND: Within the context of the obesity epidemic identifying young adults at risk for type 2 diabetes and cardiovascular disease is important. A practical approach is based on the identification of metabolic syndrome (MetS). Our objective was to develop a simple and efficient stepwise strategy to identify MetS in young adults. METHODS: Subjects were part of a birth cohort (n = 2599) in Terneuzen, The Netherlands, born in 1977-86. In 2004-05: 642 of these young adults participated in a physical examination and blood tests. Tree regression was used to determine the optimal decision strategy to identify MetS. RESULTS: Overall prevalence of MetS, defined according to the NCEP ATPIII, was 7.5%. The tree regression yielded an optimal stepwise strategy that eliminated the need for blood tests for the diagnosis of MetS in 50-90% of the cases, depending on the accepted level of error. A large group (52% of the total) with BMI <35 had a normal waist circumference (WC) and normal blood pressure (BP). None of them had MetS. Subjects with BMI > or =35 all had MetS. If BMI <30, 38% had an increased WC or increased BP with a risk of MetS of only 6%. So for them the omission of blood tests could also be considered. CONCLUSION: In most young adults MetS can be identified or excluded without blood tests by a simple and stepwise strategy, based on the measurement of BMI, WC and BP. This makes it possible to develop simple prevention strategies for young adults at risk for type 2 diabetes and cardiovascular disease.