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

April 30, 2024 updated by: Masako Mayahara, Rush University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimally important clinical change in pain intensity (at least 10 percent change on the pain intensity scale)
Time Frame: 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.
Baseline
Minimally important clinical change in pain intensity (at least 10 percent change on the pain intensity scale)
Time Frame: 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.
2-weeks post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the continuous score of the pain intensity scale
Time Frame: 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.
Baseline
Change in the continuous score of the pain intensity scale
Time Frame: 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.
2-weeks post baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Efficacy
Time Frame: 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.
Baseline
Self-Efficacy
Time Frame: 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.
2-weeks post baseline
Adherence to pain management
Time Frame: 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.
Baseline
Adherence to pain management
Time Frame: 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.
2-weeks post baseline
Knowledge
Time Frame: 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.
Baseline
Knowledge
Time Frame: 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.
2-weeks post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Masako Mayahara, PhD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19111205-IRB01
  • 5R21NR018952 (U.S. NIH Grant/Contract)
  • 310245 (Other Identifier: Rush University)
  • 310244 (Other Identifier: Rush University)
  • 310243 (Other Identifier: Rush Univesrity)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on e-PainSupport

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe