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Implementation of self management support for long term conditions in routine primary care settings: cluster randomised controlled trial [with consumer summary]
Kennedy A, Bower P, Reeves D, Blakeman T, Bowen R, Chew-Graham C, Eden M, Fullwood C, Gaffney H, Gardner C, Lee V, Morris R, Protheroe J, Richardson G, Sanders C, Swallow A, Thompson D, Rogers A, on behalf of the Salford National Institute for Health Research Gastrointestinal programme Grant Research Group
BMJ 2013 May 13;346:f2882
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To determine the effectiveness of an intervention to enhance self management support for patients with chronic conditions in UK primary care. DESIGN: Pragmatic, two arm, cluster randomised controlled trial. SETTING: General practices, serving a population in northwest England with high levels of deprivation. PARTICIPANTS: 5,599 patients with a diagnosis of diabetes (n = 2,546), chronic obstructive pulmonary disease (n = 1,634), and irritable bowel syndrome (n = 1,419) from 43 practices (19 intervention and 22 control practices). INTERVENTION: Practice level training in a whole systems approach to self management support. Practices were trained to use a range of resources: a tool to assess the support needs of patients, guidebooks on self management, and a web based directory of local self management resources. Training facilitators were employed by the health management organisation. MAIN OUTCOME MEASURES: Primary outcomes were shared decision making, self efficacy, and generic health related quality of life measured at 12 months. Secondary outcomes were general health, social or role limitations, energy and vitality, psychological wellbeing, self care activity, and enablement. RESULTS: We randomised 44 practices and recruited 5,599 patients, representing 43% of the eligible population on the practice lists. 4,533 patients (81.0%) completed the six month follow-up and 4,076 (72.8%) the 12 month follow-up. No statistically significant differences were found between patients attending trained practices and those attending control practices on any of the primary or secondary outcomes. All effect size estimates were well below the prespecified threshold of clinically important difference. CONCLUSIONS: An intervention to enhance self management support in routine primary care did not add noticeable value to existing care for long term conditions. The active components required for effective self management support need to be better understood, both within primary care and in patients' everyday lives. TRIAL REGISTRATION: Current Controlled Trials ISRCTN90940049.
Reproduced with permission from the BMJ Publishing Group.

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