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Pain-CPG-EIT for Pain

Phase 2
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test an approach to improve assessment, diagnosis and management of pain in nursing home residents living with dementia, and also evaluate differences in measurement, treatment and response to treatment between male/female and Black/White.

Who is the study for?
This trial is for nursing home residents aged 65 or older with dementia and pain. They must show signs of dementia through various tests like BIMS, AD8, CDR, or FAQ and have experienced pain recently as per staff reports or assessments.Check my eligibility
What is being tested?
The study is testing a Pain Management Clinical Practice Guideline (Pain-CPG) using the Evidence Integration Triangle (EIT). It involves education, mentoring by nurses, stakeholder teamwork, and ongoing evaluation to improve pain management in people with dementia.See study design
What are the potential side effects?
Since this trial focuses on implementing a guideline rather than a drug intervention, side effects are not typical as seen with medications. However, there may be indirect effects related to changes in care practices.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Appropriate use of opioids
Pain management in careplan
pain assessment completed
Secondary outcome measures
Pain in Alzheimer's Disease (PAIN-AD)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pain-CPG-EITExperimental Treatment1 Intervention
The four components of the PAIN-CPG-EIT are provided by a research nurse facilitator working with the champion(s) and stakeholder team. Following the first stakeholder team meeting, the research nurse facilitator works 8 hours weekly during months one and two and then for four hours weekly months three to 12 to implement: Component I: Stakeholder team meeting and goal setting; Component II: Education of the staff; Component III: Mentoring and motivating the staff to address pain using the Pain Management CPG ; and Component IV: Ongoing monitoring of pain management in the community based on the Pain Management CPG.
Group II: Pain-CPG-Education OnlyActive Control1 Intervention
Communities randomized to education only will be provided with staff education using our developed Powerpoint for Component II of the PAIN-CPG-EIT intervention in 30 minute sessions as is currently done in usual practice. They will also be given access to an online copy of the Pain Management CPG. The education will be provided in the preferred format (e.g., face-to-face; webinar).

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,356 Total Patients Enrolled
9 Trials studying Pain
1,699 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this experimental study?

"Affirmative. Details posted on clinicaltrials.gov demonstrate that this research project, initially published on December 4th 2023 is actively recruiting participants. 300 candidates are needed from one medical center."

Answered by AI

Does this research endeavor have an open enrollment period?

"Indeed, the data found on clinicaltrials.gov shows that this experiment is actively seeking applicants; it was first announced on December 4th 2023 and last revised on December 6th 2023. It requires 300 participants to come from one site."

Answered by AI

Is Pain-CPG-EIT a safe and reliable medical treatment for patients?

"With no evidence of efficacy, Pain-CPG-EIT's safety was given a ranking of 2 due to the limited data available from Phase 2 trials."

Answered by AI
~200 spots leftby Dec 2028