Browsing by Author "Davison, Sara N"

Now showing 1 - 2 of 2
  • Thumbnail Image
    ItemOpen Access
    A cluster randomized controlled trial for the Evaluation of routinely Measured PATient reported outcomes in HemodialYsis care (EMPATHY): a study protocol
    (2020-08-10) Johnson, Jeffrey A; Al Sayah, Fatima; Buzinski, Robert; Corradetti, Bonnie; Davison, Sara N; Elliott, Meghan J; Klarenbach, Scott; Manns, Braden; Schick-Makaroff, Kara; Short, Hilary; Thomas, Chandra; Walsh, Michael
    Abstract Background Kidney failure requiring dialysis is associated with poor health outcomes and health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) capture symptom burden, level of functioning and other outcomes from a patient perspective, and can support clinicians to monitor disease progression, address symptoms, and facilitate patient-centered care. While evidence suggests the use of PROMs in clinical practice can lead to improved patient experience in some settings, the impact on patients’ health outcomes and experiences is not fully understood, and their cost-effectiveness in clinical settings is unknown. This study aims to fill these gaps by evaluating the effectiveness and cost-effectiveness of routinely measuring PROMs on patient-reported experience, clinical outcomes, HRQL, and healthcare utilization. Methods The EMPATHY trial is a pragmatic multi-centre cluster randomized controlled trial that will implement and evaluate the use of disease-specific and generic PROMs in three kidney care programs in Canada. In-centre hemodialysis units will be randomized into four groups, whereby patients: 1) complete a disease-specific PROM; 2) complete a generic PROM; 3) complete both types of PROMs; 4) receive usual care and do not complete any PROMs. While clinical care pathways are available to all hemodialysis units in the study, for the three active intervention groups, the results of the PROMs will be linked to treatment aids for clinicians and patients. The primary outcome of this study is patient-provider communication, assessed by the Communication Assessment Tool (CAT). Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated. The present protocol fulfilled the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklist. Discussion While using PROMs in clinical practice is supported by theory and rationale, and may engage patients and enhance their role in decisions regarding their care and outcomes, the best approach of their use is still uncertain. It is important to rigorously evaluate such interventions and investments to ensure they provide value for patients and health systems. Trial registration Protocol version (1.0) and trial registration data are available on www.clinicaltrials.gov , identifier: NCT03535922 , registered May 24, 2018.
  • Thumbnail Image
    ItemOpen Access
    Behaviors in Advance Care Planning and ACtions Survey (BACPACS): development and validation part 1
    (2017-11-22) Kassam, Aliya; Douglas, Maureen L; Simon, Jessica; Cunningham, Shannon; Fassbender, Konrad; Shaw, Marta; Davison, Sara N
    Abstract Background Although advance care planning (ACP) is fairly well understood, significant barriers to patient participation remain. As a result, tools to assess patient behaviour are required. The objective of this study was to improve the measurement of patient engagement in ACP by detecting existing survey design issues and establishing content and response process validity for a new survey entitled Behaviours in Advance Care Planning and ACtions Survey (BACPACS). Methods We based our new tool on that of an existing ACP engagement survey. Initial item reduction was carried out using behavior change theories by content and design experts to help reduce response burden and clarify questions. Thirty-two patients with chronic diseases (cancer, heart failure or renal failure) were recruited for the think aloud cognitive interviewing with the new, shortened survey evaluating patient engagement with ACP. Of these, n = 27 had data eligible for analysis (n = 8 in round 1 and n = 19 in rounds 2 and 3). Interviews were audio-recorded and analyzed using the constant comparison method. Three reviewers independently listened to the interviews, summarized findings and discussed discrepancies until consensus was achieved. Results Item reduction from key content expert review and conversation analysis helped decrease number of items from 116 in the original ACP Engagement Survey to 24–38 in the new BACPACS depending on branching of responses. For the think aloud study, three rounds of interviews were needed until saturation for patient clarity was achieved. The understanding of ACP as a construct, survey response options, instructions and terminology pertaining to patient engagement in ACP warranted further clarification. Conclusions Conversation analysis, content expert review and think aloud cognitive interviewing were useful in refining the new survey instrument entitled BACPACS. We found evidence for both content and response process validity for this new tool.