Advanced Cancer Clinical Trial
Official title:
Variation in Cancer Centers' End-of-Life Quality
NCT number | NCT03780816 |
Other study ID # | D18149 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 5, 2019 |
Est. completion date | July 15, 2021 |
Verified date | February 2023 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 473 |
Est. completion date | July 15, 2021 |
Est. primary completion date | July 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Provider Inclusion Criteria: - 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 Patient Exclusion Criteria: - Potential medical malpractice cases |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | American Cancer Society, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Formal and informal norms influencing provider decision making as assessed using ethnographic observation | 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. | 2-week site observation period | |
Primary | Provider decision making heuristics as assessed using ethnographic observation | 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. | 2-week site observation period | |
Primary | Patient expectations as assessed using ethnographic observation | 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. | 2-week site observation period | |
Primary | Formal and informal norms influencing provider decision making as assessed using semi-structured interviews | 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. | 2-week site observation period | |
Primary | Provider decision making heuristics as assessed using semi-structured interviews | 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. | 2-week site observation period | |
Primary | Patient expectations as assessed using semi-structured interviews | 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. | 2-week site observation period |
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