Process evaluation of a pharmacist-led intervention aimed at deprescribing and appropriate use of cardiometabolic medication among adult people with type 2 diabetes.

BACKGROUND: A quasi-experimental study investigated a pharmacist-led intervention aimed at deprescribing and medication management among adult patients with type 2 diabetes at risk of hypoglycaemia. OBJECTIVE: This study aimed to evaluate the process of implementing the intervention consisting of a tailored clinical medication review (CMR) supported by a training and a toolbox. METHODS: Mixed-methods study based on the Grant framework, including the domains "recruitment," "delivery of intervention" and "response" of pharmacists and patients. Data collected were administrative logs, semi-structured observations of patient consultations (n = 8), interviews with pharmacists (n = 16) and patient-reported experience measure (PREM) questionnaires (n = 66). RESULTS: Tailored CMRs were conducted largely as intended for 90 patients from 14 pharmacies. Although patient selection based on a medication-derived hypoglycaemia risk score was considered useful, pharmacists experienced barriers to proposing deprescribing in patients with recent medication changes, without current hypoglycaemic events, or treated by medical specialists. The training and toolbox were evaluated positively by the pharmacists. Overall, patients were satisfied with the CMR. CONCLUSION: Pharmacists and patients valued the CMR focusing on deprescribing and medication management. To optimize implementation and effectiveness of the intervention, improvements can be made to the patient selection, pharmacist training and the collaboration between healthcare professionals.

How to quit cannabis when you have a mental illness: study from the perspective of patients who have successfully quit.

AIMS AND METHOD: Research regarding quitting cannabis use often excludes patients with severe mental illness (SMI). We investigated facilitating and impeding factors in SMI patients and their advice to others, using semi-structured interviews with 12 SMI-patients, who were daily cannabis users for ≥12 months and had fully stopped using for ≥6 months. RESULTS: Seeking distraction, social contacts in personal environment, avoiding temptation and support from professionals were facilitating factors in stopping. Impeding factors were withdrawal symptoms, user environment, experiencing stress and user's routine. Advice to other patients included to just do it, seek support from others, quit 'cold turkey' and acknowledge that cannabis use is a problem. Advice to mental health professionals is to discuss cannabis use from the start of treatment. CLINICAL IMPLICATIONS: It is important to inform patients that cannabis use has negative consequences and limits the effects of treatment. Do not judge cannabis use or force the patient to stop.

What Are the Drug-Related Problems Still Faced by Patients in Daily Life?-A Qualitative Analysis at the Pharmacy Counter.

BACKGROUND: Drug-related problems (DRPs) affect many patients. Many activities in general practice, hospitals, and community pharmacies have been initiated to tackle DRPs. However, recent studies exploring what DRP patients are still facing in their daily lives are scarce. METHODS: Danish pharmacy staff registered DRPs in prescription encounters to understand what DRPs patients are still experiencing in daily life. They noted short descriptions of what happened in the encounter that qualified the incident as a DRP. The descriptions were subjected to an inductive content analysis. RESULTS: A wide range of DRPs that impacted patients' daily lives practically and healthwise were identified. In total, eighteen percent of patients with prescriptions had a DRP. Three overall stages of DRPs were identified: challenges in receiving the medications, not knowing how or why to take the medications, and not experiencing satisfactory effects. Patients were emotionally affected by these problems. CONCLUSIONS: DRPs are still widespread in patients' daily lives and influence their well-being. The identified DRPs illustrated the complexity of obtaining medications to work as intended and demonstrate that health professionals must take even the basics of medication intake much more seriously.

Exploration of the effects of an innovative mentalization-based training on patient-centered communication skills of pharmacy staff: A video-observation study.

OBJECTIVE: To explore whether a mentalization-based communication training for pharmacy staff impacts their ability to elicit and recognize patients' implicit and explicit medication related needs and concerns. METHODS: A single-arm intervention pilot study was conducted, in which pre-post video-recordings of pharmacy counter-conversations on dispensed-medication (N = 50 and N = 34, respectively; pharmacy staff: N = 22) were coded. Outcome measures included: detecting needs and concerns, and implicitly and explicitly eliciting and recognizing them. Descriptive statistics and a multi-level logistic regression were conducted. Excerpts of videos with needs or concerns were analyzed thematically on mentalizing attitude aspects. RESULTS: Indications show that patients more often express their concerns in an explicit way post-measurement, just as pharmacy staffs' explicit recognition and elicitation of needs and concerns. This was not seen for patients' needs. No statistically significant differences were found for determinants for detecting needs or concerns (i.e., measurement-, professional-type, or interaction). Differences in mentalizing attitude were observed between pre-post-measurements, e.g., more attention for patients. CONCLUSION: This mentalizing training shows the potential of mentalizing to improve pharmacy staff members' explicit elicitation and recognition of patients' medication-related needs and concerns. PRACTICE IMPLICATIONS: The training seems promising for improving patient-oriented communication skills in pharmacy staff. Future studies should confirm this result.

Pharmacist-led intervention aimed at deprescribing and appropriate use of cardiometabolic medication among people with type 2 diabetes.

BACKGROUND: Potential overtreatment with cardiometabolic medication (i.e., glucose lowering medication, antihypertensives and statins) has been observed in 10-40% of older people with type 2 diabetes (T2D). OBJECTIVE: The potential effects of a pharmacist-led clinical medication review targeted at T2D patients who were at high risk of hypoglycaemia will be investigated. METHODS: A quasi-experimental study was conducted in 14 Dutch community pharmacies. Patients with a high risk of hypoglycaemia were identified using a previously developed algorithm. Pharmacists confirmed eligibility and selected patients for the intervention. Remaining eligible patients were included as controls receiving usual care. The primary outcome was the proportion of intervention patients for whom an action on deprescribing or appropriate use of cardiometabolic medication was implemented. After three months, changes in cardiometabolic medication were compared between the intervention and control group using a Fischer exact test. RESULTS: In total 90 intervention patients and 107 control patients were included. Intervention patients had an average age of 70, used on average 10 medications, five of which were cardiometabolic medication. For half of the intervention patients an action on deprescribing cardiometabolic medication was implemented (n = 25) and/or an advice about appropriate use of cardiometabolic medication was given (n = 22). In 48% of intervention patients at least one cardiometabolic medication (e.g. insulin, sulfonylurea, diuretic, beta-blocker, statin) was either stopped or reduced in dose compared to 31% of control patients (p = 0.018). CONCLUSIONS: A pharmacist-led tailored clinical medication review has the potential to increase deprescribing and improve appropriate use of cardiometabolic medication in half of T2D patients at high risk of hypoglycaemia.

Barriers and Enablers of Healthcare Providers to Deprescribe Cardiometabolic Medication in Older Patients: A Focus Group Study.

INTRODUCTION: Benefits and risks of preventive medication change over time for ageing patients and deprescribing of medication may be needed. Deprescribing of cardiovascular and antidiabetic drugs can be challenging and is not widely implemented in daily practice. OBJECTIVE: The aim of this study was to identify barriers and enablers of deprescribing cardiometabolic medication as seen by healthcare providers (HCPs) of different disciplines, and to explore their views on their specific roles in the process of deprescribing. METHODS: Three focus groups with five general practitioners, eight pharmacists, three nurse practitioners, two geriatricians, and two elder care physicians were conducted in three cities in The Netherlands. Interviews were recorded and transcribed verbatim. Directed content analysis was performed on the basis of the Theoretical Domains Framework. Two researchers independently coded the data. RESULTS: Most HCPs agreed that deprescribing of cardiometabolic medication is relevant but that barriers include lack of evidence and expertise, negative beliefs and fears, poor communication and collaboration between HCPs, and lack of resources. Having a guideline was considered an enabler for the process of deprescribing of cardiometabolic medication. Some HCPs feared the consequences of discontinuing cardiovascular or antidiabetic medication, while others were not motivated to deprescribe when the patients experienced no problems with their medication. HCPs of all disciplines stated that adequate patient communication and involving the patients and relatives in the decision making enables deprescribing. Barriers to deprescribing included the use of medication initiated by specialists, the poor exchange of information, and the amount of time it takes to deprescribe cardiometabolic medication. The HCPs were uncertain about each other's roles and responsibilities. A multidisciplinary approach including the pharmacist and nurse practitioner was seen as the best way to support the process of deprescribing and address barriers related to resources. CONCLUSION: HCPs recognized the importance of deprescribing cardiometabolic medication as a medical decision that can only be made in close cooperation with the patient. To successfully accomplish the process of deprescribing they strongly recommended a multidisciplinary approach.

Type 2 diabetes patients' views on prevention of hypoglycaemia - a mixed methods study investigating self-management issues and self-identified causes of hypoglycaemia.

BACKGROUND: Hypoglycaemia is a common and potentially avoidable adverse event in people with type 2 diabetes (T2D). It can reduce quality of life, increase healthcare costs, and reduce treatment success. We investigated self-management issues associated with hypoglycaemia and self-identified causes of hypoglycaemia in these patients. METHODS: In this mixed methods study qualitative semi-structured interviews were performed, which informed a subsequent quantitative survey in T2D patients. All interviews were audio recorded, transcribed verbatim and coded independently by two coders using directed content analysis, guided by the Theoretical Domains Framework. Descriptive statistics were used to quantify the self-management issues and causes of hypoglycaemia collected in the survey for the respondents that had experienced at least one hypoglycaemic event in the past. RESULTS: Sixteen participants were interviewed, aged 59-84 years. Participants perceived difficulties in managing deviations from routine, and they sometimes lacked procedural knowledge to adjust medication, nutrition or physical activity to manage their glucose levels. Grief and loss of support due to the loss of a partner interfered with self-management and lead to hypoglycaemic events. Work ethic lead some participant to overexerting themselves, which in turn lead to hypoglycaemic events. The participants had difficulties preventing hypoglycaemic events, because they did not know the cause, suffered from impaired hypoglycaemia awareness and/or did not want to regularly measure their blood glucose. When they did recognise a cause, they identified issues with nutrition, physical activity, stress or medication. In total, 40% of respondents reported regular stress as an issue, 24% reported that they regularly overestimated their physical abilities, and 22% indicated they did not always know how to adjust their medication. Around 16% of patients could not always remember whether they took their medication, and 42% always took their medication at regular times. Among the 83 respondents with at least one hypoglycaemic event, common causes for hypoglycaemia mentioned were related to physical activity (67%), low food intake (52%), deviations from routine (35%) and emotional burden (28%). Accidental overuse of medication was reported by 10%. CONCLUSION: People with T2D experience various issues with self-managing their glucose levels. This study underlines the importance of daily routine and being able to adjust medication in relation to more physical activity or less food intake as well as the ability to reduce and manage stress to prevent hypoglycaemic events.

Older people's attitudes towards deprescribing cardiometabolic medication.

BACKGROUND: Overtreatment with cardiometabolic medication in older patients can lead to major adverse events. Timely deprescribing of these medications is therefore essential. Self-reported willingness to stop medication is usually high among older people, still overtreatment with cardiometabolic medication is common and deprescribing is rarely initiated. An important barrier for deprescribing reported by general practitioners is the patients' unwillingness to stop the medication. More insights are needed into the influence of patients' characteristics on their attitudes towards deprescribing and differences in these attitudes between cardiometabolic medication groups. METHODS: A survey in older people using cardiometabolic medication using the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire was performed. Participants completed the general rPATD and an adapted version for four medication groups. Linear and ordinal logistic regression were used to assess the influence of age, sex, therapeutic area and number of medications used on the patients' general attitudes towards deprescribing. Univariate analysis was used to compare differences in deprescribing attitudes towards sulfonylureas, insulins, antihypertensive medication and statins. RESULTS: Overall, 314 out of 1143 invited participants completed the survey (median age 76 years, 54% female). Most participants (80%) were satisfied with their medication and willing to stop medications if their doctor said it was possible (88%). Age, sex and therapeutic area had no influence on the general attitudes towards deprescribing. Taking more than ten medicines was significantly associated with a higher perceived medication burden. Antihypertensive medication and insulin were considered more appropriate than statins, and insulin was considered more appropriate than sulfonylureas not favouring deprescribing. CONCLUSIONS: The majority of older people using cardiometabolic medication are willing to stop one of their medicines if their doctor said it was possible. Health care providers should take into account that patients perceive some of their medication as more appropriate than other medication when discussing deprescribing.

Identifying patients at increased risk of hypoglycaemia in primary care: Development of a machine learning-based screening tool.

INTRODUCTION: In primary care, identifying patients with type 2 diabetes (T2D) who are at increased risk of hypoglycaemia is important for the prevention of hypoglycaemic events. We aimed to develop a screening tool based on machine learning to identify such patients using routinely available demographic and medication data. METHODS: We used a cohort study design and the Groningen Initiative to ANalyse Type 2 diabetes Treatment (GIANTT) medical record database to develop models for hypoglycaemia risk. The first hypoglycaemic event in the observation period (2007-2013) was the outcome. Demographic and medication data were used as predictor variables to train machine learning models. The performance of the models was compared with a model using additional clinical data using fivefold cross validation with the area under the receiver operator characteristic curve (AUC) as a metric. RESULTS: We included 13,876 T2D patients. The best performing model including only demographic and medication data was logistic regression with least absolute shrinkage and selection operator, with an AUC of 0.71. Ten variables were included (odds ratio): male gender (0.997), age (0.990), total drug count (1.012), glucose-lowering drug count (1.039), sulfonylurea use (1.62), insulin use (1.769), pre-mixed insulin use (1.109), insulin count (1.827), insulin duration (1.193), and antidepressant use (1.05). The proposed model obtained a similar performance to the model using additional clinical data. CONCLUSION: Using demographic and medication data, a model for identifying patients at increased risk of hypoglycaemia was developed using machine learning. This model can be used as a tool in primary care to screen for patients with T2D who may need additional attention to prevent or reduce hypoglycaemic events.

Barriers and Enablers of Older Patients to Deprescribing of Cardiometabolic Medication: A Focus Group Study.

BACKGROUND: Deprescribing has been recommended for managing polypharmacy but deprescribing preventive medication in older patients is still uncommon. We aimed to investigate older patients' barriers to and enablers of deprescribing cardiometabolic medication. METHODS: Two focus groups were conducted among patients ≥70 years with polypharmacy, including cardiometabolic medication. Purposive sampling through four community pharmacies was used in two regions in the Netherlands. A topic list was developed using literature and the theoretical domains framework (TDF). The meetings were audio recorded, transcribed verbatim and coded using thematic coding, attribute coding and the TDF. In addition, patients were categorized on attitudes towards medication and willingness to stop. RESULTS: The meetings were attended by 17 patients and 1 caregiver (71 to 84 years). In total 15 barriers and 13 enablers were identified within four themes, partly related to beliefs, fears and experiences regarding using or stopping medication, and partly related to the relationship with the health care professional and the conditions to stop. Some patients attributed their wellbeing to their medication and were therefore unwilling to stop. Reducing cardiometabolic medication because of less strict treatment targets confused some patients and was a barrier to deprescribing. Having options to monitor clinical measurements and restart medication were enablers. Patients were only willing to stop cardiometabolic medication when this was proposed by a HCP they trusted. Patients with a positive attitude towards medication varied in their willingness to stop cardiometabolic medication. Patients with a negative attitude towards medication were generally willing to stop medication but still perceived several barriers and may consider some medication as being essential. CONCLUSION: Fears, beliefs, and experiences regarding using and stopping medication as well as trust in the HCP influence willingness to have medication deprescribed. Attitudes towards medication in general do not necessarily translate into willingness or unwillingness to stop specific medication. For deprescribing cardiometabolic medication, patient involvement when setting new treatment targets and monitoring the effects on short-term outcomes are important.

Development and Piloting of an Algorithm to Select Older Patients for Different Types of Medication Review.

Aim: To develop and pilot an algorithm to select older people for different types of medication review based on their case complexity. Methods: Experts rated complexity of patient cases through a Delphi-consensus method. The case characteristics were included in a regression model predicting complexity to develop a criteria-based algorithm. The algorithm was piloted in four community pharmacies with 38 patients of high and low complexity. Pharmacists conducted medication reviews according to their personal judgment and rated the patients' complexity. Time needed for reviewing and number of interventions (proposed and implemented) were assessed. Feasibility was evaluated with in-depth interviews. Results: We developed the algorithm with 75 cases proceeding from patients in average 79 years old and using 10 prescribed medications. The regression model (adjusted R 2 = 0.726, P < 0.0001) resulted in the following criteria for the algorithm: "number of medications" × 1 + "number of prescribers" × 3 + "recent fall incident" × 7 + "does not collect own medication" × 4. The pharmacists performed advanced medication reviews with all patients. The time needed to perform the medication review did not differ significantly according to case complexity (76.9 min for high complexity; 66.1 min for low complexity). Agreement between the algorithm scores and the pharmacists' ratings on complexity degree was slight to moderate (Kappa 0.16-0.42). The pharmacists had mixed opinions about the feasibility of applying the algorithm, particularly regarding the criterion "fall incidents." Conclusion: We developed an algorithm with four criteria that distinguished between high and low complexity patients as rated by experts. Additional validation steps are needed before implementation.

Selective targeting of CREB-binding protein/ß-catenin inhibits growth of and extracellular matrix remodelling by airway smooth muscle.

BACKGROUND AND PURPOSE: Asthma is a heterogeneous chronic inflammatory disease, characterized by the development of structural changes (airway remodelling). ß-catenin, a transcriptional co-activator, is fundamentally involved in airway smooth muscle growth and may be a potential target in the treatment of airway smooth muscle remodelling. EXPERIMENTAL APPROACH: We assessed the ability of small-molecule compounds that selectively target ß-catenin breakdown or its interactions with transcriptional co-activators to inhibit airway smooth muscle remodelling in vitro and in vivo. KEY RESULTS: ICG-001, a small-molecule compound that inhibits the ß-catenin/CREB-binding protein (CBP) interaction, strongly and dose-dependently inhibited serum-induced smooth muscle growth and TGFß1-induced production of extracellular matrix components in vitro. Inhibition of ß-catenin/p300 interactions using IQ-1 or inhibition of tankyrase 1/2 using XAV-939 had considerably less effect. In a mouse model of allergic asthma, ß-catenin expression in the smooth muscle layer was found to be unaltered in control versus ovalbumin-treated animals, a pattern that was found to be similar in smooth muscle within biopsies taken from asthmatic and non-asthmatic donors. However, ß-catenin target gene expression was highly increased in response to ovalbumin; this effect was prevented by topical treatment with ICG-001. Interestingly, ICG-001 dose-dependently reduced airway smooth thickness after repeated ovalbumin challenge, but had no effect on the deposition of collagen around the airways, mucus secretion or eosinophil infiltration. CONCLUSIONS AND IMPLICATIONS: Together, our findings highlight the importance of ß-catenin/CBP signalling in the airways and suggest ICG-001 may be a new therapeutic approach to treat airway smooth muscle remodelling in asthma.