Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial
Phase: NA
Conditions: Musculoskeletal Pain
Sponsor: University of North Carolina, Chapel Hill

Patient Education to Improve Pain Management in Older Adults with 
Acute Musculoskeletal Pain: A Pilot Randomized Trial
Protocol
July 27, 2015 
NCT02438384

SCEENING / ED INTERVIEW 
Participant Selection: To identify potential participants for this trial, monitor the ED Track Board in EPIC 
to find patients likely to be experiencing musculoskeletal pain. Eligibility criteria are listed below. Consult 
with Dr. Platts-Mills if you are unsure about a patient’s potential eligibility. 
• 
50 years old or older 
• 
Chief Complaint of musculoskeletal pain 
• 
Can read and understand English 
• 
Has a home phone or cell phone 
• 
Score of ≥4 on Six Item Screener 
 
Screening: Print out PDF copies of both the Screener and ED Interview. The other two tools will be used 
later and are not printed. The screener outlines the eligibility criteria. The last section of the Screener 
asks for verbal consent from the patient for enrollment in the trial. Completion of this form will 
determine whether or not the patient is eligible for and consenting to enrollment. 
ED Interview: Ask all questions on tis questionnaire and then follow the steps listed to randomize 
patients to treatment groups. Provide the brief explanation listed for the selected treatment group and 
show the BETTER Video to all patients selected for either “Video only” or “Video + Follow-up” 
 
 
TABLET SETUP & USE 
Two HP Stream 8 tablets are designated for use in this study. These tablets run the Windows 8.1 OS 
including full desktop capabilities. Information on important identification numbers for each of these 
tablets is available in the document titled BETTER Tablet Info. The tablets have already been set up 
specifically for use in this project. 
Basic Setup: It is recommended that these tablets are setup with a local account rather than linked to 
someone’s Microsoft account. Initially, a local account should be created with the username: BETTER 
and the password: better 
1. Set the IE home page to UNC Better. Open the desktop and use Internet Explorer (IE) to navigate 
to https://media.med.unc.edu/emergmed/better/index.html Select the gear (options) icon in 
the top right corner and select “Internet Options.” Under the General tab, tap “Use current” and 
then “Apply” on the bottom of the options box to set the new home page.  
2. Create a desktop link to the BETTER site. Open IE and navigate to the UNC Better page (it should 
be the home page). Tap the gear icon in the top right corner and select “Add site to Apps.” Tap 
the home button (Windows logo) and you are taken back to the start screen. Swipe up to view 

all apps then press and hold the app labeled “UNC Better.” Select “Pin to Start” and this link will 
now be accessible from the start screen. 
3. Unpin all other apps from the start screen. Press and hold over any app to edit. Select all apps 
except UNC Better and then tap “Unpin from Start” in the bottom left corner. 
4. Put IE in full screen mode. From the UNC Better homepage, select the gear icon in the top right 
corner, tap File, and select Full screen. 
Advanced Features: Along with the basic features listed above, these tablets have been customized for 
use in the BETTER project. All backgrounds and lock screens have been set to an image pulled from the 
video. The desktop has been cleared of all icons other than a link to the video and the taskbar is hidden. 
This helps to ensure that patients and provides do not accidentally alter the basic setup listed above. 
Because this setup does not use the traditional desktop display, a battery meter app has been installed 
on the start page. Lastly, these tablets have been set to NOT receive automatic updates. While we 
appreciate Microsoft’s dedication to providing almost a constant stream of updates for its devices, these 
tablets only experience a very specific type of use and are not likely to benefit from the vast majority of 
system updates.  
Use:  
• 
Turning the tablet on: Press and hold the small button on the side of the device. 
• 
Turning the tablet off: You can either press and hold the small button on the side followed by 
swiping down, or swipe in from the right side of the screen, select “Settings,” then tap the 
Power icon and select Shut down. 
• 
Logging in: After turning the tablet on, swipe up to reveal the Login screen. If correctly setup on 
the BETTER local account, the password will be “better” 
• 
Connecting to Wi-Fi: To connect to a wireless network, swipe in from the right on any screen, 
select Settings, and then tap the Wi-Fi icon. You can select your network from here. “UNCH-
Guest” is recommended. 
• 
Volume control: The larger button on the side of the tablet is actually a two-way volume button.  
• 
Opening the better video: From either the start screen or the desktop, select the UNC BETTER 
icon and you will be taken to the video website. 
• 
Trouble shooting: All standard features (e.g. task manager, updates, system preferences) can be 
found with the search feature. To Search, swipe in from the right at any time and select 
“Search.” Have you tried turning it off and then back on? 
 
RANDOMIZATION 
Development of the Random Number Lists 
Stratification: The two variables that we are adjusting distribution for in the BETTER Trial are gender and 
age (dichotomized into 50-64 years and 65 years or older). Age was selected as the primary variable 

because of its association with short term knowledge gained from the video demonstrated in the 
BETTER video validation study. 
Block Randomization: In each of the two random number lists, random distributed blocks of three and 
six will are used to ensure that screeners will not be able to guess the next study participant group 
assignment while still maintaining a high degree of even group distribution. A computer program 
developed by Dr. Mark Weaver was used to randomly assign numbers one through three in an even 
distribution into each block. This program works by randomly permuting the two lists 1,2,3 and 
1,1,2,2,3,3 depending on the desired block size.  
For a better understanding of the purpose of block randomization and blinding in small studies, 
refer to pages 156-159 in Designing Clinical Research  
https://books.google.com/books?id=_7UWxJ5erSsC&q=157#v=snippet&q=157&f=false 
Random Number List: There are two random number lists used in this trial, one for each of the two age 
groups begin assessed. Each list is created 21 numbers at a time and any list can be made again 
following the complete allocation of a block of six numbers. 
Block Size Randomization: Blocks are randomized to contain either three or six numbers when each 
random number list (twenty-one numbers) is created.  
Assignment of treatment group in the field 
Master List The master list is actually two different random number lists, one for each strata of the 
distribution. These lists are randomized to block sizes and numbers are edited using the method 
described above to ensure equitable distribution. To keep the randomization process blinded, these lists 
should not be accessed by screeners who are actively enrolling patients.  
Envelopes: Two sets of folded sticky notes labeled  x01 through x21 are required for the blinded 
assignment of patients to treatment groups. Each card in one set is labeled “Younger” (101-121) 
corresponding to the 50-64 year old age group. Each card in the other set is labeled “Older” (201-221) 
corresponding to the 65 and older age group.  Inside each folded sticky note is the corresponding 
number from that set’s Random number list (i.e. envelope “Younger 101” has a piece of paper in if with 
the number that identifies the randomly assigned treatment arm for the first 50-64 year old enrolled in 
the study) 
Assignment: This method requires that the screener carries the box containing both number lists (sticky 
note sets) with them when enrolling participants. After a prospective participant is deemed eligible, 
consents to participation in the trial, and completes the ED Interview, the screener will pull out the set 
of folded sticky notes that corresponds to the participant’s age group. The next unopened sticky note in 
that category is opened and number of the treatment group found inside will determine which 
treatment group the participant will be assigned to. 

 Assignment – phone call alternative: This method requires a second research assistant that can be 
contacted by phone call. Following participant eligibility assessment, consent for participation in the 
trial, and the ED Interview, the screener calls the second research assistant to complete the randomized 
assignment. The person that is contacted by phone has the box containing both sets of sticky notes. 
Using the set that represents the participant’s age group, the person on the phone will open the next 
sticky note to reveal the number of the treatment group that the participant will be assigned to. The 
phone call alternative will be used exclusively when multiple research assistants are screening 
participants at the same time.  
 
RA FOLLOW-UP CALL 
Phone calls are made to patients in the “video + follow-up” and “follow-up only” treatment arms. These 
calls must be made between 48 and 72 hours from patient enrolment. Refer to the REDcap data 
collection instrument titled “Follow-Up Call” to see the scripted introduction and questions that need to 
be asked to each patient. Using the answers given, evaluation of whether or not the patient will receive 
a phone call from Dr. Platts-Mills is made before terminating the call. The result of this decision is 
explained to the patient and a time-frame is set up for Dr. Platts-Mills to call the patient is it is deemed 
necessary.  Before terminating the call, patients are asked about the status of any appointments that 
might have been scheduled with their primary care providers (PCP). 
Study Physician Call Assessment: Based on the answers given patients in the “video + follow-up” and 
“follow-up only” treatment arms will be designated one of three status options, referred to here as 
Clear, Requesting, or Automatic.  All patients assigned the “Clear” status meet the criteria answered 
“No” to all Assessment Survey questions and they either have no pain or they have pain in the 1-3 range 
but stated that they did not want to talk to a doctor when asked. Patients assigned the “Requested” 
status answered “No” to all Assessment Survey, have pain in the 1-3 range, and stated that they did 
what to talk to a doctor when asked. Patients assigned the “Automatic” status either had pain ≥4 and/or 
answered “Yes” to any of the survey questions (not include PCP appointment questions). Flow chart 
shown below. 
 
 

 
 
 
 
 
 
 
 
 
What is the patient’s pain 
score? 
0 
1-3 
≥4 
Yes 
Does this patient want a call 
from the study physician? 
Is this patient experiencing 
pain that is preventing them 
from doing activities that are 
important to them? 
This patient does not need a 
phone call based on their pain 
score. Move on to next 
section. 
Yes 
Is this patient experiencing 
side effects from pain 
medication? 
Is this patient experiencing 
pain that is affecting their 
sleep? 
Yes 
Yes 
This patient will require a call 
from the study physician 
No 
This patient will require a call 
from the study physician 
This patient will require a call 
from the study physician 
This patient will require a call 
from the study physician 

STUDY PHYSICIAN CALL 
If a patient assessed during the RA follow up call is designated to receive a call from the study physician, 
this call will be made either the same day as the RA call or the next day. This assures that the study 
physician call always happens within 4 days of the original ER visit. Ideally, the study physician call 
should be made using REDCap because of the information that is auto-filled from the RA call. The 
patient intervention flow chart for the study physician call is listed below. 
The following protocol applies for patients in treatment arms “video + follow-up” and “follow-up only” 
who were assigned either the requested or automatic designation after RA follow-up call. Patients 
assigned the “Requested” status answered “No” to all Assessment Survey, have pain in the 1-3 range, 
and stated that they did what to talk to a doctor when asked. Patients assigned the “Automatic” status 
either had pain ≥4 and/or answered “Yes” to any of the survey questions (not include PCP appointment 
questions). Flow chart shown below. 
 
 
 
 
 
  
 
 
 
What pain medication is this 
patient taking? 
NSAID only 
Recommend acetaminophen 650mg TID (BID if the patient has liver disease). 
Both acetaminophen 
and an NSAID. 
Opioid 
• Review opioid side effects.  
• If patient is tolerating their medication, ensure that patient is taking 
maximum prescribed dose of opioid. 
• Add acetaminophen 650mg TID (BID if the patient has liver disease) unless 
the patient is taking a combined opioid/acetaminophen. 
• If patient is on max dose and still in pain, have them follow-up with PMD.  
• If under-dosed, recommend acetaminophen 650mg TID (BID if the patient 
has liver disease).  
• If adequate dose and no contraindications to NSAIDs (i.e. stomach ulcers, 
chronic renal disease, CHF, or on hypertension medication) recommend 
Naproxen 220mg BID for 5 days. 
• If adequate dose and NSAID contraindications, recommend PMD 
appointment for opioid prescription. 
Acetaminophen only 
None 
• Review NSAID dosing and continue if no side effects and not contraindicated. 
• Recommend acetaminophen 650mg TID (BID if the patient has liver disease). 
• Review NSAID dosing and continue if no side effects and not contraindicated. 
• If under-dosed, recommend acetaminophen 650mg TID (BID if the patient has 
liver disease). 
• If adequate dose, recommend PMD appointment for opioid prescription. 

 
 
 
ONE MONTH EVALUATION 
This evaluations requires an RA phone call and should be filled out in REDCap.  
 
REDCap Analysis 
Codes: In order to streamline the data analysis process, a series of rules was applied in the coding of 
answers choices in all redcap forms that will be analyzed. These codes are listed below. 
x 
This value is designated to answers that reflect that the question is Not Applicable. For 
example, the choice “No Prescription” for the question “Did you fill your prescription?” 
0 
This value is primarily designated to all minimum value answers (eg. No, None, Not at all, etc.) 
If used in a checkbox question, this value represents “Other” 
1 
If the question is yesno, then this value represents “Yes” 
If the question is a series, this number represents the next lowest value after “None”  
If the question is in a checklist or multiple choice, this value represents the first (top) choice 
2-n 
All other values are used for multiple choice questions and are listed numerically from top to 
bottom 
 
 
 
 
 
 
Recommend follow up with primary care provider or UNC clinic 
for all patients not experiencing adequate pain relief. 
 
UNC Family Medicine: 919-966-0210 
UNC Internal Medicine: 919-966-1459 
UNC Geriatrics: 919-957-6599 
UNC SCHC: 919-843-6841