Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management) : study protocol

Background: Chronic congestive heart failure (CHF) is a complex disease with rising prevalence, compromised quality of life (QoL), unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP) can improve patients' QoL. Methods/Design: HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific selfmanagement, (non)pharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation). Patients from control group receive usual care by their GPs, who were introduced to guidelineoriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ), depression and anxiety disorders (PHQ-9, GAD-7), adherence (EHFScBS and SANA), quality of care measured by an adapted version of the Patient Chronic Illness Assessment of Care questionnaire (PACIC) and NTproBNP. In addition, comprehensive clinical data are collected about health status, comorbidity, medication and health care utilisation. Discussion: As the targeted patient group is mostly cared for and treated by GPs, a comprehensive primary care-based guideline implementation including somatic, psychosomatic and organisational aspects of the delivery of care (HICMAn) is a promising intervention applying proven strategies for optimal care. Trial registration: Current Controlled Trials ISRCTN30822978

Physician and Patient Predictors of Evidence-Based Prescribing in Heart Failure: A Multilevel Study

BACKGROUND: The management of patients with heart failure (HF) needs to account for changeable and complex individual clinical characteristics. The use of renin angiotensin system inhibitors (RAAS-I) to target doses is recommended by guidelines. But physicians seemingly do not sufficiently follow this recommendation, while little is known about the physician and patient predictors of adherence. METHODS: To examine the coherence of primary care (PC) physicians' knowledge and self-perceived competencies regarding RAAS-I with their respective prescribing behavior being related to patient-associated barriers. Cross-sectional follow-up study after a randomized medical educational intervention trial with a seven month observation period. PC physicians (n = 37) and patients with systolic HF (n = 168) from practices in Baden-Wuerttemberg. Measurements were knowledge (blueprint-based multiple choice test), self-perceived competencies (questionnaire on global confidence in the therapy and on frequency of use of RAAS-I), and patient variables (age, gender, NYHA functional status, blood pressure, potassium level, renal function). Prescribing was collected from the trials' documentation. The target variable consisted of ≥50% of recommended RAAS-I dosage being investigated by two-level logistic regression models. RESULTS: Patients (69% male, mean age 68.8 years) showed symptomatic and objectified left ventricular (NYHA II vs. III/IV: 51% vs. 49% and mean LVEF 33.3%) and renal (GFR<50%: 22%) impairment. Mean percentage of RAAS-I target dose was 47%, 59% of patients receiving ≥50%. Determinants of improved prescribing of RAAS-I were patient age (OR 0.95, CI 0.92-0.99, p = 0.01), physician's global self-confidence at follow-up (OR 1.09, CI 1.02-1.05, p = 0.01) and NYHA class (II vs. III/IV) (OR 0.63, CI 0.38-1.05, p = 0.08). CONCLUSIONS: A change in physician's confidence as a predictor of RAAS-I dose increase is a new finding that might reflect an intervention effect of improved physicians' intention and that might foster novel strategies to improve safe evidence-based prescribing. These should include targeting knowledge, attitudes and skills

Patient- and provider-related determinants of generic and specific health-related quality of life of patients with chronic systolic heart failure in primary care : a cross-sectional study

Background Identifying the determinants of health-related quality of life (HRQOL) in patients with systolic heart failure (CHF) is rare in primary care; studies often lack a defined sample, a comprehensive set of variables and clear HRQOL outcomes. Our aim was to explore the impact of such a set of variables on generic and disease-specific HRQOL. Methods In a cross-sectional study, we evaluated data from 318 eligible patients. HRQOL measures used were the SF-36 (Physical/Mental Component Summary, PCS/MCS) and four domains of the KCCQ (Functional status, Quality of life, Self efficacy, Social limitation). Potential determinants (instruments) included socio-demographical variables (age, sex, socio-economic status: SES), clinical (e.g. NYHA class, LVEF, NT-proBNP levels, multimorbidity (CIRS-G)), depression (PHQ-9), behavioural (EHFScBs and prescribing) and provider (e.g. list size of and number. of GPs in practice) variables. We performed linear (mixed) regression modelling accounting for clustering. Results Patients were predominantly male (71.4%), had a mean age of 69.0 (SD: 10.4) years, 12.9% had major depression, according to PHQ-9. Across the final regression models, eleven determinants explained 27% to 55% of variance (frequency across models, lowest/highest β): Depression (6×, -0.3/-0.7); age (4×, -0.1/-0.2); multimorbidity (4×, 0.1); list size (2×, -0.2); SES (2×, 0.1/0.2); and each of the following once: no. of GPs per practice, NYHA class, COPD, history of CABG surgery, aldosterone antagonist medication and Self-care (0.1/-0.2/-0.2/0.1/-0.1/-0.2). Conclusions HRQOL was determined by a variety of established individual variables. Additionally the presence of multimorbidity burden, behavioural (self-care) and provider determinants may influence clinicians in tailoring care to individual patients and highlight future research priorities

Barrieren der Leitlinienumsetzung und Fortbildungsbedarf von Hausärzten zur Herzinsuffizienz: eine qualitative Studie [Barriers to guideline implementation and educational needs of general practitioners regarding heart failure: a qualitative study]

[english] Objectives: A clinical practice guideline (CPG) contains specifically developed recommendations that can serve physicians as a decision aid in evidence-based practice. The implementation of heart failure (HF) CPGs represents a challenge in general practice. As part of the development of a tailored curriculum, aim of this study was to identify barriers of guideline adherence and needs for medical education (CME) in HF care.Methods: We conducted a modified focus group with elements of a workshop of three hours duration. Thirteen GPs collected and discussed together and parallel in smaller groups barriers of guideline implementation. Afterwards they performed a needs assessment for a tailored CME curriculum for chronic HF. The content of the discussions was analysed qualitatively according to Mayring and categorised thematically.Results: Barriers of guideline adherence were found in the following areas: doctor: procedural knowledge (knowledge gaps), communicative and organisational skills (e.g. time management) and attitude (dissatisfaction with time-money-relation). Patients: individual case-related problems (multimorbidity, psychiatric comorbidity, expectations and beliefs). Doctor and patient: Adherence and barriers of communication. Main measures for improvement of care concerned the areas of the identified barriers of guideline adherence with the focus on application-oriented training of the abovementioned procedural knowledge and skills, but also the supply of tools (like patient information leaflets) and patient education. Conclusion: For a CME-curriculum for HF tailored to the needs of GPs, a comprehensive educational approach seems necessary. It should be broad-based and include elements of knowledge and skills to be addressed and trained case-related. Additional elements should include support in the implementation of organisational processes in the practice and patient education.<br>[german] Zielsetzung: Leitlinien zur Herzinsuffizienz (HI) enthalten systematisch entwickelte Empfehlungen, deren Umsetzung speziell in der hausärztlichen Praxis eine bekannte Herausforderung darstellt. Ziel der vorliegenden Studie war es, Barrieren bei der Umsetzung der Leitlinienempfehlungen zu identifizieren, Vorschläge zu Verbesserungsmaßnahmen der hausärztlichen Versorgung und für die Entwicklung einer bedarfsgerechten Fortbildung zu gewinnen.Methodik: Es wurde eine modifizierte Fokusgruppe mit Workshopcharakter durchgeführt. In drei parallelen Kleingruppen erarbeiteten 13 Hausärzte Barrieren bei der Leitlinienumsetzung zur HI. Darauf aufbauend wurde eine Bedarfsanalyse bzgl. der Lernziele und der spezifischen Verbesserungsmaßnahmen für eine hausärztliche Fortbildung zur HI durchgeführt. Die protokollierten Aussagen der Ärzte wurden mittels Inhaltsanalyse nach Mayring ausgewertet und anschließend thematisch kategorisiert.Ergebnisse: Als Barrieren der Umsetzung vorhandener Leitlinien nannten die teilnehmenden Ärzte arztseitige Defizite und Unterstützungsbedarf in den Dimensionen Wissen, kommunikativen und organisatorischen Fähigkeiten (z. B. Zeitmangel/-management) und der Haltung gegenüber Leitlinien (z.B. Faulheit). Den Patienten wurden individuelle, patientenbezogene Probleme (z.B. Komplexität des Einzelfalles bei Multimorbidität, psychische Komorbidität) sowie ablehnende Einstellungen (z.B. gegenüber „Schulmedizin“) zugeschrieben. Im Bereich der Arzt-Patient-Interaktion wurden u.a. mangelnde medikamentöse Adhärenz und Kommunikationsprobleme als Barrieren genannt. Vorschläge zu Verbesserungs- bzw. Schulungsmaßnahmen umfassten breit angelegte Schulungskonzepte (z.B. in interdisziplinären Qualitätszirkeln mit Fall-Audit), die neben der Vermittlung von Wissensaspekten aus einer (idealerweise einheitlichen) Leitlinie auch praktische Fertigkeiten hinsichtlich Arzt-Patienten-Kommunikation und Praxis-Organisation einschlossen. Die Bereitstellung praktikabler Arbeitsmaterialien und Patientenschulungen sollten aus Sicht der Teilnehmer die Arztschulungen ergänzen.Schlussfolgerung: Ein Fortbildungs-Curriculum für Hausärzte zur HI scheint einer umfassenden Leitlinienschulung zu bedürfen, in welchen insbesondere Handlungskompetenz und kommunikative Fertigkeiten anwendungsorientiert geübt werden sollten. Weitere Bestandteile sollten Hilfestellungen zur Implementierung von Organisationsabläufen und Patientenschulungen sein