Depression Clinical Trial
Official title:
A Pragmatic Cluster Randomised Trial of a Tailored Intervention for Implementing Recommendations for Managing Depressed Elderly Patients in Primary Care: Protocol
Background The prevalence of depression is high and the elderly have an increased risk of
developing a chronic course. International data suggest that depression in the elderly is
under-recognised, the latency before clinicians provide a treatment plan is longer, and
elderly patients with depression are not offered psychotherapy to the same degree as younger
patients. Although recommendations for the treatment of elderly patients with depression
exist, health care professionals adhere to these recommendations to a limited degree only.
Investigators conducted a systematic review to identify recommendations for managing
depression in the elderly and prioritised six recommendations. Investigators identified and
prioritised determinants of practice related to implementation of these recommendations in
primary care, and subsequently discussed and prioritised interventions to address the
identified determinants. The objective of this study is to evaluate the effectiveness of
these tailored implementation interventions to implement six recommendations for the
management of elderly patients with depression in primary care.
Methods/design Investigators will conduct a pragmatic cluster randomised trial comparing
implementation of the six recommendations using tailored interventions with usual care.
Investigators will randomize 80 municipalities into one of two groups: an intervention
group, to which investigators will deliver tailored interventions to implement the six
recommendations, and a control group, to which investigators will not deliver any
intervention. Investigators will randomise municipalities rather than patients, individual
clinicians or practices because we will deliver the intervention for the first three
recommendations at the municipal level and investigators want to minimise the risk of
contamination across practices for the other three recommendations. The primary outcome is
the proportion of general practitioners' behaviours which are consistent with the
recommendations.
Discussion This trial will investigate whether a tailored implementation approach is an
effective strategy to improve collaborative care in the municipalities and health care
professionals' practice towards elderly patients with depression in primary care. The
effectiveness evaluation described in this protocol will be accompanied with a process
evaluation exploring why and how the interventions were effective or ineffective.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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