Trial Outcomes & Findings for Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication. (NCT NCT01770314)

Results Overview

Responses are measured on a 4-point Likert scale (1= "Not at all confident" and 4= "Extremely confident"). The total Score range:8=least confident, 32=most confident. How confident do you feel in your ability to do each of the following activities, today? 1. I can recognize side effects that are related to my opioid medicine. 2. I can avoid giving my opioid medicine to someone else. Etc.. 1 - Not at all confident 2 - Somewhat confident 3 - Very confident 4 - Extremely confident Items have been generated from literature. Content validity: assessed by asking two experts if items are important and relevant. Internal consistency of the items in the pilot measure will be assessed (Cronbach's alpha). Test-retest reliability will be explored by asking 50 participants in the control group to retake the pilot measure within 3-5 days of having taken the measure as part of the pretest.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

176 participants

Primary outcome timeframe

Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention

Results posted on

2014-05-19

Participant Flow

Participants were recruited via an online advertisement as well as through posters

Participant milestones

Participant milestones
Measure	Control The control group was a waitlist control. Participants were given access to the experimental intervention program after the intervention period and follow up assessments were completed.	Experimental Participants were given instructions via email to review eleven online lessons about opioid medication safety. Instructions suggested that participants view one lesson per day for eleven consecutive days. Each educational lesson focused on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
Overall Study STARTED	86	90
Overall Study Contributed Data to Baseline	68	72
Overall Study Contributed Data to Post-test	65	67
Overall Study Contributed Data to One-month Follow-up	61	66
Overall Study COMPLETED	86	90
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=90 Participants Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.	Control n=86 Participants The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.	Total n=176 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	83 Participants n=5 Participants	85 Participants n=7 Participants	168 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	47 years STANDARD_DEVIATION 11.8 • n=5 Participants	45 years STANDARD_DEVIATION 10.5 • n=7 Participants	46 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	55 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Region of Enrollment United States	90 participants n=5 Participants	86 participants n=7 Participants	176 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention

Responses are measured on a 4-point Likert scale (1= "Not at all confident" and 4= "Extremely confident"). The total Score range:8=least confident, 32=most confident. How confident do you feel in your ability to do each of the following activities, today? 1. I can recognize side effects that are related to my opioid medicine. 2. I can avoid giving my opioid medicine to someone else. Etc.. 1 - Not at all confident 2 - Somewhat confident 3 - Very confident 4 - Extremely confident Items have been generated from literature. Content validity: assessed by asking two experts if items are important and relevant. Internal consistency of the items in the pilot measure will be assessed (Cronbach's alpha). Test-retest reliability will be explored by asking 50 participants in the control group to retake the pilot measure within 3-5 days of having taken the measure as part of the pretest.

Outcome measures

Outcome measures
Measure	Experimental n=90 Participants Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.	Control n=86 Participants The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications Baseline Least Square Means (n=72, 68)	28.1081 units on a scale Standard Error 0.5412	27.0563 units on a scale Standard Error 0.5525
Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications Post-test Least Square Means (n=67,65)	29.7143 units on a scale Standard Error 0.4222	28.3224 units on a scale Standard Error 0.4254
Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications One-month follow-up Least Square Means (n=66,61)	30.2064 units on a scale Standard Error 0.4246	28.5664 units on a scale Standard Error 0.4352

SECONDARY outcome

Timeframe: One-month followup assessment

Population: We only analyzed satisfaction data for experimental participants who had indicated that they disposed of their unused opioid medications (n=17)

We tested and analyzed participants' satisfaction with the program by asking the question: "Overall, how satisfied were you with the lessons." They answered on a 4 point Likert scale: 1=Not at all satisfied, 2=Somewhat Satisfied, 3=Satisfied, 4 = Very satisfied. Higher values indicate higher satisfaction.

Outcome measures

Outcome measures
Measure	Experimental n=17 Participants Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.	Control The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
Satisfaction With the Program	3.6470588 units on a scale Standard Deviation 0.6063391	—

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emil Chiauzzi

Inflexxion

Phone: 617-614-0429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place