Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice

NCT02026115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2025-09-15

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Summary

The study purpose is to compare usual hospice care and PAINRelieveIt groups for effects on: (1) patient outcomes (analgesic adherence; worst pain intensity, satisfaction, and misconceptions) and lay caregiver outcome (pain misconceptions) in a diverse sample of 250 cancer patient-caregiver dyads receiving hospice care; and (2) nurse outcomes (obtained appropriate analgesics for patient) in a sample of hospice nurses. The investigators hypothesize that at posttest, controlling for pretest data and compared to the usual care group, the PAINRelieveIt group will: a) report decreased scores for worst pain intensity and pain misconceptions; b) have increased analgesic adherence (primary outcome); and c) have a larger proportion who report satisfaction with pain intensity and whose nurses obtained appropriate analgesics for the patients' pain.

Conditions

Interventions

BEHAVIORAL

PAINReportIt

PAINReportIt is a software program developed with an electronic McGill Pain Questionnaire (MPQ) and now includes questions about analgesics used by patients and a shortened version of the pain Barriers Questionnaire (BQ). It is designed as an interactive, touch screen way to assess pain. It can be self-administered and requires little or no patient computer experience and little or no provider time. The patient can read instructions on-screen and practice all types of selection responses found the program. Directions from the paper tools were modified to address the touch screen method of recording responses. The copyright is owned by Dr. Ronald Melzack for the MPQ and Dr. Sandra Ward for the BQ. Both individuals authorized the modifications, format, and computerized use of the tools.

BEHAVIORAL

PAINConsultN

PAINConsultN for hospice nurses. Our previous studies support the feasibility and clinical effect of PAINConsultN. This narrative and graphic tool provides decision support for the nurse's clinical decisions regarding management of the patient's pain. Based on the PAINReportIt output and published cancer pain guidelines, PAINConsultN generates an algorithm-based consultation report with a list of recommendations that could be useful to provide improved pain relief. If the patient's PAINReportIt output indicates the pain level is consistent with the patient's goals for pain management and represents no pain or a mild pain level, the consultation report acknowledges the therapy plan and reinforces its consistency with pain guidelines.

BEHAVIORAL

PAINUCope

We tested the PAINUCope piece of the intervention in 3 completed studies. PAINUCope is a multimedia, computer generated tool that gives tailored information to overcome patients' misconceptions about pain and help them engage in activities that help reduce their pain. PAINUCope focuses on 2 crucial aspects of pain management: 1) reporting cancer pain and 2) safe and effective use of pain medicines. The educational materials are written at a 6th grade reading level and presented as 21st Century best-practices, evidence-based facts or scripts for the person with cancer or sickle cell disease (in one study). The facts or scripts are customized to the patient's need for this type of health information. The patient's responses on PAINReportIt guide the specific information shared via PAINUCope.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • JourneyCare Home Health & Hospice

    collaborator UNKNOWN
  • Rainbow Hospice

    collaborator OTHER
  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Diana J Wilkie, PhD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-09-30
Completion
2016-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02026115 on ClinicalTrials.gov