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临床试验/NCT04869085
NCT04869085
已完成
不适用

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

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 88 人2021年4月21日
适应症Pain
干预措施e-PainSupport

概览

阶段
不适用
干预措施
e-PainSupport
疾病 / 适应症
Pain
发起方
Rush University Medical Center
入组人数
88
试验地点
1
主要终点
Minimally Important Clinical Change in Worst Pain Intensity
状态
已完成
最后更新
上个月

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2021年4月21日
结束日期
2024年1月31日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor
主要研究者

Masako Mayahara

Associate Professor and Associate Chairperson

Rush University Medical Center

入排标准

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: e-PainSupport

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.

结局指标

主要结局

Minimally Important Clinical Change in Worst Pain Intensity

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Change in the Continuous Score of the Pain Intensity Scale(Baseline to 2-weeks post baseline)

研究点 (1)

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