Trial Outcomes & Findings for Efficiency And Quality In Post-Surgical Pain Therapy After Discharge (NCT NCT05221866)
NCT ID: NCT05221866
Last Updated: 2025-07-01
Results Overview
Opioids reported as taken will be recorded by type of opioid, units, and total amount taken within the first 28 days after hospital discharge. To account for different opioid potencies, the cumulative dose of opioids will be expressed in milligram morphine equivalents (MME).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
711 participants
Primary outcome timeframe
Baseline (discharge), weekly for four weeks
Results posted on
2025-07-01
Participant Flow
Participants were recruited from May 2, 2022 to December 10, 2023. Participants were enrolled in the hospital setting.
Participant milestones
| Measure |
UControlPain App With Only Data Collection
UControlPain App with only data collection function. No provider-facing tool.
|
UControlPain Educational App
UControlPain app with education components. No provider-facing tool.
|
UControlPain App and Provider Facing Tool
UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023).
|
UControlPain App With Only Data Collection and Provider Facing Tool
UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
179
|
179
|
176
|
177
|
|
Overall Study
COMPLETED
|
152
|
148
|
155
|
151
|
|
Overall Study
NOT COMPLETED
|
27
|
31
|
21
|
26
|
Reasons for withdrawal
| Measure |
UControlPain App With Only Data Collection
UControlPain App with only data collection function. No provider-facing tool.
|
UControlPain Educational App
UControlPain app with education components. No provider-facing tool.
|
UControlPain App and Provider Facing Tool
UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023).
|
UControlPain App With Only Data Collection and Provider Facing Tool
UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023).
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
6
|
4
|
|
Overall Study
Physician Decision
|
3
|
2
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
12
|
17
|
14
|
14
|
|
Overall Study
Discharge plan revised; app compatibility issue or chronic opioid use discovered post-enrollment.
|
7
|
5
|
0
|
4
|
Baseline Characteristics
Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
Baseline characteristics by cohort
| Measure |
UControlPain App With Only Data Collection Function
n=179 Participants
UControlPain App with only data collection function. No provider-facing tool.
|
UControlPain Educational App Only
n=179 Participants
UControl Pain App with education components only. No provider-facing tool.
|
UControlPain App and Provider Facing Tool
n=176 Participants
UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023).
|
UControlPain App With Only Data Collection and Provider Facing Tool
n=177 Participants
UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023).
|
Total
n=711 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
154 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
595 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
455 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
256 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
170 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
673 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
154 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
605 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
179 participants
n=5 Participants
|
179 participants
n=7 Participants
|
176 participants
n=5 Participants
|
177 participants
n=4 Participants
|
711 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (discharge), weekly for four weeksPopulation: Participants who completed at least one week of surveys were included in the analysis.
Opioids reported as taken will be recorded by type of opioid, units, and total amount taken within the first 28 days after hospital discharge. To account for different opioid potencies, the cumulative dose of opioids will be expressed in milligram morphine equivalents (MME).
Outcome measures
| Measure |
UControlPain Educational App
n=148 Participants
UControl Pain App with education components only. No provider-facing tool.
|
UControlPain App With Only Data Collection
n=152 Participants
UControlPain App with only data collection function. No provider-facing tool.
|
UControlPain App and Provider Facing Tool
n=155 Participants
UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023).
|
UControlPain App With Only Data Collection and Provider Facing Tool
n=151 Participants
UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023).
|
|---|---|---|---|---|
|
Cumulative Weekly Opioid Intake After Discharge
|
30 Morphine milligram equivalents
Interval 0.0 to 105.0
|
30 Morphine milligram equivalents
Interval 0.0 to 76.9
|
20 Morphine milligram equivalents
Interval 0.0 to 90.0
|
10 Morphine milligram equivalents
Interval 0.0 to 81.8
|
SECONDARY outcome
Timeframe: Weekly for four weeks after dischargePopulation: Subjects who completed at least one week of surveys were included in the analysis.
The Patient-Reported Outcomes Measurement Information System (PROMIS) was used to measure pain intensity, with higher scores indicating more intense pain. The PROMIS was assessed four times after discharge, once per week for 28 days, and averaged. On the PROMIS 4-item scale pain intensity scores, higher scores indicate higher pain intensity. All PROMIS scores are analyzed as standardized T-scores \[mean=50, standard deviation (SD) =10\].
Outcome measures
| Measure |
UControlPain Educational App
n=148 Participants
UControl Pain App with education components only. No provider-facing tool.
|
UControlPain App With Only Data Collection
n=152 Participants
UControlPain App with only data collection function. No provider-facing tool.
|
UControlPain App and Provider Facing Tool
n=155 Participants
UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023).
|
UControlPain App With Only Data Collection and Provider Facing Tool
n=151 Participants
UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023).
|
|---|---|---|---|---|
|
Pain Assessment-Pain Intensity
|
52.5 T-score
Standard Deviation 9.89
|
51.24 T-score
Standard Deviation 9.37
|
52.51 T-score
Standard Deviation 9.48
|
51.29 T-score
Standard Deviation 9.06
|
SECONDARY outcome
Timeframe: Weekly for four weeks after dischargePopulation: Subjects who completed at least one week of surveys were included in the analysis.
The Patient-Reported Outcomes Measurement Information System (PROMIS) was used to measure pain interference, with higher scores indicating more intense pain. The PROMIS was assessed four times after discharge, once per week for 28 days, and averaged. On the PROMIS 4-item scale pain interference scores, higher scores indicate higher pain interference. All PROMIS scores are analyzed as standardized T-scores \[mean=50, standard deviation (SD) =10\].
Outcome measures
| Measure |
UControlPain Educational App
n=148 Participants
UControl Pain App with education components only. No provider-facing tool.
|
UControlPain App With Only Data Collection
n=152 Participants
UControlPain App with only data collection function. No provider-facing tool.
|
UControlPain App and Provider Facing Tool
n=155 Participants
UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023).
|
UControlPain App With Only Data Collection and Provider Facing Tool
n=151 Participants
UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023).
|
|---|---|---|---|---|
|
Pain Assessment-Pain Interference
|
55.28 T-score
Standard Deviation 9.79
|
54.17 T-score
Standard Deviation 9.95
|
55.13 T-score
Standard Deviation 9.34
|
53.43 T-score
Standard Deviation 9.62
|
SECONDARY outcome
Timeframe: Baseline (discharge)Population: Subjects who completed at least one week of surveys were included in the analysis.
Opioids prescribed on the day of discharge will be recorded by type of opioid, unit dispensed, and total amount dispensed. To account for different opioid potencies, the cumulative dose of opioids will be expressed in milligram morphine equivalents (MME).
Outcome measures
| Measure |
UControlPain Educational App
n=148 Participants
UControl Pain App with education components only. No provider-facing tool.
|
UControlPain App With Only Data Collection
n=152 Participants
UControlPain App with only data collection function. No provider-facing tool.
|
UControlPain App and Provider Facing Tool
n=155 Participants
UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023).
|
UControlPain App With Only Data Collection and Provider Facing Tool
n=151 Participants
UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023).
|
|---|---|---|---|---|
|
Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge
|
90 Morphine milligram equivalents
Interval 60.0 to 150.0
|
77.5 Morphine milligram equivalents
Interval 60.0 to 157.5
|
75.0 Morphine milligram equivalents
Interval 56.2 to 150.0
|
75.0 Morphine milligram equivalents
Interval 40.0 to 150.0
|
SECONDARY outcome
Timeframe: Baseline (discharge) +1 day until day 28, up to 27 days totalPopulation: Subjects who completed at least one week of surveys were included in the data analysis.
Discovered by medical record review. This measure will account for opioids prescribed to patients because they run out prematurely. We will calculate opioid prescriptions from "day of discharge +1" until 28 days after discharge.
Outcome measures
| Measure |
UControlPain Educational App
n=148 Participants
UControl Pain App with education components only. No provider-facing tool.
|
UControlPain App With Only Data Collection
n=152 Participants
UControlPain App with only data collection function. No provider-facing tool.
|
UControlPain App and Provider Facing Tool
n=155 Participants
UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023).
|
UControlPain App With Only Data Collection and Provider Facing Tool
n=151 Participants
UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023).
|
|---|---|---|---|---|
|
Number of Participants With Opioids Prescribed From "Day of Discharge + 1" Until 28 Days After Discharge
|
23 Participants
|
21 Participants
|
31 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline (discharge), weekly for four weeksPopulation: Participants who answered they had opioids left over were included in this analysis.
Number of participants who reported their disposal of any leftover opioids is recorded. This is reported on the weekly surveys done in 28 days post-discharge.
Outcome measures
| Measure |
UControlPain Educational App
n=148 Participants
UControl Pain App with education components only. No provider-facing tool.
|
UControlPain App With Only Data Collection
n=152 Participants
UControlPain App with only data collection function. No provider-facing tool.
|
UControlPain App and Provider Facing Tool
n=155 Participants
UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023).
|
UControlPain App With Only Data Collection and Provider Facing Tool
n=151 Participants
UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023).
|
|---|---|---|---|---|
|
Number of Participants Who Disposed of Opioids
|
3 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
Adverse Events
UControl Pain App Educational App
Serious events: 11 serious events
Other events: 2 other events
Deaths: 0 deaths
UControlPain App With Only Data Collection
Serious events: 12 serious events
Other events: 1 other events
Deaths: 1 deaths
UControlPain App and Provider Facing Tool
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
UControlPain App With Only Data Collection and Provider Facing Tool
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UControl Pain App Educational App
n=148 participants at risk
UControl Pain App with education components. No provider-facing tool.
|
UControlPain App With Only Data Collection
n=152 participants at risk
Control UControl Pain App with data collection only. No provider-facing tool.
|
UControlPain App and Provider Facing Tool
n=155 participants at risk
UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023).
|
UControlPain App With Only Data Collection and Provider Facing Tool
n=151 participants at risk
UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023).
|
|---|---|---|---|---|
|
Surgical and medical procedures
Re-hospitalization (any reason)
|
7.4%
11/148 • Number of events 11 • Adverse event data was collected from Discharge to Day 28.
1. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. 2. Serious Adverse Events: all anticipated and unanticipated serious adverse events, including only inpatient hospitalization 3. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events
|
7.9%
12/152 • Number of events 12 • Adverse event data was collected from Discharge to Day 28.
1. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. 2. Serious Adverse Events: all anticipated and unanticipated serious adverse events, including only inpatient hospitalization 3. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events
|
5.2%
8/155 • Number of events 8 • Adverse event data was collected from Discharge to Day 28.
1. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. 2. Serious Adverse Events: all anticipated and unanticipated serious adverse events, including only inpatient hospitalization 3. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events
|
7.3%
11/151 • Number of events 11 • Adverse event data was collected from Discharge to Day 28.
1. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. 2. Serious Adverse Events: all anticipated and unanticipated serious adverse events, including only inpatient hospitalization 3. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events
|
Other adverse events
| Measure |
UControl Pain App Educational App
n=148 participants at risk
UControl Pain App with education components. No provider-facing tool.
|
UControlPain App With Only Data Collection
n=152 participants at risk
Control UControl Pain App with data collection only. No provider-facing tool.
|
UControlPain App and Provider Facing Tool
n=155 participants at risk
UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023).
|
UControlPain App With Only Data Collection and Provider Facing Tool
n=151 participants at risk
UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023).
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Requiring greater than 2 additional opioid prescriptions within 2 weeks of discharge
|
1.4%
2/148 • Number of events 2 • Adverse event data was collected from Discharge to Day 28.
1. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. 2. Serious Adverse Events: all anticipated and unanticipated serious adverse events, including only inpatient hospitalization 3. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events
|
0.66%
1/152 • Number of events 1 • Adverse event data was collected from Discharge to Day 28.
1. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. 2. Serious Adverse Events: all anticipated and unanticipated serious adverse events, including only inpatient hospitalization 3. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events
|
0.00%
0/155 • Adverse event data was collected from Discharge to Day 28.
1. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. 2. Serious Adverse Events: all anticipated and unanticipated serious adverse events, including only inpatient hospitalization 3. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events
|
0.00%
0/151 • Adverse event data was collected from Discharge to Day 28.
1. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. 2. Serious Adverse Events: all anticipated and unanticipated serious adverse events, including only inpatient hospitalization 3. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place