Primary aim
Aim 1 is to evaluate the effectiveness of CATCH in increasing MAT initiation and engagement (primary outcomes) among patients with OUD. NYC currently has the capacity to deliver MAT to over 38,000 patients and is rapidly expanding treatment access to buprenorphine treatment in primary care [
7], yet there is a large population of individuals with OUD who are not receiving treatment [
13]. Treatment initiation and engagement have been selected as the key indicators of substance use quality care in the widely-used Healthcare Effectiveness Data and Information Set (HEDIS) [
46,
47] and Washington Circle measures [
48]. In 2018, the National Committee on Quality Assurance (NCQA) updated the treatment initiation and engagement measure to include MAT for treatment of OUD [
49].
We expect that the CATCH intervention will be effective in increasing MAT initiation and engagement because it is built on a foundation of prior work demonstrating that: (1) integrating MAT with inpatient medical care is feasible and is an effective approach to engaging untreated patients in care [
50]; (2) starting MAT while patients are hospitalized improves initiation and retention in outpatient treatment [
25,
51] and decreases substance use; [
25] and (3) providing addiction counseling and peer support during the transition from hospital to outpatient treatment increases treatment initiation and early retention [
27,
52‐
54].
Outcome measures and data sources by specific aim are listed in Table
1. Treatment initiation is defined as having an outpatient MAT encounter within 14 days following hospital discharge. Engagement is defined as having two encounters in an outpatient MAT program or, for office-based treatment, filling two prescriptions for buprenorphine or naltrexone or receiving one prescription that covers at least 28 of the first 30 days following treatment initiation. We will also examine the total number of treatment visits in the 30-day post discharge period. The initiation and engagement measures include treatment provided through the bridge clinic, because this represents a successful transition from hospital to outpatient MAT. For patients who are discharged to another inpatient facility (e.g., skilled nursing facility), initiation will be measured from the final inpatient discharge.
Table 1
Outcome measures by specific aim
Aim 1 (primary aim): treatment initiation and engagement
|
Treatment initiation | Outpatient MAT encounter within 14 days of hospital discharge | Medicaid claims and encounter data (EHR data) |
Treatment engagement | Receipt of 2 + additional MAT services within 30 days of initiation | Medicaid claims and encounter data (EHR data) |
Aim 2: Treatment retention
|
Rate of treatment retention | Continuous retention in treatment for 6 months | Medicaid claims and encounter data (EHR data) |
Aim 3: Acute care utilization and OD deaths
|
Acute care | Hospital and ED admissions in 6 months following discharge | Medicaid claims and encounter data (EHR data) |
OD death | Poisoning death involving opioid(s) | DOHMH overdose data (Medicaid claims and encounter data) |
Aim 4: Implementation outcomes
a
|
Reach | Received any CATCH service(s) | EHR data |
Adoption | Referrals made to CATCH by clinical staff | EHR data |
Implementation fidelity | Ability to reach target population and deliver MAT | Interviews with CATCH staff and patients Monthly reports on CATCH activities |
Implementation barriers and facilitators | Intervention characteristics, inner setting, outer setting, and characteristics of individuals that impact intervention delivery | Interviews with CATCH staff and patients |
Secondary aims
Aim 2 is to assess the effectiveness of CATCH in increasing retention in MAT for 6 months. Patients who remain in MAT for at least 6 months have a high probability of remaining in treatment for 12 months or longer and have better long-term treatment outcomes [
55,
56]. Furthermore, patients retained in treatment for 6 months are much more likely to ‘graduate’ to long-term maintenance. [
57‐
59].
Treatment retention is defined as receiving MAT for at least 80% of days during the 6-month period following treatment initiation (i.e., ≥ 146 days of treatment). Methadone treatment is identified by claims for each day of treatment delivered by a MMT program, and buprenorphine and naltrexone are tracked by reimbursement for filled prescriptions (including number of days of treatment prescribed). Individuals who transition between treatments (e.g., from buprenorphine to methadone) will be considered retained provided that they had at least 146 total days of MAT.
Aim 3 is to compare the frequency of
acute care utilization and
overdose deaths as well as their associated costs among patients with OUD hospitalized during the CATCH period versus usual care. By effectively engaging patients with OUD in MAT, the CATCH intervention is anticipated to reduce the frequency of hospital and ED visits as well as overdose death. Decades of research on MAT, primarily on methadone treatment, demonstrate that MAT is consistently associated with less drug use and lower rates of mortality and overdose [
16,
17,
60‐
62]. A recent meta-analysis found that overdose death rates among MAT patients are at least two-thirds lower than among individuals with OUD who left treatment [
17], and MAT is a cornerstone of current efforts to reduce opioid overdose deaths in NYC [
7]. Patients with untreated OUD have disproportionately high rates of acute care utilization, most of which represents preventable admissions (i.e., high-cost but low-value care) [
27,
63‐
65]. A recent study of Medicaid patients receiving buprenorphine treatment found that the risk of any hospitalization was reduced by 18% and the risk of any ED visit was reduced by 14% among patients in treatment as compared to those who left treatment [
66].
Costs for acute care admissions are frequently borne by an individual health system (e.g., costs of uninsured patients and 30-day readmission penalties), and quantifying the cost savings associated with CATCH is important for its future adoption and sustainability at H + H and in other health systems. There are also potential savings to the broader healthcare sector associated with reducing overdose deaths, including ED and hospital admissions avoided, as well as the societal value of lives saved by preventing fatal overdoses. We will compare program costs related to CATCH with savings estimates for both acute care utilization and overdose death outcomes from the perspectives of the medical care provider (H + H), the healthcare sector, and society at large.
Acute care utilization is defined as hospital and ED admissions in the 12 months following the index hospitalization. The primary measure is the total number of admissions (hospital and ED). We will also assess the number of hospital days. Overdose deaths are tracked using the DOHMH comprehensive database of NYC overdose deaths. We will identify individuals within the Medicaid database who had no claims activity in month 7 following hospital discharge and identify any matches in the overdose database. Program costs will be measured from H + H administrative records for the CATCH program that document medical and non-medical personnel assigned to the program by location.
Aim 4 is to evaluate implementation outcomes at each CATCH hospital using a mixed-methods approach to assess the RE-AIM elements of Reach, Adoption, and Implementation fidelity. An advantage of the Hybrid Type 1 study design is that implementation measures can be collected alongside the effectiveness study for the purpose of formative evaluation; the design provides important information about the barriers to introduction and sustainability in practice [
30,
31,
67]. To supplement the RE-AIM evaluation framework, we will use the Consolidated Framework for Implementation Science (CFIR) to explore in-depth the characteristics of the organization (organizational readiness, culture, priorities), individual (attitudes, norms), and intervention (complexity, relative advantage) that affect the effectiveness and implementation of the intervention. The CFIR framework incorporates theories of behavior change, and its domains include the characteristics of individuals that may lead to behavior change (e.g., knowledge and beliefs, stage of change, and self-efficacy) as well as the interplay between individuals, the context in which the intervention is provided (inner setting and outer setting), and the characteristics and delivery of the intervention itself, which may not be fully captured by RE-AIM [
68,
69]. Findings will help us to interpret any differences in effectiveness across sites and populations, provide insight into potential barriers and facilitators of full scale implementation, and inform plans for future dissemination of the model to additional hospitals, both within the H + H system and in other health systems.
Reach is defined as the proportion of patients with OUD who receive CATCH services. A descriptive analysis will use EHR data to ascertain the proportion of patients with OUD who had at least one contact with the CATCH team during the 6-month study period. Adoption is the proportion of eligible patients referred to the CATCH service by clinical staff. Additionally, we will assess the characteristics (demographics, comorbidities, inpatient service (medical/surgical/psychiatric), and number of hospital days) of OUD patients who were referred versus those who were not referred. Implementation fidelity considers the delivery of MAT to the target population and barriers to providing high-quality care in the hospital and post-discharge. Our fidelity measures are informed by the CFIR framework and are both quantitative and qualitative. Process measures capture the planning and execution of the intervention and are primarily quantitative. These measures will be assessed quarterly for a total of 12 months after CATCH introduction at each hospital, using registry and EHR data. Qualitative interviews will characterize intervention characteristics, inner and outer setting, and characteristics of individuals that may affect the implementation and effectiveness of the intervention. Individual interviews will be conducted with CATCH staff and patients during early implementation of the program and 9–12 months post-implementation of CATCH (five staff and five patients per hospital). Patient interviews will include those who both receive and decline CATCH services. A purposive sampling approach will be used to select CATCH staff and patients with a variety of roles, demographic characteristics, and backgrounds to participate in interviews, and participants will receive $50 compensation.