Trial Outcomes & Findings for Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice (NCT NCT02026115)

NCT ID: NCT02026115

Last Updated: 2025-09-15

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

262 participants

Primary outcome timeframe

Average of daily adherence (days 1 to 7)

Results posted on

2025-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Hospice Care 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.	PAINRelieveIt (Experimental Group) 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.
Overall Study STARTED	170	92
Overall Study COMPLETED	154	80
Overall Study NOT COMPLETED	16	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Hospice Care n=154 Participants 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.	PAINRelieveIt (Experimental Group) n=80 Participants 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.	Total n=234 Participants Total of all reporting groups
Age, Continuous	67.9 years STANDARD_DEVIATION 14.4 • n=5 Participants	69.5 years STANDARD_DEVIATION 13.1 • n=7 Participants	68.4 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	38 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	42 Participants n=7 Participants	115 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	14 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	126 Participants n=5 Participants	66 Participants n=7 Participants	192 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	56 Participants n=5 Participants	25 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants	44 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	11 Participants n=7 Participants	33 Participants n=5 Participants
Adherence Rate for Scheduled Opioids	0.59 proportion of adherence (0-1) STANDARD_DEVIATION 0.33 • n=5 Participants	0.66 proportion of adherence (0-1) STANDARD_DEVIATION 0.31 • n=7 Participants	0.61 proportion of adherence (0-1) STANDARD_DEVIATION 0.33 • n=5 Participants
Worst Pain Intensity	7.09 units on a scale (0-10) STANDARD_DEVIATION 2.29 • n=5 Participants	6.99 units on a scale (0-10) STANDARD_DEVIATION 2.52 • n=7 Participants	7.06 units on a scale (0-10) STANDARD_DEVIATION 2.37 • n=5 Participants
Least Pain Intensity	3.17 units on a scale (0-10) STANDARD_DEVIATION 2.40 • n=5 Participants	3.09 units on a scale (0-10) STANDARD_DEVIATION 2.27 • n=7 Participants	3.15 units on a scale (0-10) STANDARD_DEVIATION 2.35 • n=5 Participants
Current Pain Intensity	4.76 units on a scale (0-10) STANDARD_DEVIATION 2.72 • n=5 Participants	4.64 units on a scale (0-10) STANDARD_DEVIATION 2.51 • n=7 Participants	4.72 units on a scale (0-10) STANDARD_DEVIATION 2.64 • n=5 Participants
Satisfaction with Pain Level Satisfied	56 Participants n=5 Participants	31 Participants n=7 Participants	87 Participants n=5 Participants
Satisfaction with Pain Level Not sure	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Satisfaction with Pain Level Not satisfied	82 Participants n=5 Participants	39 Participants n=7 Participants	121 Participants n=5 Participants
Pain Barrier -- Patient	2.75 units on a scale (0-5) STANDARD_DEVIATION 0.81 • n=5 Participants	2.44 units on a scale (0-5) STANDARD_DEVIATION 0.86 • n=7 Participants	2.64 units on a scale (0-5) STANDARD_DEVIATION 0.84 • n=5 Participants
Pain Barrier -- Caregiver	2.74 units on a scale (0-5) STANDARD_DEVIATION 0.93 • n=5 Participants	2.81 units on a scale (0-5) STANDARD_DEVIATION 0.85 • n=7 Participants	2.77 units on a scale (0-5) STANDARD_DEVIATION 0.90 • n=5 Participants

PRIMARY outcome

Timeframe: Average of daily adherence (days 1 to 7)

Population: Intent to treat analysis with multiple imputation based missing data processing.

Outcome measures

Outcome measures
Measure	Usual Hospice Care n=154 Participants 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.	PAINRelieveIt (Experimental Group) n=80 Participants 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.
Analgesic Adherence-patient	0.66 proportion (0-1), higher is better Standard Deviation 0.27	0.67 proportion (0-1), higher is better Standard Deviation 0.24

SECONDARY outcome

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

Population: Intent to treat analysis with multiple imputations.

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.

Outcome measures

Outcome measures
Measure	Usual Hospice Care n=154 Participants 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.	PAINRelieveIt (Experimental Group) n=80 Participants 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.
Worst Pain Intensity-patient	6.05 units on a scale (0-10); lower is better Standard Deviation 2.24	6.63 units on a scale (0-10); lower is better Standard Deviation 2.12

OTHER_PRE_SPECIFIED outcome

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

Population: Intent to treat analysis with multiple imputation based missing data processing.

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.

Outcome measures

Outcome measures
Measure	Usual Hospice Care n=154 Participants 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.	PAINRelieveIt (Experimental Group) n=80 Participants 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.
Misconceptions About Pain and Pain Management--patient	2.72 units on a scale (0-5); lower is better Standard Deviation 0.79	2.56 units on a scale (0-5); lower is better Standard Deviation 0.87

OTHER_PRE_SPECIFIED outcome

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

Population: Intent to treat analysis with multiple imputation based missing data processing

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.

Outcome measures

Outcome measures
Measure	Usual Hospice Care n=154 Participants 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.	PAINRelieveIt (Experimental Group) n=80 Participants 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.
Satisfaction With Pain Levels -- Patient Satisfied	50 Participants	24 Participants
Satisfaction With Pain Levels -- Patient Not sure	24 Participants	13 Participants
Satisfaction With Pain Levels -- Patient Not satisfied	80 Participants	43 Participants

OTHER_PRE_SPECIFIED outcome

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

Population: Intent to treat analysis with multiple imputation based missing data processing.

Outcome measures

Outcome measures
Measure	Usual Hospice Care n=154 Participants 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.	PAINRelieveIt (Experimental Group) n=80 Participants 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.
Misconceptions About Pain and Pain Management--caregiver	2.97 units on a scale (0-5); lower is better Standard Deviation 0.81	2.67 units on a scale (0-5); lower is better Standard Deviation 0.82

OTHER_PRE_SPECIFIED outcome

Timeframe: proportion of days (days 1 to 7) with appropriate analgesics

We will measure the appropriateness of a patient's analgesic prescription on a given day using Cleeland's Pain Management Index (PMI). For a given day, a patient's analgesic score (0=no analgesic, 1=non-opioid, 2=weak opioid, 3=strong opioid) is subtracted by their pain intensity category (0 = worst pain of 0; 1 = worst pain of 1-3; 2 = worst pain of 4-6; 3 = worst pain of 7-10) to obtain their PMI score for the day. Negative PMI scores indicate inadequate analgesics while 0 or positive PMI scores indicate appropriate analgesics. For each patient, the outcome measure is the proportion of day with appropriate analgesics.

Outcome measures

Outcome measures
Measure	Usual Hospice Care n=154 Participants 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.	PAINRelieveIt (Experimental Group) n=80 Participants 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.
Appropriateness of Analgesics Prescribed --Hospice Nurse	0.98 proportion of days (0-1), higher=better Standard Deviation 0.13	0.91 proportion of days (0-1), higher=better Standard Deviation 0.29

Adverse Events

Usual Hospice Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 14 deaths

PAINRelieveIt (Experimental Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Diana J. Wilkie, PhD, RN, FAAN, Professor, Prairieview Trust - Earl and Margo Powers Endowed Profess

University of Florida

Phone: 352-273-6401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place