Navigating High Risk Surgery: Empowering Older Adults to Ask Questions That Inform Decisions About Surgical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 446
- 主要终点
- Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised
研究概览
简要总结
The investigators will perform a multi-site cluster randomized trial that uses a stepped-wedged design to compare the effectiveness of a Question Prompt List (QPL) intervention to usual care for patients considering high-risk vascular (peripheral, cardiac, neuro) and oncologic operations. This 24-month study will use a time-dependent cluster randomization plan within each of the five study sites: the investigators will randomly assign time points for surgeons who perform high risk operations to cross over from usual care to QPL intervention. Study staff will audiotape the conversation between the patient and surgeon during one preoperative clinic visit; administer surveys to patients and family members at 24 hours, 6 weeks and 12 weeks after that visit; and record surgical decisions, treatments received and associated outcomes. The investigators will use stratified purposeful sampling to identify a subset of patients in each study arm who have experienced serious complications for qualitative interviews.
详细描述
To answer the research question, "Could a patient-driven approach that improves decision making and informs postoperative expectations have more effectiveness than the current surgeon-directed preoperative conversation?" the investigators will conduct a multi-site randomized controlled trial of the question prompt list intervention (QPL) for high risk surgery that will:
- Compare the effectiveness of the intervention relative to usual care on the extent of patient engagement in decision-making for high risk surgery. (Aim 1)
- Compare the effectiveness of the intervention relative to usual care on treatment choice and on psychological well-being and post-treatment regret for patients and family members. (Aim 2)
- Compare the effectiveness of the intervention relative to usual care on interpersonal and intrapersonal conflict relating to treatment decisions and subsequent treatments received. (Aim 3)
The overall goals of the study are to help patients and families:
- make treatment decisions aligned with their values and goals;
- anticipate and make sense of postoperative outcomes; and
- experience less postoperative conflict about treatment of serious complications.
Enrolled surgeons will be grouped based on self-report of their clinic practices. "Visit 1 Surgeons" typically have a treatment decision making conversation with patients at their initial new patient consult. For enrolled patients of these surgeons, we will audio-record their first consult visit. "Visit 2 Surgeons" typically do not have treatment decision making discussions at the initial visit- this discussion is generally delayed until a follow up appointment, after additional testing or review of medical records. The return/second visit of enrolled patients under the care of Visit 2 Surgeons will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Consenting surgeons at participating hospital sites who practice vascular, cardiothoracic, hepatobiliary, colorectal, urologic, gynecologic, head and neck or neurosurgery
- •Regularly see patients preoperatively in the surgical clinic
- •Perform high risk operations on older patients with multiple comorbid conditions
排除标准
- •Exclusively perform minimally invasive surgery (laparoscopy), endocrine or breast surgery as these procedures are not typically considered "high risk"
- •Patient panel is not generally comprised of older adults considering high risk procedures
- •Inclusion Criteria:
- •Age 60 and older
- •One or more chronic conditions from a list comprised of those included in the Charlson Comorbidity Index with 9 additional conditions included due to their saliency to surgical decision making
- •Have an upcoming outpatient consultation with an enrolled surgeon to discuss treatment for a vascular or oncologic problem that can be treated with a high risk operation
- •English speaking and Spanish-speaking patients who require an interpreter will be included
- •Exclusion Criteria:
- •Lack decision-making capacity
- •Deemed too physically or mentally ill to participate by their surgeon or clinic nurse
- •Self-report that their vision or literacy skills are too poor to read a newspaper
- •Cannot speak either English or Spanish with the fluency required to have a valid medical decision-making conversation as the QPL is currently only available in English and Spanish (Spanish speaking patients who require an interpreter to speak with their surgeon will be included)
- •Participating surgeons may also choose to exclude specific patients for study participation based on their own concerns about the patient participating in the study, for example patients who have urgent surgical needs or don't actually have a surgical problem
- •Family members
- •Inclusion Criteria:
- •Family member (patient participant) is enrolled in the study
- •Present at time of patient enrollment in study
- •Exclusion Criteria:
- •Lack decision-making capacity
- •Self-report that their vision or literacy skills are too poor to read a newspaper
- •Cannot speak either English or Spanish with the fluency required to have a valid medical decision-making conversation as the QPL is currently only available in English and Spanish (Spanish speaking patients who require an interpreter to speak with the surgeon will be included)
研究组 & 干预措施
QPL (question prompt list) brochure
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
干预措施: QPL (question prompt list) brochure (Other)
Usual care
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
结局指标
主要结局
Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised
时间窗: Within 2 hours of enrollment in the study
Patient engagement in decision making was measured by coding the transcript for the patient's clinic visit, using a pre-defined coding scheme that focused on the number and types of questions raised in the audio-recorded treatment decision-making visit. The types of questions that were coded were options questions, expectations questions, risks questions and advance directive questions.
Change in Illness-related Stress Measured by Participant Self-report on MYCaW Instrument
时间窗: 24-48 hours after enrollment, 6-8 weeks post-enrollment and 3-4 months post-enrollment
Changes in concerns and well-being were measured using the self-report instrument Measure Yourself Concerns and Well-being (MYCaW) instrument. The minimum value for differences in this scale is -6 and maximum value is 6. Higher scores indicate that problems and concerns have diminished.
Perceived Self-efficacy in Patient-physician Interactions Measured by Participant Self-report on the PEPPI-5 Scale
时间窗: 24-48 hours after enrollment
Perceived self-efficacy in patient-physician interactions was measured by participant self-report, using the 5-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) scale. Maximum value for this scale is 25 and minimum is 0. Higher scores indicate greater self-efficacy.
Post-treatment Regret Measured by a Specific Participant Self-report Survey Item
时间窗: 3-4 months post-enrollment
Post-treatment regret was assessed by the following participant self-report survey item: "Looking back, is there anything about your treatment that you would do differently?"
次要结局
- Number of Participants Who Had Surgery During the Study Period(From enrollment to end of data collection 3-4 months later)
- Participant Autonomy Support Measured by Self-report on the HCCQ Instrument(24-48 hours after enrollment)
- Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Positive Scale(6-8 weeks post-enrollment, 3-4 months post-enrollment post-enrollment)
- Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Negative Scale(6-8 weeks post-enrollment, 3-4 months post-enrollment)
- Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Anxiety 4a Scale(6-8 weeks post-enrollment, 3-4 months post-enrollment)
- Physician Engagement With Patient Measured by Clinic Visit Transcript Coding Using OPTION Coding System(Within 2 hours of enrollment in the study)