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Table 2 Study-specific aims and study inclusion and exclusion criteria

From: Implementing the DEcision-Aid for Lupus (IDEAL): study protocol of a multi-site implementation trial with observational, case study design

Specific aim Inclusion criteria Exclusion criteria
Specific aim 1: To assess stakeholder needs and identify clinic and contextual characteristics (e.g., readiness for change, physician attitudes, patient barriers) that inform IDEAL strategy component selection and influence implementation effectiveness through the conduct of a formative evaluation in 15 lupus clinics
 Specific aim 1 clinic personnel Clinic personnel involved in the care processes of lupus patients Clinic personnel not involved in the care processes of lupus patients
Specific aim 2: To implement and assess the effectiveness of the IDEAL (standardized and tailored) strategy in 15 lupus clinics by examining changes in subjective and objective measures of implementation effectiveness over 27 months through an observational, case study design where each clinic serves as a case
 Specific aim 2 patients Men and women ≥ 18 years of age of all races/ethnicities with a diagnosis of systemic lupus erythematosus, regardless of current active flare No diagnosis of lupus; not English or Spanish speaking; visually impaired; or have altered mental status
 Specific aim 2 clinic personnel Clinic personnel involved in the care processes of lupus patients Clinic personnel not involved in the care processes of lupus patients
Specific aim 3: To identify opportunities for sustaining and disseminating our lupus DA via semi-structured debriefing interviews with key clinic informants of aim 1 and patients of aim 2 and develop a manual that provides a step-by-step implementation guide for incorporating lupus DA into regular clinic visits and care pathways for lupus patients
 Specific aim 3 clinic personnel Participating clinical personnel from specific aim 1 Clinic personnel who are not involved in specific aim 1
 Specific aim 3 patients 2 patient participants randomly chosen from patient participants from specific aim 2 from each of the 15 clinic sites Patients with lupus who are not involved in specific aim 2