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Table 1 Six pragmatic trial design features intended to foster intervention sustainment at the participating opioid treatment program

From: Finding harmony so the music plays on: pragmatic trial design considerations to promote organizational sustainment of an empirically-supported behavior therapy

Feature

Feature

Intended benefit

1. Collaborative intervention design process involving both the study investigator (a CM purveyor) and the OTP director

Shared design responsibility allowed intervention to be theoretically-informed and matched to setting-specific fiscal and logistical implementation capacities

Enhanced ‘ownership’ of intervention by setting management and staff; increased likelihood of post-trial sustainment

2. Voluntary recruitment of OTP staff for therapy training and subsequent delivery to patients on a provisional basis

‘Real-world’ conditions would require that this CM intervention be delivered by direct-care staff amidst their regular contact with patients in usual care

Culling of internal expertise in the setting; greater opportunity to identify barriers and contextual adaptations for the intervention

3. Serial training outcome assessments, with quasi-experimental staff randomization to single versus multiple baseline conditions

Longitudinal assessment of staff-based outcomes (i.e., skills, knowledge, adoption readiness) was needed, but with means to account for assessment reactivity

Sufficient staff data collection absent undue setting burden; avoidance of contamination concerns given training of intact staff group

4. Provisional 90-day implementation period for CM-trained staff to deliver the focal intervention to their caseload patients

An interim period during which setting staff would form experience-based impressions of intervention feasibility as well as determine site-specific clinical effectiveness

Setting able to make proximal, and informed decisions about the feasibility, effectiveness, and sustainability of the intervention

5. Broadly inclusive patient eligibility during provisional implementation, comparison to matched group of historical control patients

Heterogeneity of OTP setting patients suggested need to maximize generalizability in documenting the feasibility

Meaningful conclusions about site-specific intervention utility; more expedient accrual and effectiveness of the intervention of staff implementation experiences

6. Designation of local implementation leaders, included in consultative planning discussions with purveyor and OTP director

The OTP was well-positioned for autonomous period of provisional implementation, and this was expected to better inform setting decision about therapy sustainment

Internal support for implementation efforts integrated into supervision-as-usual instead of a resource-intensive fidelity rating system

  1. Pragmatic design features associated with single-site trial conducted by Hartzler et al. [29] testing implementation of a contingency management (CM) intervention at a community-based opioid treatment program (OTP)