COPDNCT03391115
Personalized Experiences to Inform Improved Communication for Minorities With Life Limiting Illness
An observational study of COPD and Heart Failure, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Heart Failure, Cancer
- What is being tested?
- Storytelling Intervention for Patient Participants and Storytelling Intervention for Nurse Participants
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 30 Nov 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inpatient population description: Patient's on inpatient with the following diagnoses: * COPD * Heart Failure * Cancer 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.
Who may be able to join
- 18 years of age or older
- able to read English
- capable of giving informed consent
- self-identifying as part of a racial or ethnic minority
- diagnosed with at least one LLI. The operational definition of LLI eligible for this study includes the following diagnoses:
- metastatic solid cancer or inoperable lung cancer;
Show all 10Show fewer
- COPD with FEV1 values < 35% predicted or oxygen dependence;
- New York Heart Association Class III or IV heart failure (CHF).
- 18 years of age or older
- Confirm verbally that they were involved in the care of a patient who is participating in the storytelling intervention
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
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.
- Conditions
- COPD, Heart Failure, Cancer
- Being tested
- Storytelling Intervention for Patient Participants, Storytelling Intervention for Nurse Participants
- Keywords
- Psychosocial, Underserved, Palliative, Electronic Health Record, Narrative
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure, Neoplasms, Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storytelling Intervention for Patient ParticipantsBehavioural
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.
Storytelling Intervention for Nurse ParticipantsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient Participants | Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:
* Heart Failure
* COPD
* Cancer Receives: Behavioral: Storytelling Intervention for Patient Participants | |
| Nurse Participants | Bedside nurses who provide care at the inpatient level for the following diseases:
* Heart Failure
* COPD
* Cancer Receives: Behavioral: Storytelling Intervention for Nurse Participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start15 Nov 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391115
- Sponsor's protocol ID
- 17-1885.cc
- Other IDs
- 1K99NR016686-01A1
- Status last verified
- Jan 2021
- First submitted
- 8 Dec 2017
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coats H, Meek PM, Schilling LM, Akard TF, Doorenbos AZ. "Connection": The Integration of a Person-Centered Narrative Intervention into the Electronic Health Record: An Implementation Study. J Palliat Med. 2020 Jun;23(6):785-791. doi: 10.1089/jpm.2019.0376. Epub 2020 Jan 6.
PubMed 31905039
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Experiences to Inform Improved Communication for Minorities With Life Limiting Illness
- ClinicalTrials.gov ID
- NCT03391115
- Acronym / sponsor ID
- 17-1885.cc
- Conditions
- COPD, Heart Failure, Cancer
- Keywords
- Psychosocial, Underserved, Palliative, Electronic Health Record, Narrative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Posted 27 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient Participants | – | Behavioral: Storytelling Intervention for Patient ParticipantsPatients admitted to University of Colorado Hospital with at least one of the following diagnoses: * Heart Failure * COPD * Cancer |
| Nurse Participants | – | Behavioral: Storytelling Intervention for Nurse ParticipantsBedside nurses who provide care at the inpatient level for the following diseases: * Heart Failure * COPD * Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient population description: Patient's on inpatient with the following diagnoses: * COPD * Heart Failure * Cancer 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.
Key inclusion criteria (10 listed)
- 18 years of age or older
- able to read English
- capable of giving informed consent
- self-identifying as part of a racial or ethnic minority
- diagnosed with at least one LLI. The operational definition of LLI eligible for this study includes the following diagnoses:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Storytelling Intervention for Patient ParticipantsThe 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. | Behavioural | Inpatient Participants |
| Storytelling Intervention for Nurse ParticipantsOnce 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. | Behavioural | Nurse Participants |
Primary outcome
Number of Completed Exit Interviews From Patients on Feasibility of Their Use of Their Narrative Integrated Into EHR
Time frame: 1-2 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31905039Coats H, Meek PM, Schilling LM, Akard TF, Doorenbos AZ. "Connection": The Integration of a Person-Centered Narrative Intervention into the Electronic Health Record: An Implementation Study. J Palliat Med. 2020 Jun;23(6):785-791. doi: 10.1089/jpm.2019.0376. Epub 2020 Jan 6.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Heart Failure, run by University of Colorado, Denver 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 10 inclusion and 0 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 18 Feb 2021. 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 27 Dec 2019). 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?
Number of Completed Exit Interviews From Patients on Feasibility of Their Use of Their Narrative Integrated Into EHR (time frame: 1-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03391115, which also lists 1 linked publication.
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 18 Feb 2021.