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Variation in Cancer Centers' End-of-Life Quality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780816
Recruitment Status : Active, not recruiting
First Posted : December 19, 2018
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Amber Barnato, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment
Advanced Cancer Other: Observation of provider-patient interactions and interviews

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 6 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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Ecologic or Community
Time Perspective: Other
Official Title: Variation in Cancer Centers' End-of-Life Quality
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Group/Cohort Intervention/treatment
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.
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.

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

UNC Lineberger Comprehensive Cancer Center
Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data.
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.

UAB O'Neal Comprehensive Cancer Center
Observations and interviews will be analyzed to identify any emergent concepts, categories, and relationships in the data.
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.

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

Cancer Center 5
Pending theoretical sampling
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.

Cancer Center 6
Pending theoretical sampling
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.




Primary Outcome Measures :
  1. Formal and informal norms influencing provider decision making as assessed using ethnographic observation [ Time Frame: 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.

  2. Provider decision making heuristics as assessed using ethnographic observation [ Time Frame: 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.

  3. Patient expectations as assessed using ethnographic observation [ Time Frame: 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.

  4. Formal and informal norms influencing provider decision making as assessed using semi-structured interviews [ Time Frame: 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.

  5. Provider decision making heuristics as assessed using semi-structured interviews [ Time Frame: 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.

  6. Patient expectations as assessed using semi-structured interviews [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Hospital-based providers who are on service during the 2-week site visit will be observed. Outpatient oncology providers who meet inclusion criteria and are nominated by their oncology practice managers will also 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.

Additionally, a sub-sample of all patients (and their 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.

Selected other informants - such as personnel involved in developing and enforcing organizational policies, procedures, and practices, including allocation of resources, will also be invited to participate in semi-structured interviews.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780816


Locations
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United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
American Cancer Society, Inc.
Investigators
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Principal Investigator: Amber E Barnato, MD Dartmouth-Hitchcock Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amber Barnato, Principal Investigator, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03780816    
Other Study ID Numbers: D18149
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No