The IKT team will be involved in and provide leadership throughout the 2 phases of the study that tailor (phase 1) and then field-test (phase 2) a peer support SDM strategy (“SDM strategy”) (Fig. 1). The IKT team will recruit and work closely throughout the study with a Steering Committee consisting of members that span the Ontario cancer system and who are familiar with the settings where cancer care delivery occurs for those likely to participate in this study (that is, urban settings of care). As the Cancer Care Ontario Aboriginal Navigators are linked closely to CSWs and FNIM communities in Ontario, the progress of the study will be reported at their monthly meetings for their monitoring and/or input. The two study phases are described across 5-stages (a-e): Phase 1 includes a) tailor the SDM strategy, b) develop training for CSWs in the use of the SDM strategy, c) train CSWs in the use of the SDM strategy, and Phase 2 includes d) field test the SDM strategy, e) evaluate the use of the SDM strategy to determine contributions to the science of KT.
The Ottawa Health Science Network Research Ethics Board (OHSN-REB) granted ethics approval for this study in May 2017 (#20170150-01H).
Phase 1
Tailor a knowledge translation strategy to enhance participation of FNIM people in decisions about their cancer care.
Research question 1 (stage a)
How might a previously developed peer support SDM strategy need to be tailored to enhance participation of FNIM people in making decisions about their cancer care?
Design
A Steering Committee will tailor a previously developed peer support SDM strategy for use by CSWs, who support people that make cancer care decisions. Consensus building methods, that is, a structured process of deliberation and debate about concepts among members, will be used with the Steering Committee to iteratively tailor the SDM strategy (or strategies, to meet the preferences/needs of different FNIM-user community groups) with documentation of decision points in the process. The resulting SDM strategy will be agreed upon by the IKT team.
Intervention for adaptation
The SDM strategy consists of the Adapted Ottawa Personal Decision Guide used with decision coaching and is designed to foster SDM [28]. It is based on the Ottawa Personal Decision Guide (OPDG), a tool that is validated for use in making any health-related or social decision. It can be used to help people summarize their current knowledge (of options, benefits, and harms), clarify their values associated with option outcomes, plan the next steps, and track their progress in decision making. The OPDG underwent a process of adaptation by and with the community using focus groups and usability testing, to become the Adapted OPDG, and for which FNIM participants recommended the use of a decision coach, and that is reported in detail elsewhere [28, 35]. Decision coaching is non-directive decision support provided by a trained individual. Training in the use of the Adapted OPDG with decision coaching has been developed as a workshop [44].
Participants and procedures
Participants will be Steering Committee members who live in Ontario and who are members of the Cancer Care Ontario network of the Aboriginal Cancer Control Unit. The invitation to join the 7 to 9 member Steering Committee will be extended to individuals who themselves are members of FNIM communities and/or work with FNIM people who are in Ontario cancer care systems. The Steering Committee will consist of representatives of the Patient Family Steering Committee, CSWs, community health directors, members of the First Nations-Inuit-Métis Regional Health Tables, and healthcare providers. An important first step in the Steering Committee members’ work together involves the development of terms of reference, and in which Steering Committee members can indicate their preferences for when and how to meet as well as on points such as facilitation of the group meetings. It is proposed that they will be asked to participate in 2 to 3 focus groups conducted on-line, in an iterative process of tailoring the strategy to meet the needs of FNIM people accessing care situated in an urban setting and who are interacting with Ontario’s cancer system. The focus groups are proposed to be facilitated by the researcher(s) and a research assistant. They are anticipated to take up to 1 h each. Although the Steering Committee is to be considered a partner in the research, informed consent from members will be sought as information will be gathered from the Steering Committee during the study processes. Non-identifying demographic information will be collected from Steering Committee members, and they will then be guided as a group by the researcher(s) through use of the strategy with an example decision. The Steering Committee members will be asked to provide general feedback (for instance, organization, readability of the decision guide). Then, the strategy will be reviewed step by step to discuss specific adaptations to language and/or flow of ideas, and to document a rationale for changes. Field notes and/or audio recording by the researcher(s) and/or the research assistant will document the input by the Steering Committee members.
Analysis
Data will be organized to map the adaptation process and summaries about the SDM strategy tailoring will be developed and analyzed for criteria indicating equivalence between the original and end product(s). The findings will be reflected back to the Steering Committee for further input, and then to the IKT team and any additional information will be incorporated into the tailored strategy(ies).
Research question 2 (stage b)
What training is needed to deliver the strategy to community support workers?
Design
The Steering Committee will be engaged in consensus building methods during an iterative process of focus groups to develop both strategy training objectives and processes. The training development will be documented during the focus groups, and in consultation with the IKT team until there is full agreement on both strategy training objectives and process among IKT team members.
Participants and procedures
Participants will be the Steering Committee members who will be invited to participate in 1 to 3 focus groups in an on-line process of developing training for the strategy. The focus groups are anticipated to take up to 1 h each and to be facilitated by researcher(s) and a research assistant. The Steering Committee will be guided as a group by the researcher through SDM strategy training using a previously developed SDM workshop based on the original strategy. The group will be asked to provide feedback on the training objectives and processes, and field notes and/or audio recording by the researcher and/or the research assistant will document Steering Committee input.
Analysis
Data will be organized to map the training development process and summaries developed to explain the development of the end product(s). The final training product(s) will undergo a pilot test within the IKT team to ensure no further adaptations are required, and will then be agreed upon by the IKT team members and the Steering Committee.
Research questions 3,4 (stage c)
Do the CSWs learn how to use the peer support SDM strategy in the training program?
How acceptable, useful/relevant is the training perceived by trainee CSWs?
Design
Consensus building methods will be used to introduce and seek approval from urban-based FNIM communities and the CSWs for the use of the strategy.
Participants and procedures
Steering Committee members will identify potential community partners to be invited to learn about the study and will be communities situated in urban settings. Members of the IKT team will make contact with the communities and inform them of the study; if interested, a community agreement can be used to structure conversation about possible engagement in the research study. If needed, adjustments to the proposed research strategy can be made. Then, a plan to introduce the study to the community will be enacted. Participants will be general FNIM community members and will include CSWs. Community members will be purposefully invited (using posters, email) to participate with the researcher(s) in an English or InuktitutFootnote 2 introductory presentation about the SDM strategy and the research plan. If the community agrees with the proposed study aims, then a local CSW will be purposefully invited to participate in the strategy training following the community meeting.
It is proposed that the SDM strategy will be introduced at a community meeting by the researcher(s) and a research assistant to 3 FNIM communities who have responded to invitations to learn about the research study and the SDM strategy. The proposed method of introductions to community are subject to modification depending on preferences of community for necessary research approvals. Response to the community presentation about the SDM strategy will be documented in field notes by the researcher(s). If needed, adaptations to the SDM strategy/presentation will be made to ensure relevance to the particular community/ies. The appropriateness of the SDM strategy concepts will be indicated by community leaders through the granting of permission to recruit study participants (i.e., no objection to recruitment of community CSWs and community members).
If the community indicates that the SDM strategy and plan for research are appropriate, then the CSW from 3 communities will be invited to participate in the study. After reviewing and signing the consent form with the researcher, the CSW will be asked for some basic demographic information and then will be trained in the SDM strategy and their experience evaluated. CSW agreement to participate and training attendance will be considered to indicate SDM strategy concept appropriateness. Training acceptability, usefulness and relevance will be indicated by CSW training attendance and demonstration of learning objectives, and CSW self-report.
Analysis (community meetings)
Expressions of concern or acceptance from the communities documented in field notes by the researcher will be entered into an Excel database and analyzed descriptively by the researcher, reviewed with the IKT team and with the Steering committee for input and approval of findings.
Analysis (CSW training)
Information on acceptability, usefulness and relevance of the training will be gathered through (written) documented observations in field notes, and in the CSW interviews that are conducted post-training. Researcher field notes will be entered into an Excel database and analyzed descriptively by the researcher. Adjustments to the strategy training objectives or process will be mapped to decision points. Post-training interviews will be analyzed to seek demonstration for evidence of self-efficacy and learning objectives, that is, for evidence that demonstrates (such as in role play, during discussion) how to use SDM in their practice. Findings will be reviewed with the IKT team and Steering Committee.
Phase 2
Field-test the use of a knowledge translation SDM strategy to enhance participation of FNIM people in decisions about their cancer care and will also build evidence about KT science.
Research questions 5,6,7 (stage d)
Does the peer support SDM strategy support elements of shared decision making?
Do CSWs and community members perceive the peer support SDM strategy as acceptable, useful, and relevant?
What is the perceived feasibility of using the tailored peer support SDM strategy within cancer care systems?
Design
A field test of the strategy will be conducted and the interaction between CSWs and matched community members evaluated. The SDM strategy will be evaluated for evocation of elements of SDM and to understand whether and how the CSWs and community members perceive the SDM strategy to be acceptable, useful and relevant, and the feasibility of its use. Our interpretation of success will be that of gaining consensus among community partners about the content and method of delivery of the intervention. As well, it is anticipated that the Steering committee and IKT team will define success based on criteria that are appropriate to the community and reflect the use of the SDM strategy: for example, do CSWs and community members feel satisfied with the interaction, does it help them to feel informed, do they indicate feeling supported, do they think it will help to foster better participation in making health decisions with their healthcare providers.
Participants and procedures
Community members who have had a diagnosis of cancer or has supported a family member with cancer and is familiar with Ontario cancer systems from each community will be recruited for participation using posters as a handout or posting of them by CSWs and according to community protocol. Following a process of informed consent, community members will be asked some basic demographic information.
The use of the SDM strategy will be evaluated in a 30 to 60-min role-play of preparation to make a decision with a healthcare provider. The CSW and community member will choose a decision that is preferred by the community member before the role-play. The interaction between a CSW and 3 to 4 community members will be recorded and/or observed by the researcher (a total of 3 to 4 interactions per community). A standardized tool [45] and thematic analysis of the recorded and/or observed interactions will be used to evaluate the CSW-community member interaction for elements of SDM. Pre- and post-interaction surveys (for acceptability) and recorded and/or observed post interaction semi-structured interviews (usefulness, relevance) with the researcher will be used to evaluate CSW and community member experience.
To understand the feasibility of the strategy use, data will be collected on health systems’ factors that reflect barriers and facilitators and that are from researcher reflective notes and post-interaction interviews with CSW and community members. In addition, community health managers will be invited to comment on the feasibility of the SDM strategy. Following a process of informed consent, the manager will be asked for demographic information and then to indicate their preference to either participate in a short survey and/or interview related to the perceived feasibility, that is, barriers and facilitators in their area of the health system, for the use of the SDM strategy.
The Steering Committee and IKT team will agree (in consultation with respective communities) upon key criteria to determine the indicators for SDM strategy evaluation, that is, to identify whether the SDM strategy is favourable or unfavourable to evoke SDM, as well as the SDM strategy acceptability, usefulness, relevance and feasibility (see analysis).
Analysis (evidence for elements of shared decision making; perceived to be acceptable, useful, and relevant)
The recorded and/or observed interaction between CSW-community member pairs will be analyzed using a standardized tool and a six-step thematic analysis [40] of the interaction to describe elements of SDM. Pre- and post-interaction surveys (for acceptability of SDM strategy) and post interaction semi-structured interviews (usefulness, relevance of SDM strategy) of CSW and community member experiences will be recorded and evaluated using thematic analysis to identify content (for evidence of strategy concepts) and process (for evidence of SDM strategy delivery approach) factors and contextualized using a postcolonial theoretical lens. Findings will be reviewed with the IKT team and the Steering Committee.
Analysis (feasibility of use)
To understand the feasibility of the SDM strategy use, collected data from researcher reflective notes will be entered into an Excel database and analyzed descriptively by the researcher. Post-interaction interviews with CSW’s, community members, and managers will be analyzed descriptively with a six-step thematic analysis [46] process to determine feasibility for the use of the SDM strategy. Data will be contextualized using a postcolonial theoretical lens. Findings will be reviewed with the IKT team and the Steering Committee.
Research questions 8, 9 (stage e)
How can integrated knowledge translation research be conducted with FNIM communities?
What are the perceived determinants (that is, barriers and facilitators) for implementation of the peer supported SDM strategy?
Design
The use of the SDM strategy will be evaluated using consensus methods to determine contributions to the science of KT and to understand i) how integrated KT can be conducted with FNIM communities and ii) the perceived determinants for future implementation of the SDM strategy.
Participant and procedures
The Steering Committee and participating FNIM community members will be engaged to provide feedback to understand how integrated KT can be conducted with FNIM communities. An invitation to the community to meet will be made by poster/email and/or meeting with community leaders. The Steering Committee will be invited to review and comment by email or through an online or telephone meeting. Study documentation including meeting notes and a reflective journal that will have been kept by researcher(s) will be used in a process of document analysis. To identify the determinants for implementation of the strategy, an online and/or in-person presentation of study findings will be made to the Steering Committee and community members. Then, a survey and/or meeting discussion will be facilitated to obtain feedback about key facilitators and barriers to the use of the SDM strategy. Determinants for the future implementation of the SDM strategy will be developed and shared with the Steering Committee and the IKT team, and with final findings agreed upon by all. Final results will be disseminated using a plan agreed upon by the IKT team, Steering Committee members and participating communities.
Analysis
Study documentation (meeting notes, reflective journal, study paperwork) will undergo a process of document analysis and findings summarized and situated in relation to the current integrated KT literature. The information will then be reflected to the Steering Committee and participating communities in the form of an online survey and/or in-person presentations and that considers issues of sustainability [47]. Information will be collected and organized to describe stakeholder perspectives on needs, supports and barriers for the determinants of SDM strategy implementation.
Limitations and strengths
Limitations of the study include failing to fully comprehend experiences of cancer care systems users as a small group of research participants are engaged from a limited number of communities. While the work proposed in this protocol may have some impacts it does not purport to directly tackle the substantial issue of institutional racism and exclusionary protocols and policies of cancer care and broader health systems. The strengths are that research approaches that strive for respectful and inclusive approaches towards FNIM people are being used. A Steering Committee and community participants are to be sought from distinct communities and that are anticipated to include one Inuit community, so that the socio-cultural context of potential users is incorporated into the tailoring and testing of the SDM strategy. As well, it is not the intent of the study to generate information that is generalizable to other communities, but to gather information that may potentially be used to collaboratively develop a larger study that can be designed to include a broader range of users designated as representative of groups for which the SDM strategy would be most important. To facilitate the evaluation of the data synthesis and credibility processes and demonstrate an awareness of how the study findings may potentially be transferred rich description, journal keeping, an audit trail, identification of clear outcomes, and contextualization of study findings are proposed.