Aim 1: Effectiveness
The study includes three distinct time periods. Pre-implementation includes the six months prior to the site visit (Phase 1). Implementation includes the 12-month period of active implementation following the site visit (Phase 2). Sustainment includes the 9-month period following the end of active implementation (Phase 3).
Hypothesis 1
For intensive external facilitation sites, the proportion of Veterans with OUD diagnoses receiving OAT will increase significantly from pre-implementation (Phase 1) to the end of implementation (Phase 2) and this increase will be significantly greater than for implementation as usual sites.
Hypothesis 2
For intensive external facilitation sites, the proportion of Veterans with OUD who persist with OAT for 90 days or greater will increase significantly from pre-implementation (Phase 1) to the end of implementation (Phase 2) and this increase will be significantly greater than for implementation as usual sites.
Hypothesis 3
Increases in receipt of and persistence on OAT for intensive external facilitation sites will be maintained during the sustainment period. Hypothesis 3 mirrors hypothesis 1 and 2 but compares the two outcomes (proportion of Veterans with OUD receiving OAT and proportion of Veterans sustaining OUD) from pre-implementation (Phase 1) to the end of the sustainment period (Phase 3).
Since our change measures (proportion of Veterans with OUD receiving OAT and sustaining OAT over 90 days) are recorded from all the eligible facilities through their usual recording activities, data can be collected for all the patients of all the eligible facilities. We will use all these sites and all of their corresponding OUD patients in our study. However, the source of sampling variation is through random site selection for the implementation intervention.
We will record the two primary outcomes for each patient with an OUD diagnosis: (1) whether s/he has received OAT, and (2) whether s/he has persisted with OAT for at least 90 days. These primary measures with be collected at the end of the pre-implementation phase for all patients with an OUD diagnosis during the 6-month pre-implementation phase, at the end of the implementation phase for all patients with a diagnosis of OUD during the 12-month implementation phase, and at the end of the sustainment phase for all patients with a diagnosis of OUD during the 9-month sustainability phase. Also, administratively available patient, provider and facility covariates will be collected for all the patients in all the 35 sites. Simple summary statistics, estimates and confidence intervals will be constructed. The classical repeated measure design will be modelled through a stratified/generalized linear logistic mixed model incorporating the possible site and provider dependence and clustering into the analysis.
Aim 2: Formative evaluation
Finalization of the intervention is informed by the rapid analysis of the pre-implementation staff and leadership interviews. Fidelity to the implementation plan is monitored using contact logs created for each intervention site to document on-going facilitation activities. These logs will provide information on the “dose” of facilitation received at each site, the number of local implementation team members involved and their roles, and the specific facilitation strategies employed (e.g., education, technical support, resource identification/development, consultation). Progress toward implementation goals is tracked through quarterly feedback reports of prescribing rate, actionable patients and waivered providers. At the end of the implementation process, all of these sources, along with post-intervention provider and leadership interviews, will be used to enhance interpretation of quantitative results. Post-intervention interviews will also be conducted to determine whether barriers identified during the pre-implementation interviews were successfully addressed and which implementation strategies were most successful, acceptable and feasible. Following the implementation phase, pre- and post- implementation qualitative interviews will be coded and analyzed guided by the i-PARIHS framework to examine the impact of evidence, context and facilitation constructs on the implementation process and outcomes.
Aim 3: Cost assessment
The budget impact analysis for the proposed intervention will be conducted from the VHA’s perspective by Dr. Wei Yu and his team. Dr. Yu, is a Health Economist who has been faculty at the VA Health Economics Resource Center (HERC) conducting cost analyses using VHA administrative data for over 10 years. For each facility, we will estimate three cost components: (1) intervention cost, (2) treatment cost and (3) downstream cost.
Intervention cost: The intervention in this study is the implementation strategy of intensive external facilitation. We will identify costs related to the intensive external facilitation by a micro-costing method. We will document every action taken during the three steps of intervention: stakeholder interviews, facilitators’ site visit, and ongoing facilitation. Costs associated with staff participation in interviews, site-visit meetings, education workshops and conference calls will be measured by meeting time and staff average salary. The cost associated with facilitators and consultants will be measured separately as it may not affect the budget of local sites. We will use the VA Managerial Cost Accounting System (MCA) Account-Level Budgeter Cost Center (ALBCC) datasets to identify costs for staff time at average levels in each category of staff involved in those activities.
Treatment cost: We will estimate the incremental cost of increasing buprenorphine treatment following the proposed implementation intervention. We will first estimate an average treatment cost for buprenorphine. Then, we will estimate the net increase in buprenorphine use by a difference in difference method (i.e., the difference between the pre-post difference and the intervention-control difference). We will identify healthcare costs from MCA national data extract (NDE), including inpatient, outpatient and pharmacy data.
Downstream cost: Increasing buprenorphine utilization is likely to decrease emergency department visits and emergency hospitalizations associated with overdose and other complications of OUD. We will analyze changes in health care utilization related to OUD following the proposed intervention. First, we will estimate the difference of an average annual cost of all healthcare utilization excluding OAT between those who received buprenorphine and those who did not receive any OAT, respectively. Then, we will estimate the net increase of buprenorphine use following the intensive external facilitation using the difference-in-difference method discussed in the treatment cost analysis above. We will then estimate the downstream cost by multiplying the average cost difference estimated in step 1 by the net increase of buprenorphine treatment following the implementation intervention. We will separate healthcare related to OUD and care for other health conditions.