Development of a patient decision aid for people with refractory angina: protocol for a three-phase pilot study

Multiple intervention approaches for RFA have been developed and tested (to varying degrees of rigour) in North America and continental Europe over the last two decades, including: neuromodulation techniques, enhanced external counter-pulsation, temporary cardiac sympathectomy, laser revascularization, high thoracic epidural anesthesia, heart rate modulating and metabolic agents, opioids, shock wave therapy, myocardial cryotherapy, coronary sinus reducer, stem cell therapy, and cognitive-behavioural interventions [5]. Prior to submission of this protocol for research ethics board (REB) approval, our investigative team developed and published the Joint Canadian Cardiovascular Society-Canadian Pain Society clinical practice guidelines (CPGs) for the management of RFA [5]. These CPGs featured a large-scale systematic review and meta-analysis of all above-listed treatment options for RFA; the evidence base included systematic reviews, randomized controlled trials (RCT), quasi-experimental studies, and pre-post observational designs. All studies were evaluated for methodological rigor using the Grading Recommendations, Assessment, Development and Evaluation (GRADE) system of evidence evaluation. Based on the IPDAS 2006 Checklist for Judging the Quality of Patient Decision Aids [33], we developed a data extraction form in order for the Research coordinator (RC) to extract the information needed on each treatment option for the PtDA (e.g. availability, safety, modes of action, logistical considerations, cost implications, and potential risks/benefits).

We have published and are aware of several publications on the information and decision-related needs of people with RFA [10, 11, 34‐36]. The RC abstracted relevant data from these publications including a) the natural course of RFA, b) patients’ experiences of various treatment options (e.g. life implications, side effects), c) degree of difficulty in making treatment-related choices, and d) attitudes about decision support.

Input from key informants was obtained via a full-day, investigator-decision maker-collaborator consensus meeting in order to come to consensus on decision tool content and format. Our process was governed by an inductive consensus procedure entitled Technique for Research of Information by Animation of a Group of Experts (TRIAGE) [37]. Rooted in the constructivist paradigm of social research, the TRIAGE procedure differs from the Delphi Technique [38] and the Nominal Group Technique [38] in that exchange of ideas is not exclusively via control of a group leader or survey medium. Three formal steps are involved: 1) preparation, 2) individual production, and 3) interactive production [37]. Preparation: Our key informants included those directly involved in the governance of this research project as well as the primary authorship panel of the Joint RFA guidelines [5]. The RC mailed each participant a package containing a) a briefing document on our collective purpose, b) the Ottawa Decision Making Framework [15] and IPDAS quality checklist [33], c) the specific aims of the decision support tool, and d) a consensus conference worksheet. They were also sent an abridged version of the Joint RFA guidelines [5], highlighting the data on the effectiveness of the available treatment options, as well as outcome probabilities. Participants were asked to review these materials in advance of the conference. Individual production: Participants were asked to document up to 5 priorities for the PtDA on their worksheets, in light of the materials they reviewed. They then sent their worksheets back to the RC by mail or portable document format (PDF) via email. Prior to the consensus meeting, these priorities were categorized into the key ‘indicators’ or stems for discussion/debate. Interactive production: This final step involved the consensus conference itself. According to TRIAGE [37] a pre-established agenda is required as well as a facilitator who is competent in group dynamics management. An appointed facilitator guided the discussion to generate consensus on specific content around each ‘indicator’ (identified in Step 2). The mechanics of this process relied on a prominent visual aid, whereby ideas were documented as collectively ‘accepted’, ‘vetoed’, or ‘held’ for future consideration [37].

Information garnered from all preceding stages of Phase 1 was incorporated into the draft PtDA. The construction of the draft PtDA was based on the following components, according to the IPDAS quality checklist [33] framework and the guiding principles of the Ottawa Decision Framework [15], as follows:

The draft PtDA will be reviewed and critiqued by all stakeholders who were involved in our consensus conference proceedings, plus external RFA content experts. For the purposes of this review, we have created a secure, password-protected and interactive online environment entitled Decision Aid Manager. All reviewers will be asked to logon to Decision Aid Manager in order to view a PDF of the PtDA and assess its content using a quality assessment tool we adapted from the IPDAS quality checklist [33]. This exercise will include rigor of development as well as the effectiveness of the PtDA to help patients a) recognize that a decision needs to be made, b) know the available treatment options, as well as their features and potential risks and benefits (in equal detail), c) understand their values and preferences that affect decision making, and d) become involved in decision making in preferred ways. Decision Aid Manager includes both a ‘yes/no’ checklist for content-related items and a 5-point Likert scale for effectiveness-related items, ranging from 0 = ‘not effective at all’ to 4 = ‘very much effective’. This scale was adapted, with permission, from the effectiveness subscale of Sidani et al.’s Treatment Acceptability and Preference Questionnaire (TAP) [40]. The TAP has established internal consistency and validity, demonstrated by a 1-factor structure and significant differences in scores between patients with differing treatment preferences [40]. We will use our scale to assess areas of strengths and weaknesses of the PtDA; items rated as 2/4 (i.e. effective) or lower will indicate areas requiring attention. Our Decision Aid Manager also includes an open comment box to facilitate feedback on the overall presentation of the tool including clarity, user-friendliness, and visual appeal. Descriptive statistics will be computed by the biostatistician on our team and the RC will use the quantitative and qualitative data derived to create a feedback report of the findings of this review. As a form of integrated knowledge translation (KT), this report will be made available online to all reviewers via Decision Aid Manager, which also features a web-based discussion forum. We will host a week-long asynchronous discussion forum, calling for a collective ‘brainstorming’ session on how the PtDA should be revised, based on our feedback report. This study phase (i.e. review and feedback) will be carried out via a mail out and telephone-based feedback process for those who prefer paper-based media, or do not have convenient access to a computer.

Pilot 1 will involve a convenience sample of 40 RFA patients from across Canada. Those eligible will include patients who a) have a confirmed diagnosis of RFA [5], b) are currently being treated, and c) are able to read, speak and understand English. We are including experienced patients in this phase of the study because the effectiveness of the tool for supporting ‘good decisions’ cannot be presumed until accessibility is assessed; those newly diagnosed could be unduly influenced by a potentially unacceptable tool. This convenience sample will be recruited from 8 cardiac centres across Canada, with established cohorts of RFA patients undergoing active treatment.

Regional variations in RFA care exist across Canada with respect to availability of treatment options, requisite clinical skills, and insurance coverage [1]. Inherent in the notion of acceptability is relevance to our end-users. Hence, acceptability assessment by patients from across Canada is critical. Our total sample size of 40 patients is based on a review by Hertzog [41], suggesting a range of 20–40 participants to allow for sufficient variability in acceptability assessment of an intervention. Our acceptability data will be used to revise the PtDA, which will be tested as an intervention in a subsequent randomized controlled trial.

The research process will be governed centrally. Each clinical site has a running list of known RFA patients. Designated third-party clinicians at each site will ask eligible patients if they would be willing to speak to the RC about the study. If verbal consent is obtained, contact information will be sent to the RC via telephone (to preserve confidentiality). The RC will then phone the referred individual to confirm eligibility, provide a detailed study explanation, and obtain preliminary verbal consent. Eligible patients agreeing to participate will be asked for baseline demographic information via phone interview. They will receive the study explanation, two copies of the consent form, and the draft decision support tool in the mail; a postage-paid, addressed envelope will be included to return one signed consent form to the RC. Participants will be asked to take 1–2 weeks to review the PtDA. The RC will schedule a follow-up phone call wherein participants will be asked to complete a PtDA Acceptability Questionnaire via phone interview; this process will take approximately 10–15 minutes. The RC will collate the data from this acceptability pilot and appropriate revisions will be made to the PtDA. A maximum of 5 participants per site is required. Based on up-front consultation with our clinical sites, we foresee no difficulty in obtaining the required sample.

The primary purpose is to determine the appropriateness and acceptability of the PtDA for our key effectiveness outcomes including decisional conflict (primary outcome) and knowledge of treatment options, and choice predisposition (secondary outcomes). This pilot test will allow us to determine the effect size of the PtDA, which will inform the required sample size for a randomized controlled trial (RCT) of the effectiveness of the tool as an intervention.

The secondary purpose is to a conduct a formative evaluation of the use of PtDA while in use. This evaluation will allow us to conduct a preliminary assessment of predisposing, enabling, and reinforcing factors [42] which may impact the ability of the tool to effectively translate knowledge about various treatment options, and support informed decision making, within the clinical context.

Pilot 2 will involve a convenience sample of 20 RFA patients from two, large urban cardiac centres in Southern Ontario, Canada. Two centres will be used to allow for examination of differences in contextual factors that may impact the effectiveness of the PtDA. Those eligible will include patients who a) are diagnosed with RFA [15], b) require, and have not yet undergone, a specific treatment for RFA [15], c) have an appointment booked to speak with a site-designated HCP about treatment options within the study period, and d) are able to read, speak, and understand English. This sample size was chosen based on Hertzog’s recommendation [41] of a minimum of 20 participants for single sample pre-post pilot studies used to develop both estimates of effect size and variance for a RCT. larger trial. In addition, based on Cochrane data [14], we anticipate that for a level of significance of alpha = 0.05, power (1-beta) = 0.80, a standard deviation of 0.81, and a correlation between pretest and posttest scores of 0.80, we will be able to detect a difference of 0.34 in decisional conflict scores (range: 1–5). This represents a moderate effect size [43], which is typical of PtDAs [14] and also clinically meaningful given that it is has been observed between those who make decisions versus those who delay decisions [44].

As guided by OMRU [42], our implementation, structured adoption (for the purposes of pilot testing), and outcome evaluation will be as follows:

As an integrated KT strategy involving stakeholders from the inception of this project, Pilot 2 site co-investigators and collaborators are assisting us to establish site-designated HCPs, who will assist us with recruitment. These HCPs will be oriented to the study and procedures for pilot testing the PtDA during scheduled visits with their patients enrolled in the study. Potentially eligible patients, identified by these HCPs, will be asked if they would be willing to speak to the RC about the study. If verbal consent is obtained, contact information will be sent to the RC via telephone. The RC will then phone the referred individual to confirm eligibility, provide a detailed study explanation, and obtain preliminary verbal consent. Eligible patients agreeing to participate will be asked for baseline demographic information via phone interview. They will receive the study explanation, and two copies of the consent form; a postage-paid, addressed envelope will be included to return one signed consent form to the RC. Approximately 1 month prior to their scheduled visits with a site-designated HCP, the RC will conduct pre-test data collection via telephone interview, using our pre/post-test questionnaires. These instruments are designed to assess knowledge about treatment options, decisional conflict, and predisposition about treatment options. Upon completion of baseline data collection, the RC will mail participants a copy of the decision support tool. Participants will be asked to review the decision support tool and arrangements will be made for them to complete the PtDA Acceptability Questionnaire via telephone with the RC.

A paper-based version of the decision support tool will be implemented during participants’ scheduled visits with their site-designated HCPs. Where permission is granted (by participants and site-HCPs), the RC will make arrangements for these sessions to be audio-taped and later, transcribed verbatim. While discussing/deliberating treatment options, participants will be encouraged to share their thoughts on the decision support tool, ask questions about the available RFA treatment options, and discuss any concerns that they may have. This iterative approach supports the interactive principles of integrated knowledge translation [45‐47]. One week following these scheduled visits, the RC will conduct post-test outcome assessment via telephone interviews, using our pre/post-test questionnaires.

Once post-test measures are completed, the RC will conduct a brief, semi-structured follow up debriefing interview with each participant, focusing on the experience of using the decision support tool; this will also be conducted via telephone. These interviews will be conducted according to a semi-structured patient interview guide we have developed based on the OMRU knowledge translation framework. This guide will solicit participants’views about the impact of their values on decsions made, changes that may have occurred in treatment-related preferences and perceptions of risks/benefits, general reflections on the decision making process, applicability and usefulness of the decision support tool in context (e.g. barriers, facilitators to use), and their level of comfort interacting with the HCPs when using the tool. For efficiency of data collection, the RC will conduct a similar debriefing with our site HCPs in the form of focus groups; one focus group per site will be conducted. A semi-structured HCP focus group interview guide will also be used, also based on OMRU. These discussion questions will target HCPs’ views of the applicability and utility of the decsion support tool in their respective practice contexts, perceived efficacy of the tool in assisting their patients to arive at treatment-related decions, and perceived enablers and facilitators to decision tool implementation. The RC will take field notes, and these sesions will be audio-taped and transcribed verbatim, in preparation for qualitative content analyses.

All electronic and audio-taped data will be secured in a locked facility. To inform sample size calculations and data analysis feasibility for a larger trial, data will be analyzed as in a larger study, and estimates of variance and correlation (i.e. intracluster correlation within site) will be generated. All quantitative data collected will be checked for departures from normality and analyzed initially with descriptive statistics; measures of central tendency and dispersion (e.g. means and standard deviations) will be computed for continuous variables. For categorical demographic variables, frequencies and proportions will be reported. Differences between pre and post-intervention measures will be examined using paired t-tests for all interval scaled measures, provided the assumption of normality is met [51]. Where the normality assumption is violated, the non-parametric Wilcoxon signed-rank test will be used [51].

As this protocol focuses on appropriateness, acceptability and pilot testing of the PtDA, no sub-analyses were planned to examine the influence of participant characteristics such as age, sex, and highest level of formal education on the outcomes of decisional conflict, knowledge of treatment items, and choice predisposition. Examination of the influence of participant characteristics will be undertaken in a subsequent effectiveness RCT.

An examination of missing data will be of particular importance to the pilot analysis. The level and pattern of missing data will be quantified. Presence versus absence of data for each scale will be compared across demographic and clinical characteristics to identify particular groups of individuals that may have a higher propensity for missing data.

All transcribed qualitative data, including needs assessment data, HCP-participant visits, participant follow-up interviews, and HCP focus groups will be analyzed using inductive thematic qualitative content analysis [52‐54]. The frequency, extensiveness, and specificity of comments will guide data categorization into recurrent themes [52‐54]. These themes will be altered and refined through a recursive process from the data to analyst-generated categorical and conceptual definitions.