ePainSupport: The Use of a Digital Application for Reporting Pain and Pain Management in Home Hospice
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: 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.
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| No Intervention: 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. |
Outcome Measures
Primary Outcome Measures
- Minimally important clinical change in pain intensity (at least 10 percent change on the pain intensity scale) [Baseline]
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0 v3 items: 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.
- Minimally important clinical change in pain intensity (at least 10 percent change on the pain intensity scale) [2-weeks post baseline]
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, 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.
Secondary Outcome Measures
- Change in the continuous score of the pain intensity scale [Baseline]
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, 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.
- Change in the continuous score of the pain intensity scale [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.
Other Outcome Measures
- Self-Efficacy [Baseline]
Chronic Pain Self-Efficacy Scale: Self-efficacy for pain management subscale measures confidence in managing pain, 5 items on 10-point Likert scale anchored on the ends by 10=very uncertain and 100=very certain. The score ranges from 50 to 500. Higher scores indicate higher perceived self efficacy.
- Self-Efficacy [2-weeks post baseline]
Chronic Pain Self-Efficacy Scale: Self-efficacy for pain management subscale measures confidence in managing pain, 5 items on a 10-point Likert scale anchored on the ends by 10=very uncertain and 100=very certain. The score ranges from 50 to 500. Higher scores indicate higher perceived self efficacy.
- Adherence to pain management [Baseline]
Morisky Medication Adherence Scale-4 item version: Measures medication adherence, 4 items on a five-point Likert scale. Patients answer yes or no to questions (e.g., Do you sometimes forget to take your pain medication?).Each "yes" answer is scored as 1.The score ranges from 0 to 4. Lower score indicates better adherence.
- Adherence to pain management [2-weeks post baseline]
Morisky Medication Adherence Scale-4 item version : Measures medication adherence, 4 items on a five-point Likert scale. Patients answer yes or no to questions (e.g., Do you sometimes forget to take your pain medication?). Each "yes" answer is scored as 1. The score ranges from 0 to 4. Lower score indicates better adherence.
- Knowledge [Baseline]
Barriers Questionnaire II measures 8 knowledge barriers about reporting pain and using analgesics, with four subscales (physiological effects, 12 items; fatalism, 3 items; communication, 6 items; and harmful effects, 6 items (total 27 items) on a 6-point scale (0 = don't agree, 5 = agree very much), items averaged (range 0 to 5). The score ranges from 0-135. Higher scores indicate stronger barriers.
- Knowledge [2-weeks post baseline]
Barriers Questionnaire II (BQ-II) measures 8 knowledge barriers about reporting pain and using analgesics, with four subscales (physiological effects, 12 items; fatalism, 3 items; communication, 6 items; and harmful effects, 6 items (total 27 items), 6-point scale (0 = don't agree, 5 = agree very much), items averaged (range 0 to 5).The score ranges from 0-135. Higher scores indicate stronger barriers.
Eligibility Criteria
Criteria
Inclusion criteria (patient)
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prior enrollment of their hospice nurse
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receives analgesics for pain
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speaks and reads English
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age 18 or older
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has a primary informal caregiver who is available for the 2 weeks of the study
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expected survival of at least 2 weeks
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can verbalize pain.
Inclusion criteria (caregiver)
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speaks and reads English
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age 18 or older
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cares for an enrolled patient
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available for the 2 weeks of the study.
Inclusion criteria (nurses participating in the RTC)
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registered nurse (RN)
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provides direct care to patients
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has not had a prior patient enrolled in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- Rush University Medical Center
- National Institute of Nursing Research (NINR)
Investigators
- Principal Investigator: Masako Mayahara, PhD, Rush University Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- 2020 Edition: Hospice Facts and Figures.
- Hospice care: Services provided to beneficiaries residing in nursing facilities
- Common Errors in Using Analgesics by Home-Based Nonprofessional Hospice Caregivers
- A Representational Approach to Patient Education
- How many interviews are enough to identify metathemes in multisited and cross-cultural research? Another perspective on Guest, Bunce, and Johnson's (2006) landmark study.
Publications
- Borneman T, Koczywas M, Sun V, Piper BF, Smith-Idell C, Laroya B, Uman G, Ferrell B. Effectiveness of a clinical intervention to eliminate barriers to pain and fatigue management in oncology. J Palliat Med. 2011 Feb;14(2):197-205. doi: 10.1089/jpm.2010.0268. Epub 2011 Jan 27.
- Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009 Dec;146(3):238-244. doi: 10.1016/j.pain.2009.08.019. Review.
- Irani E, Hirschman KB, Cacchione PZ, Bowles KH. How home health nurses plan their work schedules: A qualitative descriptive study. J Clin Nurs. 2018 Nov;27(21-22):4066-4076. doi: 10.1111/jocn.14548. Epub 2018 Jul 23.
- Keefe FJ, Ahles TA, Porter LS, Sutton LM, McBride CM, Pope MS, McKinstry ET, Furstenberg CP, Dalton J, Baucom DH. The self-efficacy of family caregivers for helping cancer patients manage pain at end-of-life. Pain. 2003 May;103(1-2):157-62.
- 19111205-IRB01
- R21NR018952