RISE Residents: RISE With Residents

Sponsor

McMaster University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05490121

Collaborator

Royal College of Physicians and Surgeons of Canada (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Prevention of child maltreatment (CM) remains a public health priority in Canada; approximately one-third of Canadians report exposure to at least one form of CM. Physicians play an important role in recognizing and responding to CM and its associated sequelae. However, increasing evidence indicates that physicians receive insufficient training related to recognizing and responding to CM. CM education is especially pertinent during the pediatric and psychiatry residency period but it remains unclear what the optimal approach is for preparing Canadian physicians with the knowledge and skills to effectively recognize and respond to CM. Those educational interventions that have been evaluated in medical education contexts have comparatively little emphasis on the complex overlap between IPV, children's exposure to IPV, and other forms of CM. The Violence, Evidence, Guidance, Action Project (VEGA) is a novel educational intervention that has the potential to improve the preparation of physicians to be able to effectively recognize and respond to CM in their clinical encounters and takes into account this complex overlap. The purpose of this study is to assess the acceptability and feasibility of a future randomized-controlled trial comparing two approaches to administering the VEGA intervention, facilitator-led or self-directed VEGA and whether/how these approaches can support residents' education.

The investigators hypothesize that there will be significant increases in preparedness, knowledge and skills, and self-efficacy to recognize and respond to CM in both the experimental and AC arms from Time 1 (baseline) to Time 2 (immediately after the intervention) and Time 1 (baseline) to Time 3 (3 month follow-up). The investigators also predict that these improvements will be slightly attenuated in the experimental arm. Qualitative data pertaining to perceived value and impact will corroborate the quantitative findings.

Condition or Disease	Intervention/Treatment	Phase
Domestic Violence Child Maltreatment Pediatric ALL Psychiatry Education, Medical, Graduate	Other: Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

To determine the feasibility of evaluating the effectiveness of both of VEGA's educational approaches, as well as to generate preliminary estimates of effect for sampling and effect size calculations, a two-arm pilot randomized controlled trial (RCT) will be used (Eldridge et al., 2016). Eligible participants will be randomly assigned to receive either self-directed (i.e., experimental) or facilitator-led (i.e., active control (AC)) VEGA.To determine the feasibility of evaluating the effectiveness of both of VEGA's educational approaches, as well as to generate preliminary estimates of effect for sampling and effect size calculations, a two-arm pilot randomized controlled trial (RCT) will be used (Eldridge et al., 2016). Eligible participants will be randomly assigned to receive either self-directed (i.e., experimental) or facilitator-led (i.e., active control (AC)) VEGA.

Masking:

Single (Outcomes Assessor)

Masking Description:

The Research Assistant will be blinded to group allocation. The RA will be responsible for following-up with participants to make sure they've completed quantitative assessments (online survey) or, if participants choose to complete the surveys over the phone, the RA will complete them over the phone with the participant.

Primary Purpose:

Other

Official Title:

Evaluating an Educational Intervention for Improving Residents' Recognition and Response to Child Maltreatment - A Mixed Method Acceptability and Feasibility Study With a Pilot Randomized Trial

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Facilitator-Led VEGA Facilitator-led VEGA uses a group-based approach where participants complete the Violence, Evidence, Guidance, Action Project (VEGA) content as a virtual or face-to-face workshop. In this study, all workshops will be virtual to prevent social gathering during COVID-19. If a participant is randomized to this arm, the active control (AC) arm, they will be informed that they need to attend a facilitator-led VEGA session via virtual workshop format. The AC intervention will be facilitated via Zoom technology, by two trained facilitators with between 10 to 20 participants in each workshop (keeping the recommended 10:1 participant-to-facilitator ratio) and will last approximately 3 hours. The workshop approach is delivered by trained facilitators and is standardized via the use of a flexibly structured facilitator's guide. Facilitator-led VEGA will deliver material didactically with synchronous lecturing, use case-based role play, and include group-based polling.	Other: Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention VEGA is a novel education intervention that has the potential to improve the preparation of healthcare and social service providers (HHSPs) to be able to effectively recognize and respond to intimate partner violence (IPV) and related forms of family violence, including child maltreatment (CM), in their clinical encounters. VEGA was developed based on systematic reviews and consultation with individuals belonging to 22 national healthcare and social service organizations, including the Royal College of Physicians and Surgeons of Canada. VEGA follows a competency-based framework and a participatory, encounter-based curriculum that includes four learning modules: (a) the epidemiology of IPV and CM; (b) strategies for safely recognizing and responding to (i) IPV and (ii) CM; and (c) principles for ensuring safe clinical encounters for IPV and CM discussions. Other Names: VEGA Family Violence Education Resources
Experimental: Self-Directed VEGA Self-directed VEGA uses an approach where participants complete the Violence, Evidence, Guidance, Action Project (VEGA) content online as a self-directed educational activity, at their own pace in a series of modules. Individuals will register to access the VEGA Educational Resources site. Participants have the option of completing the self-directed VEGA arm in either English or French as the VEGA Educational Resources site offers the content in French and English. If a participant is randomized to the experimental arm, they will be asked to complete the self-directed VEGA at their convenience, within one week of when they are informed they have been asked to complete the self-directed VEGA program. It will take approximately 3 hours for participants to complete all modules. Participants will read didactic material, complete case-based animated simulations, and complete individual multiple-choice questions with response feedback.	Other: Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention VEGA is a novel education intervention that has the potential to improve the preparation of healthcare and social service providers (HHSPs) to be able to effectively recognize and respond to intimate partner violence (IPV) and related forms of family violence, including child maltreatment (CM), in their clinical encounters. VEGA was developed based on systematic reviews and consultation with individuals belonging to 22 national healthcare and social service organizations, including the Royal College of Physicians and Surgeons of Canada. VEGA follows a competency-based framework and a participatory, encounter-based curriculum that includes four learning modules: (a) the epidemiology of IPV and CM; (b) strategies for safely recognizing and responding to (i) IPV and (ii) CM; and (c) principles for ensuring safe clinical encounters for IPV and CM discussions. Other Names: VEGA Family Violence Education Resources

Arm

Intervention/Treatment

Active Comparator: Facilitator-Led VEGA

Facilitator-led VEGA uses a group-based approach where participants complete the Violence, Evidence, Guidance, Action Project (VEGA) content as a virtual or face-to-face workshop. In this study, all workshops will be virtual to prevent social gathering during COVID-19. If a participant is randomized to this arm, the active control (AC) arm, they will be informed that they need to attend a facilitator-led VEGA session via virtual workshop format. The AC intervention will be facilitated via Zoom technology, by two trained facilitators with between 10 to 20 participants in each workshop (keeping the recommended 10:1 participant-to-facilitator ratio) and will last approximately 3 hours. The workshop approach is delivered by trained facilitators and is standardized via the use of a flexibly structured facilitator's guide. Facilitator-led VEGA will deliver material didactically with synchronous lecturing, use case-based role play, and include group-based polling.

Other: Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention

VEGA is a novel education intervention that has the potential to improve the preparation of healthcare and social service providers (HHSPs) to be able to effectively recognize and respond to intimate partner violence (IPV) and related forms of family violence, including child maltreatment (CM), in their clinical encounters. VEGA was developed based on systematic reviews and consultation with individuals belonging to 22 national healthcare and social service organizations, including the Royal College of Physicians and Surgeons of Canada. VEGA follows a competency-based framework and a participatory, encounter-based curriculum that includes four learning modules: (a) the epidemiology of IPV and CM; (b) strategies for safely recognizing and responding to (i) IPV and (ii) CM; and (c) principles for ensuring safe clinical encounters for IPV and CM discussions.

Other Names:

VEGA Family Violence Education Resources

Experimental: Self-Directed VEGA

Self-directed VEGA uses an approach where participants complete the Violence, Evidence, Guidance, Action Project (VEGA) content online as a self-directed educational activity, at their own pace in a series of modules. Individuals will register to access the VEGA Educational Resources site. Participants have the option of completing the self-directed VEGA arm in either English or French as the VEGA Educational Resources site offers the content in French and English. If a participant is randomized to the experimental arm, they will be asked to complete the self-directed VEGA at their convenience, within one week of when they are informed they have been asked to complete the self-directed VEGA program. It will take approximately 3 hours for participants to complete all modules. Participants will read didactic material, complete case-based animated simulations, and complete individual multiple-choice questions with response feedback.

Other: Violence, Evidence, Guidance, Action Project (VEGA) Education Intervention

Other Names:

VEGA Family Violence Education Resources

Outcome Measures

Primary Outcome Measures

Number of Residents Who Meet Eligibility Criteria [Through study completion, an average of 4 months]
The RC will track the number of residents who meet eligibility criteria, our aims are that we will recruit a total of 80 participants within 8 weeks, an average of 10 residents per week.
Number of Residents who Consent [Through study completion, an average of 4 months]
The RC will track the number of residents who consent to the study and agree to be randomized to either self-directed or facilitator-led VEGA education approaches, both overall and per week of recruitment. Our aim is that the proportion of residents who contact the research team about participation and who consent to randomization will be 75% or greater.
Number of Residents who Complete Assigned Intervention [Through study completion, an average of 4 months]
The RC will track the proportion of residents who are randomized and complete each arm, with completion consisting of reviewing all module content and the animated simulations in the case of self-directed VEGA and full attendance of the virtual workshop in the case of facilitator-led VEGA. Our goal is that the proportion of residents who are randomized and complete the assigned intervention will be 75% or greater for each arm. The acceptability of the facilitator-led and self-directed educational approaches as well as their value and impact will be determined via the coding of qualitative interview data from a sub-sample of participants.
Number of Residents who Complete Assessments [Through study completion, an average of 4 months]
The RC will track the feasibility of collecting trial outcome data (survey assessments) at Time 1, Time 2, and Time 3. Our goal is that the proportion of missing data for each time point will be less than 20%. Qualitative description will be used to expand and extend what we learn about acceptability and feasibility of implementing the associated research activities, we anticipate participants will not identify any fatal flaws related to the conduct of an RCT.

Secondary Outcome Measures

Child Maltreatment Vignette Scale [Time 1 (one week before intervention), Time 2 (immediately after the intervention), Time 3 (3 month follow-up)]
Child Maltreatment Vignette scale (Pelletier et al., 2014; Pelletier & Knox, 2017) is a psychometrically validated measure of knowledge and skill accuracy related to recognizing and responding to child maltreatment. Respondents will be prompted to review 14 distinct analog vignettes that depict a range of signs and symptoms of possible CM exposure and asked if they suspect child maltreatment and if they would report to Child Welfare Services. Changes to the question wording and small changes to the wording of the scenarios were made to align the measure with the Canadian context. A mean "knowledge and skill accuracy" score will be produced for analysis, with higher scores indicative of greater knowledge and skill accuracy related to CM. In a future RCT, this would be one of the primary outcomes of interest since this is a robust measure of knowledge and skills related to CM.
Child Maltreatment Knowledge and Skills Questions (Developed by VEGA Team) [Time 1 (one week before intervention), Time 2 (immediately after the intervention), Time 3 (3 month follow-up)]
Participants will be asked a series of questions about their knowledge and skills related to recognizing and responding to child maltreatment. These were developed by the VEGA training research team to capture specific aspects of child maltreatment knowledge directly addressed in the VEGA intervention and which are outside the scope of the child maltreatment vignette scale. The questions ask about the following topics (and more not mentioned here): parental/family risk factors for family violence, what future outcomes are associated with child maltreatment, other possible signs of child abuse, and principles for good documentation and providing ongoing care to children experiencing maltreatment. Including this measure in our study will allow us to make cross sample comparisons.
The Physician Readiness to Manage Intimate Partner Violence Survey: Preparedness Subscale [Time 1 (one week before intervention), Time 3 (3 month follow-up)]
The Physician Readiness to Manage Intimate Partner Violence Survey (PREMIS) is a 67-item self-report tool that was developed to assess physician management of intimate partner violence across 10 subscales (Short et al.,2006; Connor et al., 2011). The preparedness subscale of PREMIS asks respondents to indicate the extent to which they feel prepared to address various aspects of IPV recognition and response when working with their clients across 10 items, including asking appropriate questions about IPV and responding to IPV disclosures. Response options are on a 7-item Likert type scale ranging from "Not prepared" (1) to "Quite Well Prepared" (7) and items are averaged to generate a mean score for practitioner preparedness, with higher scores indicative of greater perceived preparedness to recognize and respond to IPV. All items will be changed to be related to child maltreatment instead of IPV, several items were dropped as they are not relevant in the case of CM.
Mandatory Reporting Self-Efficacy Scale (MRSES) [Time 1 (one week before intervention), Time 2 (immediately after the intervention), Time 3 (3 month follow-up)]
The MRSES is a 7-item self-report measure that asks respondents to indicate the extent to which they perceive their ability to implement a series of behaviours related to mandatory reporting of CM (Ayling, 2019). Informed by Bandura's self-efficacy theory and recommendations for self-efficacy scales (Bandura, 2006), response options are anchored on a scale from 0 to 100 with: "cannot do at all (0)"; moderately can do (50)"; and "highly certain can do (100)." A total score is generated by summing items across the scale for each participant, with higher scores indicative of greater self-efficacy related to recognizing and reporting suspected CM. We anticipate that this measure will be a key mediator of interest in a future definitive RCT given that across provincial and territorial jurisdictions in Canada (including Ontario), a suspicion of CM meets the threshold for a report to child protection authorities (Dubowitz, 2014; Mathews and Kenny, 2008).
Brief Individual Readiness for Change Scale (BIRCS) [Time 1 (one week before intervention)]
The BIRCS scale is a 5-item readiness for change tool (Goldman, 2009). The scale's purpose is to screen for practitioners' readiness for change, in other words their receptivity to learning and applying new evidence-based research practices. For the purpose of this study, the items were adapted to assess provider's readiness to recognize and respond to all forms of child maltreatment (CM) in their clinical encounters. Response options range from '0' Strongly Disagree to '4' Strongly Agree. Two items were added, "I believe recognizing and responding to child maltreatment in my practice improves outcomes for my clients," and "I am motivated to learn about child maltreatment" to capture other aspects of residents' readiness to learn about CM and their belief's about how this will impact their practice.
Achievement Goals for Work Domain (AGWD) [Time 1 (one week before intervention)]
The Achievement Goals for Work Domain (AGWD) scale is a 23-item, psychometrically validated measure of work-related achievement goals that map onto the four goal orientations described by Achievement Goal Theory (Daniels & Daniels, 2018; Baranik et al., 2007). Respondents are asked to indicate their agreement with 23 statements, response options range from '1' strongly disagree to '7' strongly agree and responses are summed to generate a total score for each subscale corresponding to each type of goal orientation; higher scores are more indicative of the respondent's affinity to that goal orientation. In this study, they will be asked about their achievement goals for residency.

Other Outcome Measures

Demographics [Pre-Intervention]
Sociodemographic characteristics will be collected for all participants who are screened for the study, whether they are ineligible or eligible. These will include their age, their program (psychiatry or pediatrics), their sex at birth and their self-identified gender.
Previous Training in Child Maltreatment [Time 1 (one week before intervention)]
Participants will be asked questions to gauge their previous education or training in various areas of CM. Participants will be given a definition of CM and asked in what areas they have received education or training related to CM, in what environment(s) they have learned about CM, and in which of these environments they have learned the most.
Thoughts and Beliefs about Recognizing and Responding to CM in Professional Roles [Time 1 (one week before intervention)]
Participants will be asked to rate their agreement with two statements about how much they believe (1) recognizing and (2) responding to CM is a part of their professional role. In qualitative interviews we will ask participants how often they believe they will encounter family violence in their future practice (how relevant it is to their future professional role as a psychiatrist or pediatrician), the purpose of these questions is to gauge this in our entire sample.
Satisfaction with VEGA Training [Time 2 (immediately after the intervention)]
Participants will complete a series of multiple choice and short-answer questions asking what they thought about the VEGA training. These questions will apply to all participants whether they completed self-directed or facilitator-led VEGA. Questions will include whether they believe the intended learning outcomes were achieved, what they thought of the instructional materials and educational scenarios, and how they would rate the usefulness of VEGA.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participant is a resident in psychiatry or pediatrics.
Participant is currently enrolled in residency training at either McMaster University or University of Toronto.
Participant is fluent in written and spoken English.

Exclusion Criteria:

Participant has previously accessed VEGA intervention materials.
Participant is currently enrolled in or plans to enroll in any other educational intervention focused on family violence within the study time period (approximately next 3 months).