Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Pragmatic Cluster Randomised Trial of a Tailored Intervention for Implementing Recommendations for Managing Depressed Elderly Patients in Primary Care: Protocol
Brief Summary: 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.


Options:
A: Arm Label: Implementation intervention; Type: EXPERIMENTAL; Interventions: Other: Implementation intervention | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Implementation intervention; Assigned to Arm(s): Implementation intervention
B: Arm Label: FLARE Intervention Group; Type: OTHER; Interventions: Other: FLARE Intervention Group | Arm Label: Standard of Care (SOC) Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: FLARE Intervention Group; Assigned to Arm(s): FLARE Intervention Group
C: Arm Label: Personal counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Personal Counseling | Arm Label: Computer generated feedback letters; Type: EXPERIMENTAL; Interventions: Behavioral: Computer-generated feedback letters | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Personal Counseling; Assigned to Arm(s): Personal counseling | Intervention Type: BEHAVIORAL; Name: Computer-generated feedback letters; Assigned to Arm(s): Computer generated feedback letters
D: Arm Label: Feedback Group; Type: EXPERIMENTAL; Interventions: Behavioral: Communication Feedback Form for Patients with Serious Illness | Arm Label: Comparison/Usual Care Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Communication Feedback Form for Patients with Serious Illness; Assigned to Arm(s): Feedback Group

Answer: A