Variation in Cancer Centers' End-of-Life Quality

NCT ID: NCT03780816

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

473 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-05

Study Completion Date

2021-07-15

Brief Summary

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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

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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.

Conditions

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Advanced Cancer

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

OTHER

Study Groups

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Pilot Site: Norris Cotton Cancer Center

Observation and interview protocols will be piloted at this site. The content of these observations and interviews will not be analyzed for content.

Observation of provider-patient interactions and interviews

Intervention Type OTHER

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.

Karmanos Cancer Institute

Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data.

Observation of provider-patient interactions and interviews

Intervention Type OTHER

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.

UNC Lineberger Comprehensive Cancer Center

Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data.

Observation of provider-patient interactions and interviews

Intervention Type OTHER

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.

UAB O'Neal Comprehensive Cancer Center

Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data.

Observation of provider-patient interactions and interviews

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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


* Advanced cancer
* Provider "would not be surprised" if patient died in the next 12 months




\- Member of the cancer center, hospital, unit, or service line leadership

Exclusion Criteria

\- Potential medical malpractice cases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Amber Barnato

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amber E Barnato, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32854691 (View on PubMed)

Other Identifiers

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D18149

Identifier Type: -

Identifier Source: org_study_id

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