Thousands of public sector clinicians have been trained to deliver evidence-based psychotherapies (EBPs) due to recent mandates and investments in implementation [
1,
2]. Patients treated during EBP training programs experience substantial symptom improvement [
3‐
5]. Despite this progress, efforts to implement and sustain EBPs in these systems face significant challenges. One finding is that penetration (integration of a practice within a service setting and its subsystems) is low [
6,
7]. Veteran Affairs clinicians rarely cite established contraindications as reasons not to offer EBPs; [
8,
9] instead, they cite challenging symptom profiles, a need for more consultation, and clinic-level barriers [
10,
11]. A second challenge is that research suggests that fidelity (adherence to prescribed elements of treatment and competence/skill of delivery) [
12] may be low when these interventions are implemented [
13,
14]. Challenges in implementing EBPs lead to adaptation without systematic efforts to understand the impact on symptoms and other outcomes [
15,
16]. While some adaptation and latitude in EBP delivery may be appropriate [
17], effective [
18‐
21], or promote implementation [
22], other adaptations result in discontinuation of core elements [
15], integration of non-evidence-based strategies [
13,
23], and worse outcomes [
24,
25]. In addition to these challenges, local capacity can impact sustainability and quality of delivery. A significant minority of clinician trainees do not meet established EBP competency criteria but deliver EBP protocols or EBP elements in their practice [
11,
13,
15]. Turnover and organizational context can also impact sustained EBP delivery [
26,
27]. Patient access and clinical outcomes may suffer as a result [
23,
24,
28‐
30]. Thus, in the context of routine care, improvement, rather than maintenance, [
31] of clinical outcomes may be an appropriate goal. Finally, while EBPs are cost-effective [
32], the budget impact of supporting implementation can be a barrier [
33‐
35].
Failure to provide EBPs to those with PTSD can have a significant public health impact. Consequences of inadequate treatment include risk of suicide, overuse of healthcare, work absenteeism, reduced productivity, unemployment, and family disruption [
36,
37]. Cognitive processing therapy (CPT), which has been implemented in at least eight countries and in mental health systems throughout the world, has a strong evidence base and is effective with a variety of patient populations [
19,
20,
38‐
42]. The current study will aid in identifying strategies to promote sustainability of CPT and improve patient-level outcomes, thereby informing efforts to implement EBPs for psychiatric disorders more broadly.
Researchers have identified serious gaps in knowledge regarding best practices for improving and sustaining EBPs in routine care [
43‐
45]. There have been few, if any, experimental investigations of strategies to sustain EBPs. Few studies on sustainability have assessed a full range of the key outcomes, such as patient-level mental health outcomes [
46]. To address these gaps and identify effective strategies for sustaining EBPs in routine care, we seek to compare two promising yet different implementation strategies (ISs), fidelity-oriented consultation, and continuous quality improvement.
Fidelity-oriented learning collaborative (FID)
Studies show that without consistent follow-up or ongoing support of clinicians to promote fidelity after initial training, the training effects quickly dissipate [
47,
48]. Although a recent meta-analysis demonstrated no overall link between observer-rated fidelity and symptom change across a range of treatments and disorders, when analyses were conducted to avoid the potential temporal confound between fidelity and symptom change and establish the temporal precedence of fidelity, two aspects of fidelity, adherence to the protocol and competence (skill of delivery) in early CBT sessions were associated with subsequent decreases in depression [
49]. Later research suggested that fidelity to the key aspects of CPT, as opposed to prescribed session elements, was associated with symptom change [
50]. Other studies demonstrated patient-level benefits of fidelity-oriented support for EBPs as compared to general professional development-oriented support [
51‐
53]. A FID strategy has been shown to lead to clinician achievement of benchmark levels of fidelity [
54]. We would thus expect FID to impact clinical outcomes through CPT fidelity as a mechanism of change. Fidelity support also appears to impact other implementation outcomes, most notably sustained EBP capacity, delivery [
55], and support activities [
56]. Fidelity support has also been associated with lower staff turnover, which improves workforce capacity [
53].
Continuous quality improvement-oriented learning collaboratives (CQI)
Organization-level barriers to implementation are commonly found in routine care settings and may impact sustainability [
4,
26,
57,
58]. In our study on CPT training consultation in Canada, [
59] in Texas, and in the US VA [
10,
11], clinicians cited organization-level challenges to delivering EBPs for PTSD and hesitance about offering EBPs, due in part to a perceived lack of fit between the treatment and the patients [
9]. These problems may contribute to the low rates of penetration [
6,
7]. The Dynamic Sustainability Framework (DSF) suggests that the dynamic “fit” between an intervention and its delivery context is critical to sustainability [
60]. It rejects the assumption that deviation from the protocol leads to decreased benefit and advocates for mutual adaptation and continuous refinement of EBPs in real world contexts [
60]. CQI, identified in the DSF as a facilitator of sustainability, has been used successfully in healthcare and mental health settings [
61,
62] and has guided EBP adaptation [
63]. CQI also fosters learning organizations, which are more likely to improve care and innovate [
64]. We therefore expect that the mechanisms by which CQI impacts clinical outcomes are EBP adaptation and functioning as a learning organization.
While high-level leadership support is strong, and structural and policy level changes and investments have been made to support implementation within many systems, [
2] the individual clinicians who must ultimately deliver treatments have identified idiosyncratic challenges at local levels. The locally oriented, clinician-led approach of CQI-oriented learning collaboratives [
61] (LCs) may facilitate sustainability, but this possibility remains unexamined [
65]. On the other hand, greater time, cost, and personnel burden [
66,
67] may be a barrier to CQI, and whether the CQI process and resulting adaptations lead to more effective treatment and implementation is unknown. To answer these questions, we will conduct a mixed method, type-III hybrid design, which allows simultaneous study of ISs, their mechanisms, and clinical outcomes [
68].
Summary of the proposed project
Clinics in three mental health systems that have implemented CPT for PTSD will submit baseline session recordings and patient data for at least two patients (
n = 192) before random assignment to either 12 months of FID (
n = 16 clinics, 48 clinicians, 192 patients), or CQI (
n = 16 clinics, 48 clinicians, 192 patients). Outcomes will include patient self-reported PTSD symptom outcomes (primary); independent fidelity ratings; and penetration, adaptation, and capacity to deliver CPT [
46,
69]. We will also investigate engagement in, credibility and costs of, and satisfaction with each IS [mechanisms by which the interventions impact patient outcomes] as well as contextual factors that may impact sustainability. The mixed method design will include qualitative methods for a richer understanding of the process and outcomes for each of the ISs [
70]. This study will capitalize on infrastructure created for a previous trial comparing EBP consultation strategies [
59] as well as existing infrastructure in the participating mental health systems and strong collaborative relationships and experience with each participating mental health system. The study has the potential to advance implementation science beyond observational studies of EBP sustainability by providing much-needed information on the effectiveness of interventions to promote long-term EBP implementation.