Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice

Pain Clinical Trial

Official title:

Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02026115
• Other study ID #: IH-1304-6553
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 28, 2013
• Last updated: May 26, 2015
• Start date: January 2014
• Est. completion date: September 2016

Study information

• Verified date: May 2015
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Unrelieved cancer pain at the end of life is a major health problem and is inconsistent with patient-centered goals for their last days. Building on a successful approach researched in outpatient oncology settings, the investigators propose a study testing PAINRelieveIt, a system-level intervention of computerized tools with patient-reported pain outcomes (in English, Spanish, Chinese languages), decision support for clinicians (English) and multimedia education tailored to each cancer patient and lay caregiver.

Using a 1-week pre-test/post-test randomized design in patients receiving home level hospice care provided by two Chicago-area hospices, we will compare effects of usual hospice care with PAINReportIt Summary and usual hospice care with PAINRelieveIt on pain outcomes. The tablet-based PAINRelieveIt includes valid and reliable pain tools (PAINReportIt), a summary of the patient's pain data with decision support for hospice nurses to obtain recommendations for algorithm-based analgesic therapies (PAINConsultN), and multimedia education tailored to the patient's and lay caregiver's pain management misconceptions (PainUCope). Patient's/caregiver's answers are automatically stored in an electronic database, from which the system generates a PAINReportIt Summary (usual hospice care control group); PAINConsultN and PainUCope (experimental group). All patients will receive usual hospice care. All patients/caregivers will complete PAINReportIt at pretest and 1-week later (posttest); patients also complete parts of PAINReportIt daily. Via daily e-mail updates, the control-group hospice nurses will receive a PAINReportIt Summary and experimental-group hospice nurses will receive a PAINConsultN. Additionally, experimental group patients/caregivers will view multimedia educational materials via PAINUCope to help patients report pain and adhere to prescribed analgesics.

Specific aims are 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.

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.

Findings will guide future system-level research to implement PAINRelieveIt in a multi-site, longitudinal trial that will test the effect of disseminating this technology on clinical decisions for managing pain and patient/caregiver pain outcomes in a national sample of hospices. This approach offers improved pain control for dying patients and other populations.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 380
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Study inclusion criteria require that the patient: (1) be admitted to home care level of hospice service; (2) has a diagnosis of cancer; (3) has experienced worst pain in the past 24 hours >3 on a 0-10 scale; (4) speaks, reads and writes English, Spanish, or Chinese; (5) is > 18 years of age; 6) has a lay caregiver who is > 18 years of age and willing to participate; and (7) has a life expectancy of about 19 days at the time of study enrollment, as suggested by a Palliative Performance Scale (PPS)41 score of > 40.

The lay caregiver inclusion criteria require that the individual: (1) be designated as the primary lay caregiver for the participating patient during the 7-day study period; (2) speaks, reads and writes English, Spanish, or Chinese; and (3) is > 18 years of age.

The hospice nurse inclusion criteria require that the individual: (1) be assigned as the primary hospice nurse for the participating patient during the 7-day study period; (2) speaks, reads and writes English (since the PAINConsultN is in English) but may speak Spanish or Chinese for clinical care purposes; and (3) is > 18 years of age.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

Behavioral:
• PAINReportIt
PAINReportIt is a software program first developed with an electronic MPQ (1970 version) and now includes questions about analgesics used by the patient and a shortened version of the pain Barriers Questionnaire (BQ). PAINReportIt is designed as an interactive, touch screen method for assessment of pain. It can be self-administered and requires little or no patient computer experience and minimal or no provider time for administration. Directions for self-administration allow the patient to read instructions on-screen and practice making all types of selection responses that are available in the program. Directions from the paper and pencil tools were modified to address the touch screen method of recording patient responses. The copyright is owned by Dr. Ronald Melzack for the MPQ and Dr. Sandra Ward for the BQ. Both of these individuals have authorized the modifications, presentation format, and computerized use of their tools.
• 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.
• PAINUCope
We tested the prototype of the PAINUCope component of the intervention in three completed studies. PAINUCope is a multimedia, computer generated tool that provides tailored patient information to overcome their misconceptions about pain and to help them engage in self-care activities that contribute to reducing their pain. PAINUCope focuses on two crucial aspects of pain management: 1) reporting cancer pain; and 2) safe and effective use of pain medicines. All the educational materials were written at a 6th grade reading level and presented as 21st Century best-practices, evidence-based facts or scripts for the person living 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 govern the specific health information that is shared with the patient via PAINUCope.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Horizon Hospice & Palliative Care, Patient-Centered Outcomes Research Institute, Rainbow Hospice

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	misconceptions about pain and pain management--patient	Misconceptions are measured with a computer version of the Barriers Questionnaire (BQ) with response options from 0 to 5 indicating the amount of agreement with statements about barriers to pain assessment or management. Items relate to communicating with the physician about pain, side effects of analgesics, concerns about addiction, tolerance, disease progression, and being perceived as a good patient. Validity of the BQ is supported by its ability to discriminate cancer patients who report high BQ scores and also were under-medicated for their pain level and were hesitant to report their pain to their clinicians. To improve the acceptability of the tool to patients with cancer, we reduced the tool to 13 items with demonstrated validity and reliability. In prior cancer studies, patients found it to be a simple, easily understood tool that they completed in 5 minutes or less on 13 screens using a touch-screen pentablet computer.	pretest at baseline (day 1) & posttest on day 7	No
Other	Satisfaction with pain levels -- patient	Satisfaction with pain levels is measured by two single item questions that ask the patient if he or she is satisfied with the level of pain. A three-option response allows the patient to indicate yes, no, or not sure. We tested this item in our previous study and found that 49% of patients were satisfied with their pain level at baseline were also satisfied 4 weeks later, 21% became satisfied, 18% became less satisfied and 12% were never satisfied during the 4-week study. These data are consistent with the high percentage (98%) of patients who reported a desire for no pain but whose worst pain was greater than the level they desired. Focusing on satisfaction with level of pain allows us to have greater variability in this variable than has been typically noted by other investigators.	pretest at baseline (day 1), daily for 5 days (days 2-6), posttest on day 7	No
Other	Misconceptions about pain and pain management--caregiver	Misconceptions are measured with a computer version of the Barriers Questionnaire (BQ) with response options from 0 to 5 indicating the amount of agreement with statements about barriers to pain assessment or management. Items relate to communicating with the physician about pain, side effects of analgesics, concerns about addiction, tolerance, disease progression, and being perceived as a good patient. Validity of the BQ is supported by its ability to discriminate cancer patients who report high BQ scores and also were under-medicated for their pain level and were hesitant to report their pain to their clinicians. To improve the acceptability of the tool to patients with cancer, we reduced the tool to 13 items with demonstrated validity and reliability. In prior cancer studies, patients found it to be a simple, easily understood tool that they completed in 5 minutes or less on 13 screens using a touch-screen pentablet computer.	pretest at baseline (day 1) & posttest on day 7	No
Other	appropriateness of analgesics prescribed --hospice nurse	We will measure the appropriateness of analgesics prescribed by review of the hospice medication list that is required to be in the home. The proportion of participants with an appropriate analgesic prescription will be calculated using Cleeland's Pain Management Index (PMI). The PMI is an indicator of the appropriateness of pain prescriptions based on the patient's reported pain intensity level. Calculation of the PMI requires a medication score and a worst pain intensity score. The PMI score is calculated by subtracting the worst pain category score from the prescribed pain medication score. Negative PMI scores indicate inadequate analgesics (coded as appropriate, no) and 0 or positive PMI scores indicate appropriate analgesics (coded as appropriate, yes).	pretest at baseline (day 1) & posttest on day 7	No
Primary	worst pain intensity-patient	worst pain intensity in previous 24 hours measured on 0 to 10 scale where 0 means no pain and 10 means pain as bad as it can be.	pretest at baseline (day 1), daily for 5 days (days 2-6), posttest on day 7	No
Secondary	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 will calculate the prescribed and 24 hour analgesic consumption for around the clock (ATC) and as needed (PRN) analgesics, but not the emergency analgesic pack opioids. We will 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).	pretest at baseline (day 1), daily for 5 days (days 2-6), posttest on day 7	No