The Use of a Digital Application for Reporting Pain and Pain Management in Home Hospice

Pain Clinical Trial

— ePainSupport  

Official title:

The Use of a Digital Application for Reporting Pain and Pain Management in Home Hospice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04869085
• Other study ID #: 19111205-IRB01
• Secondary ID: 5R21NR0189523102
• Status: Completed
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

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* Note: There are 49 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Efficacy	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.	Baseline
Other	Self-Efficacy	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.	2-weeks post baseline
Other	Adherence to pain management	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.	Baseline
Other	Adherence to pain management	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.	2-weeks post baseline
Other	Knowledge	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.	Baseline
Other	Knowledge	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.	2-weeks post baseline
Primary	Minimally important clinical change in pain intensity (at least 10 percent change on the pain intensity scale)	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.	Baseline
Primary	Minimally important clinical change in pain intensity (at least 10 percent change on the pain intensity scale)	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.	2-weeks post baseline
Secondary	Change in the continuous score of the pain intensity scale	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.	Baseline
Secondary	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.	2-weeks post baseline