跳至主要内容
临床试验/NCT03780816
NCT03780816已完成不适用

Variation in Cancer Centers' End-of-Life Quality

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 473 人开始时间: 2019年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
473
试验地点
1
主要终点
Patient expectations as assessed using ethnographic observation

研究概览

简要总结

This is a qualitative study of local organizational and provider practice norms, and how these norms influence patient and family expectations and provider decision-making heuristics for minority patients with advanced cancer at major US cancer centers. Outpatient visits with oncologists will be observed and documented via hand-written field notes. Semi-structured interviews with selected participating clinicians, patients, caregivers, and other informants will follow the initial observation.

详细描述

The purpose of this study is to identify organizational and provider practice norms at major US cancer centers, and how these norms influence patient and family expectations and provider decision-making heuristics for later-line chemotherapy, hospice, and ICU admission among minority patients with advanced cancer. Norms are rules about which there is at least some degree of consensus, enforced through social sanctions. Heuristics are unconscious judgments or rules of thumb.The study team will collect direct observation data from outpatient clinic visits, and semi-structured interview data from selected participating providers, patients, caregivers, and other informants following the initial observation.

The study team will perform 2-week, qualitative case studies of 3 theoretically sampled National Comprehensive Cancer Network (NCCN) and NCI Comprehensive Cancer Centers. Oncology practice managers' nominations of providers with particular cancer focuses, high volumes, and high peer influence will be used to sample oncologic clinicians to shadow in outpatient clinic settings. Observations will be hand-written during the clinic visit, and later dictated and transcribed. Observed providers will be invited to be interviewed. Select patients and caregivers will also be invited to be interviewed following initial clinic observation. Other informants will be invited to be interviewed on an ad hoc basis. All interviews will be audio recorded and transcribed, and interviews will be semi-structured to allow for natural flow of conversation. Observations and interviews will all be done by the study PI, project coordinator, and/or another research team member.

Clinical observations and semi-structured interviews will assess the following outcomes: 1) formal and informal organizational norms influencing provider decision-making, 2) provider decision-making heuristics, and 3) patient and caregiver expectations. All outcomes will be assessed regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral.

The investigators aim to to explore the how COVID-19 intersects with organizational and provider norms, practices, and service delivery for patients with advanced cancer.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospital-based providers (e.g., hospitalists, intensivists, emergency medicine, advanced practice providers) or oncology providers (e.g. medical oncologists, radiation oncologists, surgical oncologists, advanced practice providers)
  • Care for patients with advanced cancer
  • High clinical load
  • Have high peer influence
  • Patient Inclusion Criteria:
  • Advanced cancer
  • Provider "would not be surprised" if patient died in the next 12 months
  • Caregiver Inclusion Criteria:
  • Self-reported caregiver of a patient meeting inclusion criteria
  • Other Informant Inclusion Criteria:
  • Member of the cancer center, hospital, unit, or service line leadership

排除标准

  • Potential medical malpractice cases

结局指标

主要结局

Patient expectations as assessed using ethnographic observation

时间窗: 2-week site observation period

Patient expectations (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.

Formal and informal norms influencing provider decision making as assessed using semi-structured interviews

时间窗: 2-week site observation period

Formal and informal norms influencing provider decision making (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.

Formal and informal norms influencing provider decision making as assessed using ethnographic observation

时间窗: 2-week site observation period

Formal and informal norms influencing provider decision making (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, multidisciplinary tumor boards, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.

Provider decision making heuristics as assessed using ethnographic observation

时间窗: 2-week site observation period

Provider decision making heuristics (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using ethnographic observation in outpatient oncology clinics, multidisciplinary tumor boards, emergency departments, inpatient units, and other appropriate settings. All observations will be hand-written and later transcribed. Observations will be coded using an a priori framework, and subjected to thematic analysis.

Provider decision making heuristics as assessed using semi-structured interviews

时间窗: 2-week site observation period

Provider decision making heuristics (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.

Patient expectations as assessed using semi-structured interviews

时间窗: 2-week site observation period

Patient expectations (regarding receipt of chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, and non or late hospice referral) will be assessed using a study-specific semi-structured interview, with all interviews audio recorded and transcribed, coded using an a priori framework, and subjected to thematic analysis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amber Barnato

Principal Investigator

Dartmouth-Hitchcock Medical Center

研究点 (1)

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