Design
A prospective quasi-experimental intervention study with repeated measures (baseline and post decision support intervention) over an 18 month period will be conducted). This study incorporates quantitative and qualitative approaches to triangulate findings and provide a fuller perspective[13]. The use of qualitative and quantitative data will contribute to our understanding of decisional conflict and potential modifiers in the context of HD access decisions for patients with Stage 5 CKD [14].
Intervention
Decisional conflict can be screened with the 4 item SURE tool. Based on core concepts of the validated Ottawa Decisional Conflict Scale[15] the SURE tool has been found suitable for screening decisional conflict in French and English-speaking patients with a variety of health conditions[16]. Four questions target sources of decisional conflict (feeling uncertain, feeling informed, feeling clear about values and feeling supported in decision making). Responses are scored as yes (score = 1) or no (score = 0). Scores of less than 3 indicate decisional conflict. Coupling the SURE tool with a decision support system structured so that a positive test result (scores of 3 or less) triggers providers to help patients through the decision-making process through a collaborative effort involving the interprofessional health care team and/or refer patients to appropriate resources could benefit patients and ensure patients have the opportunity to make informed HD access choices.
Setting
The study will take place at Toronto's St. Michael's Hospital. St Michael's is a tertiary care teaching and research hospital with more than 5,000 staff, 600 physicians and 1,100 students, which is affiliated with the University of Toronto. With more than 450 inpatient beds and extensive outpatient clinics, the Hospital has a large kidney disease program including an in-centre hemodialysis unit providing outpatient and inpatient hemodialysis unit where 235 patients with Stage 5 D CKD receive care.
Participants
A purposive sampling strategy will be used to ensure that the study sample will be representative of the level of care within the renal patient population. Participants will be recruited from the following categories: a) patients (n = 40) receiving HD; b) professionals from the interprofessional team (n = 10-12) providing direct patient care within and/or directly associated with HD delivery; and c) managers and educators (n = 4-6) with varying levels of influence in the renal program practice environment (e.g., managers, educators, senior leaders influencing practice). Eligible patient participants include Stage 5 CKD HD patients with CVCs who would be candidates for AVF who are receiving maintenance HD in the hemodialysis unit and who are able to communicate in English and who are judged mentally and physically able to participate by the HD care team. Eligible health professional participants include nurses, physicians, dieticians, pharmacists, and social workers. Eligible managers and educators include nurse practitioners, nurse educators, vascular access coordinators, clinical leader managers, and the program director.
Data Collection and Procedures
Sessions outlining study information and procedures will be held in staff meetings and rounds. Education based on the RNAO BPG for Decision Support in CKD[1] recommendations will be provided to HD clinic nurses by the HD Nurse Practitioner (a member of the CKD BPG development team). Table 2 summarizes the relationship between research objectives, data collection and analysis. In line with our research objectives, study procedures include three main phases:
Phase 1: Identify the prevalence of decisional conflict (research objective 1&2: BPG recommendation 1,2, 3,4,5). Nurses in the HD clinic will provide information about the study to eligible patients. The research coordinator will obtain informed consent from patients indicating an interest in participating. The HD nurse will then screen for decisional conflict using the SURE tool. Results of the screening (presence or absence of decisional conflict and source(s)) will be verbally communicated to the interprofessional team and will be recorded in the patient health record. After the source(s) of decisional conflict has been pinpointed, a decision support intervention will be developed using the Decision Support for Adults Living with Chronic Kidney Disease BPG. This intervention will be tailored to meet the identified need and will be led by an Advanced Practice Nurse who specializes in CKD Stage 5 D care. For instance, the nurse will help the patients through a decision-making process (i.e.: provide facts; discuss with patient what is personally important for them to achieve or avoid; clarify what resources patient needs to make a decision) and/or refer patients to appropriate resources or members of the interprofessional team (i.e.: facilitate team conference/family meeting; refer to social worker). The SURE tool will be repeated following the decision support intervention to evaluate the intervention and plan next steps. Intervention details, outcomes and planned next steps will be documented in the patient health record.
Phase 2: Determine the impact of tailored decision support interventions (research objective 3: BPG recommendation 4,7,8). We will aggregate and compare the pre and postintervention SURE scores. Using chart review and our Program's HD Vascular Access Database, congruence between identified preferred choice following the intervention and actual HD access will be assessed. Interviews based on previous research related to patient decision making needs will be conducted with patient participants [17].
Phase 3: Identify the acceptability, feasibility of such an approach (research objective 4: BPG recommendation 7,8). We will conduct focus groups with members of the interprofessional team who have been directly or indirectly involved with patient participants. A focus group will also be held with the renal program management and educator group. Focus group guides will be adapted from our previous research about barriers, facilitators and implementation strategies for decision support interventions [18].
Data Analysis
Quantitative data will be analyzed using descriptive and inferential statistics. Statistical significance of difference between means over time for aggregated SURE scores will be assessed using a paired t-test. The estimated sample size for the t-test is based on a test for differences in mean scores of decision conflict (SURE scores) pre and post intervention. An effect size of .70 requires n = 32/group, when alpha error = 0.05 and beta error = 0.20[19]. To accommodate attrition we plan to recruit 40 patients. Congruence between identified preferred HD access choice following intervention and actual HD access will be analyzed using Pearson r correlation. Qualitative analysis with content coding and identification of themes will be conducted for the focus group and patient interview data using well established criteria to maintain trustworthiness and credibility of analysis processes and findings [20].
Ethical Considerations
Ethics approval has been obtained from St Michaels Research Ethics Board. All participants will receive study information letters and informed consent forms.
Dissemination
Patients and providers will be directly involved in providing feedback about the feasibility and acceptability of the SURE tool and decision support intervention on the process of care thereby making the findings from this study more relevant to the organization's processes of care. Intended users of our research results include kidney health teams, educators, organizational managers and senior leaders and health policy makers interested in addressing barriers to HD access in clinical practice. As well, members of the research team have extensive and relevant experience and connections with the intended users. End of grant activities will include dissemination of study results: a) at conferences (scientific and professional) with themes related to shared decision making, interprofessionalism and renal policy; and b) on the website of institutions where team members are located. The research protocol and study results will be published in peer reviewed open-accessed journals.
