Project Details
Abstract
To improve end-of-life (EOL) care, the U.S. Institute of Medicine (IOM) advocates a good death that is “in accord with the patients' and families' wishes.” Adequate knowledge of prognosis is a prerequisite for planning appropriate EOL care that supports one’s own values and limits the use of “futile” treatments that prolong unnecessary suffering, thus improving quality of life (QOL) at EOL. The literature and results from our own studies indicate that only a minority of terminally ill cancer patients is aware of their prognosis and that EOL care discussions between healthcare professionals and terminally ill cancer patients and/or family caregivers remain exceptional rather than common. Therefore, current EOL care does not conform well to individual patients’ EOL care preferences, suggesting a target for improving care quality. However, only a handful of interventional studies have targeted improving the quality of EOL care, and their outcomes did not comprehensively reflect the essential goals of EOL care suggested by the IOM and World Health Organization. Furthermore, few studies have been theoretically based and tailored to participants’ readiness to engage in advance care planning (ACP).
Therefore, the primary objectives of this 5-year randomized controlled trial of a theory-based, tailored, multifaceted, interactive ACP intervention are to examine the extent to which the proposed ACP intervention will increase the congruence between terminally ill cancer patients’ preferred and actual EOL care, improve QOL, depressive symptoms, and anxiety of patients and family caregivers during the patient’s dying process, and enhance family caregivers’ bereavement adjustment. The secondary objectives are to determine the effectiveness of the proposed ACP intervention in facilitating patients’ prognostic awareness and EOL care discussions among patients, family caregivers, and physicians; in increasing the extent of patient-caregiver agreement on preferences for EOL care; and in reducing aggressive EOL care treatments for terminally ill cancer patients.
We hypothesize that the proposed ACP intervention will (1) facilitate patients’ prognostic awareness; EOL care discussions among patients, family caregivers, and physicians; and patient-caregiver agreement on preferences for EOL care as the patient’s death approaches; (2) reduce aggressive healthcare resource utilization at EOL; (3) increase the congruence between patients’ preferred and actual EOL care; (4) improve QOL, depressive symptoms, and anxiety of patients and family caregivers during the patient’s dying process; and (5) enhance family caregivers’ bereavement adjustment.
A convenience sample of 418 patient-caregiver dyads will be randomly and equally assigned to the intervention or attention-control groups. Participants, investigators, data collectors, and data analysts will be blinded to intervention assignments. Patients and caregivers in each dyad in the intervention group will be individually and separately assessed about readiness to engage in ACP by a trained, master’s-prepared ACP interventionist experienced in palliative care. Tailored interventions will be offered according to participants’ stage of readiness to engage in ACP based on the Transtheoretical Model. The intervention will include two decision aids (a workbook and a video) designed to enhance participants’ understanding of the essential elements of ACP as well as the probability of survival and consequences of life-sustaining treatment. The goal of the ACP intervention is to facilitate patients, family caregivers, and physicians discussing and understanding the patient's prognosis and preferences for EOL care by appropriately weighting the benefits and burdens of medical treatments at EOL. During these discussions, patients’ EOL care preferences will be clearly defined and documented to later guide the patient's primary physician in EOL care decisions. These preferences in EOL care will be revisited periodically to ascertain any changes over time. The attention-control group will be given general social support and passive education on symptom management by a bachelor’s-prepared nurse not experienced in palliative care.
Validated instruments will be used to measure preferences for prognostic information and EOL care, confounding factors (symptom distress, functional dependency, and social support), and outcome variables (QOL, depressive and anxiety symptoms, and bereavement grief). Data will be collected every 3 weeks until the patient’s death. Bereavement interviews will be conducted at 1, 3, 6, and 13 months after the patient’s death; 13 months was chosen to avoid contamination from anniversary grief reactions. After each patient’s death, data on use of healthcare services at EOL will be collected from medical records.
The effectiveness of the ACP intervention will be examined using intention-to-treat analyses with generalized estimating equations (GEE). Besides the percentage of overall agreement between patients’ preferred and actual EOL care, kappa coefficients will be computed to correct for the agreement that can be expected by chance alone. Multivariate logistic regression with the GEE method will be used to examine the impact of the ACP intervention on improving the congruence between patients’ preferred and actual EOL care, increasing prognostic awareness, EOL care discussions, and patient-caregiver agreement on preferences for EOL care, and decreasing aggressive healthcare resource utilization at EOL with simultaneous adjustment for confounding factors. Multivariate multiple linear regression with the GEE method will be used to test the effectiveness of intervention in improving patients’ and family caregivers’ QOL and psychological well-being (anxiety and depressive symptoms) before the patient’s death, and family caregiver bereavement outcomes (QOL, depressive symptoms, and grief reactions). Results from this study will contribute to improving EOL care and policies that ensure appropriate EOL care and efficient use of healthcare resources to honor cancer patients’ preferences for EOL care.
Project IDs
Project ID:PG10601-0424
External Project ID:NHRI-EX106-10208PI
External Project ID:NHRI-EX106-10208PI
Status | Finished |
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Effective start/end date | 01/01/17 → 31/12/17 |
Keywords
- End-of-life care
- preferences of end-of-life care
- randomized controlled trial
- terminally ill cancer patients
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