The Use of a Digital Application for Reporting Pain and Pain Management in Home Hospice
NCT ID: NCT04869085
Last Updated: 2024-05-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
124 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-04-21
Study Completion Date
2024-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Pain
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Data Collectors will be blinded to the intervention. Study participants will be asked to not disclose their treatment condition.
Study Groups
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e-PainSupport Condition
e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
Group Type
EXPERIMENTAL
e-PainSupport
Intervention Type
BEHAVIORAL
Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
Standard Care Condition
Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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e-PainSupport
Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* 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.
* speaks and reads English
* age 18 or older
* cares for an enrolled patient
* available for the 2 weeks of the study.
* registered nurse (RN)
* provides direct care to patients
* has not had a prior patient enrolled in the study
* 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.
* speaks and reads English
* age 18 or older
* cares for an enrolled patient
* available for the 2 weeks of the study.
* registered nurse (RN)
* provides direct care to patients
* has not had a prior patient enrolled in the study
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Sponsor Role
collaborator
Rush University Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Masako Mayahara
Associate Professor and Associate Chairperson
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Masako Mayahara, PhD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Site Status
Countries
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United States
References
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Mayahara M, Wilbur J, Fogg L, Houlihan MC, Oliver DP, Benson JJ, Miller AM. The e-PainSupport Digital Application for Assessing Pain and Pain Management in Home Hospice: A Randomized Controlled Trial. West J Nurs Res. 2025 Aug;47(8):708-719. doi: 10.1177/01939459251338392. Epub 2025 Jun 10.
Reference Type
DERIVED
Other Identifiers
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310245
Identifier Type: OTHER
Identifier Source: secondary_id
310244
Identifier Type: OTHER
Identifier Source: secondary_id
310243
Identifier Type: OTHER
Identifier Source: secondary_id
19111205-IRB01
Identifier Type: -
Identifier Source: org_study_id
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