An observational study in COPD, Heart Failure and Cancer, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by University of Colorado, Denver · Observational
The purpose of this research is to develop patient-centered palliative care interventions to improve patient-provider communication and Quality of Life (QoL) of ethnic and racial minority patients living with life-limiting illnesses. Eliciting personal experiences is an effective way for patients to communicate their cultural values and beliefs. This study will assess how to integrate the patients' personal experience narratives into the electronic health record (EHR). The primary hypothesis is that the implementation of a patient-centered intervention to elicit personal experiences that are included in the EHR will improve patient-provider communication and patients' QoL.
Racial and ethnic minority patients with a Life Limiting Illnes (LLI) in the United States are underserved in many ways, including quality of palliative care. Specific disparities have been reported in palliative care for minority patients, including sub-optimal patient-provider communication and resulting lower QoL. A potential approach to improve communication is to elicit patients' personal narratives that address their cultural or spiritual values and beliefs, and include them in the EHR. The objective of this observational study is to assess the feasibility and efficacy of a palliative care nursing intervention designed to 1) identify barriers and facilitators for eliciting and recording relevant narratives from the perspectives of the key stakeholders: minority patients with LLI; 2) to conduct usability testing, applying a user-system-environment evaluation process to determine essential requirements for integration of the patient-centered narratives into the EHR; and 3) identify barriers and facilitators of integration of the patient's narrative into daily workflow from the perspectives of key stakeholders: acute care bedside nurse.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 38 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inpatient population description:
Patient's on inpatient with the following diagnoses:
Nurse patient population:
Bedside nurses who are involved in the care of a patient who is participating in the storytelling intervention with the diagnoses listed above.
Inclusion Criteria: Patients
diagnosed with at least one LLI. The operational definition of LLI eligible for this study includes the following diagnoses:
Inclusion criteria: Nurse
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients admitted to University of Colorado Hospital with at least one of the following diagnoses: * Heart Failure * COPD * Cancer
Behavioral: Storytelling Intervention for Patient Participants
Bedside nurses who provide care at the inpatient level for the following diseases: * Heart Failure * COPD * Cancer
Behavioral: Storytelling Intervention for Nurse Participants
The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR.
Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the "strength" of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material.
Number of Completed Exit Interviews From Patients on Feasibility of Their Use of Their Narrative Integrated Into EHR
Using an observational design, this measure (exit interviews) were completed with 20 inpatient participants and 18 nurse participants. The qualitative data from the interviews were used to define and refine the storytelling intervention. The data collected from the exit interview is qualitative in nature and therefore does not have a numerical value.
Time frame: 1-2 weeks
Usability Assessment Via the System Usability Scale(SUS), Range of 0 to 100, With Higher Number Representing a Better Outcome SUS Scores Have a Range of 0 to 100, the Higher the Number Represents a Better Outcome.
This study will utilize an observational design to define and refine the storytelling intervention, seeking input from the key stakeholders: providers (acute care bedside nurses).The SUS scale is a 10 item Likert scale which gives a global view of subjective assessment of usability with five item responses options from strongly agree to strongly disagree. SUS yields a single number representing a composite measure of the overall usability of the system being studied. Note that scores for individual items are not meaningful on their own. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7, and 9, the score contribution is the scale position minus 1. For items 2,4,6,8, and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of the SUS, with the higher the number, the better the outcome.
Time frame: 1-2 weeks
| Milestone | Inpatient Participants | Nurse Participants |
|---|---|---|
| Started | 20 | 18 |
| Completed | 20 | 18 |
| Not completed | 0 | 0 |
Using an observational design, this measure (exit interviews) were completed with 20 inpatient participants and 18 nurse participants. The qualitative data from the interviews were used to define and refine the storytelling intervention. The data collected from the exit interview is qualitative in nature and therefore does not have a numerical value.
| Participants | Inpatient Participants | Nurse Participants |
|---|---|---|
| Number of Completed Exit Interviews From Patients on Feasibility of Their Use of Their Narrative Integrated Into EHR | 20 | 18 |
This study will utilize an observational design to define and refine the storytelling intervention, seeking input from the key stakeholders: providers (acute care bedside nurses).The SUS scale is a 10 item Likert scale which gives a global view of subjective assessment of usability with five item responses options from strongly agree to strongly disagree. SUS yields a single number representing a composite measure of the overall usability of the system being studied. Note that scores for individual items are not meaningful on their own. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7, and 9, the score contribution is the scale position minus 1. For items 2,4,6,8, and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of the SUS, with the higher the number, the better the outcome.
| score on a scale | Inpatient Participants | Nurse Participants |
|---|---|---|
| Usability Assessment Via the System Usability Scale(SUS), Range of 0 to 100, With Higher Number Representing a Better Outcome SUS Scores Have a Range of 0 to 100, the Higher the Number Represents a Better Outcome. | — | 89.71 (75 to 100) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inpatient Participants | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Nurse Participants | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Inpatient Participants | Nurse Participants | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 18 | 35 |
| >=65 years | 3 | 0 | 3 |
| Age, Continuous(years) | Inpatient Participants | Nurse Participants | Total |
|---|---|---|---|
| Mean | 52.15 (29 to 72) | 31.39 (23 to 53) | 41.77 (23 to 72) |
| Sex: Female, Male(Participants) | Inpatient Participants | Nurse Participants | Total |
|---|---|---|---|
| Female | 8 | 17 | 25 |
| Male | 12 | 1 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Inpatient Participants | Nurse Participants | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 0 | 9 |
| Not Hispanic or Latino | 11 | 18 | 29 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Inpatient Participants | Nurse Participants | Total |
|---|---|---|---|
| American Indian or Alaska Native | 11 | 0 | 11 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 0 | 8 |
| White | 0 | 17 | 17 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Inpatient Participants | Nurse Participants | Total |
|---|---|---|---|
| United States | 20 | 18 | 38 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Pulmonary Disease, Chronic Obstructive →
University of Colorado, Denver →