Clinical trial NCT03780816: Variation in Cancer Centers' End-of-Life Quality
Official title: Variation in Cancer Centers' End-of-Life Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2018-12-19
Enrollment: 473
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient and inpatient oncology providers who meet inclusion criteria and are nominated by their practice managers will be observed. If providers do not opt out after being introduced to the study by cancer center leadership, providers will be contacted directly for recruitment. A sub-sample of observed providers will be invited to participate in semi-structured interviews.

A sub-sample of all patients (and caregivers) cared for by the shadowed provider who meet inclusion criteria will be invited to participate in semi-structured interviews. Recruitment will seek equal numbers of minority and non-minority participants.

Personnel involved in developing and enforcing organizational policies, procedures, and practices, will also be invited to participate in semi-structured interviews.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Formal and informal norms influencing provider decision making as assessed using ethnographic observation
timeFrame: 2-week site observation period
measure: Provider decision making heuristics as assessed using ethnographic observation
timeFrame: 2-week site observation period
measure: Patient expectations as assessed using ethnographic observation
timeFrame: 2-week site observation period
measure: Formal and informal norms influencing provider decision making as assessed using semi-structured interviews
timeFrame: 2-week site observation period
measure: Provider decision making heuristics as assessed using semi-structured interviews
timeFrame: 2-week site observation period
measure: Patient expectations as assessed using semi-structured interviews
timeFrame: 2-week site observation period
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Amber E Barnato, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knutzen KE, Schifferdecker KE, Murray GF, Alam SS, Brooks GA, Kapadia NS, Butcher R, Barnato AE. Role of norms in variation in cancer centers' end-of-life quality: qualitative case study protocol. BMC Palliat Care. 2020 Aug 27;19(1):136. doi: 10.1186/s12904-020-00641-x.