Trial Outcomes & Findings for Effectiveness of a Computerized Tool (PAINRelieveIt) to Help Manage Pain Related to Sickle Cell Disease (NCT NCT00600665)

Last Updated: 2026-08-04

Results Overview

Range 0-5. Higher score indicates more perceived barriers (greater concern about pain management beliefs and/or analgesic side effects)

Recruitment status

COMPLETED

Study phase

Target enrollment

279 participants

Primary outcome timeframe

Measured at Month 3

Results posted on

2026-08-04

Participant Flow

Of 279 enrolled subjects, 38 subjects were lost before randomization. 1 subject was determined to not have SCD and was thus excluded.

Participant milestones

Participant milestones
Measure	Control In Phase 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Phase 2 of the study, participants will continue to access PAINReportIt when they are seen in the clinic, emergency department (ED), acute care center (ACCA), and hospital. They will gain access to the PAINUCope computer-based programs, which provides multimedia education tailored to the patient's misconceptions about pain management. They will receive medial usual care at the outpatient clinic, ED, ACC, and hospital. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions	Experimental In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions PAINConsultN: A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
Phase 1, 3 months STARTED	124	116
Phase 1, 3 months Completed baseline	118	110
Phase 1, 3 months COMPLETED	97	87
Phase 1, 3 months NOT COMPLETED	27	29
Phase 2, 2 years STARTED	92	85
Phase 2, 2 years COMPLETED	92	85
Phase 2, 2 years NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This table contains baseline measures for both Phase 1 (N=228) and Phase 2 (N=177).

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Measured at Month 3

Population: The analysis included all participants that completed the baseline. Multiple imputation was used for missing data processing. This is a Phase 1 only outcome measure.

Range 0-5. Higher score indicates more perceived barriers (greater concern about pain management beliefs and/or analgesic side effects)

Outcome measures

Outcome measures
Measure	Usual Care n=118 Participants In Phase 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Phase 2 of the study, participants will continue to access PAINReportIt when they are seen in the clinic, emergency department (ED), acute care center (ACCA), and hospital. They will gain access to the PAINUCope computer-based programs, which provides multimedia education tailored to the patient's misconceptions about pain management. They will receive medial usual care at the outpatient clinic, ED, ACC, and hospital. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions	PAINUCope/PAINConsultN n=110 Participants In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions PAINConsultN: A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
Misperception About Pain (BQ-13)	2.26 units on a scale Standard Deviation 0.86	2.05 units on a scale Standard Deviation 0.80

PRIMARY outcome

Timeframe: Measured at Month 3

Population: The analysis included all participants that completed the baseline. Multiple imputation was used for missing data processing. This is a Phase 1 only outcome measure.

Range 0-100. Higher score indicates worse pain.

Outcome measures

Outcome measures
Measure	Usual Care n=118 Participants In Phase 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Phase 2 of the study, participants will continue to access PAINReportIt when they are seen in the clinic, emergency department (ED), acute care center (ACCA), and hospital. They will gain access to the PAINUCope computer-based programs, which provides multimedia education tailored to the patient's misconceptions about pain management. They will receive medial usual care at the outpatient clinic, ED, ACC, and hospital. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions	PAINUCope/PAINConsultN n=110 Participants In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions PAINConsultN: A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
Composite Pain Index (CPI)	41.2 units on a scale Standard Deviation 13.7	43.0 units on a scale Standard Deviation 13.6

PRIMARY outcome

Timeframe: Measured at Month 3

Population: The analysis included all participants that completed the baseline. Multiple imputation was used for missing data processing. Collected in Phase 1 only.

Range 0-1. Higher is better.

Outcome measures

Outcome measures
Measure	Usual Care n=118 Participants In Phase 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Phase 2 of the study, participants will continue to access PAINReportIt when they are seen in the clinic, emergency department (ED), acute care center (ACCA), and hospital. They will gain access to the PAINUCope computer-based programs, which provides multimedia education tailored to the patient's misconceptions about pain management. They will receive medial usual care at the outpatient clinic, ED, ACC, and hospital. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions	PAINUCope/PAINConsultN n=110 Participants In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions PAINConsultN: A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
Analgesic Adherence	52 percentage of pills taken Standard Deviation 68	45 percentage of pills taken Standard Deviation 48

PRIMARY outcome

Timeframe: Measured over the course of Phase 2, a 2-year period.

Population: Patients that participated in Phase 2. This is a Phase 2 only outcome measure.

Percentage of days in pain crisis during Phase 2. Range 0-100. Lower is better.

Outcome measures

Outcome measures
Measure	Usual Care n=92 Participants In Phase 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Phase 2 of the study, participants will continue to access PAINReportIt when they are seen in the clinic, emergency department (ED), acute care center (ACCA), and hospital. They will gain access to the PAINUCope computer-based programs, which provides multimedia education tailored to the patient's misconceptions about pain management. They will receive medial usual care at the outpatient clinic, ED, ACC, and hospital. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions	PAINUCope/PAINConsultN n=85 Participants In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions PAINConsultN: A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
Time in Pain Crisis	7.6 percentage of days Standard Deviation 11.2	6.2 percentage of days Standard Deviation 11.3

PRIMARY outcome

Timeframe: Measured over the course of Phase 2, a two-year period.

Population: Patients with pain encounters (clinic, acute care center, emergency department, hospital) during Phase 2. This is a Phase 2 only outcome measure.

Completeness of pain documentation during Phase 2. Range 0-100. Higher is better.

Outcome measures

Outcome measures
Measure	Usual Care n=87 Participants In Phase 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Phase 2 of the study, participants will continue to access PAINReportIt when they are seen in the clinic, emergency department (ED), acute care center (ACCA), and hospital. They will gain access to the PAINUCope computer-based programs, which provides multimedia education tailored to the patient's misconceptions about pain management. They will receive medial usual care at the outpatient clinic, ED, ACC, and hospital. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions	PAINUCope/PAINConsultN n=79 Participants In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions PAINConsultN: A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
Pain Documentation	55.0 percentage of pain doc completed Standard Deviation 11.3	54.3 percentage of pain doc completed Standard Deviation 15.5

PRIMARY outcome

Timeframe: Average over the course of Phase 2, a two-year period.

Population: Patients treated with Opioids for pain in emergency departments or acute care center during Phase 2. This is a Phase 2 only outcome measure.

Percentage of appropriate analgesic prescriptions during Phase 2. Range 0-100. Higher is better.

Outcome measures

Outcome measures
Measure	Usual Care n=77 Participants In Phase 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Phase 2 of the study, participants will continue to access PAINReportIt when they are seen in the clinic, emergency department (ED), acute care center (ACCA), and hospital. They will gain access to the PAINUCope computer-based programs, which provides multimedia education tailored to the patient's misconceptions about pain management. They will receive medial usual care at the outpatient clinic, ED, ACC, and hospital. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions	PAINUCope/PAINConsultN n=70 Participants In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions PAINConsultN: A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
Appropriateness of Analgesic Prescription	72.5 percentage of appropriate prescription Standard Deviation 34.0	69.3 percentage of appropriate prescription Standard Deviation 36.0

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PAINUCope/PAINConsultN

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Diana Wilkie

University of Florida

Phone: 3522736401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control n=118 Participants In Phase 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Phase 2 of the study, participants will continue to access PAINReportIt when they are seen in the clinic, emergency department (ED), acute care center (ACCA), and hospital. They will gain access to the PAINUCope computer-based programs, which provides multimedia education tailored to the patient's misconceptions about pain management. They will receive medial usual care at the outpatient clinic, ED, ACC, and hospital. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions	Experimental n=110 Participants In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain. PAINReportIt: A pain assessment data collection tool PAINUCope: A multimedia patient education program tailored to the participant's SCD pain management misconceptions PAINConsultN: A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level	Total n=228 Participants Total of all reporting groups
Age, Continuous Phase 1	32.7 years STANDARD_DEVIATION 11.1 • n=118 Participants • This table contains baseline measures for both Phase 1 (N=228) and Phase 2 (N=177).	33.8 years STANDARD_DEVIATION 11.2 • n=110 Participants • This table contains baseline measures for both Phase 1 (N=228) and Phase 2 (N=177).	33.2 years STANDARD_DEVIATION 11.1 • n=228 Participants • This table contains baseline measures for both Phase 1 (N=228) and Phase 2 (N=177).
Age, Continuous Phase 2	34.0 years STANDARD_DEVIATION 11.5 • n=92 Participants • This table contains baseline measures for both Phase 1 (N=228) and Phase 2 (N=177).	34.7 years STANDARD_DEVIATION 11.5 • n=85 Participants • This table contains baseline measures for both Phase 1 (N=228) and Phase 2 (N=177).	34.4 years STANDARD_DEVIATION 11.5 • n=177 Participants • This table contains baseline measures for both Phase 1 (N=228) and Phase 2 (N=177).
Sex: Female, Male Phase 1 · Female	77 Participants n=118 Participants • The numbers of subjects for the two phases were different.	65 Participants n=110 Participants • The numbers of subjects for the two phases were different.	142 Participants n=228 Participants • The numbers of subjects for the two phases were different.
Sex: Female, Male Phase 1 · Male	41 Participants n=118 Participants • The numbers of subjects for the two phases were different.	45 Participants n=110 Participants • The numbers of subjects for the two phases were different.	86 Participants n=228 Participants • The numbers of subjects for the two phases were different.
Sex: Female, Male Phase 2 · Female	61 Participants n=92 Participants • The numbers of subjects for the two phases were different.	51 Participants n=85 Participants • The numbers of subjects for the two phases were different.	112 Participants n=177 Participants • The numbers of subjects for the two phases were different.
Sex: Female, Male Phase 2 · Male	31 Participants n=92 Participants • The numbers of subjects for the two phases were different.	34 Participants n=85 Participants • The numbers of subjects for the two phases were different.	65 Participants n=177 Participants • The numbers of subjects for the two phases were different.
Ethnicity (NIH/OMB) Phase 1 · Hispanic or Latino	3 Participants n=118 Participants • The numbers of subjects for the two phases were different.	4 Participants n=110 Participants • The numbers of subjects for the two phases were different.	7 Participants n=228 Participants • The numbers of subjects for the two phases were different.
Ethnicity (NIH/OMB) Phase 1 · Not Hispanic or Latino	115 Participants n=118 Participants • The numbers of subjects for the two phases were different.	106 Participants n=110 Participants • The numbers of subjects for the two phases were different.	221 Participants n=228 Participants • The numbers of subjects for the two phases were different.
Ethnicity (NIH/OMB) Phase 1 · Unknown or Not Reported	0 Participants n=118 Participants • The numbers of subjects for the two phases were different.	0 Participants n=110 Participants • The numbers of subjects for the two phases were different.	0 Participants n=228 Participants • The numbers of subjects for the two phases were different.
Ethnicity (NIH/OMB) Phase 2 · Hispanic or Latino	4 Participants n=92 Participants • The numbers of subjects for the two phases were different.	1 Participants n=85 Participants • The numbers of subjects for the two phases were different.	5 Participants n=177 Participants • The numbers of subjects for the two phases were different.
Ethnicity (NIH/OMB) Phase 2 · Not Hispanic or Latino	88 Participants n=92 Participants • The numbers of subjects for the two phases were different.	84 Participants n=85 Participants • The numbers of subjects for the two phases were different.	172 Participants n=177 Participants • The numbers of subjects for the two phases were different.
Ethnicity (NIH/OMB) Phase 2 · Unknown or Not Reported	0 Participants n=92 Participants • The numbers of subjects for the two phases were different.	0 Participants n=85 Participants • The numbers of subjects for the two phases were different.	0 Participants n=177 Participants • The numbers of subjects for the two phases were different.
Race/Ethnicity, Customized Phase 1 · Black	116 Participants n=118 Participants • The numbers of participants for the two phases were different.	107 Participants n=110 Participants • The numbers of participants for the two phases were different.	223 Participants n=228 Participants • The numbers of participants for the two phases were different.
Race/Ethnicity, Customized Phase 1 · Other	2 Participants n=118 Participants • The numbers of participants for the two phases were different.	3 Participants n=110 Participants • The numbers of participants for the two phases were different.	5 Participants n=228 Participants • The numbers of participants for the two phases were different.
Race/Ethnicity, Customized Phase 2 · Black	89 Participants n=92 Participants • The numbers of participants for the two phases were different.	85 Participants n=85 Participants • The numbers of participants for the two phases were different.	174 Participants n=177 Participants • The numbers of participants for the two phases were different.
Race/Ethnicity, Customized Phase 2 · Other	3 Participants n=92 Participants • The numbers of participants for the two phases were different.	0 Participants n=85 Participants • The numbers of participants for the two phases were different.	3 Participants n=177 Participants • The numbers of participants for the two phases were different.
BQ-13	2.39 units on a scale STANDARD_DEVIATION 0.92 • n=118 Participants	2.15 units on a scale STANDARD_DEVIATION 0.87 • n=110 Participants	2.27 units on a scale STANDARD_DEVIATION 0.90 • n=228 Participants
CPI	41.8 units on a scale STANDARD_DEVIATION 14.6 • n=118 Participants	41.9 units on a scale STANDARD_DEVIATION 13.7 • n=110 Participants	41.9 units on a scale STANDARD_DEVIATION 14.1 • n=228 Participants
Analgesic adherence	45 percentage of pills taken STANDARD_DEVIATION 44 • n=118 Participants	32 percentage of pills taken STANDARD_DEVIATION 38 • n=110 Participants	39 percentage of pills taken STANDARD_DEVIATION 42 • n=228 Participants