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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
650 mg pills
650 mg liquid
Primed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed.
Yale New Haven Hospital at St. Raphael's Campus
New Haven, Connecticut, United States
Participant enrollment rate
The percentage of participants that enroll
Time frame: 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
Time frame: 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)
Time frame: Study day 0, 1, 2 and 3
Mean daily acetaminophen consumption
Mean daily acetaminophen consumption in milligrams collected using the electronic medical record
Time frame: 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.
Time frame: 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
Time frame: 12 months
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