As the population ages, more people will have comorbid disorders and polypharmacy. Medication should be reviewed regularly in order to avoid adverse drug reactions and medication-related hospital visits, but this is often not done. As part of our student-run clinic project, we investigated whether an interprofessional student-run medication review program (ISP) added to standard care at a geriatric outpatient clinic leads to better prescribing. In this controlled clinical trial, patients visiting a memory outpatient clinic were allocated to standard care (control group) or standard care plus the ISP team (intervention group). The medications of all patients were reviewed by a review panel (“gold standard”), resident, and in the intervention arm also by an ISP team consisting of a group of students from the medicine and pharmacy faculties and students from the higher education school of nursing for advanced nursing practice. For both groups, the number of STOPP/START-based medication changes mentioned in general practitioner (GP) correspondence and the implementation of these changes about 6 weeks after the outpatient visit were investigated. The data of 216 patients were analyzed (control group = 100, intervention group = 116). More recommendations for STOPP/STARTbased medication changes were made in the GP correspondence in the intervention group than in the control group (43% vs. 24%, P = < 0.001). After 6 weeks, a significantly higher proportion of these changes were implemented in the intervention group (19% vs. 9%, P = 0.001). The ISP team, in addition to standard care, is an effective intervention for optimizing pharmacotherapy and medication safety in a geriatric outpatient clinic.
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Background. Violent criminal offenders with personality disorders (PD’s) can cause immense harm, but are often deemed untreatable. This study aimed to conduct a randomized clinical trial to test the effectiveness of long-term psychotherapy for rehabilitating offenders with PDs. Methods. We compared schema therapy (ST), an evidence-based psychotherapy for PDs, to treatment-as-usual (TAU) at eight high-security forensic hospitals in the Netherlands. Patients in both conditions received multiple treatment modalities and differed only in the individual, study-specific therapy they received. One-hundred-three male offenders with antisocial, narcissistic, borderline, or paranoid PDs, or Cluster B PD-not-otherwise specified, were assigned to 3 years of ST or TAU and assessed every 6 months. Primary outcomes were rehabilitation, involving gradual reintegration into the community, and PD symptoms. Results. Patients in both conditions showed moderate to large improvements in outcomes. ST was superior to TAU on both primary outcomes – rehabilitation (i.e. attaining supervised and unsupervised leave) and PD symptoms – and six of nine secondary outcomes, with small to moderate advantages over TAU. ST patients moved more rapidly through rehabilitation (supervised leave, treatment*time: F(5308) = 9.40, p < 0.001; unsupervised leave, treatment*- time: F(5472) = 3.45, p = 0.004), and showed faster improvements on PD scales (treatment*- time: t(1387) = −2.85, p = 0.005). Conclusions. These findings contradict pessimistic views on the treatability of violent offenders with PDs, and support the effectiveness of long-term psychotherapy for rehabilitating these patients, facilitating their re-entry into the community
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Background: A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered. This paper reports on the experiences and lessons learned from the conduct of a cluster randomized, stepped wedge trial evaluating the effect of the Hospital Elder Life Program (HELP) in a Dutch hospital setting to prevent older patients from developing delirium. Methods: We evaluated our trial which was conducted in eight departments in two hospitals in hospitalized patients aged 70 years or older who were at risk for delirium by reflecting on the assumptions that we had and on what we intended to accomplish when we started, as compared to what we actually realized in the different phases of our study. Lessons learned on the design, the timeline, the enrollment of eligible patients and the use of routinely collected data are provided accompanied by recommendations to address challenges. Results: The start of the trial was delayed which caused subsequent time schedule problems. The requirement for individual informed consent for a quality improvement project made the inclusion more prone to selection bias. Most units experienced major difficulties in including patients, leading to excluding two of the eight units from participation. This resulted in failing to include a similar number of patients in the control condition versus the intervention condition. Data on outcomes routinely collected in the electronic patient records were not accessible during the study, and appeared to be often missing during analyses. Conclusions: The stepped wedge, cluster randomized trial poses specific risks in the design and execution of research in real-life settings of which researchers should be aware to prevent negative consequences impacting the validity of their results. Valid conclusions on the effectiveness of the HELP in the Dutch hospital setting are hampered by the limited quantity and quality of routine clinical data in our pragmatic trial. Executing a stepped wedge design in a daily practice setting using routinely collected data requires specific attention to ethical review, flexibility, a spacious time schedule, the availability of substantial capacity in the research team and early checks on the data availability and quality.
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ABSTRACT Background: We investigated if the addition of an inter-professional student-led medication review team (ISP-team) to standard care can increase the number of detected ADRs and reduce the number of ADRs 3 months after an outpatient visit. Research design and methods: In this controlled clinical trial, patients were allocated to standard care (control group) or standard care plus the ISP team (intervention group). The ISP team consisted of medical and pharmacy students and student nurse practitioners. The team performed a structured medication review and adjusted medication to reduce the number of ADRs. Three months after the outpatient visit, a clinical pharmacologist who was blinded for allocation performed a follow-up telephone interview to determine whether patients experienced ADRs. Results: During the outpatient clinic visit, significantly more (p < 0.001) ADRs were detected in the intervention group (n = 48) than in the control group (n = 10). In both groups, 60–63% of all detected ADRs were managed. Three months after the outpatient visit, significantly fewer (predominantly mild and moderately severe) ADRs related to benzodiazepine derivatives and antihypertensive causing dizziness were detected in the patients of the intervention group. Conclusions: An ISP team in addition to standard care increases the detection and management of ADRs in elderly patients resulting in fewer mild and moderately severe ADRs
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Background: after hospitalisation for cardiac disease, older patients are at high risk of readmission and death. Objective: the cardiac care bridge (CCB) transitional care programme evaluated the impact of combining case management, disease management and home-based cardiac rehabilitation (CR) on hospital readmission and mortality. Design: single-blind, randomised clinical trial. Setting: the trial was conducted in six hospitals in the Netherlands between June 2017 and March 2020. Community-based nurses and physical therapists continued care post-discharge. Subjects: cardiac patients ≥ 70 years were eligible if they were at high risk of functional loss or if they had had an unplanned hospital admission in the previous 6 months. Methods: the intervention group received a comprehensive geriatric assessment-based integrated care plan, a face-to-face handover with the community nurse before discharge and follow-up home visits. The community nurse collaborated with a pharmacist and participants received home-based CR from a physical therapist. The primary composite outcome was first all-cause unplanned readmission or mortality at 6 months. Results: in total, 306 participants were included. Mean age was 82.4 (standard deviation 6.3), 58% had heart failure and 92% were acutely hospitalised. 67% of the intervention key-elements were delivered. The composite outcome incidence was 54.2% (83/153) in the intervention group and 47.7% (73/153) in the control group (risk differences 6.5% [95% confidence intervals, CI -4.7 to 18%], risk ratios 1.14 [95% CI 0.91-1.42], P = 0.253). The study was discontinued prematurely due to implementation activities in usual care. Conclusion: in high-risk older cardiac patients, the CCB programme did not reduce hospital readmission or mortality within 6 months.
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IMPORTANCE People with a severe mental illness (SMI) have a life expectancy reduced by 10 to 20 years compared with the general population, primarily attributable to cardiometabolic disorders. Lifestyle interventions for people with SMI can improve health and reduce cardiometabolic risk. OBJECTIVE To evaluate the effectiveness of a group-based lifestyle intervention among people with SMI in outpatient treatment settings compared with treatment as usual (TAU). DESIGN, SETTING, AND PARTICIPANTS The Severe Mental Illness Lifestyle Evaluation (SMILE) study is a pragmatic cluster randomized clinical trial performed in 8 mental health care centers with 21 flexible assertive community treatment teams in the Netherlands. Inclusion criteria were SMI, age of 18 years or older, and body mass index (calculated as weight in kilograms divided by height in meters squared) of 27 or greater. Data were collected from January 2018 to February 2020, and data were analyzed from September 2020 to February 2023. INTERVENTIONS Weekly 2-hour group sessions for 6 months followed by monthly 2-hour group sessions for another 6 months, delivered by trained mental health care workers. The intervention targeted overall lifestyle changes, emphasizing establishing a healthy diet and promoting physical activity. TAU (control) did not include structured interventions or advice on lifestyle. MAIN OUTCOMES AND MEASURES Crude and adjusted linear mixed models and multivariable logistic regression analyses were performed. The main outcome was body weight change. Secondary outcomes included changes in body mass index, blood pressure, lipid profiles, fasting glucose level, quality of life, self-management ability, and lifestyle behaviors (physical activity and health, mental health, nutrition, and sleep). RESULTS The study population included 11 lifestyle intervention teams (126 participants) and 10 TAU teams (98 participants). Of 224 included patients, 137 (61.2%) were female, and the mean (SD) age was 47.6 (11.1) years. From baseline to 12 months, participants in the lifestyle intervention group lost 3.3 kg (95%CI, −6.2 to −0.4) more than those in the control group. In the lifestyle intervention group, people with high attendance rates lost more weight than participants with medium and low rates (mean [SD] weight loss: high, −4.9 [8.1] kg; medium, −0.2 [7.8] kg; low, 0.8 [8.3] kg). Only small or no changes were found for secondary outcomes. CONCLUSIONS AND RELEVANCE In this trial, the lifestyle intervention significantly reduced weight from baseline to 12 months in overweight and obese adults with SMI. Tailoring lifestyle interventions and increasing attendance rates might be beneficial for people with SMI. TRIAL REGISTRATION Netherlands Trial Register Identifier: NTR6837
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Background: To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies. Objective: The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users. Methods: We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses. Results: The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients. Conclusions: This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice.
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This study evaluated the Toddler Oral Health Intervention (TOHI) for preventing early childhood caries (ECC) by 48 months. TOHI, an add-on to standard care in well-baby clinics (WBCs), aims to reduce ECC incidence and severity.
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Purpose: The aim of this study was to assess physiotherapists’ clinical use and acceptance of a novel telemonitoring platform to facilitate the recording of measurements during rehabilitation of patients following anterior cruciate ligament reconstruction. Additionally, suggestions for platform improvement were explored. Methods: Physiotherapists from seven Dutch private physiotherapy practices participated in the study. Data were collected through log files, a technology acceptance questionnaire and focus group meetings using the “buy a feature” method. Data regarding platform use and acceptance (7-point/11-point numeric rating scale) were descriptively analysed. Total scores were calculated for the features suggested to improve the platform, based on the priority rating (1 = nice to have, 2 = should have, 3 = must have). Results: Participating physiotherapists (N = 15, mean [SD] age 33.1 [9.1] years) together treated 52 patients during the study period. Platform use by the therapists was generally limited, with the number of log-ins per patient varying from 3 to 73. Overall, therapists’ acceptance of the platform was low to moderate, with average (SD) scores ranging from 2.5 (1.1) to 4.9 (1.5) on the 7-point Likert scale. The three most important suggestions for platform improvement were: (1) development of a native app, (2) system interoperability, and (3) flexibility regarding type and frequency of measurements. Conclusions: Even though health care professionals were involved in the design of the telemonitoring platform, use in routine care was limited. Physiotherapists recognized the relevance of using health technology, but there are still barriers to overcome in order to successfully implement eHealth in routine care.
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Fully aware of the unusual timing of submitting a commentary 30 years later, we want to reflect on the June edition of the British Journal of Clinical Pharmacology (BJCP) (1993), which featured four research articles on education in clinical pharmacology and therapeutics (CPT) written by our former professor, Theo de Vries, and an editorial highlighting the imperative to improve CPT education, specifically by paying more attention to rational drug prescribing for common diseases.1–5 This plea was illustrated by five cartoons (Figure 1) and formed the basis for the World Health Organization's (WHO) Guide to Good Prescribing and its 6-step. The first four cartoons portrayed the suboptimal state of CPT education as a metaphorical ‘Clinical Pharmacology Continent’ (CPC) and a ‘General Practitioners Island’ (GPI), with a large gap between them. While clinical pharmacologists investigated new drug therapies, general practitioners frequently found themselves unprepared when making rational treatment decisions.1 The final cartoon introduced a solution: problembased learning education, depicted as a bridge connecting the continent and the island. Over the past 30 years, considerable progress has been achieved in bridging the gap. Therefore, we intend to illustrate this transformation with a similar cartoon (Figure 2).
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