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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
88
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.
Rush University Medical Center
Chicago, Illinois, United States
Minimally Important Clinical Change in Worst Pain Intensity
At least 20 percent change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: 3 items: Worst pain and average pain in past 7 days scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain. Higher scores indicates higher pain intensity.
Time frame: Baseline to 2-weeks post baseline
Minimally Important Clinical Change in Average Pain Intensity
At Least 20 Percent Change on the PROMIS Average Pain Scale. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: Average pain in past 7 days, and current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain, summed for a range of 3 to 15. Higher scores indicates higher pain intensity.
Time frame: Baseline to 2-weeks post baseline
Minimally Important Clinical Change in Current Pain Intensity
At least 20 percent change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: 3 items: current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain. Higher scores indicates higher pain intensity.
Time frame: Baseline to 2-weeks post baseline
Change in the Continuous Score of the Pain Intensity Scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0. 3items: worst pain and average pain in past 7 days, and current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain, summed for a range of 3 to 15. Higher scores indicates higher pain intensity.
Time frame: Baseline to 2-weeks post baseline
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