Clinical trial NCT04869085: The Use of a Digital Application for Reporting Pain and Pain Management in Home Hospice
Official title: The Use of a Digital Application for Reporting Pain and Pain Management in Home Hospice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain, Pain management, Analgesics, Adherence
Hospice, End-of-Life Care
Caregiver
m-Health, digital interventions
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-05-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Poor adherence to pain management and high pain intensity associated with serious, advanced illness is a major public health concern. This randomized clinical trial will test the efficacy of a newly enhanced digital pain and pain management application (e-PainSupport) for use in a home hospice setting. The e-PainSupport application delivers an education module about pain management to patients and caregivers, expedites pain reporting to nurses, and facilitates adherence to pain management. The overall goal of the e-PainSupport application is to improve pain management and reduce patient pain intensity in the home hospice setting.

Detailed description: High pain intensity is a common symptom experienced by patients with serious advanced illness. However, pain management for patients in home hospice is less than optimal. Impediments to improving pain intensity are poor adherence to pain management regimen due in part to caregiver lack of knowledge (a barrier to reporting pain and using analgesics) and lack of self-efficacy (confidence) in administering analgesics. Digital applications may facilitate pain management by: (1) delivering education to increase knowledge and self-efficacy, (2) expediting pain reporting to nurses, and (3) improving adherence to pain management. e-PainSupport is a self-administered, digital pain management application developed in collaboration with hospice nurses and caregivers. It is directly linked to a patient's medical record and enhanced by an evidence-based educational module. It has three elements: (a) Educational Module, (b) Patient Pain Record, and (c) Pain Summary for Nurses. The purpose of this study is to test the effects of e-PainSupport on home hospice patient pain intensity when used by patients, caregivers and nurses. Participants (132 triads of patient, caregiver, and the hospice nurse assigned to the patient will be recruited from one large Midwest hospice agency. Patient and caregiver outcomes will be assessed at baseline and 2 weeks post baseline. Data will be analyzed with multi-level modeling. Post-intervention semi-structured interviews will be conducted with nurses who provided care to patients in the e-PainSupport condition. Qualitative content analysis will be used to identify themes related to perceived practice changes after using e-PainSupport. e-PainSupport has potential as a useful tool to advance home hospice care by enhancing the quality of caregiver pain management, facilitating nurse-patient communication, and improving management of patient pain intensity.

Eligibility criteria: Inclusion criteria (patient)

* prior enrollment of their hospice nurse
* receives analgesics for pain
* speaks and reads English
* age 18 or older
* has a primary informal caregiver who is available for the 2 weeks of the study
* expected survival of at least 2 weeks
* can verbalize pain.

Inclusion criteria (caregiver)

* speaks and reads English
* age 18 or older
* cares for an enrolled patient
* available for the 2 weeks of the study.

Inclusion criteria (nurses participating in the RTC)

* registered nurse (RN)
* provides direct care to patients
* has not had a prior patient enrolled in the study

Primary outcomes:
measure: Minimally important clinical change in pain intensity (at least 10 percent change on the pain intensity scale)
timeFrame: Baseline
measure: Minimally important clinical change in pain intensity (at least 10 percent change on the pain intensity scale)
timeFrame: 2-weeks post baseline
Secondary outcomes:
measure: Change in the continuous score of the pain intensity scale
timeFrame: Baseline
measure: Change in the continuous score of the pain intensity scale
timeFrame: 2-weeks post baseline
Other outcomes:
measure: Self-Efficacy
timeFrame: Baseline
measure: Self-Efficacy
timeFrame: 2-weeks post baseline
measure: Adherence to pain management
timeFrame: Baseline
measure: Adherence to pain management
timeFrame: 2-weeks post baseline
measure: Knowledge
timeFrame: Baseline
measure: Knowledge
timeFrame: 2-weeks post baseline
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Masako Mayahara, PhD
role: PRINCIPAL_INVESTIGATOR
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