Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period

Study Overview
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Brief Summary
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Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with substantial morbidity within the hospital and beyond. Particular patient populations are at high risk for poor outcomes after an episode of delirium. Patients with hip and other long bone fractures are at increased risk of developing delirium (acute confusion) which impedes functional recovery. This is a pilot study to test the tolerability and efficacy of donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for the prevention of new or worsening delirium in aged hip and other long-bone fracture patients. Additional purposes involve gathering a small amount of patients' serum to better understand the pathophysiology of delirium in this population. The purposes of this pilot study are to determine: 1) the safety and tolerability a cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To obtain estimates of subject accrual and preliminary estimates of effect size on the development of new delirium symptoms to allow for planning of a larger, definitive trial, 3) To better understand the underlying causes of delirium by examining whether a measure of blood anticholinergic activity relates to the incidence and persistence of delirium symptoms, and 4) To explore the interaction between anticholinergic activity, donepezil therapy, and delirium symptoms.

Official Title
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Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period

Conditions
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Delirium

Intervention / Treatment
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* Drug: donepezil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hip or other long bone fracture undergoing operative repair age of 70 years or older the ability to communicate effectively in English (including adequate hearing) residence within a 50 mile radius of the BIDMC life expectancy 6 months or greater not currently on cholinesterase inhibitor therapy not with known hypersensitivity to cholinesterase inhibitors not a previous study participant or refusal Exclusion Criteria: patients with sick sinus syndrome or greater than 1st degree AV block without a pacemaker patients with a pathologic fracture due to metastatic cancer patients with advanced dementia or total functional dependence.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: donepezil<br>* 5 mg each day for 30 days<br>* Other names: Aricept;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Encapsulated cornstarch One capsule daily for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Delirium Using the CAM Over Time | Confusion Assessment Method (CAM)-Measure of the presence or absence of delirium. Requires 1) acute change with fluctuating course, 2) inattention, and either 3) disorganized thinking or 4) altered level of consciousness. | Baseline, hospital interviews, weeks 2, 4 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline and MDAS Scores Over Time | Measures severity of 10 delirium symptoms items (0 not present, 1 mild, 2 moderate, 3 severe) yielding a total score of 0 to 30, with 30 most severe. | Baseline, hospital discharge, weeks 2, 4 and 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Postoperative confusion, Hip fracture, Long bone fracture