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This is a proof of concept pilot study investigating the feasibility and acceptability of patient controlled oral medication administration, using the commonly used and low risk medication in the hospital, oral acetaminophen.
The primary objective of this prospective pilot study is to determine the feasibility of patient-controlled administration of liquid oral acetaminophen using recruitment rate and adherence to the study protocol rate as surrogate markers. Investigators hypothesize that patients will accept the new concept of self-controlled oral administration of liquid acetaminophen, with more than 50% patient enrollment rate and less than 20% withdrawal rate from the study group to the traditional nurse-administered acetaminophen pills.
The secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration.
If the medication is spilled or otherwise not dispensed correctly, the patients will be instructed to report this instantly to the nurse. The nurse will document and provide a replacement.
All study participants have the option to call the nurse for assistance with break through pain. In addition, there is a call button to call for help with any other needs or discomfort.
All other medications, such as NSAIDs or oral opioids, will be administered as prescribed.
Participants will have to fill out a paper questionnaire and keep a pain diary, and nurses will have to fill out a questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse Administered Acetaminophen | Active Comparator | Participants will receive acetaminophen pills 650 mg every 4 hours as needed (PRN) administered by nurse per standard of care |
|
| CADD pump Administered Acetaminophen (Participant Controlled) | Experimental | Participants will receive a CADD pump primed and programmed to deliver 650 mg liquid acetaminophen into a medication cup every 4 hours as needed (PRN). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen 650 mg Oral Tablet | Drug | 650 mg pills |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant enrollment rate | The percentage of participants that enroll | up to 12 months |
| Participant adherence to the study protocol | Percentage of participants that withdraw from treatment group, i.e. switch from patient controlled liquid group to the nurse-administered pill control group | up to 12 months |
| Nurse Questionnaire | Nurse ranking of patient controlled liquid oral acetaminophen vs. nurse-administered pill acetaminophen. (Mean score, Total Scale of 0-10: 0: much worse; 5:same; 10: much better) | Study day 0, 1, 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean daily acetaminophen consumption | Mean daily acetaminophen consumption in milligrams collected using the electronic medical record | 12 months |
| Mean Pain score | Participants will be asked via Pain Diary to rate their pain using numeric pain scores from 0 to 10, 0 as no pain, 10 is the worst possible. |
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Inclusion Criteria:
Participants
Nurses
Exclusion Criteria:
Participants
Nurses
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinlei Li, MD, PhD | Contact | 475-434-4038 | jinlei.li@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jinlei Li, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital at St. Raphael's Campus | Recruiting | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D013607 | Tablets |
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty at Yale New Haven Hospital at St. Raphael's Campus.
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| Acetaminophen 650mg Liquid | Drug | 650 mg liquid |
|
|
| CADD pump | Device | Primed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed. |
|
| 12 months |
| Mean time to medication delivery | Medication delivery: Mean time in minutes from the time when pain medication requested by the participant to the time pain medication is delivered | 12 months |
| D010335 | Pathologic Processes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |