title: Case management for patients with chronic systolic heart failure in primary care: the HICMan exploratory randomised controlled trial.
abstract: BACKGROUND
  Chronic (systolic) heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improving patient outcomes, but lack a robust evidence base, especially for primary care. The aim of the study was to explore the effectiveness of a new model of CHF case management conducted by doctors' assistants (DAs, equivalent to a nursing role) and supported by general practitioners (GPs).
  
  
  METHODS
  This patient-randomised controlled trial (phase II) included 31 DAs and employing GPs from 29 small office-based practices in Germany. Patients with CHF received either case management (n = 99) consisting of telephone monitoring and home visits or usual care (n = 100) for 12 months. We obtained clinical data, health care utilisation data, and patient-reported data on generic and disease-specific quality of life (QoL, SF-36 and KCCQ), CHF self-care (EHFScBS) and on quality of care (PACIC-5A). To compare between groups at follow-up, we performed analyses of covariance and logistic regression models.
  
  
  RESULTS
  Baseline measurement showed high guideline adherence to evidence-based pharmacotherapy and good patient self-care: Patients received angiotensin converting enzyme inhibitors (or angiotensin-2 receptor antagonists) in 93.8% and 95%, and betablockers in 72.2% and 84%, and received both in combination in 68% and 80% of cases respectively. EHFScBS scores (SD) were 25.4 (8.4) and 25.0 (7.1). KCCQ overall summary scores (SD) were 65.4 (22.6) and 64.7 (22.7). We found low hospital admission and mortality rates. EHFScBS scores (-3.6 [-5.7;-1.6]) and PACIC and 5A scores (both 0.5, [0.3;0.7/0.8]) improved in favour of CM but QoL scores showed no significant group differences (Physical/Mental SF-36 summary scores/KCCQ-os [95%CI]: -0.3 [-3.0;2.5]/-0.1 [-3.4;3.1]/1.7 [-3.0;6.4]).
  
  
  CONCLUSIONS
  In this sample, with little room for improvement regarding evidence-based pharmacotherapy and CHF self-care, case management showed no improved health outcomes or health care utilisation. However, case management significantly improved performance and key intermediate outcomes. Our study provides evidence for the feasibility of the case management model.
  
  
  BACKGROUND
  ISRCTN30822978.
authors.affiliation: Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany. frank.peters@med.uni-heidelberg.de
authors.forename: Frank
authors.initials: F
authors.lastname: Peters-Klimm
authors.forename: Stephen
authors.initials: S
authors.lastname: Campbell
authors.forename: Katja
authors.initials: K
authors.lastname: Hermann
authors.forename: Cornelia U
authors.initials: CU
authors.lastname: Kunz
authors.forename: Thomas
authors.initials: T
authors.lastname: Müller-Tasch
authors.forename: Joachim
authors.initials: J
authors.lastname: Szecsenyi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002317:Cardiovascular Agents / Q000627:therapeutic use; D019090:Case Management; D002908:Chronic Disease; D019317:Evidence-Based Medicine; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D019983:Guideline Adherence; D054143:Heart Failure, Systolic / Q000401:mortality / Q000523:psychology / Q000628:therapy*; D006760:Hospitalization; D006792:House Calls; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D010823:Physician Assistants; D010821:Physicians, Family; D017410:Practice Guidelines as Topic; D011320:Primary Health Care / Q000379:methods* / Q000706:statistics & numerical data; D011787:Quality of Health Care; D011788:Quality of Life; D012648:Self Care; D013689:Telephone; D013997:Time Factors; D016896:Treatment Outcome; D000078329:Workforce
chemical_list: D002317:Cardiovascular Agents