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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will adapt and scale existing AHRQ-supported interoperable CDS for patient-centered chronic pain care. The objective of this project is to study the adaptation and implementation of an existing interoperable CDS tool for pain treatment shared decision making, with tailored implementation support, in primary care clinical settings. The central hypothesis is that tailored implementation support will increase CDS adoption and shared decision making.

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 data supports the effectiveness of the treatment Pain Manager for chronic pain?

The research highlights the importance of a coordinated strategy and interdisciplinary approaches in managing chronic pain, which suggests that treatments like Pain Manager could be effective if they incorporate these elements. Additionally, the need for improved communication and standardized care in pain management supports the potential effectiveness of structured treatments. ^{1 2 3 4 5}

Is Pain Manager safe for humans?

The research articles do not provide specific safety data for Pain Manager, but they discuss general safety concerns in pain management, such as preventable incidents and adverse drug reactions, especially in older adults using pain relief treatments. ^{6 7 8 9 10}

How is the Pain Manager treatment different from other chronic pain treatments?

The Pain Manager treatment is unique because it likely involves a comprehensive approach that includes elements like exercise, relaxation, and cognitive strategies to manage pain, rather than relying solely on medication. This holistic approach aims to improve functionality and quality of life by teaching patients pain management skills. ^{2 3 11 12 13}

Research Team

Christopher Harle, Ph.D.

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Road to excellence in pain management: research, outcomes and direction (ROAD). [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Opioid crisis renews interest in osteopathic manipulation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Pain management: screening and assessment of pain as part of a comprehensive case management process. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Implementing Population Medicine in a Pain Management Practice. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The Pain Associates' International Network Initiative: a novel practical approach to the challenge of chronic pain management in Europe. [2011]

6. England pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of pain outcomes in the clinical setting: development of the "APOLO" electronic data capture system. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Incident reporting in acute pain management. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Incident reporting by acute pain service at a tertiary care university hospital. [2020]

9. New Zealand 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Older Adults' Response to Analgesic Adverse Drug Reactions: A Pilot Study. [2019]

11. China pubmed.ncbi.nlm.nih.gov

Clinical experience with a chronic pain management programme in Hong Kong Chinese patients. [2018]

12. United States 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. [2015]

13. England pubmed.ncbi.nlm.nih.gov

Pilot study of a 4-week Pain Coping Strategies (PCS) programme for the chronic pain patient. [2011]