Purpose. To systematically develop and conduct preliminary evaluation of a decision support intervention to engage patients and their families about whether to accept or decline implantable cardioverter-defibrillator (ICD) pulse generator replacement.
Methods. A series of studies using multi-methods and guided by the Ottawa Decision Support Framework and the Normalization Process Theory: 1) an integrative review of patients’ perspectives on ICD decision-making; 2) a systematic review of the risks and benefits of ICD replacement; 3) an embedded mixed methods study to iteratively develop a patient decision aid (PDA) and simultaneously plan for its implementation; and 4) a feasibility pilot randomized controlled trial to evaluate ease of recruitment, decision support intervention delivery and data collection.
Findings. The integrative review of 25 articles reported that ICD decision-making was difficult and the majority of patients misunderstood ICD therapy. The systematic review of 17 nonrandomized studies reported that complication rates are higher at replacement as compared to initial implant, mortality benefit post ICD replacement is unclear, and patients’ clinical profile can affect ICD’s effectiveness. Findings from both studies were used to draft a PDA. Interviews with 18 end-users (clinicians, patients, spouses) revealed that the current ICD replacement process is automated and needs to elicit patient preferences. The PDA was considered the optimal tool to initiate the discussion of options. In a feasibility trial, 30 patients were randomized to the decision support intervention (PDA + decision coaching) (n=15) or usual care (n=15). The intervention was used as intended, users found the PDA acceptable but acceptability of decision coaching was variable. Patients exposed to the intervention had better knowledge scores compared to controls.
Conclusion. The Ottawa Decision Support Framework and Normalization Process Theory were complementary frameworks to ensure that the decision support intervention has the potential for implementation. To determine whether this approach was successful, future research is required to evaluate and implement the intervention in clinical practice. Findings from the feasibility study will be used to design an effectiveness trial.
| Identifer | oai:union.ndltd.org:uottawa.ca/oai:ruor.uottawa.ca:10393/37824 |
| Date | 06 July 2018 |
| Creators | Lewis, Krystina B. |
| Contributors | Stacey, C. Dawn |
| Publisher | Université d'Ottawa / University of Ottawa |
| Source Sets | Université d’Ottawa |
| Language | English |
| Detected Language | English |
| Type | Thesis |
| Format | application/pdf |
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