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Clinical Trials/NCT04118569
NCT04118569
Completed
Not Applicable

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

University of Colorado, Denver1 site in 1 country51 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Colorado, Denver
Enrollment
51
Locations
1
Primary Endpoint
Change in Quality of Communication: QOC (Quality of Communication) survey
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
June 22, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS)- 29 Profile(Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2)
  • Change in Patient-Reported Outcome Measurement Information-System (PROMIS)- Psychosocial Illness Impact(Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2)

Study Sites (1)

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