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A Mobile Application for Post-op Analgesic Consumption

Primary Purpose

Tooth Extraction Status Nos, Post Operative Pain, Patient Satisfaction

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile app
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tooth Extraction Status Nos focused on measuring Oral surgery, Medication adherence

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between the age of 18-40 years
  • Patients who require two mandibular third molars extracted
  • Patients with a smartphone

Exclusion Criteria:

  • Patients taking any recreational drugs and medications for chronic pain

Sites / Locations

  • Boston University Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile app group

Control group

Arm Description

In addition to receiving standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions a customized mobile app will be downloaded to the participant's smartphone to application to monitor postoperative analgesic consumption, disposal and pain control and patient satisfaction for one week after surgery.

The control group will receive the standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions and a case report form will be used to gather data from the medical record and from a post op telephone survey a week after surgery..

Outcomes

Primary Outcome Measures

Assessment of quantity of postop analgesic (narcotic and non narcotic) medications used.
Each patient will be given 18-24 tablets the prescription: 1. Acetaminophen with 5mg oxycodone 2. Acetaminophen with 5mg hydrocodone 3. Acetaminophen with 30 mg codine and asked to report each time they take a tablet via the app in the experimental group while the control group will answer the question how many tablets do you have remaining as part of the post survey at the end of 1 week.
Assessment of change in Postoperative pain control
The Short Form McGill Pain Questionnaire (SF-MPQ) will be used to assess post-op pain control. It consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. Lower scores are associated with less pain..

Secondary Outcome Measures

Satisfaction with the education received regarding the prescribed medications.
Assessment of patient satisfaction using a survey. For the subjects in the experimental group, they will be asked to complete a emoticon survey on the app which would correspond to the following descriptions: Excellent=4, good=3, average=2, poor=1.The subjects in the control group will be asked the same question as part of the post satisfaction survey without the emoticons as a sentence question. A lower score indicates low satisfaction.
Use of the analgesic and post-op care education links on the mobile app.
Educational links will be available to view as part of the app and usage will be monitored by website traffic. Higher numbers would indicate greater usage of educational links.

Full Information

First Posted
June 21, 2017
Last Updated
October 6, 2019
Sponsor
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT03197311
Brief Title
A Mobile Application for Post-op Analgesic Consumption
Official Title
A Mobile Application to Monitor Patient's Analgesic Consumption After Minor Oral Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to obtain funding for this research.
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Surgical extraction of third molars is one of the most common outpatient procedures performed by oral surgeons. The prescription of postoperative narcotic and NSAID analgesics is the standard of care practice to relieve symptoms of pain, swelling, and trismus after these procedures. The majority of these patients do not return for follow up unless they experience a problem. There is limited data on whether the patients use the narcotics as directed and what is their practice of disposal of the remaining medications that were not consumed. In this research the effectiveness of postop analgesic consumption, analgesic disposal practice, pain control, and patient satisfaction will be compared between patients who are randomized to the intervention group who will use a developed mobile application and a control group who will not use the mobile app.
Detailed Description
A pilot randomized clinical trial will be conducted to determine if use of a mobile application improves adherence to narcotic analgesic use and their disposal and patient satisfaction post-surgical extraction of third molars in an outpatient setting. Eligible consented subjects will be randomized into either the mobile app group or the control group. Both groups will receive standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions.For the mobile group, the Medable Axon Software developed by Stanford University will be used to customize a mobile application that will be used one week post surgery to monitor postoperative analgesic consumption and disposal practices, pain control, and patient satisfaction, In the control group, case report forms will be used to gather data from the electronic medical records and a telephone survey will be done one week post surgery to obtain data on patient satisfaction. A total of 20 consecutive eligible patients will be enrolled in this pilot trial..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Extraction Status Nos, Post Operative Pain, Patient Satisfaction, Narcotic Use, Mobile App
Keywords
Oral surgery, Medication adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile app group
Arm Type
Experimental
Arm Description
In addition to receiving standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions a customized mobile app will be downloaded to the participant's smartphone to application to monitor postoperative analgesic consumption, disposal and pain control and patient satisfaction for one week after surgery.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive the standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions and a case report form will be used to gather data from the medical record and from a post op telephone survey a week after surgery..
Intervention Type
Other
Intervention Name(s)
Mobile app
Intervention Description
A customized mobile application will be developed and downloaded to subjects; smartphones to monitor postoperative analgesic consumption, and disposal; pain control and patient satisfaction. The mobile app will provide notifications for medications and select education links on the prescribed analgesics. Subjects will receive reminders to take medications as directed. Subjects will be able to monitor and report their pain during the first week after surgery.
Primary Outcome Measure Information:
Title
Assessment of quantity of postop analgesic (narcotic and non narcotic) medications used.
Description
Each patient will be given 18-24 tablets the prescription: 1. Acetaminophen with 5mg oxycodone 2. Acetaminophen with 5mg hydrocodone 3. Acetaminophen with 30 mg codine and asked to report each time they take a tablet via the app in the experimental group while the control group will answer the question how many tablets do you have remaining as part of the post survey at the end of 1 week.
Time Frame
At the end of 7 days
Title
Assessment of change in Postoperative pain control
Description
The Short Form McGill Pain Questionnaire (SF-MPQ) will be used to assess post-op pain control. It consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. Lower scores are associated with less pain..
Time Frame
Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
Secondary Outcome Measure Information:
Title
Satisfaction with the education received regarding the prescribed medications.
Description
Assessment of patient satisfaction using a survey. For the subjects in the experimental group, they will be asked to complete a emoticon survey on the app which would correspond to the following descriptions: Excellent=4, good=3, average=2, poor=1.The subjects in the control group will be asked the same question as part of the post satisfaction survey without the emoticons as a sentence question. A lower score indicates low satisfaction.
Time Frame
Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
Title
Use of the analgesic and post-op care education links on the mobile app.
Description
Educational links will be available to view as part of the app and usage will be monitored by website traffic. Higher numbers would indicate greater usage of educational links.
Time Frame
Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between the age of 18-40 years Patients who require two mandibular third molars extracted Patients with a smartphone Exclusion Criteria: Patients taking any recreational drugs and medications for chronic pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radhika Chigurupati, DMD, MS
Organizational Affiliation
Boston University Medical Campus
Official's Role
Study Director
Facility Information:
Facility Name
Boston University Medical Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Mobile Application for Post-op Analgesic Consumption

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