Clinical trial NCT04118569: Personalized Experiences to Inform Improved Communication for Patients With Life Limiting Illness
Official title: Personalized Experiences to Inform Improved Communication for Patients With Life Limiting Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Renal Failure
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-10-08
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 50% of patient participants will complete the narrative intervention and outcome measures. 50% will complete outcome measures only.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quality of Communication: QOC (Quality of Communication) survey
timeFrame: Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2
Secondary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)- 29 Profile
timeFrame: Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2
measure: Change in Patient-Reported Outcome Measurement Information-System (PROMIS)- Psychosocial Illness Impact
timeFrame: Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Heather Coats, PhD, APRN-BC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.