Colonic NeoplasmsNCT02320123
End-of-Life Care for African Americans
A study testing Educational DVD in people with Colonic Neoplasms and Breast Neoplasms, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Racial differences in health care are documented across the health care continuum and persist in aging and end-of-life (EOL) care. African Americans (AA) and other underrepresented minorities often choose more aggressive therapies at the end of life and are less likely to utilize hospice care in the terminal stages of… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasms, Breast Neoplasms, Lung Neoplasms
- What is being tested?
- Educational DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2016to 10 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aim 1 patients must:
- receive their care at Parkland and be diagnosed with advanced cancer (breast, lung, or colon);
- self-identify as AA;
- be proficient in English;
- be competent to give informed consent; and
- have no evidence of cognitive impairment (Mini-Cog score of ≥3 or 1-2 with normal clock draw).
Show all 21Show fewer
- Aim 2 Patients must:
- be hospitalized at Parkland
- be diagnosed with advanced cancer (breast, lung, or colon)
- self-identify as AA;
- be proficient in English;
- be competent to give informed consent;
- have no evidence of cognitive impairment (Mini-Cog score of ≥3 or 1-2 with normal clock draw); and
- have never received palliative or hospice care.
- All Caregivers (Aim 1 and 2) must be:
- identified by the selected patients as their primary caregiver;
- be 21 years of age or older;
- proficient in English; and
- competent to give informed consent.
- For the expert provider focus group, participants must be a health care provider (physician, nurse practitioner, chaplain, social worker, nurse) who works within hospice and palliative medicine.
- (Note: patients who enter palliative care or hospice during follow-up interviews will be allowed to remain in the study)
Who cannot join
- For patients:
- identify with a race other than African American or
- have a diagnosis other than advanced breast, lung, or colorectal cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: End-of-Life Care for African Americans: Intervention Design and Implementation
Racial differences in health care are documented across the health care continuum and persist in aging and end-of-life (EOL) care. African Americans (AA) and other underrepresented minorities often choose more aggressive therapies at the end of life and are less likely to utilize hospice care in the terminal stages of their illness. Potential reasons for these disparities include: lack of knowledge of and misperceptions about palliative and hospice care, spiritual beliefs, and mistrust in the health care system, among others. Despite the literature on disparities in end-of-life (EOL) care and reasons for underuse and the presence of national EOL care guidelines, attempts to address this problem have been limited and often not rigorously evaluated. The majority of interventions to promote EOL care were done in majority populations and focused predominantly on trying to change physician awareness of patient's pain, symptoms, and values or to change physician communication behavior. While these early studies made tremendous contributions to the study of EOL care and the needs of the terminally ill, the interventions associated with these studies did not reach their desired effectiveness. The investigators propose a different strategy that would focus specifically on previously identified barriers to utilization of advance directives, palliative care, and hospice care among African Americans - including physicians' difficulty and discomfort with prognostication, AA patients' knowledge, attitudes and beliefs towards hospice and palliative care, conflict between patients' spiritual beliefs and the general hospice and palliative medicine philosophy of care, and medical mistrust. The goal of this project is to improve methods of prognostication for physicians and increase awareness of EOL care options for AAs. To overcome the dual challenges of physicians' reluctance to discuss EOL care and patients' discomfort in engaging in such conversations, the investigators will use the electronic medical record (EMR) to automatically identify AA patients with life-limiting illness who are eligible for counseling about EOL care options. To change knowledge and attitudes toward EOL care options among AA patients, the investigators will design a culturally sensitive intervention that will combine multimedia materials and a culturally concordant lay health advisor who will deliver tailored education and counseling.
Read the detailed description
Aim 1:
- We will conduct semi-structured interviews with patient/caregiver pairs and focus groups with providers that will test the communication strategies of available audiovisual materials and materials that we will develop for the intervention. The audiovisual segments will be taken from an available EOL care educational digital versatile disc (DVD). We aim to interview 12 patients and their caregivers, or more until thematic saturation is reached. We will obtain informed consent, and all interviews will be audiotaped and transcribed. Interviews will be conducted separately, and will last 30 to 45 minutes.
- Two focus groups will be conducted with palliative care providers to identify communication strategies they use with AAs. One will be conducted with providers from Parkland Hospital. The other will be conducted with providers from University Hospitals, the Dallas VA, and Baylor University Medical Center in Dallas. Informed consent will be obtained. All sessions will be audiotaped and transcribed. The focus groups will last 45 to 60 minutes.
- We will create additional DVD segments that will address previously identified barriers to EOL care for AAs, including: 1) spiritual/religious conflict, and 2) medical mistrust. We will obtain feedback on the newly developed segments from 10 new patient/caregiver dyads (semi-structured interviews) and 6 to 8 AA religious leaders (focus group) recruited from local churches. Informed consent will be obtained prior to conducting the interviews and focus groups. All will last 30 to 60 minutes.
- A lay health advisor (LHA) will be recruited from the community to provide counsel about EOL care to patients who will receive the intervention. The LHA and the PI of the project will undergo training in how to provide culturally sensitive EOL care for AAs via the APPEAL (A Progressive Palliative Care Educational Curriculum for the Care of AAs at Life's End) Curriculum created at Duke University. After training, the LHA will participate in in-service work with the Parkland Palliative Care Team and the PI.
Aim 2:
We will use an e-EOL algorithm to identify AA patients hospitalized at Parkland who have advanced breast, lung, and colorectal cancer to identify potentially eligible candidates for the intervention utilizing EMR data from Parkland Hospital (See Aim 1 eligibility criteria). Once eligibility is confirmed the LHA will introduce the study to the patient and obtain informed consent. Each patient will be asked to identify a primary caregiver that will be able to participate in the intervention. The LHA will contact the patients' primary caregivers to confirm participation in the study and arrange a time to meet with both the patient and caregiver to conduct the intervention. We anticipate that 24 patient-caregiver pairs will receive the intervention (8 for each type of cancer).
The LHA will meet with eligible patients and caregivers and assist them in watching the developed DVD segments. Afterward, the LHA will answer questions and provide additional information. They will tailor the discussion to the patient's values, preferences, concerns, and clinical circumstances.
The primary process outcome tested will be the feasibility and acceptability of the intervention. Feasibility success will be measured by the number and rates of patients/caregivers who complete the intervention and follow-up interviews. The primary decision-making outcome is change in intent to discuss EOL care options based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, and action). Secondary outcomes measured will include: knowledge of prognosis and EOL care options, decisional conflict, quality of life, and health care utilization. Other patient and treatment variables will also be collected, per the study protocol.
- Conditions
- Colonic Neoplasms, Breast Neoplasms, Lung Neoplasms
- Being tested
- Educational DVD
- Keywords
- Terminal Care, Decision Making, Communication
- Medical subject headings
- Colonic Neoplasms, Breast Neoplasms, Lung Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational DVDBehavioural
African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
| Study group | Role | What they receive |
|---|---|---|
| Patients - intervention | Experimental | For the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion. Receives: Behavioral: Educational DVD |
| Patients - Control | No intervention | Patients will receive usual care (nor view the DVD or meet with the lay health advisor). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intent to Discuss Advance Directives (Based on the Transtheoretical Stages of Change Model)
The primary decision-making outcome is change in intent to discuss advance directives based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Measured: Within six months after patient enrolls in study, June 2017.
Intent to Discuss Medical Power of Attorney (Based on the Transtheoretical Stages of Change Model)
The primary decision-making outcome is change in intent to discuss medical power of attorney based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Measured: Within six months after patient enrolls in study, June 2017.
Intent to Discuss Palliative Care (Based on the Transtheoretical Stages of Change Model)
The primary decision-making outcome is change in intent to discuss palliative care based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Measured: Within six months after patient enrolls in study, June 2017.
Intent to Discuss Hospice Care (Based on the Transtheoretical Stages of Change Model)
The primary decision-making outcome is change in intent to discuss hospice care based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Measured: Within six months after patient enrolls in study, June 2017.
Secondary outcomes (5)
Quality of Life at the End of Life
This will be assessed by using the McGill QOL Questionnaire, Part A, which measures overall quality of life in a 48 hour period: "Considering all parts of my life - physical, emotional, social, spiritual, and financial - over the past two (2) days the quality of my life has been: 0-10," with 0=very bad and 10=excellent.
Measured: Within six months after patient enrolls in study, June 2017.
Health Care Utilization: Emergency Room
Health care utilization will be measured mean number of ER visits for the intervention and control groups.
Measured: Within six months after patient enrolls in study, June 2017.
Number of Patients Who Died
The principal investigator or research staff will attempt to determine the date and location of death for patients who have died while enrolled in the study by reviewing the patient's electronic health record.
Measured: Within six months after patient enrolls in study, June 2017.
Utilization of Advance Care Planning and End-of-life Care
The number of participants who have documentation of advance care planning, palliative care clinic visits, and/or hospice enrollment.
Measured: Within six months after patient enrolls in study, June 2017.
Health Care Utilization: Mean Number of Hospitalizations in Six Months by Group
Health care utilization will be measured mean number of hospitalizations by group, obtained by chart abstraction.
Measured: Within six months after patient enrolls in study, June 2017.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study start23 May 2016
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Ramona L. Rhodes, University of Texas Southwestern Medical Center
- Investigators
- Ethan Halm, MD, Study director, Chair, Department of General Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320123
- Sponsor's protocol ID
- STU 032013-051
- Status last verified
- Aug 2020
- First submitted
- 15 Dec 2014
- Last updated
- 12 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-of-Life Care for African Americans: Intervention Design and Implementation
- ClinicalTrials.gov ID
- NCT02320123
- Acronym / sponsor ID
- STU 032013-051
- Conditions
- Colonic Neoplasms, Breast Neoplasms, Lung Neoplasms
- Keywords
- Terminal Care, Decision Making, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 23 May 2016
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Racial differences in health care are documented across the health care continuum and persist in aging and end-of-life (EOL) care. African Americans (AA) and other underrepresented minorities often choose more aggressive therapies at the end of life and are less likely to utilize hospice care in the terminal stages of their illness. Potential reasons for these disparities include: lack of knowledge of and misperceptions about palliative and hospice care, spiritual beliefs, and mistrust in the health care system, among others. Despite the literature on disparities in end-of-life (EOL) care and reasons for underuse and the presence of national EOL care guidelines, attempts to address this problem have been limited and often not rigorously evaluated. The majority of interventions to promote EOL care were done in majority populations and focused predominantly on trying to change physician awareness of patient's pain, symptoms, and values or to change physician communication behavior. While these early studies made tremendous contributions to the study of EOL care and the needs of the terminally ill, the interventions associated with these studies did not reach their desired effectiveness. The investigators propose a different strategy that would focus specifically on previously identified barriers to utilization of advance directives, palliative care, and hospice care among African Americans - including physicians' difficulty and discomfort with prognostication, AA patients' knowledge, attitudes and beliefs towards hospice and palliative care, conflict between patients' spiritual beliefs and the general hospice and palliative medicine philosophy of care, and medical mistrust. The goal of this project is to improve methods of prognostication for physicians and increase awareness of EOL care options for AAs. To overcome the dual challenges of physicians' reluctance to discuss EOL care and patients' discomfort in engaging in such conversations, the investigators will use the electronic medical record (EMR) to automatically identify AA patients with life-limiting illness who are eligible for counseling about EOL care options. To change knowledge and attitudes toward EOL care options among AA patients, the investigators will design a culturally sensitive intervention that will combine multimedia materials and a culturally concordant lay health advisor who will deliver tailored education and counseling.
Detailed description
Aim 1:
- We will conduct semi-structured interviews with patient/caregiver pairs and focus groups with providers that will test the communication strategies of available audiovisual materials and materials that we will develop for the intervention. The audiovisual segments will be taken from an available EOL care educational digital versatile disc (DVD). We aim to interview 12 patients and their caregivers, or more until thematic saturation is reached. We will obtain informed consent, and all interviews will be audiotaped and transcribed. Interviews will be conducted separately, and will last 30 to 45 minutes.
- Two focus groups will be conducted with palliative care providers to identify communication strategies they use with AAs. One will be conducted with providers from Parkland Hospital. The other will be conducted with providers from University Hospitals, the Dallas VA, and Baylor University Medical Center in Dallas. Informed consent will be obtained. All sessions will be audiotaped and transcribed. The focus groups will last 45 to 60 minutes.
- We will create additional DVD segments that will address previously identified barriers to EOL care for AAs, including: 1) spiritual/religious conflict, and 2) medical mistrust. We will obtain feedback on the newly developed segments from 10 new patient/caregiver dyads (semi-structured interviews) and 6 to 8 AA religious leaders (focus group) recruited from local churches. Informed consent will be obtained prior to conducting the interviews and focus groups. All will last 30 to 60 minutes.
- A lay health advisor (LHA) will be recruited from the community to provide counsel about EOL care to patients who will receive the intervention. The LHA and the PI of the project will undergo training in how to provide culturally sensitive EOL care for AAs via the APPEAL (A Progressive Palliative Care Educational Curriculum for the Care of AAs at Life's End) Curriculum created at Duke University. After training, the LHA will participate in in-service work with the Parkland Palliative Care Team and the PI.
Aim 2:
We will use an e-EOL algorithm to identify AA patients hospitalized at Parkland who have advanced breast, lung, and colorectal cancer to identify potentially eligible candidates for the intervention utilizing EMR data from Parkland Hospital (See Aim 1 eligibility criteria). Once eligibility is confirmed the LHA will introduce the study to the patient and obtain informed consent. Each patient will be asked to identify a primary caregiver that will be able to participate in the intervention. The LHA will contact the patients' primary caregivers to confirm participation in the study and arrange a time to meet with both the patient and caregiver to conduct the intervention. We anticipate that 24 patient-caregiver pairs will receive the intervention (8 for each type of cancer).
The LHA will meet with eligible patients and caregivers and assist them in watching the developed DVD segments. Afterward, the LHA will answer questions and provide additional information. They will tailor the discussion to the patient's values, preferences, concerns, and clinical circumstances.
The primary process outcome tested will be the feasibility and acceptability of the intervention. Feasibility success will be measured by the number and rates of patients/caregivers who complete the intervention and follow-up interviews. The primary decision-making outcome is change in intent to discuss EOL care options based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, and action). Secondary outcomes measured will include: knowledge of prognosis and EOL care options, decisional conflict, quality of life, and health care utilization. Other patient and treatment variables will also be collected, per the study protocol.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients - intervention | Experimental | Behavioral: Educational DVDFor the intervention arm of the study, patients will be invited to view the educational DVD explaining end-of-life care options and meet with a lay health advisor for discussion. |
| Patients - Control | No intervention | –Patients will receive usual care (nor view the DVD or meet with the lay health advisor). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- receive their care at Parkland and be diagnosed with advanced cancer (breast, lung, or colon);
- self-identify as AA;
- be proficient in English;
- be competent to give informed consent; and
- have no evidence of cognitive impairment (Mini-Cog score of ≥3 or 1-2 with normal clock draw).
Key exclusion criteria (3 listed)
- identify with a race other than African American or
- have a diagnosis other than advanced breast, lung, or colorectal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational DVDAfrican American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care. | Behavioural | Patients - intervention |
Primary outcome
Intent to Discuss Advance Directives (Based on the Transtheoretical Stages of Change Model)
Time frame: Within six months after patient enrolls in study, June 2017.
The primary decision-making outcome is change in intent to discuss advance directives based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Intent to Discuss Medical Power of Attorney (Based on the Transtheoretical Stages of Change Model)
Time frame: Within six months after patient enrolls in study, June 2017.
The primary decision-making outcome is change in intent to discuss medical power of attorney based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Intent to Discuss Palliative Care (Based on the Transtheoretical Stages of Change Model)
Time frame: Within six months after patient enrolls in study, June 2017.
The primary decision-making outcome is change in intent to discuss palliative care based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
Intent to Discuss Hospice Care (Based on the Transtheoretical Stages of Change Model)
Time frame: Within six months after patient enrolls in study, June 2017.
The primary decision-making outcome is change in intent to discuss hospice care based on the Transtheoretical Stages of Change Model (i.e., pre-contemplation, contemplation, preparation, action, and maintenance).
5 secondary outcomes
Quality of Life at the End of Life
Time frame: Within six months after patient enrolls in study, June 2017.
Health Care Utilization: Emergency Room
Time frame: Within six months after patient enrolls in study, June 2017.
Number of Patients Who Died
Time frame: Within six months after patient enrolls in study, June 2017.
Utilization of Advance Care Planning and End-of-life Care
Time frame: Within six months after patient enrolls in study, June 2017.
Health Care Utilization: Mean Number of Hospitalizations in Six Months by Group
Time frame: Within six months after patient enrolls in study, June 2017.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethan Halm, MD study director
Chair, Department of General Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational DVD in people with Colonic Neoplasms and Breast Neoplasms, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intent to Discuss Advance Directives (Based on the Transtheoretical Stages of Change Model) (time frame: Within six months after patient enrolls in study, June 2017.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.