Personalized Experiences to Inform Improved Communication for Patients With Life Limiting Illness
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|ClinicalTrials.gov Identifier: NCT04118569|
Recruitment Status : Suspended (On hold due to COVID-19 pandemic.)
First Posted : October 8, 2019
Last Update Posted : February 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Renal Failure||Behavioral: Narrative Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||50% of patient participants will complete the narrative intervention and outcome measures. 50% will complete outcome measures only.|
|Masking:||None (Open Label)|
|Masking Description:||Assigned group is not masked. All roles will know which group (narrative or usual care) the patient has been assigned to.|
|Primary Purpose:||Supportive Care|
|Official Title:||Personalized Experiences to Inform Improved Communication for Patients With Life Limiting Illness|
|Estimated Study Start Date :||October 1, 2021|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||July 31, 2022|
Experimental: Narrative Intervention Group
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.
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.
No Intervention: Usual Care Group
Patients in the usual care group will complete outcome measures (questionnaires) and exit interview only.
- Change in Quality of Communication: QOC 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.
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS)- 29 Profile [ Time Frame: Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2 ]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.
- Change in Patient-Reported Outcome Measurement Information-System (PROMIS)- Psychosocial Illness Impact [ Time Frame: Time 1= Baseline, Time 2= 24-48 hours after baseline, Time 3- 24-48 hours after Time 2 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118569
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Heather Coats, PhD, APRN-BC||University of Colorado, Denver|