We used four guidelines to inform protocol reporting: 1) the Mixed Methods Article Reporting Standards (MMARS)16; 2) the Journal Article Reporting Standards for Qualitative Research (JARS-Qual)16; the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement and recommendations for pilot and feasibility trials17,18; and the guideline for reporting health design research19 (reporting checklists in Additional file 1).
Overview
This will be conducted as a study within a trial (SWAT) embedded in the REMAP-CAP trial (NCT02735707).9,20 This SWAT will be jointly coordinated at St. Michael’s Hospital Unity Health Toronto (Toronto, Ontario) and McMaster University (Hamilton, Ontario).
We will apply an exploratory sequential, mixed methods research design (Figure 1).21 This design is characterized by two phases: 1) qualitative data collection and analyses to inform infographic refinement, and 2) testing the infographic through quantitative data collection and analyses.21 Integration will occur at two points; first the results of phase one will be used to refine the infographic which will be pilot tested in phase two, and second the results of phase two will be used to understand if and how they expand upon results from phase one.
Research Ethics Approval
This study has been approved by the Unity Health Toronto Research Ethics Board (ID # 3779).
Phase 1 Methods: Infographic Refinement
Design: Phase one involves two semi-structured focus groups, a stakeholder review meeting, and will follow the principles of qualitative description. We will explore participant experiences of the consent process in depth, with analysis remaining close to the data.22
Setting: Participants will be recruited from within Canada. All activities for will occur remotely via Zoom, an externally hosted cloud-based videoconferencing service (San Jose, California: Zoom Video Communications Inc.). We will also use a web-based visual collaboration platform, Miro (Miro, San Francisco, CA, USA) to facilitate discussion during focus groups.
Eligibility Criteria:
- Adults >18 years
- Patients or SDMs with lived experience in the ICU and RCs with experience consenting patients or SDMs for REMAP-CAP
- Able to read, write and speak in English
- Access to internet and technology (e.g., computer, tablet, mobile phone) to participate in video calling
Outcomes: The primary outcome is an in-depth understanding of patient, SDM and RC perspectives of infographic prototypes through key themes from focus groups, to inform infographic refinement.
Sampling, Recruitment and Consent: We will use two sampling strategies to identify potential participants: purposive criterion sampling, where participants are intentionally selected based on predefined eligibility criteria, and snowball sampling, where participants recommend other individuals for participation.23,24 We will recruit participants from two distinct stakeholder groups, patients/SDMs and RCs.
Patients and SDMs have the critical role of making an informed decision to consent to participation and enrolling themselves/their loved one in a clinical trial in the ICU. We will recruit a diverse group of patients and SDMs approached for consent in any ICU research study. We will use four key strategies to invite patients and SDMs to join our study: 1) CAPTIC Patient Panel – individuals who have previously expressed interest in patient-engagement activities related to CAPTIC and REMAP-CAP; 2) Twitter; 3) REMAP-CAP site study update meetings; and 4) Critical Care/Patient Engagement Networks. Efforts to build relationships with community-based research organizations, social service agencies and health care organizations are ongoing. Typically, these groups have their own volunteer, patient committees and distribution lists, such as the SPOR Support Units, the Health Quality Ontario’s Patient, Family and Public Advisor Network, the South Asian Health Research Hub, Access Alliance, and the Yee Hong Geriatric Care Centre. In our recruitment materials and communications, we will explicitly invite individuals from underrepresented populations and those not commonly represented in research to join our study.
RCs play an important role in the informed consent process, from the design and development of consent documents, to approaching individuals for participation in the study. Thus, our second stakeholder group includes RCs who seek consent from patients or SDMs in the ICU to participate in REMAP-CAP. We will recruit RCs using two strategies: 1) REMAP-CAP site study update meetings; 2) we will email current REMAP-CAP RCs.
Efforts to accommodate varied schedules and availabilities, while compensating for time and expertise are also being made, to ensure panelists can participate, regardless of their occupation and socioeconomic status. Participation in the focus group will be considered implied consent. We will use member checking throughout focus groups to ensure accuracy in interpretation of responses.9 With participants’ consent, focus groups will be audio recorded using Zoom’s built-in recording software. Participant timeline and activities are summarized in Table 2.
Sample Size: We will recruit 4-6 participants from each of our two stakeholder groups, each with 3-4 patients/SDMs and 2 RCs, for a total of 8-12 participants.24
Data Collection: We will host two semi-structured focus groups for feedback on infographic prototypes and use two methods of data collection: focus group transcripts and field notes. Based on preliminary research and conversations with the study team, we have developed three infographic prototypes (Additional file 2) which will be presented to stakeholders. Prototype 1 was developed by our research team, however, after receipt of funding and further discussion, a decision was made to consult a design expert who developed Prototypes 2 and 3. This design consultant is trained in co-design and HCD methodology and will facilitate the focus groups and analyze data.
Both focus groups will cover the same content. We developed a preliminary semi-structured facilitation guide which will be pilot tested prior to data collection (Additional file 3).24 Focus-groups will be a maximum of 120-minutes in length, allowing detailed discussion of specific elements of the infographic prototypes, including: flow, content, organization, imagery, relatability, appropriateness and ease of understanding. Before the focus-groups, participants will receive a pre-work document which will describe the purpose and objectives of the focus groups and guide participants through a preliminary review of the infographic prototypes. Pre-work materials will take approximately 1.5-2 hours to complete and will be sent two weeks before the focus group dates (Additional file 4).
Data collected during focus groups will inform refinement and development of one final infographic prototype. All participants will be invited to a stakeholder review meeting where the revised infographic will be presented. The purpose of this meeting is to elicit any final feedback and to achieve consensus among study participants on a final infographic for pilot testing. Field notes will be documented after focus groups and the stakeholder review meeting to provide an audit trail of researcher experience and decisions.25
Data Management: Focus group and stakeholder review meeting audio recordings will be stored in Zoom’s Cloud service (Canada) and manually transcribed. All study documents (e.g., audio recordings, transcripts, field notes) will be password-protected, stored on the McMaster University secure network, and only research team members will have access to these files. Audio recordings will be destroyed immediately following completion of data analysis for both phases of this study. No personal identifying information will be requested. Any personal identifying information voluntarily given during the focus groups will be deleted from the final transcripts. The focus group transcripts, as well as all contact information, and other research data will be stored securely on encrypted, password-protected servers at McMaster University.
Data Analysis:We will use a “tape-based” approach for analysis of focus group data.26 Tape-based analysis involves listening to focus group-audio recordings during analysis versus analyzing transcripts in a textual format. We will use inductive content analysis.27This includes open coding (making notes and assigning codes), creating categories (grouping similar codes) and abstracting data (to represent each category).28 Categories identified during analysis will be grouped into themes which will serve as the results of phase one and will provide an in-depth understanding of participants’ perspectives and experiences, to inform infographic refinement.
Confidentiality: We will take necessary precautions to ensure participant privacy and data safety (meeting passwords, use of domains for participants, locking meetings once started, allowing participants to change/abbreviate their name). While our local research ethics boards have approved the use of Zoom for data collection, there is a small risk of a privacy breach for data collected on external servers. We will offer participants the opportunity to make alternative arrangements (e.g., phone interview) if they have concerns. At the start of the focus groups and review meeting, we will review the purpose of the study, describe the role of participants, and inform participants that they may discontinue participation at any time.
Remuneration: We will provide participants with a $100-dollar gift card to compensate for their time. This is intended to recognize participants’ time and important contributions; however, we do not believe this is enough to coerce study participation. Compensation will not be revoked upon focus-group cessation.
Phase 2 Methods: Pilot Testing
Design: This is a SWAT embedded in the REMAP-CAP trial. We will conduct a prospective cohort study at up to five Canadian REMAP-CAP sites.
Setting: Phase two will be initiated at St. Michael’s Hospital Unity Health Toronto in Toronto, Ontario, Canada. We selected this as the primary site as it is the Canadian REMAP-CAP Regional Coordinating Center. St. Michael’s Hospital Unity Health Toronto has a 29-bed mixed medical-surgical ICU. After initiation of the pilot, we will scale up to include up to four additional Canadian REMAP-CAP sites (maximum five sites). These sites will be selected based on willingness to participate and capacity to implement the intervention.
Eligibility Criteria for SWAT Consent encounters:
- Patients or SDMs approached to participate in REMAP-CAP
- RCs conducting consent encounters using the infographic
- Patients or SDMs able to read, write and speak in English
- Patients or SDMs able to receive REMAP-CAP consent documents either in person or by email
Exclusion Criteria:
- Patients enrolled in REMAP-CAP by deferred consent
Recruitment and Consent:
RCs: We will contact REMAP-CAP site RCs by email and invite them to participate in this SWAT. RCs who consent to participate in this SWAT will screen patients for eligibility for the REMAP-CAP trial as usual and include the infographic as part of their standard verbal description of the REMAP-CAP trial. At the conclusion of each consent encounter, regardless of their decision to participate, the RC will inform the patient/SDM that our research team is working to improve the consent experience for future trial participants and invite them to participate in a follow-up survey.
Patient/SDM: REMAP-CAP requires written consent for study participation. All participants will receive the standard REMAP-CAP consent documents with a verbal description of the trial. Eligible patients, or their SDMs, who are approached for participation in REMAP-CAP with the infographic will automatically be eligible for this SWAT. At the conclusion of the REMAP-CAP consent discussion, patients or SDMs will be invited to participate in a follow-up survey. If the patient/SDM agrees to follow-up and can receive and complete an electronic survey, the RC will advise the patient/SDM that a member of the research team will send an email within 24 hours to seek feedback on their consent experience. The RC will inform the patient/SDM that the decision to provide feedback will not impact quality of care and the RCs will not see their responses. The RC will provide the SWAT research team with the participant’s name and contact information by email or by phone. The follow-up email, sent centrally by the SWAT research team, will outline survey objectives, invite the individual to participate and will contain an electronic survey link.
For patients/SDMs who are unable to receive or complete an electronic survey, we will provide the option to complete a paper version. If the patient/SDM agrees to follow-up, the RC will provide them with a paper copy in an unsealed envelope. These patients/SDMs will be asked to complete the paper survey within one week and return it to the ICU research office. Site RCs will be asked to scan, and email completed surveys to the SWAT research team for central data entry.
At the beginning of the survey, we will: inform potential respondents that their participation is voluntary, that completed questionnaires will remain confidential, and provide contact information where a member of the team can address any questions. For electronic questionnaires, we will send non-respondents a reminder email one week after the initial email. Before re-contacting patients and/or SDMs, the SWAT research team will communicate with site RCs to ensure it is an appropriate time for communication. Participant timeline and activities are summarized in Table 1.
Sample Size: We will use a sample of consecutive REMAP-CAP consent encounters for up to six months at each of our study sites. Based on historical recruitment rates, we anticipate 2 patients per month, per site, for a total sample size of up to 60 patients/SDMs. We will seek feedback from all RCs consenting during this time. We anticipate 1-2 RCs per site for a total of 5-10 RCs. We will meet with RCs at each site before study implementation.
Intervention: We will provide patients/SDMs with the infographic from Phase 1 to augment the standard REMAP-CAP consent process. The standard consent process includes consent documents provided to the patient/SDM and an explanation/discussion of the study between the patient/SDM and study RCs. For consent encounters that occur in-person, a paper copy of the infographic will be provided to the patient/SDM with the standard consent documents. For remote consent encounters (by telephone or videoconference), an electronic copy of the infographic will be provided with the standard consent documents.
Outcomes: The primary outcome of this pilot study is feasibility. For patients/SDMs this will include receipt of the infographic, consent to follow-up and the completion of follow-up surveys. For RCs, this will include successful implementation of the infographic. We will collect additional data regarding the feasibility and acceptability of this intervention using patient-centred outcomes. We will collect data from both patients/SDMs and RCs who participate in the consent encounters.
Patients/SDMs: We will use a modified version of the Consent Understanding Evaluation-Revised tool (CUE-R).29 The CUE-R is a structured interview tool which was developed through a literature review and expert opinion, and validated through focus groups with research participants and community advisory board members, and later expanded to assess satisfaction with the consent process and consent documents.29,30 We modified the CUE-R to a self-administered survey, include both patients and SDMs as potential survey respondents, and fewer questions. Modifications were made through consensus among our multidisciplinary SWAT research team, including patients/SDMs, REMAP-CAP RCs and investigators. We called our modified version of the CUE-R tool the “CUE-R 2” (Table 2). Participants who choose to complete an electronic survey will receive a unique survey link through LimeSurvey that will prevent duplicate responses.
RCs: We will collect data using a modified version of a case report form (CRF) used in a SWAT of video-augmented consent for an ICU rehabilitation trial.31 Outcomes are summarized in Table 2 and Figure 2. RCs will be asked to complete an electronic CRF on LimeSurvey for each consent encounter within 24 hours, to decrease the potential influence of recall bias.32
Data Management: Data will be analyzed using Stata (v. 15.0, StataCorp LP, College Station, Texas). Raw data and analysis files will be password-protected and stored on a password-protected computer. We will keep a copy of data files on the McMaster University secure network and only SWAT research team members will have access. Completed hard copy surveys will be stored in a locked filing cabinet in a locked office.
Data Analysis: For the CUE-R 2, we will analyze demographic and survey response data using descriptive statistics, including using counts, frequencies and means (standard deviations) or medians (1st, 3rd quartiles) for Likert-style questions or if data are skewed. We will narratively summarize text data from open-ended questions. We will calculate survey response rate as the proportion of completed surveys compared to the number of patients/SDMs who are invited to participate.33 We will also calculate the proportion of partially completed and fully completed surveys. We will analyze RC CRFs using descriptive statistics. We will assess success of implementation using three metrics: 1) eligible consent encounters (proportion of patients/SDMs identified to receive the infographic compared to total number of REMAP-CAP consent encounters during the study period); 2) receipt of infographic (number of patients/SDMs who received the infographic as a proportion of eligible consent encounters); and 3) feasibility of data collection will be assessed by consent rate for follow-up and the survey response rate.
Confidentiality: Emails will be stored separately from survey responses; a master log containing email information will be created for this purpose. All email communication will be through a generic study email, hosted on the McMaster University secure domain.
Remuneration: After survey completion, we will provide survey respondents with a $5 gift card.. This is intended to recognize participants’ time and important contributions; however, we do not believe this is enough to coerce study participation. Compensation will not be revoked in the case of incomplete survey responses. We will also provide RCs at our pilot sites with a $50 gift card in appreciation of their time and expertise in implementing our study protocol.
Dissemination Policy
We will disseminate results through a peer-reviewed publication, national and international presentations.
Mixed Methods Integration
Data integration will occur at two points in this study.21 The first, primary point of integration is before phase two, where qualitative focus group data will be used to develop a consent infographic that will be tested quantitatively. Once phase two is complete, we will integrate the results from both phases to understand if and how the quantitative results build upon the qualitatively informed infographic. Transcripts from phase one will be used during this point of integration. This second point of integration will inform future evaluation of the infographic in a future randomized trial across REMAP-CAP sites. Lastly, we will use investigator triangulation (multiple researchers involved in data collection and analysis) and methodologic triangulation (multiple methods of data collection) to improve the validity of our results.34