Determining feasibility of incorporating consumer engagement into implementation activities: study protocol of a hybrid effectiveness-implementation type II pilot.

INTRODUCTION: Implementation researchers could draw from participatory research to engage patients (consumers of healthcare) in implementation processes and possibly reduce healthcare disparities. There is a little consumer involvement in healthcare implementation, partially because no formal guidance exists. We will create and pilot a toolkit of methods to engage consumers from the US' Veterans Health Administration (VHA) in selecting and tailoring implementation strategies. This toolkit, Consumer Voice, will provide guidance on what, when, where, how and why an implementer might engage consumers in implementing treatments. We will pilot the toolkit by implementing Safety Planning Intervention for suicide prevention with rural veterans, a population with suicide disparities. Safety Planning Intervention is effective for reducing suicidal behaviours. METHODS AND ANALYSIS: In Aim 1, we will use participatory approaches and user-centred design to develop Consumer Voice and its methods. In Aim 2, we will pilot Consumer Voice by implementing the Safety Planning Intervention in two clinics serving rural VHA patients. One site will receive a current implementation strategy (Implementation Facilitation) only; the second will receive Implementation Facilitation plus Consumer Voice. We will use mixed methods to assess feasibility and acceptability of Consumer Voice. We will compare sites on preliminary implementation (reach, adoption, fidelity) and clinical outcomes (depression severity, suicidal ideation, suicidal behaviour). In Aim 3, we will evaluate Aim 2 outcomes at 20 months to assess sustained impact. We will gather qualitative data on sustainability of the Safety Planning Intervention. ETHICS AND DISSEMINATION: These studies are overseen by the Institutional Review Board at the Central Arkansas Veterans Healthcare System. We plan to use traditional academic modalities of dissemination (eg, conferences, publications). We plan to disseminate findings through meetings with other trainers in implementation practice so they may adopt Consumer Voice. We plan to share results with local community boards.