Clinical trial NCT02026115: Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice
Official title: Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Pain
Keywords: cancer
hospice
pain
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Horizon Hospice & Palliative Care
name: Rainbow Hospice
First posted: 2014-01-01
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: worst pain intensity-patient
timeFrame: pretest at baseline (day 1), daily for 5 days (days 2-6), posttest on day 7
Secondary outcomes:
measure: analgesic adherence-patient
timeFrame: pretest at baseline (day 1), daily for 5 days (days 2-6), posttest on day 7
Other outcomes:
measure: misconceptions about pain and pain management--patient
timeFrame: pretest at baseline (day 1) & posttest on day 7
measure: Satisfaction with pain levels -- patient
timeFrame: pretest at baseline (day 1), daily for 5 days (days 2-6), posttest on day 7
measure: Misconceptions about pain and pain management--caregiver
timeFrame: pretest at baseline (day 1) & posttest on day 7
measure: appropriateness of analgesics prescribed --hospice nurse
timeFrame: pretest at baseline (day 1) & posttest on day 7
Locations:
Study officials:
affiliation: University of Illinois at Chicago
name: Diana J Wilkie, PhD
role: PRINCIPAL_INVESTIGATOR
References: