Effectiveness of a Computerized Tool (PAINRelieveIt) to Help Manage Pain Related to Sickle Cell Disease

NCT ID: NCT00600665

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2014-06-30

Brief Summary

Sickle cell disease (SCD) is a blood disorder that is characterized by intense, painful episodes known as sickle cell crises. This study will evaluate the effectiveness of PAINRelieveIt, a three-part computer-based pain management tool, in treating adults with SCD.

Detailed Description

SCD is an inherited blood disorder that mainly affects people of African, Mediterranean, or Latin descent. Symptoms include anemia, infections, organ damage, and painful sickle cell crises. Adults with SCD who experience frequent painful crises are more likely to die sooner than are adults with SCD who have fewer painful crises. Experts suggest that SCD pain be treated in the same way that cancer pain is treated because both types of pain are sustained and severe. However, unlike the research directed towards cancer pain, research focused on the characteristics of SCD pain has been limited. Although medications are available to treat SCD pain, the SCD pain management process is complex and often requires more time than what is available during the typical medical appointment. Recent advances in computer technologies may provide an opportunity to improve the effectiveness of SCD pain management by combining online patient education with decision-making support tools for doctors. This study will evaluate three touch screen computerized tools that are known collectively as PAINRelieveIt. The three tools include the following:

1. PAINReportIt-a pain assessment data collection tool

2. PAINUCope-a multimedia patient education program tailored to the participant's SCD pain management misconceptions

3. PAINConsultN-a decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level

This two-part study will evaluate the effectiveness of PAINReportIt and PAINUCope, alone and in combination with PAINConsultN, at improving participants' SCD pain by educating participants about their role in pain management and by providing decision-making support to doctors.

This study comprises two parts. Part 1 of the study will enroll patients who are receiving care at the University of Illinois at Chicago Sickle Cell Clinic. The patients will be randomly assigned to receive 3 months of either access to PAINReportIt and PAINUCope or usual care. At baseline and Month 3, participants will complete questionnaires on misconceptions about pain, medication adherence, and pain intensity. The same participants from Part 1 of the study will be enrolled into Part 2 of the study, which will last 2 years. Part 2 participants will be randomly assigned to receive either care from doctors who have access to PAINConsultN or usual care. All participants will have access to PAINReportIt and PAINUCope. At baseline and Year 2, participants will complete questionnaires on pain episodes. Information will also be collected from doctors, including pain documentation, appropriateness of prescribed pain medications, and the number of emergency department visits by and hospitalizations of participants experiencing painful SCD crises.

Conditions

Anemia, Sickle Cell; Hemoglobin SC Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Usual Care

In Part 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Part 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.

Group Type: ACTIVE_COMPARATOR

PAINReportIt

Intervention Type: BEHAVIORAL

A pain assessment data collection tool

PAINUCope

Intervention Type: BEHAVIORAL

A multimedia patient education program tailored to the participant's SCD pain management misconceptions

PAINUCope/PAINConsultN

In Part 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 Part 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.

Group Type: EXPERIMENTAL

PAINReportIt

Intervention Type: BEHAVIORAL

A pain assessment data collection tool

PAINUCope

Intervention Type: BEHAVIORAL

A multimedia patient education program tailored to the participant's SCD pain management misconceptions

PAINConsultN

Intervention Type: BEHAVIORAL

A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level

Interventions

PAINReportIt

A pain assessment data collection tool

Intervention Type: BEHAVIORAL

PAINUCope

A multimedia patient education program tailored to the participant's SCD pain management misconceptions

Intervention Type: BEHAVIORAL

PAINConsultN

A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosed with SCD
• Scheduled for continuing care at the University of Illinois at Chicago Sickle Cell Clinic
• Experienced a moderate to severe level of pain (at least 3 on 0 to 10 scale) related to the SCD within the 12 months prior to study entry
• Had a emergency department visit or hospitalization within the 2 years prior to study entry
• Speaks and reads English

Exclusion Criteria

• Legally blind
• Physically unable to complete study questionnaire

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Diana J. Wilkie

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diana J. Wilkie, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago Sickle Cell Center and Medical Center

Chicago, Illinois, United States

Countries

United States

References

Wilkie DJ, Molokie R, Boyd-Seal D, Suarez ML, Kim YO, Zong S, Wittert H, Zhao Z, Saunthararajah Y, Wang ZJ. Patient-reported outcomes: descriptors of nociceptive and neuropathic pain and barriers to effective pain management in adult outpatients with sickle cell disease. J Natl Med Assoc. 2010 Jan;102(1):18-27. doi: 10.1016/s0027-9684(15)30471-5.

Reference Type: RESULT

PMID: 20158132 (View on PubMed)

Other Identifiers

R01HL078536

Identifier Type: NIH

Identifier Source: secondary_id

View Link

420

Identifier Type: -

Identifier Source: org_study_id