Objective: To determine the effectiveness of a patient
decision aid (PDA) to improve decision quality and
glycaemic control in people with diabetes making
treatment choices using a cluster randomised
controlled trial (RCT).
Design: A cluster RCT.
Setting: 49 general practices in UK randomised into
intervention (n=25) and control (n=24).
Participants: General practices Inclusion criteria:
>4 medical partners; list size >7000; and a diabetes
register with >1% of practice population. 191 practices
assessed for eligibility, and 49 practices randomised
and completed the study. Patients People with type 2
diabetes mellitus (T2DM) taking at least two oral
glucose-lowering drugs with maximum tolerated dose
with a glycosolated haemoglobin (HbA1c) greater than
7.4% (IFCC HbA1c >57 mmol/mol) or advised in the
preceeding 6 months to add or consider changing to
insulin therapy. Exclusion criteria: currently using
insulin therapy; difficulty reading or understanding
English; difficulty in understanding the purpose of the
study; visual or cognitive impairment or mentally ill. A
total of 182 assessed for eligibility, 175 randomised to
95 intervention and 80 controls, and 167 completion
and analysis.
Intervention: Brief training of clinicians and use of
PDA with patients in single consultation.
Primary outcomes: Decision quality (Decisional
Conflict Scores, knowledge, realistic expectations and
autonomy) and glycaemic control (glycosolated
haemoglobin, HbA1c).
Secondary outcomes: Knowledge and realistic
expectations of the risks and benefits of insulin therapy
and diabetic complications.
Results: Intervention group: lower total Decisional
Conflict Scores (17.4 vs 25.2, p<0.001); better
knowledge (51.6% vs 28.8%, p<0.001); realistic
expectations (risk of ‘hypo’, ‘weight gain’,
‘complications’; 81.0% vs 5.2%, 70.5% vs 5.3%
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)