Pain
Conditions
Keywords
Pain, Pain management, Analgesics, Adherence, Hospice, End-of-Life Care, Caregiver, m-Health, digital interventions
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.
Interventions
BEHAVIORALe-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.
Sponsors
Rush University Medical Center
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data Collectors will be blinded to the intervention. Study participants will be asked to not disclose their treatment condition.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimally Important Clinical Change in Worst Pain Intensity | Baseline to 2-weeks post baseline | 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. |
| Minimally Important Clinical Change in Average Pain Intensity | Baseline to 2-weeks post baseline | 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. |
| Minimally Important Clinical Change in Current Pain Intensity | Baseline to 2-weeks post baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Continuous Score of the Pain Intensity Scale | Baseline to 2-weeks post baseline | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMasako Mayahara, PhD
Rush University Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical Caregiver demographics <=18 years | 0 Participants |
| Age, Categorical Caregiver demographics >=65 years | 5 Participants |
| Age, Categorical Caregiver demographics Between 18 and 65 years | 18 Participants |
| Age, Categorical Patient demographics <=18 years | 0 Participants |
| Age, Categorical Patient demographics >=65 years | 19 Participants |
| Age, Categorical Patient demographics Between 18 and 65 years | 4 Participants |
| Age, Continuous Caregiver participant age | 55.21 years STANDARD_DEVIATION 12.48 |
| Age, Continuous Patient participant age | 72.65 years STANDARD_DEVIATION 13.84 |
| Ethnicity (NIH/OMB) Caregiver Ethnicity Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Caregiver Ethnicity Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Caregiver Ethnicity Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Patient Ethnicity Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Patient Ethnicity Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Patient Ethnicity Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregiver participants American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Caregiver participants Asian | 1 Participants |
| Race (NIH/OMB) Caregiver participants Black or African American | 2 Participants |
| Race (NIH/OMB) Caregiver participants More than one race | 0 Participants |
| Race (NIH/OMB) Caregiver participants Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Caregiver participants Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) Caregiver participants White | 14 Participants |
| Race (NIH/OMB) Patient participants American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Patient participants Asian | 4 Participants |
| Race (NIH/OMB) Patient participants Black or African American | 8 Participants |
| Race (NIH/OMB) Patient participants More than one race | 0 Participants |
| Race (NIH/OMB) Patient participants Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Patient participants Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Patient participants White | 14 Participants |
| Region of Enrollment United States Caregivers | 23 Participants |
| Region of Enrollment United States Patients | 23 Participants |
| Sex: Female, Male Caregiver gender Female | 33 Participants |
| Sex: Female, Male Caregiver gender Male | 11 Participants |
| Sex: Female, Male Patient gender Female | 13 Participants |
| Sex: Female, Male Patient gender Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 46 | 1 / 42 |
| other Total, other adverse events | 0 / 46 | 0 / 42 |
| serious Total, serious adverse events | 0 / 46 | 0 / 42 |
Outcome results
None listed