Efficacy of a computer based discontinuation strategy to reduce PPI prescriptions: a multicenter cluster-randomized controlled trial.

Deprescribing of inappropriate long-term proton pump inhibitors (PPI) is challenging and there is a lack of useful methods for general practitioners to tackle this. The objective of this randomized controlled trial was to evaluate the effectiveness of the electronic decision aid tool arriba-PPI on reduction of long-term PPI intake. Participants (64.5 ± 12.9 years; 54.4% women) with a PPI intake of at least 6 months were randomized to receive either consultation with arriba-PPI from their general practitioner (n = 1256) or treatment as usual (n = 1131). PPI prescriptions were monitored 6 months before, 6 and 12 months after study initiation. In 49.2% of the consultations with arriba-PPI, the general practitioners and their patients made the decision to reduce or discontinue PPI intake. At 6 months, there was a significant reduction by 22.3% (95% CI 18.55 to 25.98; p < 0.0001) of defined daily doses (DDD) of PPI. A reduction of 3.3% (95% CI - 7.18 to + 0.62) was observed in the control group. At 12 months, the reduction of DDD-PPI remained stable in intervention patients (+ 3.5%, 95% CI - 0.99 to + 8.03), whereas control patients showed a reduction of DDD-PPI (- 10.2%, 95% CI - 6.01 to - 14.33). Consultation with arriba-PPI led to reduced prescription rates of PPI in primary care practices. Arriba-PPI can be a helpful tool for general practitioners to start a conversation with their patients about risks of long-term PPI intake, reduction or deprescribing unnecessary PPI medication.

Patients' perspectives on a patient-oriented electronic decision support tool to reduce overuse of proton pump inhibitors (arriba-PPI): a qualitative study in primary care.

BACKGROUND: To evaluate patients' perspectives and their experiences with a consultation involving a computer-assisted and patient-centered discontinuation strategy (arriba-PPI tool) as part of a German multicenter study on reducing the prescription of proton pump inhibitors (PPIs). METHODS: Qualitative in-depth telephone interviews on proton pump inhibitors with patients who had received an arriba-PPI tool-based counseling by their general practitioner (GP). A random sample of 30 patients was taken from study participants. Interviews were conducted in 2020 and analyzed using a thematic qualitative text analysis. RESULTS: Although this was meant to be the key to shared decision making with regard to PPI reduction, study participants mostly did not recall the visual features of the tool. However, a few patients remembered them very clearly. Above all, patients appreciated a trustful relationship with the GP as well as comprehensive, individualized counseling. CONCLUSION: Application of the arriba-PPI tool can support the decision process but can also hinder the consultation process if the tool is not properly embedded in the consultation. GPs using the arriba-PPI tool to support the shared decision-making process should consider the patients' and their own expectations on the benefit of the visual representation of the tool.

Diabetes-related research priorities of people with type 1 and type 2 diabetes: a cross-sectional study in Germany.

To investigate (i) the importance and priorities of research objectives for people with type 1 (T1DM) and type 2 diabetes (T2DM); (ii) subgroups with specific research priorities; (iii) associated factors (e.g., sociodemographic characteristics) of the subgroups. The cross-sectional survey was conducted in 2018 using data from 869 respondents (29.0% response, 31.2% female, mean age 61.3 years, 62.7% T2DM) from a German statutory health insurance population. Diabetes-related research priorities were assessed with a questionnaire. Subgroups and associated factors were identified using latent class analysis. Three subgroups were found in T1DM: (1) high priority for the research topic 'healing diabetes' and moderate priority for the research topic 'prevention of long-term complications', (2) priorities for simplifying handling (high) and stress reduction (moderate), (3) priorities for healing diabetes (high) and simplifying handling (high). Three subgroups were found in T2DM: (1) priorities for simplifying handling (moderate), diabetes prevention (moderate) and prevention of long-term complications (moderate), (2) priorities for stress reduction (high) and diabetes prevention (moderate), (3) priorities for simplifying handling (high) and stress reduction (high). Classes differed in age and HbA1c. Knowledge about research priorities enables researchers to align their work with the needs of people with diabetes.

HIOPP-6 - a pilot study on the evaluation of an electronic tool to assess and reduce the complexity of drug treatment considering patients' views.

BACKGROUND: A complex drug treatment might pose a barrier to safe and reliable drug administration for patients. Therefore, a novel tool automatically analyzes structured medication data for factors possibly contributing to complexity and subsequently personalizes the results by evaluating the relevance of each identified factor for the patient by means of key questions. Hence, tailor-made optimization measures can be proposed. METHODS: In this controlled, prospective, exploratory trial the tool was evaluated with nine general practitioners (GP) in three study groups: In the two intervention groups the tool was applied in a version with (GI_with) and a version without (GI_without) integrated key questions for the personalization of the analysis, while the control group (GC) did not use any tools (routine care). Four to eight weeks after application of the tool, the benefits of the optimization measures to reduce or mitigate complexity of drug treatment were evaluated from the patient perspective. RESULTS: A total of 126 patients regularly using more than five drugs could be included for analysis. GP suggested 117 optimization measures in GI_with, 83 in GI_without, and 2 in GC. Patients in GI_with were more likely to rate an optimization measure as helpful than patients in GI_without (IRR: 3.5; 95% CI: 1.2-10.3). Thereby, the number of optimization measures recommended by the GP had no significant influence (P = 0.167). CONCLUSIONS: The study suggests that an automated analysis considering patient perspectives results in more helpful optimization measures than an automated analysis alone - a result which should be further assessed in confirmatory studies. TRIAL REGISTRATION: The trial was registered retrospectively at the German Clinical Trials register under DRKS-ID DRKS00025257 (17/05/2021).

Prevalence and patient-rated relevance of complexity factors in medication regimens of community-dwelling patients with polypharmacy.

PURPOSE: To describe the prevalence of complexity factors in the medication regimens of community-dwelling patients with more than five drugs and to evaluate the relevance of these factors for individual patients. METHODS: Data were derived from the HIOPP-6 trial, a controlled study conducted in 9 general practices which evaluated an electronic tool to detect and reduce complexity of drug treatment. The prevalence of complexity factors was based on the results of the automated analysis of 139 patients' medication data. The relevance assessment was based on the patients' rating of each factor in an interview (48 patients included for analysis). RESULTS: A median of 5 (range 0-21) complexity factors per medication regimen were detected and at least one factor was observed in 131 of 139 patients. Almost half of these patients found no complexity factor in their medication regimen relevant. CONCLUSION: In most medication regimens, complexity factors could be identified automatically, yet less than 15% of factors were indeed relevant for patients as judged by themselves. When assessing complexity of medication regimens, one should especially consider factors that are both particularly frequent and often challenging for patients, such as use of inhalers or tablet splitting. TRIAL REGISTRATION: The HIOPP-6 trial was registered retrospectively on May 17, 2021, in the German Clinical Trials register under DRKS-ID DRKS00025257.

Reduction of the long-term use of proton pump inhibitors by a patient-oriented electronic decision support tool (arriba-PPI): study protocol for a randomized controlled trial.

BACKGROUND: Proton pump inhibitors (PPIs) are increasingly being prescribed, although long-term use is associated with multiple side effects. Therefore, an electronic decision support tool with the aim of reducing the long-term use of PPIs in a shared decision-making process between general practitioners (GPs) and their patients has been developed. The developed tool is a module that can be added to the so-called arriba decision support tool, which is already used by GPs in Germany in routine care. In this large-scale cluster-randomized controlled trial we evaluate the effectiveness of this arriba-PPI tool. METHODS: The arriba-PPI tool is an electronic decision support system that supports shared decision-making and evidence-based decisions around the long-term use of PPIs at the point of care. The tool will be evaluated in a cluster-randomized controlled trial involving 210 GP practices and 3150 patients in Germany. GP practices will be asked to recruit 20 patients aged ≥ 18 years regularly taking PPIs for ≥ 6 months. After completion of patient recruitment, each GP practice with enrolled patients will be cluster-randomized. Intervention GP practices will get access to the software arriba-PPI, whereas control GPs will treat their patients as usual. After an observation period of six months, GP practices will be compared regarding the reduction of cumulated defined daily doses of PPI prescriptions per patient. DISCUSSION: Our principal hypothesis is that the application of the arriba-PPI tool can reduce PPI prescribing in primary care by at least 15% compared to conventional strategies used by GPs. A positive result implies the implementation of the arriba-PPI tool in routine care. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00016364. Registered on 31 January 2019.

A qualitative meta-summary using Sandelowski and Barroso's method for integrating qualitative research to explore barriers and facilitators to self-care in heart failure patients.

BACKGROUND: Individual qualitative studies provide varied reasons for why heart failure patients do not engage in self-care, yet articles that aggregated primary studies on the subject have methodological weaknesses that justified the execution of a qualitative meta-summary. AIM: The aim of this study is to integrate the findings of qualitative studies pertaining to barriers and facilitators to self-care using meta-summary techniques. METHODS: Qualitative meta-summary techniques by Sandelowski and Barroso were used to combine the findings of qualitative studies. Meta-summary techniques include: (1) extraction of relevant statements of findings from each report; (2) reduction of these statements into abstracted findings and (3) calculation of effect sizes. Databases were searched systematically for qualitative studies published between January 2010 and July 2015. Out of 2264 papers identified, 31 reports based on the accounts of 814 patients were included in the meta-summary. RESULTS: A total of 37 statements of findings provided a comprehensive inventory of findings across all reports. Out of these statements of findings, 21 were classified as barriers, 13 as facilitators and three were classed as both barriers and facilitators. The main themes relating to barriers and facilitators to self-care were: beliefs, benefits of self-care, comorbidities, financial constraints, symptom recognition, ethnic background, inconsistent self-care, insufficient information, positive and negative emotions, organizational context, past experiences, physical environment, self-initiative, self-care adverse effects, social context and personal preferences. CONCLUSION: Based on the meta-findings identified in this study, future intervention development could address these barriers and facilitators in order to further enhance self-care abilities in heart failure patients.

Home-Based Exercise Supported by General Practitioner Practices: Ineffective in a Sample of Chronically Ill, Mobility-Limited Older Adults (the HOMEfit Randomized Controlled Trial).

OBJECTIVES: To evaluate the effects a home-based exercise program delivered to ill and mobility-limited elderly individuals on physical function, physical activity, quality of life, fall-related self-efficacy, and exercise self-efficacy. DESIGN: Randomized controlled trial (ISRCTN Registry, Reg.-No. ISRCTN17727272). SETTING: Fifteen general practitioner (GP) practices and participants' homes. PARTICIPANTS: Chronically ill and mobility-limited individuals aged 70 and older (N = 209). INTERVENTIONS: An exercise therapist delivered the experimental intervention-a 12-week multidimensional home-based exercise program integrating behavioral strategies-in individual counseling sessions at the GPs' practices and over the telephone. The control intervention focused on promoting light-intensity activities of daily living. Interventions took place between February 2012 and March 2013. MEASUREMENTS: The primary outcome was functional lower body strength (chair-rise test). Secondary outcomes were physical function (battery of motor tests), physical activity (step count), health-related quality of life (Medical Outcomes Study 8-item Short-Form Survey), fall-related (Falls Efficacy Scale-International Version), and exercise self-efficacy (Selbstwirksamkeit zur sportlichen Aktivitaet (SSA) scale). Postintervention differences between the groups were tested using analysis of covariance (intention to treat; adjusted for baseline value and GP practice; significance level P ≤ .05). RESULTS: Participants had a mean age ± standard deviation of 80 ± 5, 74% were female, 87% had three or more chronic diseases, and 54% used a walking aid. The difference (intention to treat; experimental minus control) between adjusted postintervention chair-rise times was -0.1 (95% confidence interval = -1.8-1.7). Differences for all secondary outcomes were also nonsignificant. CONCLUSION: The program was ineffective in the target population. Possibilities for improving the concept will have to be evaluated.

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices.

OBJECTIVES: To present detailed adverse event (AE) data from a randomized controlled trial (RCT) of a home-based exercise program delivered to an elderly high-risk population by an exercise therapist after medical clearance from a general practitioner (GP). DESIGN: Randomized controlled trial. SETTING: General practitioner practices and participant homes. PARTICIPANTS: Community-dwelling, chronically ill, mobility-limited individuals aged 70 and older (mean 80 ± 5) participating in a RCT of an exercise program (HOMEfit; ISRCTN17727272) (N = 209; n = 106 experimental, n = 103 control; 74% female). INTERVENTION: A 12-week multidimensional home-based exercise program (experimental) versus baseline physical activity counseling (control). An exercise therapist delivered both interventions to participants during counseling sessions at the GP's practice and on the telephone. MEASUREMENTS: Adverse events were documented at least at every counseling session and assessed by the GP and an AE manager. RESULTS: One hundred fifty-one AEs were reported in 47% (n = 99) of all participants. Twenty-one (14%) events were classified as serious. In six events (4%; n = 4 experimental, n = 2 control), participation in the study had to be discontinued immediately. In 25 events (17%; n = 9 experimental, n = 16 control), the intervention had to be suspended. The intervention was determined to have caused two events (both nonserious and in the experimental group). CONCLUSION: Even though the program appears to be safe, high morbidity unrelated to exercise can constitute a critical challenge for sustained exercise participation.

Recruiting hard-to-reach subjects for exercise interventions: a multi-centre and multi-stage approach targeting general practitioners and their community-dwelling and mobility-limited patients.

The general practitioner (GP)'s practice appears to be an ideal venue for recruiting community-dwelling older adults with limited mobility. This study (Current Controlled Trials ISRCTN17727272) aimed at evaluating the recruiting process used for a multi-centre exercise intervention (HOMEfit). Each of six steps resulted in an absolute number of patients (N1-N6). Sex and age (for N4-N6) and reasons for dropping out were assessed. Patient database screening (N1-N3) at 15 GP practices yielded N1 = 5,990 patients aged 70 and above who had visited their GP within the past 6 months, N2 = 5,467 after exclusion of institutionalised patients, N3 = 1,545 patients eligible. Using a pre-defined limitation algorithm in order to conserve the practices' resources resulted in N4 = 1,214 patients (80.3 ± 5.6 years, 68% female), who were then officially invited to the final assessment of eligibility at the GP's practice. N5 = 434 patients (79.5 ± 5.4 years, 69% female) attended the practice screening (n = 13 of whom had not received an official invitation). Finally, N6 = 209 (79.8 ± 5.2 years, 74% female) were randomised after they were judged eligible and had given their written informed consent to participate in the randomised controlled trial (overall recruitment rate: 4.4%). The general strategy of utilising a GP's practice to recruit the target group proved beneficial. The data and experiences presented here can help planners of future exercise-intervention studies.

["All of us actually practice EBM!" - Attitudes of German GPs towards evidence-based medicine and clinical guidelines in daily practice: a focus group study]. / "Wir machen doch eigentlich alle EbM!" - Vorstellungen und Haltungen deutscher Hausärzte zu Evidenzbasierter Medizin und Leitlinien im Praxisalltag: Eine qualitative Studie.

BACKGROUND: Implementation of guidelines in general practice is difficult. Do general practitioners (GPs) reject evidence-based medicine (EBM) in general? Which attitudes do GPs have towards EBM and guidelines, and which value do they attach to EBM in daily routine? METHODS: We conducted a qualitative study using five focus groups with 53 GPs. The study was set in the German federal states of Bavaria, Saxony, North Rhine-Westphalia, Hesse and Hamburg. Participants were selected according to area (rural/urban), region (North/South, East/West) and grade of professionalisation. Focus groups were digitally recorded and fully transcribed. Data were analysed in a multidisciplinary team using qualitative content analysis. RESULTS: Most participants felt positive towards EBM. Lack of feasibility was explicitly mentioned: the participants distinguished between "practised" and "true" EBM. Guidelines are often considered unsuitable for general practice. The GPs felt confident that their treatment of patients was evidence-based. CONCLUSIONS: Compared to older studies, German GPs have an increasingly favourable opinion about EBM. In order to enhance the practical application of EBM and guidelines the attitudes of GPs need to be considered.