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Heart FailureNCT04118569

Personalized Experiences to Inform Improved Communication for Patients With Life Limiting Illness

A study testing Narrative Intervention in people with Heart Failure and Renal Failure, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Disparities in palliative care for patients with serious illness exist because of gaps in knowledge around patient centered psychological, social, and spiritual palliative care interventions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Renal Failure
What is being tested?
Narrative Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
1 Oct 2019to 22 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older.
  • Has ability to read English.
  • Capable of giving informed consent.
  • Has diagnosis of at least one serious illness. For this study, the eligible diagnoses include: 1) New York Heart Class III or IV heart failure and/or 2) dialysis-dependent renal failure

Who cannot join

  • None.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Hospital

    Aurora, Colorado, 80045

Other trials in United States

About this study

Disparities in palliative care for patients with serious illness exist because of gaps in knowledge around patient centered psychological, social, and spiritual palliative care interventions. Patient-centered palliative care communication interventions must be informed by the perspectives of patients who are living each day with their serious illness. Yet, there is a lack of research about how to efficiently and effectively integrate the patient's narrative into the electronic health record (EHR). The central hypothesis of this proposal is that the implementation of a patient-centered narrative intervention with patients with serious illness will result in improved patient-nurse communication and improved patient psychosocial and spiritual well-being.

Read the detailed description

The overall goal during this study will be to conduct a small scale pilot study with 80 hospitalized patients and 80 acute care nurses. Specific Aim 1 will establish acceptability, feasibility, and potential effect size of the patient-centered narrative intervention for hospitalized patients with serious illness. For specific aim 2, the investigators will compare the effects of the narrative intervention to usual care for the primary outcome of patient's perception of quality of communication and patient's psychosocial and spiritual well-being. For specific aim 3, the investigators will conduct usability testing, applying a user-task-system-environment evaluation process to determine essential requirements for integration and use of the patient-centered story into the EHR, from the perspective of an important end user: the acute-care bedside nurse. These results will support future R01 applications for testing/tailoring patient-centered narrative interventions to improve QoL for patients living with serious illness.

Being tested
Narrative Intervention
Medical subject headings
Heart Failure, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Narrative InterventionBehavioural

    Research staff conducts an open-ended, audio-recorded interview with the patient about their illness and how this illness has affected their psycho-social-spiritual well-being. The investigators will use the interview transcription to create a meta-narrative, which is then uploaded to the electronic medical record and the patient's primary nurse is notified that it is available to read.

Study groups in NCT04118569
Study groupRoleWhat they receive
Narrative Intervention GroupExperimentalPatients in the narrative intervention group will participate in an interview and the resulting narrative will be uploaded to the electronic medical record. This group will also complete outcome measures (questionnaires) and exit interview.
Receives: Behavioral: Narrative Intervention
Usual Care GroupNo interventionPatients in the usual care group will complete outcome measures (questionnaires) and exit interview only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Quality of Communication: QOC (Quality of Communication) survey

    The QOC survey assesses patients' perceptions of the quality of communication with nurses. The QOC was initially developed from qualitative interviews and focus groups with diverse set of patients, families and providers. The QOC has 19 items, with scores ranging from 0 (worst) to 10 (best). Internal consistency reliability and construct validity of the QOC has been established across several illness groups, and the QOC survey's responsiveness to communication interventions has been demonstrated by changes in pre- and post-intervention scores.

    Measured: Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2

Secondary outcomes (2)

  1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS)- 29 Profile

    PROMIS- 29 profile v2.0 form (29 items), which assesses physiological, social, and psychological outcomes. These biopsychosocial domains include physical function, anxiety, depression, fatigue, sleep, ability to participate in social roles/activities, pain interference and intensity. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. High scores represent more of the domain being measured. Thus, on symptom-oriented domains of PROMIS-29 (anxiety, depression, fatigue, pain interference, and sleep disturbance), higher scores represent worse symptomatology. On the function-oriented domains (physical functioning and social role) higher scores represent better functioning. For example, a high sleep disturbance score indicates high levels of sleep disturbance; a high physical functioning score indicates better physical function.

    Measured: Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2

  2. Change in Patient-Reported Outcome Measurement Information-System (PROMIS)- Psychosocial Illness Impact

    The PROMIS positive item bank measure (8 items) assesses positive psychosocial outcomes of illness.The PROMIS negative item bank measure (8 items) assesses the direct negative psychosocial effect of illness, distinct from general emotional distress. The item bank instructs participants to think about how their illness has affected them. The item bank uses the time frames: before your illness" and "since your illness". For adults, each question has five response options ranging in value from two to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question, range 16-40. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Psychosocial Illness Impact-Positive, a T-score of 60 is one standard deviation (SD) better than average. By comparison, a Psychosocial Illness Impact-Positive T-score of 40 is one SD worse than average.

    Measured: Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2019
  2. Study start1 Oct 2019
  3. Primary completion22 Jun 2022
  4. Study completion22 Jun 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
50% of patient participants will complete the narrative intervention and outcome measures. 50% will complete outcome measures only.
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04118569
Sponsor's protocol ID
19-1874
Other IDs
4R00NR016686-03
Status last verified
Apr 2023
First submitted
3 Oct 2019
Last updated
10 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The final data set will include de-identified self-reported demographic and behavioral data from self-report, questionnaires, and interviews. The de-identified data and associated documentation will be made available to the community of scientists interested in palliative care as described in "access criteria." Additionally, aggregate, de-identified results will be submitted to ClinicalTrials.gov no later than one year after the trial's primary completion date.

Publications

  • Coats H, Shive N, Adrian B, Doorenbos AZ, Schmiege SJ. "We Wanna Be Nurses Because We Want the Human Connection": Acceptability and Usability of a Person-Centered Narrative Intervention in an Acute Care Setting. J Hosp Palliat Nurs. 2024 Oct 1;26(5):E143-E153. doi: 10.1097/NJH.0000000000001043. Epub 2024 Jun 25.

    PubMed 38917206

  • Coats H, Shive N, Adrian B, Doorenbos AZ, Schmiege SJ. Integration of Person-Centered Narratives Into the Electronic Health Record. Nurs Res. 2023 Nov-Dec 01;72(6):421-429. doi: 10.1097/NNR.0000000000000680. Epub 2023 Aug 3.

    PubMed 37582297

  • Coats H, Shive N, Doorenbos AZ, Schmiege SJ. Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol. Nurs Res. 2020 Nov/Dec;69(6):483-489. doi: 10.1097/NNR.0000000000000463.

    PubMed 32740306

Questions about this trial

What is this clinical trial studying?

A study testing Narrative Intervention in people with Heart Failure and Renal 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 4 inclusion and 1 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 10 Apr 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Quality of Communication: QOC (Quality of Communication) survey (time frame: Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2). 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 NCT04118569, which also lists 3 linked publications.

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 10 Apr 2023.

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