This is an excellent starting point! Choosing CFIR (Consolidated Framework for Implementation Research) is a solid decision due to its comprehensive nature, covering multiple levels of influence on implementation.

Let's design a robust implementation science study.

Implementation Science Study Design: Integrated Behavioral Health in Primary Care

1. Study Title: Implementing Integrated Behavioral Health in Primary Care: A Hybrid Type 2 Stepped-Wedge Cluster Randomized Trial Guided by CFIR.

2. Evidence-Based Clinical Intervention (EBI): Integrated Behavioral Health (IBH) in Primary Care

• Description: Co-location and collaborative care between primary care providers (PCPs) and behavioral health providers (BHPs – e.g., psychologists, licensed clinical social workers) within primary care clinics. The model emphasizes warm hand-offs, brief, targeted interventions, population-based screening, and shared electronic health record (EHR) documentation.


• Rationale: IBH improves access to mental health/substance use care, reduces stigma, enhances patient outcomes (e.g., depression, anxiety, substance use), and can reduce overall healthcare costs. It is well-established as an effective intervention but faces significant implementation challenges in real-world settings.


• Target Population: Adult patients presenting to primary care clinics with mild-to-moderate mental health or substance use concerns (e.g., positive screens for depression, anxiety, unhealthy alcohol use).


• Target Sites: Primary care clinics within a healthcare system.

• Role of CFIR: CFIR will serve as the guiding framework for:


• Pre-implementation Assessment: Identifying key barriers and facilitators to IBH adoption within clinics.


• Strategy Design: Informing the selection and tailoring of implementation strategies.


• Process Evaluation: Guiding data collection and analysis regarding how implementation unfolds and why.


• Interpretation: Helping to understand variations in implementation outcomes across clinics and explain successful or unsuccessful implementation.

• CFIR Domains Addressed: Inner Setting, Characteristics of Individuals, Intervention Characteristics, Process, Outer Setting.


• Strategy 1: Multi-level Leadership Engagement & Facilitation (Primarily CFIR: Inner Setting – Leadership, Culture; Process – Engaging, Planning)


• Theory: Organizational Change Theory, Transformational Leadership.


• Description:


• System-Level: Establish a steering committee with executive sponsorship to champion IBH, secure resources, and align policies (e.g., billing, EMR integration).


• Clinic-Level: Designate internal champions (e.g., clinic manager, lead PCP, lead BHP) and provide them with training and ongoing support/coaching from an external implementation facilitator. Facilitators will conduct regular meetings to identify and address clinic-specific barriers.


• Activities: Regular meetings, coaching, resource allocation, policy adjustments.


• Strategy 2: Collaborative Training & Skill-Building (Primarily CFIR: Characteristics of Individuals – Knowledge, Self-Efficacy; Intervention Characteristics – Adaptability, Complexity)


• Theory: Social Cognitive Theory (Bandura – observational learning, self-efficacy), Adult Learning Theory.


• Description: Provide joint training sessions for PCPs, nurses, and BHPs on the IBH model. Training will cover:


• The rationale and evidence base for IBH.


• Roles and responsibilities of each team member.


• Effective warm hand-off techniques.


• Brief intervention strategies for PCPs.


• Shared documentation practices in the EHR.


• Addressing stigma and communication about mental health.


• Activities: Interactive workshops, simulation exercises, didactic sessions, online modules, ongoing peer consultation groups.


• Strategy 3: Workflow Redesign & Tool Development (Primarily CFIR: Inner Setting – Networks, Resources; Intervention Characteristics – Design Quality & Packaging, Complexity)


• Theory: Systems Theory, Lean Process Improvement.


• Description: Collaborate with clinic staff to adapt existing workflows or design new ones that integrate IBH seamlessly. This includes developing user-friendly tools.


• Activities:


• Mapping current and desired workflows for patient screening, referral, scheduling, and follow-up.


• Developing standardized EHR templates for IBH consultations and shared care plans.


• Creating patient educational materials about IBH.


• Optimizing clinic space if needed for co-location.


• Strategy 4: Performance Feedback & Quality Improvement (Primarily CFIR: Process – Reflecting & Evaluating; Inner Setting – Readiness for Implementation)


• Theory: Social Cognitive Theory (performance feedback), Quality Improvement cycles (PDSA).


• Description: Provide regular, actionable feedback to clinics and individual providers on key IBH implementation metrics.


• Activities:


• Monthly data reports to clinics on warm hand-off rates, patient engagement, screening rates, and patient outcomes.


• Facilitating Plan-Do-Study-Act (PDSA) cycles to address identified challenges based on feedback.


• Peer benchmarking opportunities.


• Strategy 5: Financial & Policy Alignment (Primarily CFIR: Outer Setting – External Policies, Incentives; Inner Setting – Available Resources)


• Theory: Economic Incentive Theory, Policy Implementation Theory.


• Description: Address systemic financial and policy barriers to IBH sustainability.


• Activities:


• Educate clinics on appropriate billing codes for IBH services.


• Advocate for policy changes at the health system or payer level to support team-based care and integrate BH services.


• Explore value-based care models that incentivize IBH.


• Secure initial "seed" funding or resources from the health system to support initial implementation costs (e.g., hiring BHPs, EMR modifications).

• Rationale:


• Hybrid Type 2: This design is ideal as we are primarily interested in the implementation of the proven IBH model (effectiveness is assumed or has prior evidence), but we also want to measure patient outcomes. It balances the need to evaluate the implementation strategy with simultaneously assessing the intervention's impact.


• Stepped-Wedge Cluster Randomized Trial:


• Ethical/Practical: Allows all participating clinics to eventually receive the intervention and implementation support, which is often preferred when an intervention is believed to be beneficial. It avoids withholding a beneficial intervention from a control group indefinitely.


• Clustered: The intervention (IBH model and implementation strategies) is delivered at the clinic level, not individually.


• Stepped-Wedge: Clinics are randomized to the order (or "wedge") in which they transition from a control period (usual care) to an intervention period (IBH with implementation strategies). This design provides within-cluster and between-cluster comparisons.


• Study Population: 12-16 primary care clinics (clusters) within a healthcare system.


• Phases:


• Baseline Period: All clinics operate under usual care. Data collected across all clinics.


• Implementation Rollout: Clinics are randomized into 3-4 groups (wedges). Each group will receive the implementation strategies and deploy IBH sequentially over 12-18 months. For example, if there are 4 wedges:


• Time 1: Wedge 1 implements. Wedges 2, 3, 4 remain control.


• Time 2: Wedge 2 implements. Wedges 1, 3, 4 remain control.


• ...until all wedges have implemented.


• Sustainment Period: All clinics maintain IBH, with continued monitoring.

• Aim 1 (Primary Implementation Aim): To evaluate the effectiveness of the multi-level, CFIR-informed implementation strategy in improving the adoption, fidelity, and penetration of IBH in primary care clinics.


• Aim 2 (Primary Effectiveness Aim): To assess the impact of IBH on patient-level behavioral health outcomes (e.g., depression, anxiety, substance use symptoms) and functional status.


• Aim 3 (Mechanisms & Contextual Factors - Process Evaluation): To identify CFIR-defined barriers and facilitators influencing the implementation of IBH across clinics, and to explore how these factors mediate or moderate the relationship between implementation strategies and outcomes.

A. Implementation Outcomes (Proctor et al. 2011):

• Acceptability:


• Measure: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM) surveys for PCPs and BHPs. Qualitative interviews.


• Data Source: Surveys, qualitative interviews/focus groups.


• Adoption:


• Measure: Proportion of PCPs conducting warm hand-offs to BHPs; number of unique patients referred to and seen by BHPs.


• Data Source: EMR data, implementation logs.


• Appropriateness:


• Measure: Clinician perceptions of IBH fit with clinic needs (surveys, qualitative).


• Data Source: Surveys, qualitative interviews/focus groups.


• Fidelity:


• Measure: Adherence to core components of the IBH model (e.g., co-location, shared care planning, warm hand-offs) via fidelity checklists (completed by facilitators/observers) and EMR chart audits.


• Data Source: Fidelity checklists, EMR audits.


• Penetration:


• Measure: Proportion of eligible primary care patients (e.g., positive mental health screen) who receive an IBH consultation.


• Data Source: EMR data.


• Sustainability:


• Measure: Continued delivery of IBH services, staffing of BHPs, and use of integrated workflows at 6 and 12 months post-active implementation period.


• Data Source: EMR data, leadership reports, follow-up surveys.


• Cost:


• Measure: Cost of implementing strategies; cost-effectiveness of IBH (e.g., cost per quality-adjusted life year gained).


• Data Source: Budget tracking, billing data.

• Access to care: Time from positive screen to first BHP visit; number of follow-up BHP visits.


• Utilization: Primary care visits for mental health concerns; specialist mental health referrals; emergency department visits for mental health/substance use.


• Data Source: EMR data.

• Depression: Patient Health Questionnaire-9 (PHQ-9).


• Anxiety: Generalized Anxiety Disorder-7 (GAD-7).


• Substance Use: Alcohol Use Disorders Identification Test-Concise (AUDIT-C), Drug Abuse Screening Test-10 (DAST-10).


• Functional Status: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0).


• Patient Satisfaction: Custom survey questions on satisfaction with integrated care.


• Data Source: Patient self-report surveys (baseline, 3-month, 6-month post-IBH engagement).

• Data Source:


• Qualitative Interviews/Focus Groups: With clinic leadership, PCPs, BHPs, nurses, and administrative staff at different time points (pre-implementation, mid-implementation, post-implementation). Guided by CFIR domains and constructs to explore perceived barriers and facilitators.


• Organizational Surveys: e.g., Organizational Readiness for Implementing Change (ORIC), Primary Care Implementation Readiness Survey (PARIS).


• Implementation Facilitator Logs: Documenting observed barriers, solutions, and context.


• Clinic-Level Data: Staffing levels, patient panel size, leadership turnover, funding sources.

• Quantitative:


• EMR Data Extraction: Automated extraction of patient demographics, diagnoses, medication lists, screening scores, referral patterns, and service utilization (pre-IBH, during IBH, post-IBH).


• Provider Surveys: Administered via REDCap or similar platform at baseline, mid-point, and end-of-study.


• Patient Surveys: Administered via REDCap or tablet in clinics at baseline (for those engaging in IBH) and follow-up (3 and 6 months).


• Fidelity Checklists: Completed by trained research staff or implementation facilitators during clinic visits/audits.


• Qualitative:


• Semi-structured Interviews & Focus Groups: Audio-recorded and transcribed verbatim.


• Field Notes: Taken by implementation facilitators and research staff.

• Quantitative Analysis (Aims 1 & 2):


• Descriptive Statistics: For all demographic, clinical, and outcome variables.


• Mixed-Effects Models: Given the stepped-wedge cluster randomized design, linear or generalized linear mixed models will be used to analyze changes in implementation and patient outcomes over time, accounting for clustering within clinics and the staggered rollout. Models will include fixed effects for time, wedge, and covariates (e.g., clinic size, patient demographics), and random effects for clinics.


• Cost-Effectiveness Analysis: Conducted using standard methods, comparing costs of implementation and IBH to health outcomes.


• Qualitative Analysis (Aim 3):


• Thematic Analysis: Using a deductive approach initially guided by the CFIR domains and constructs, followed by an inductive approach to identify emergent themes. Data will be coded using qualitative data analysis software (e.g., NVivo).


• Framework Analysis: For organizational surveys and structured qualitative data, using CFIR domains as the analytical framework.


• Mixed Methods Integration (Aim 3):


• Triangulation: Quantitative findings (e.g., variations in fidelity or adoption) will be explored and explained by qualitative insights from CFIR-guided interviews (e.g., specific barriers related to "Inner Setting - Culture" or "Characteristics of Individuals - Knowledge and Beliefs").


• Joint Displays: Create visual representations to present convergent and divergent findings across quantitative and qualitative data.

• Institutional Review Board (IRB) Approval: Protocol submitted and approved by the relevant IRBs.


• Informed Consent: Obtained from all participating clinics, providers, and patients.


• Confidentiality: Protection of all patient and provider data, using de-identified data where possible.


• Data Security: Secure storage and transmission of all research data.


• Minimizing Burden: Strategies designed to minimize disruption to clinic operations and participant time.

This comprehensive design leverages CFIR to understand the complex process of implementing IBH, employs robust methodology to evaluate both implementation and patient outcomes, and includes a strong mixed-methods approach to gain deep insights into how and why the implementation strategies succeed or fail.