Designing and Implementing Research on a Statewide Quality Improvement Initiative

Abstract

Objective To demonstrate a rigorous methodology that optimally balanced internal validity with generalizability to evaluate a state-wide collaborative that implemented an evidenced-based, collaborative care model for depression management in primary care. Study Design and Setting Several operational features of the DIAMOND Initiative suggested that the DIAMOND Study employ a staggered implementation design with repeated cross-sections of patients across clinical settings. A multi-level recruitment strategy elicited virtually complete study participation from the medical groups, clinics and health plans that coordinated efforts to deliver and reimburse DIAMOND care. Patient identification capitalized on large health plan claims databases to rapidly identify the population of patients newly treated for depression in DIAMOND clinics. Results The staggered implementation design and multi-level recruitment strategy made it possible to evaluate DIAMOND by holding confounding factors constant and accurately identifying an intent-to-treat population of patients treated for depression without intruding on or requiring effort from their clinics. Conclusion Recruitment and data collection from health plans, medical groups and clinics, and patients ensured a representative, intent-to-treat sample of study-enrolled patients. Separating patient identification from care delivery reduced threats of selection bias and enabled comparisons between the treated population and study sample. A key challenge is that intent-to-treat patients may not be exposed to DIAMOND which dilutes the effect size but offers realistic expectations of the impact of quality improvement in a population of treated patients.

Mental Health Collaborative Care and its Role in Primary Care Settings

“…The CCM has potential to be an effective strategy to support U.S. healthcare reforms but practical issues to disseminating the model into routine care have yet to be resolved [••48]. Financial and organizational incentives must be aligned so that public and private health plans have the capacity to adopt and sustain the model [•22, 26].…”

“…To achieve this end, we conducted a rigorous search of Pubmed® to identify relevant English-language articles published between January 2012 and March 2013 that included empirically-based research studies, topical reviews, influential commentaries, and guideline/consensus statements focused on collaborative care for mental health in adult patient populations. Key words utilized in the search included: “primary care”, “general medicine”, “collaborative care”, “integrative care”, “chronic care model”, “patient-centered medical home”, “medical home” “treatment model”, “mental health”, “mental health disorders” “mood disorders”, “anxiety disorders”, “depression”, “bipolar disorder”, “substance abuse disorder”, “addiction disorder”, “serious mental illness”, and “behavioral medicine.” A total of 74 articles were identified for inclusion in this review of the literature [5-10, 13, ••14, ••15, 16-21, •22, 23, 24, 26, 27, 29, 30, 32-36, ••37, 38-40, •41, •42, 43-47, ••48, 49-53, ••54, 55-68, •69, 70-83]. …”

“…Until recently, there have been few examples of organizational strategies that demonstrate how to disseminate CCMs on a large scale [••15, ••48, 56, 98]. Qualitative studies [47, 61, 99, 100], case studies [••48, 51], and qualitative reviews [7, 16, 45] outline the significant challenges to implementing CCMs in primary care.…”

“…Qualitative studies [47, 61, 99, 100], case studies [••48, 51], and qualitative reviews [7, 16, 45] outline the significant challenges to implementing CCMs in primary care. Implementation of integrated care is expensive, presenting a high cost to reorganize existing services, standardize systems of care, adopt an EMR, develop registries, hire new staff, train staff in new treatment protocols, adopt measurement care process, and come to terms with significant role resistance from being a hierarchical, physician-centered practice focused on workflow, to a patient-centered practice [86].…”

“…DIAMOND (Depression Improvement Across Minnesota, Offering a New Direction) [••48] is a state-level initiative started with the goal of developing a bundled payment model to support the CCM for depression treatment in Minnesota. This initiative utilized a unique approach in which an independent quality improvement organization (the Institute for Clinical Systems Improvement (ICSI)) brokered an arrangement between six private healthcare plans, 22 medical groups, 84 primary care clinics, and the Minnesota Department of Human Services to implement a CCM for depression based on specific goals, and clinical outcomes.…”