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Table 3 Primary and secondary objectives, outcome variables, hypotheses, and analysis for phase 3 of the RISE Project

From: Researching the Impact of Service provider Education (RISE) Project — a multiphase mixed methods protocol to evaluate implementation acceptability and feasibility

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