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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118569
• Other study ID #: 19-1874
• Secondary ID: 4R00NR016686-03
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 22, 2022

Study information

• Verified date: April 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Heart Failure
• Renal Failure
• Renal Insufficiency

Intervention

Behavioral:
• Narrative Intervention
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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2
Secondary	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.	Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2
Secondary	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.	Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2