Reach (Proportion and representativeness of individuals willing to participate) | Participants: % excluded by reason; % who participate; comparison of clinical and demographic characteristics of participants versus non-participants; barriers and facilitators* to participation, reasons for declining participation |
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Effectiveness (The influence of an intervention on important outcomes, including potential negative effects, quality of life, economic outcomes) | Participants: See Effectiveness Outcomes; Healing Encounters and Attitudes List (HEAL) patient-provider connection, healthcare environment, treatment expectancy, and positive outlook; [81] COVID-19 Impact+; [82]) Telehealth Usability Questionnaire (TUQ)+; [83] % drop out of treatment in short term (2 months) by patient characteristics, intervention; barriers and facilitators*to intervention effectiveness |
Providers: confidence in own pre-defined intervention related competencies (0–10); modified TUQ+; confidence in remote environment+; [84] barriers and facilitators*to intervention effectiveness | |
Adoption (The proportion and representativeness of intervention staff willing to initiate and adopt the intervention) | Providers: demographics, training/educational background; Pain Attitudes and Beliefs Scale (PABS) [85] |
Implementation (How consistently various elements of an intervention are delivered as intended) | Participants: adaptations to interventions; barriers and facilitators* to engaging in interventions at 2 months; % of prescribed visits attended (fidelity) |
Providers: adaptations to intervention delivery processes; % of required intervention elements delivered (fidelity); barriers and facilitators* to delivering interventions | |
Other staff, system stakeholders: estimated costs, time and resources needed to implement intervention with fidelity; opinions about process** | |
Maintenance (The extent to which participants make & maintain a behavior change and the sustainability of a program) | Participants: % completed and % lost to follow up at 2, 6 and 12 months; % return to baseline pain and disability; % change in primary outcomes (see Responder Analysis); barriers and facilitators* to engaging in intervention recommendations at 6 and 12 months |
Providers: changes in attitudes and beliefs after trial completion; views of barriers and facilitators* to implementing intervention in the field |