title: Lessons learnt from a cluster-randomised trial evaluating the effectiveness of Self-Management Support (SMS) delivered by practice nurses in routine diabetes care.
abstract: OBJECTIVE
  To evaluate the effectiveness of biopsychosocial Self-Management Support (SMS) delivered by practice nurses in routine diabetes care.
  
  
  METHODS
  A pragmatic cluster-randomised controlled trial within a hybrid effectiveness-implementation study design. Practice nurses were cluster-randomised.
  
  
  METHODS
  A regional care group in the Netherlands consisting of 77 family practices. The study involved practice nurses (n=40) providing care to approximately 4000 patients with diabetes.
  
  
  METHODS
  Patients with type 2 diabetes (n=264) selected by a self-administered questionnaire aimed at measuring emotional distress and diabetes-related reduced daily functioning.
  
  
  METHODS
  Practice nurses in the intervention arm (n=19) were trained to integrate SMS into their routine consultations. SMS included detection of patients with emotional distress and reduced daily functioning, and supporting them when needed through problem solving and reattribution techniques. Practice nurses in the control arm (n=21) provided usual care.
  
  
  METHODS
  The primary outcome measure was a dichotomised score on a Visual Analogue Scale that measured the perceived effect of diabetes on daily functioning. Secondary measures included patients' diabetes-related distress, quality of life, autonomy and participation, self-efficacy, self-management and glycaemic control. Outcomes were measured at baseline and at 4-month and 12-month follow-ups.
  
  
  RESULTS
  Only 16 of the 117 patients in the intervention arm (14%) who were found eligible by the posted research-driven screening questionnaire were detected by their practice nurses. Extra consultations for the self-management support were delivered to only 11 study participants. In the control arm, 147 patients received usual care. Multilevel analyses showed no significant differences in outcomes between the intervention and control arms.
  
  
  CONCLUSIONS
  SMS in its present form was not effective. The research-driven screening to select trial participants appeared to be inconsistent with nurse-led detection in routine practice. Adequate follow-up moments need to be built in to overcome barriers resulting from tension between the implementation and effectiveness parts of hybrid studies.
  
  
  BACKGROUND
  Current Controlled Trials NTR2764.
authors.affiliation: Department of Family Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands Department of Social Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
authors.forename: Anneke
authors.initials: A
authors.lastname: van Dijk-de Vries
authors.affiliation: Department of Family Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
authors.forename: Marloes A
authors.initials: MA
authors.lastname: van Bokhoven
authors.affiliation: Department of Methodology and Statistics, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
authors.forename: Bjorn
authors.initials: B
authors.lastname: Winkens
authors.affiliation: Department of General Practice and Elderly Care Medicine, VU University Medical Centre, EMGO Institute for Health and Care Research, Amsterdam, The Netherlands.
authors.forename: Berend
authors.initials: B
authors.lastname: Terluin
authors.affiliation: Department of Family Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
authors.forename: J André
authors.initials: JA
authors.lastname: Knottnerus
authors.affiliation: Department of Family Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
authors.forename: Trudy
authors.initials: T
authors.lastname: van der Weijden
authors.affiliation: Department of Social Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
authors.forename: Jacques Th M
authors.initials: JT
authors.lastname: van Eijk
mesh_terms: D000203:Activities of Daily Living / Q000523:psychology; D000368:Aged; D016000:Cluster Analysis; D003924:Diabetes Mellitus, Type 2 / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009726:Nurses; D011320:Primary Health Care / Q000379:methods*; D012648:Self Care / Q000379:methods* / Q000523:psychology; D013315:Stress, Psychological; D016896:Treatment Outcome
keywords: PRIMARY CARE; PUBLIC HEALTH