Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice

NCT02026115 | Completed Results

• 2 other identifiers: 2013-0986IH-1304-6553
• Study Type: interventional
• Target: 262
• Locations: 0 countries
• Sites: N/A

Brief 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

Cancer; Pain

Keywords

cancer; hospice; pain

Outcome Measures

Primary Outcomes (1)

• Analgesic Adherence-patient

  Analgesic adherence is derived from data regarding analgesics documented as prescribed (available to the patient as indicated from the medication list in the home) and analgesics consumed (from PAINReportIt). We calculate an analgesic adherence rate (dose reported as consumed divided by dose documented as prescribed, multiplied by 100) for all World Health Organization (WHO) analgesics (adjuvants, NSAIDs and non-opioids, and ATC and PRN Step 2 and Step 3 opioids).

  Average of daily adherence (days 1 to 7)

Secondary Outcomes (1)

• Worst Pain Intensity-patient

  Average of daily worse pain intensity (days 1 to 7)

Other Outcomes (4)

• Misconceptions About Pain and Pain Management--patient

  pretest at baseline (day 0) & posttest on day 7; day 7 reported

• Satisfaction With Pain Levels -- Patient

  Average of distribution of satisfaction with pain level reported each day (days 1 to 7).

• Misconceptions About Pain and Pain Management--caregiver

  pretest at baseline (day 0) & posttest on day 7; day 7 reported

Study Arms (2)

usual hospice care

ACTIVE COMPARATOR

The usual care group will receive the typical hospice care and interact with PAINReportIt to provide data necessary for the analysis of study aims. They will use the tablet computer at baseline and at the study end and daily between. They also will have access to what looks like PAINUCope, but is really computer games so that they have similar attention with the computer as the experimental group. For ethical purposes, we will provide a PAINReportIt Summary to their hospice nurses to have access to their pain assessment information, something we did not do in previous studies focused on efficacy of the interventions.

Behavioral: PAINReportIt

PAINRelieveIt (experimental group)

EXPERIMENTAL

We will use Nursing Consult LLC's PAINRelieveIt software that includes: (1) PAINReportIt that has screens to collect pain, medications, and misconception data; (2) the intervention for the nurse clinicians, PAINConsultN; and (3) the intervention for the patients and lay caregiver, PAINUCope. This innovative, new program is the first computerized, multi-dimensional, self-report measure of pain with clinician decision support for analgesic prescriptions and multimedia patient education tailored to the patient's misconceptions and pain. Prototype versions of PAINConsultN and PAINUCope were tested in recently completed studies among outpatients with cancer and patients with sickle cell disease in outpatient, emergency and hospital settings.

Behavioral: PAINReportIt; Behavioral: PAINConsultN; Behavioral: PAINUCope

Interventions

PAINReportIt BEHAVIORAL

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.

Also known as: PAINRelieveIt's PAINReportIt

PAINRelieveIt (experimental group); usual hospice care

PAINConsultN BEHAVIORAL

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.

Also known as: PAINRelieveIt's PANConsultN

PAINRelieveIt (experimental group)

PAINUCope BEHAVIORAL

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.

Also known as: PAINRelieveIt's PAINUCope

PAINRelieveIt (experimental group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients and lay caregivers will be excluded if they: (1) are legally blind or deaf; or (2) have cognitive or physical impairments making it impossible to communicate or to complete study instruments at enrollment or any time during the study.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Patient-Centered Outcomes Research Institute: collaborator
• JourneyCare Home Health & Hospice: collaborator
• Rainbow Hospice: collaborator

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Diana J. Wilkie, PhD, RN, FAAN, Professor, Prairieview Trust - Earl and Margo Powers Endowed Profess
• Organization: University of Florida

diwilkie@ufl.edu

352-273-6401

Study Officials

• Diana J Wilkie, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: December 28, 2013
• First Posted: January 1, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share