Pain Manager for Chronic Pain

(IPRO Trial)

Overseen By Ramzi Salloum, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must be taking: Opioids

Disqualifiers: Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on improving decision-making between doctors and patients regarding chronic pain treatment using the Pain Manager, a digital tool. The goal is to determine if additional support for using the tool enhances its effectiveness in managing pain in primary care settings. Participants should be primary care patients with ongoing musculoskeletal pain who have recently used opioids. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in pain management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this decision support tool is safe for patient-centered chronic pain care?

Research has shown that the Pain Manager tool, which aids doctors in managing long-term pain, has been used in past studies without reports of serious side effects. Studies examining its design and use in regular doctor visits have not identified major safety issues. The Pain Manager integrates with electronic health records to assist in making decisions about pain treatment. It is designed to facilitate collaboration between doctors and patients for more effective pain management. Overall, the tool is well-received, and existing research provides no evidence of harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pain Manager tool because it revolutionizes how chronic pain is managed in clinics. Unlike traditional treatments that rely heavily on medication, Pain Manager is a decision support tool that integrates into electronic health records (EHR), providing clinicians with tailored recommendations to manage pain more effectively. What sets it apart is the inclusion of intensive implementation support, like administrative and technical assistance, ensuring that clinics can fully leverage its capabilities. By potentially enhancing decision-making and reducing reliance on medications, this approach could transform chronic pain management for both patients and healthcare providers.

What evidence suggests that the Pain Manager decision support tool is effective for chronic pain management?

Research shows that the Pain Manager tool helps doctors make better choices for treating long-term pain. It uses patient-specific information to give doctors a clear understanding of a patient's pain and treatment options. Studies have found that this tool can improve pain management by making the process more personalized and efficient. It also encourages collaboration between patients and doctors to decide on the best treatment. In this trial, one group of clinics will use the Pain Manager tool integrated into their EHR without additional support, while another group will receive tailored implementation support to enhance its use. The Pain Manager tool is designed to fit easily into current healthcare systems, simplifying its use in everyday medical practice. Overall, it aims to improve patient care by tailoring treatment to each person's needs. ^{2 4 6 7 8}

Who Is on the Research Team?

Christopher Harle, Ph.D.

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for primary care patients at participating clinics who have chronic non-cancer musculoskeletal pain and a recent history of opioid use. It's not specified who can't join, but typically those with conditions that could interfere with the study or its outcomes would be excluded.

Inclusion Criteria

Primary care patients receiving care at a participating clinic

I have long-term muscle or bone pain and have recently used opioids.

Exclusion Criteria

Non-English speaking patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Pain Manager integrated into EHRs with tailored implementation support provided to select clinics

5 months

Ongoing clinic visits

Follow-up

Participants are monitored for safety and effectiveness after implementation

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Pain Manager

Trial Overview

The study is testing a 'Pain Manager' tool plus tailored support to help doctors and patients make better decisions together about treating chronic pain. The goal is to see if this support increases the use of the decision-making tool in primary care settings.

How Is the Trial Designed?

Group I: Pain Manager implementation in EHR Active Control 1 Intervention

Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. The other 6 clinics will have no additional tailor support.

Group II: Pain Manager + tailored implementation support Pain Manager Active Control 1 Intervention

Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. Consistent with the stepped-wedge design, intensive implementation support (e.g, administrative support, technical support)will be provided to two clinics at once by a multidisciplinary team.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

A new system for collecting pain management data, called the Assessment of Pain Outcomes Longitudinal Electronic Data Capture, has been successfully implemented, with 951 new patient and 688 return visit forms entered by December 2011.

The data collection process has shown high completion rates (over 90%) and excellent accuracy (error rate of 1 in 11,250), indicating that creating a reliable pain outcomes database using validated measures is achievable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of pain outcomes in the clinical setting: development of the "APOLO" electronic data capture system. Hassett, AL., Wasserman, R., Goesling, J., et al.[2019]

In a study involving 454 patients over 12 months, only 34% completed a 6-month cycle of chronic pain management, highlighting significant challenges with patient follow-up and engagement.

Despite the low completion rate, most patients who did complete the cycle reported improvements in their pain levels, indicating that the chronic pain management strategies implemented were effective for those who participated fully.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Population Medicine in a Pain Management Practice. Koschak, B., Bryce, DA., Harrington, JT.[2018]

Chronic pain is increasingly recognized as a significant public health issue, necessitating improved management strategies that address its complex nature and impact on patients and communities.

The P.A.I.N. Initiative has been established to enhance pain management quality through workshops for professionals, a software program for documenting patient data, an online discussion forum, and an education program for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pain Associates' International Network Initiative: a novel practical approach to the challenge of chronic pain management in Europe. Morlion, B., Walch, H., Yihune, G., et al.[2011]

Pain management is a critical issue affecting over 76 million people, and professional case managers play a vital role in addressing both acute and chronic pain through comprehensive assessments and care coordination across various healthcare settings.

Case managers must not only assess pain but also monitor for signs of depression and the risk of opioid misuse, emphasizing their importance in advocating for patient safety and effective pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management: screening and assessment of pain as part of a comprehensive case management process. Carter, JJ., Watson, AC., Sminkey, PV.[2014]

In a pilot survey of 22 older adults with chronic pain, gastrointestinal adverse drug events (ADEs) were the most commonly reported, with upset stomach being the most frequent issue, affecting 31.8% of participants.

Many older adults self-manage their analgesic-related ADEs without consulting their healthcare provider; 54.5% contacted their physician, while others changed their medication or stopped taking it altogether, highlighting the need for better communication about ADE management in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults' Response to Analgesic Adverse Drug Reactions: A Pilot Study. McDonald, DD., Coughlin, S., Jin, C.[2019]

A 14-day Comprehensive Out-patient Pain Engagement programme for chronic pain patients in Hong Kong led to significant improvements in physical function and psychological well-being, as measured by various assessment tools, including the Medical Outcome Survey and Pain Catastrophizing Scale.

The programme also resulted in increased physical tolerances for standing and sitting, and a notable improvement in employment rates, suggesting enhanced productivity among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with a chronic pain management programme in Hong Kong Chinese patients. Man, AK., Chu, MC., Chen, PP., et al.[2018]

A survey of 482 healthcare providers at the University of Washington Medical Center revealed that 75% use different pain-evaluation techniques for chronic pain patients compared to average patients, focusing more on activity levels than pain scores.

Concerns about medication dosage and sedation levels were common among caregivers, with 88% finding a time-contingent 'pain cocktail' effective, while patient-controlled analgesia (PCA) was the least labor-intensive method preferred by 84.5% of respondents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute pain management of the chronic pain patient on opiates: a survey of caregivers at University of Washington Medical Center. Rapp, SE., Wild, LM., Egan, KJ., et al.[2015]

Effective chronic pain management starts with counseling patients to set realistic goals for pain relief, emphasizing improvement in functionality and quality of life rather than complete pain elimination.

Engaging patients in their own pain management and considering multidisciplinary approaches can enhance treatment outcomes and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid crisis renews interest in osteopathic manipulation. Johnson, SR.[2019]

In a study of 288,912 veterans aged 55 and over, COX-2 inhibitors were more commonly prescribed than non-selective NSAIDs (NS-NSAIDs) for patients with a history of gastrointestinal (GI) events, myocardial infarction (MI), or stroke, indicating a preference for potentially safer options in at-risk populations.

Despite the preference for COX-2 inhibitors, 2.5% of patients with a history of GI events were still using NS-NSAIDs, highlighting a gap in adherence to treatment guidelines that recommend avoiding these medications in high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COX-2 inhibitor and non-selective NSAID use in those at increased risk of NSAID-related adverse events: a retrospective database study. Gadzhanova, S., Ilomäki, J., Roughead, EE.[2021]

A 4-week Pain Coping Strategies (PCS) program significantly improved mood, functional status, and physical ability in 31 chronic pain patients, as measured by standardized scales before and 6 weeks after the program.

The study suggests that early intervention with pain management strategies can effectively promote self-management and positive coping skills in chronic pain patients, even while they are undergoing other medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a 4-week Pain Coping Strategies (PCS) programme for the chronic pain patient. Mead, K., Theadom, A., Byron, K., et al.[2011]

An interdisciplinary model for pain management was developed within an integrated health care system, focusing on improving outcomes across various care settings, including acute care and home care.

The model established four key clinical indicators to measure pain management effectiveness, emphasizing strategies like staff accountability and patient education to enhance overall care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Road to excellence in pain management: research, outcomes and direction (ROAD). Vega-Stromberg, T., Holmes, SB., Gorski, LA., et al.[2019]

In a 12-month study involving 1275 patients receiving pain management, 53 incidents were reported, with 81.4% deemed preventable, highlighting the potential for improving safety in clinical practices.

Human factors, such as inexperience and communication issues, contributed to 41.9% of incidents, indicating the need for targeted training and better communication strategies to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incident reporting in acute pain management. Chen, PP., Ma, M., Chan, S., et al.[2022]

During a study involving 2042 patients, 442 incidents related to postoperative pain management were reported, highlighting the importance of monitoring and improving pain management practices.

Despite the high number of reported incidents, no harm was caused to any patients, indicating that the acute pain services (APS) effectively managed and rectified issues to maintain patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incident reporting by acute pain service at a tertiary care university hospital. Ahmed, A., Yasir, M.[2020]

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