Pain Management Guideline for Dementia in Nursing Homes
This study aims to evaluate the appropriate use of opioids and completion of pain assessments in developing effective pain management guidelines for dementia patients in nursing homes.
Pain-CPG-EIT
+ Pain-CPG-Education Only
Mental Disorders+7
+ Brain Diseases
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: December 1, 2023
Actual date on which the first participant was enrolled.This clinical trial is focused on improving how pain is assessed, diagnosed, and managed in older adults with dementia living in nursing homes. Many residents with dementia experience pain that is not properly identified or treated, often because staff may lack the necessary knowledge or resources. This can lead to untreated or over-treated pain, which can severely affect the residents' quality of life. The study aims to implement a new Pain Management Clinical Practice Guideline (Pain CPG) to ensure better care for these residents. By doing so, the study seeks to address the disparities in pain management based on sex, race, and ethnicity, and improve overall treatment outcomes. Participants in the study will be nursing home residents with dementia and pain, and they will be part of communities that are randomly assigned to either receive the new Pain Management CPG approach (PAIN-CPG-EIT) or standard education. A research nurse facilitator will work closely with community champions and a stakeholder team over 12 months to implement the guideline. The study will measure how effectively the guideline improves pain assessment and management, the appropriate use of opioids, and the inclusion of pain management plans in care plans. It will also evaluate how consistently the guideline is implemented and whether there are differences in pain treatment and outcomes based on gender and race. This study hopes to demonstrate that using the Pain Management CPG can lead to better pain care for older adults with dementia.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Living in a participating community * 60 years of age or older * Evidence of dementia based on a score of 0-12 on the Brief Interview of Mental Status (BIMS); a score of \>2 on the AD8 Dementia Screening Interview; a score of 0.5 to 2.0 on the Clinical Dementia Rating Scale (CDR); and lastly to differentiate between dementia and mild cognitive impairment a score of 9 or greater on the Functional Activities Questionnaire (FAQ). * have evidence of pain at the time of recruitment based on the Minimum Data set assessment item: How much of the time over the past 5 days have you experienced pain or hurting with eligibility based on the following responses or evidence: occasionally, frequently or almost constantly, or staff report of pain at the same frequency; or if the resident is receiving nonpharmacological or pharmacological treatment for pain. Exclusion Criteria: * admitted to the nursing home for short-stay rehabilitation or other subacute needs (e.g., intravenous antibiotics); * receiving Hospice care.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Future Care Coldspring
Baltimore, United StatesFuture Care Courtland
Baltimore, United StatesFuturecare Northpoint
Baltimore, United States