Lessons learnt from a cluster-randomised trial evaluating the effectiveness of XXXX ( @entity14062 ) delivered by practice nurses in routine @entity6 care.

@entity1 @entity6 @entity164 @entity14062
OBJECTIVE: To evaluate the effectiveness of biopsychosocial @entity14062 ( @entity14062 ) delivered by practice nurses in routine @entity6 care. DESIGN: A pragmatic cluster-randomised controlled trial within a hybrid effectiveness-implementation study design. Practice nurses were cluster-randomised. SETTING: A regional care group in the Netherlands consisting of 77 family practices. The study involved practice nurses (n=40) providing care to approximately 4000 @entity1 with @entity6 . @entity1 : @entity1 with @entity164 2 @entity6 (n=264) selected by a self-administered questionnaire aimed at measuring emotional distress and @entity6 -related reduced daily functioning. INTERVENTION: Practice nurses in the intervention arm (n=19) were trained to integrate @entity14062 into their routine consultations. @entity14062 included detection of @entity1 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. MAIN OUTCOME MEASURES: The primary outcome measure was a dichotomised score on a Visual Analogue Scale that measured the perceived effect of @entity6 on daily functioning. Secondary measures included @entity1 ' @entity6 , 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 @entity1 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 @entity1 . In the control arm, 147 @entity1 received usual care. Multilevel analyses showed no significant differences in outcomes between the intervention and control arms. CONCLUSIONS: @entity14062 in its present form was not effective. The research-driven screening to select trial @entity1 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. TRIAL REGISTRATION NUMBER: Current Controlled Trials NTR2764.
