Table 3 Primary and secondary objectives, outcome variables, hypotheses, and analysis for phase 3 of the RISE Project
Objective | Focus | Outcome measure; data source | Criteria for success/hypothesis | Analysis |
|---|---|---|---|---|
Primary objective “A” | ||||
Determine the proportion of primary care clinics who are approached and agree to participate | Feasibility of clinic recruitment and retention | (i) Percentage of eligible clinics who are approached and enroll; RC tracking | Criteria for success (i) A 60% or greater enrollment rate of primary care clinics approached for participation | (i) Descriptive counts, percentages, and range across provinces |
Primary objective “B” | ||||
Determine the proportion of primary care providers who (i) enroll in the study, (ii) complete all VEGA modules, (iii) are retained for all follow-up timepoints | Acceptability and feasibility of VEGA education Acceptability and feasibility of staff recruitment and retention procedures | (i) Percentage of eligible providers that enroll; RC tracking (ii) Percentage of enrolled providers that complete all VEGA modules; RC tracking (iii) Percentage of providers that complete quantitative research assessments at all timepoints; RC tracking | Criteria for success (i) A 60% or greater enrollment rate of providers at each of the clinics; (ii) A 70% or greater VEGA completion rate among enrolled providers; (iii) 70% or more of enrolled providers will be retained at a 12-week follow-up | (i–iv) Descriptive counts, percentage, and range across provinces |
Primary objective “C” | ||||
Determine the feasibility of collecting provider-level outcome data at baseline, 1-, and 3-month follow-up timepoints | Feasibility of secondary outcome data collection | Percentage of missing data on secondary outcomes at each time point; RC tracking Percentage of missing research assessments; RC tracking | Criteria for success: There will be less than 20% missing data at the individual and group level for each timepoint Our RC is able to generate estimates of effect and variability (with 95% confidence intervals) for the secondary outcomes | Percentages and range of missing data at the item, individual, and group level across sites for each of the secondary outcome measures and across secondary outcome measures Regression estimates and associated confidence intervals |
Primary objective “D” | ||||
Explore the acceptability and feasibility of the intervention and evaluation procedures in (i) a sub-sample of providers who fully completed the VEGA intervention, as well as (ii) managers of participating primary care clinics | Acceptability of training Acceptability of research procedures Proof-of-concept/clinical impact | Narrative descriptions of perceived acceptability and burden of intervention and research activities; qualitative interviews with providers and clinic managers Narrative description of perceived value and impacts of intervention in practice; qualitative interviews with providers and clinic managers. Narrative descriptions of implementation successes and challenges; consultation sessions with providers | N/A | Directed content analysis; summative content analysis; thematic analysis |
Secondary objective (A) | ||||
Describe the change in provider (i) knowledge and skill accuracy to recognize and respond to IPV and child maltreatment, as well as change in their perceived; (ii) preparedness to recognize and respond to IPV and child maltreatment; (iii) attitudes towards recognizing and responding to IPV and child maltreatment from baseline to post-intervention and 3-month, follow-up timepoints | Proof of concept/educational impact | Quantitative research assessments; provider self-report | Hypothesis: Self-reported knowledge and skill accuracy (Child Maltreatment Vignette Scale; Actual Knowledge Subscale - PREMIS), preparedness (Mandatory Reporting Self-Efficacy Scale; Preparedness Subscale-PREMIS measure), attitudes (Role Beliefs Scale) will be better at all follow-up timepoints, relative to baseline | Regression analysis |
Secondary objective “B” | ||||
Describe the change in the number of referrals made by enrolled providers over the previous month to (i) intimate partner violence services; (ii) parenting services/interventions; (iii) child welfare services; or (vi) psychotherapy services at baseline, post-intervention, and 3-month follow-up timepoints | Proof of concept/educational impact | Quantitative research assessments; provider self-report | Hypothesis: Provider self-reported referrals of patients to (i) intimate partner violence services; (ii) parenting services/interventions; (iii) child welfare services; or (vi) will be higher at all follow-up timepoints, relative to baseline | Regression analysis |