NCT04118569|CompletedDMC
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Sponsor study identifier
Secondary identifiers
interventional
51
1 country
1
Study Start
October 1, 2019
Actual (reported)Primary Completion
June 22, 2022
Actual (reported)Study Completion
June 22, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 22, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2019
Actual (reported)October 3, 2019
Actual (reported)October 8, 2019
Actual (reported)June 22, 2022
Actual (reported)June 22, 2022
Actual (reported)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
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
Patients 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.
Patients in the usual care group will complete outcome measures (questionnaires) and exit interview only.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Colorado Hospital
Aurora, Colorado, 80045, United States
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.
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.
Heather Coats, PhD, APRN-BC
University of Colorado, Denver
51 participants (actual enrollment reported by the registry).
First Submitted
October 3, 2019
First Posted
October 8, 2019
Study Start
An Innovative Mobile Health Intervention to Improve Self-care in Patients With Heart Failure
Contact the study team to confirm eligibility.
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.
October 1, 2019
Actual (reported)Primary Completion
June 22, 2022
Actual (reported)Study Completion
June 22, 2022
Actual (reported)Last Updated
April 10, 2023
Record last verified: 2023-04
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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