Improving informed consent for palliative chemotherapy / Andrea Enzinger [and three others].

Format:

Book

Author/Creator:

Enzinger, Andrea, author.

Language:

English

Subjects (All):

Informed consent (Medical law).

Patient-centered health care.

Physical Description:

1 online resource (1 PDF file (67 pages)) : illustrations

Place of Publication:

Washington, DC : Patient-Centered Outcomes Research Institute (PCORI), 2019.

Summary:

BACKGROUND: Many patients with metastatic cancer receive chemotherapy, without expressing their understanding that cure is unlikely. OBJECTIVES: Aim 1: To develop a suite of patient-centered videos and booklets to support informed consent (IC) for common palliative chemotherapy regimens. Aims 2 and 3: To determine if these IC tools improve patients' understanding of palliative chemotherapy risks and benefits, and reduce decisional conflict. METHODS: Aim 1: We partnered with patients, caregivers, and clinicians to develop a prototype chemotherapy IC video and companion booklet, which underwent acceptability testing by a national panel of 57 patient advocates and 25 oncologists. After iterative stakeholder-driven revisions, the prototype was extended to other chemotherapy regimens. Aim 2: In a randomized trial at 5 academic centers, patients with advanced colorectal or pancreatic cancers considering first- or second-line chemotherapy were randomized 1:1, stratified by line of treatment, to the usual IC process or to IC supplemented by access to the IC tools. Patients were surveyed at baseline, 2 weeks, and 3 months. Our primary outcome was the proportion of patients at 3 months who understood that chemotherapy was "not at all likely" to cure their cancer. Prespecified secondary outcomes were understanding of chemotherapy risks and treatment goal, decisional conflict, decisional regret, emotional distress, and satisfaction. Analyses used multiple imputation to account for missing data. RESULTS: Aim 1: Few oncologists (5 of 25 [20%]) or advocates (10 of 22 [45%]) were satisfied with standardly available IC materials. In contrast, most oncologists and advocates rated our intervention highly, with 89% to 96% agreeing that it would be useful and promote informed decisions. Inclusion of patient voices in developing the intervention was considered a key strength. Every oncologist indicated they would use the intervention regularly. Aim 2: For the study, 186 patients were randomized and completed at least 1 survey. Most participants indicated desire for maximal information about chemotherapy risks/benefits; however, 80% (59 of 64) had reviewed the IC booklet, but only 41% (30/66) had watched the IC video by 2 weeks. Accurate understanding of the likelihood of cure was similar between intervention and control arms at 3 months (52.6%; 95% CI, 40.3%-65.0% vs 55.5%; 95% CI, 45.1%-66%; P = .72). Very few patients in either arm (9% and10%; P = .80) reported that the goal of treatment was cure. Intervention patients were slightly more likely to have an accurate understanding of chemotherapy risks (56.0%; 95% CI, 44.3%-67.7% vs 40.2%; 95% CI, 29.5%-50.9%; P = .05). Decisional conflict, decisional regret, satisfaction, prognostic understanding, and emotional distress did not differ by study arm. CONCLUSIONS: Aim 1: Chemotherapy IC videos and booklets were highly acceptable to patient advocates and oncologists and were considered an improvement over existing resources. Aim 2: Our intervention did not impact patients' reported understanding of the likelihood of cure from chemotherapy, which was high before the intervention. LIMITATIONS: Aim 1: We assessed acceptability among advocates, whose perspectives may differ from those of patients. Aim 2: Use of the intervention, particularly video, was poor despite ready access and patients' desire for maximal information. Structured intervention review might have yielded different results. Future interventions should consider the optimal timing and modes of information delivery.

Contents:

Background

Participation of Patients and Other Stakeholders in the Design and Conduct of Research and Disseminating of Findings

Methods

Results

Discussion

Conclusions

References

Publications

Acknowledgment.

Notes:

Description based on publisher supplied metadata and other sources.