Variation in Cancer Centers' End-of-Life Quality

Advanced Cancer Clinical Trial

Official title:

Variation in Cancer Centers' End-of-Life Quality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780816
• Other study ID #: D18149
• Status: Completed
• Start date: July 5, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: February 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Advanced Cancer
• Death

Intervention

Other:
• Observation of provider-patient interactions and interviews
Clinical interactions between cancer patients and providers will be observed and hand-written field notes recorded and later transcribed. Semi-structured interviews with providers, patients, caregivers, and other informants will take place following initial observation.

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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