Opioid Dependence, Opioid Misuse, Opioid Use, Post-Surgical Complication
Conditions
Brief summary
Following inpatient surgery, more than 80% of patients are prescribed opioids for use after discharge, yet up to 90% of patients report leftover opioids, and only 16% maximize non-opioid therapy. The proposed study seeks to test a provider-facing decision support tool and a participant-facing smartphone app to reduce the amount of opioids prescribed and taken following discharge, while ensuring effective treatment of pain after surgery. Adult participants with smart phones having had inpatient surgery requiring at least over-night hospitalization with anticipated discharge to home will be randomized to one of the two groups. Study measurements will include self-reported cumulative amounts of opioids taken after discharge, non-opioid analgesic taken, prescribed post-discharge opioid doses in morphine milligram equivalents (MME), pain intensity and pain interference scores (PROMIS), need for additional opioid prescriptions within one-month post-discharge, as well as any self-reported disposal of leftover medications.
Detailed description
Prior to discharge from the hospital, patients will be approached regarding interest in the study with an introductory letter that describes the content and purpose of the study. Following informed consent, participants will be randomized to receive the consumer health informatics app (UControlPain) versus provision of an app with only data collection function (no educational components). Randomization will be implemented via REDCap by the study coordinators. Further, information on which type of app was installed will not be shared with providers or participants. During the second half of the trial, a provider-facing electronic decision support tool will be activated. This will create a 2:2 design to test the provider-facing tool. Four arms will be described: the UControlPain App with Only data collection, the UControlPain Educational app only, the UControlPain App and provider-facing tool, and the UControlPain App with only data collection function and provider-facing tool. Once half of the subjects are enrolled, the provider-facing tool will be turned on.
Interventions
BEHAVIORALEmpowering Patient to Steer Their Pain Management After Surgery
Participants will be randomized to receive the consumer health informatics app (UControlPain) versus an app with only data collection function (no educational components) in an intent-to-treat design. Randomization will be implemented via REDCap by the study coordinators so that all investigators will remain blind to group assignment. Further, information on which type of app was installed will not be shared with providers or participants.
BEHAVIORALProvider-facing Prescription Aid
Providers will be given information to inform a participant-centered post-discharge pain management plan. This tool will be activated once half the subjects are enrolled. Participants will be masked when the provider-facing tool is turned on.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Randomization to the participant facing app will be implemented via REDCap. There will be no randomization in regard to the provider-facing intervention.The provider-facing intervention will be turned on once half the subjects are enrolled.
Intervention model description
The participant-facing app will be trialed prior to and after implementation of a provider-facing prescription intervention using a 2x2 design. Four arms will be described: the UControlPain App with Only data collection, the UControlPain Educational app only, the UControlPain App and provider-facing tool, and the UControlPain App with only data collection function and provider-facing tool. Once half of the subjects are enrolled, the provider-facing tool will be turned on.
Eligibility
Sex/Gender
ALL
Age
19 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* 19-89 years old * Access to a smartphone (iOS or Android) * Inpatient surgery requiring at least over-night hospitalization and anticipated discharge to home
Exclusion criteria
* Re-hospitalization within 30 days * Pregnant * Unable to read the English language * Discharge to a post-acute care facility * Contraindications to opioids, acetaminophen, or NSAIDs * Long-term opioid therapy (AHRQ definition - opioid use on most days \>3 months) prior to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Weekly Opioid Intake After Discharge | Baseline (discharge), weekly for four weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment-Pain Intensity | Weekly for four weeks after discharge | 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 \[mean=50, standard deviation (SD) =10\]. |
| Pain Assessment-Pain Interference | Weekly for four weeks after discharge | 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 \[mean=50, standard deviation (SD) =10\]. |
| Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge | Baseline (discharge) | 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). |
| Number of Participants With Opioids Prescribed From Day of Discharge + 1 Until 28 Days After Discharge | Baseline (discharge) +1 day until day 28, up to 27 days total | 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. |
| Number of Participants Who Disposed of Opioids | Baseline (discharge), weekly for four weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from May 2, 2022 to December 10, 2023. Participants were enrolled in the hospital setting.
Participants by arm
| Arm | Count |
|---|---|
| UControlPain App With Only Data Collection Function UControlPain App with only data collection function. No provider-facing tool. | 179 |
| UControlPain Educational App Only UControl Pain App with education components only. No provider-facing tool. | 179 |
| 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). | 176 |
| 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). | 177 |
| Total | 711 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Discharge plan revised; app compatibility issue or chronic opioid use discovered post-enrollment. | 7 | 5 | 0 | 4 |
| Overall Study | Lost to Follow-up | 12 | 17 | 14 | 14 |
| Overall Study | Physician Decision | 3 | 2 | 1 | 4 |
| Overall Study | Withdrawal by Subject | 5 | 7 | 6 | 4 |
Baseline characteristics
| Characteristic | UControlPain App With Only Data Collection Function | UControlPain Educational App Only | UControlPain App and Provider Facing Tool | UControlPain App With Only Data Collection and Provider Facing Tool | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 34 Participants | 30 Participants | 27 Participants | 116 Participants |
| Age, Categorical Between 18 and 65 years | 154 Participants | 145 Participants | 146 Participants | 150 Participants | 595 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 7 Participants | 9 Participants | 12 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 170 Participants | 171 Participants | 167 Participants | 165 Participants | 673 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 11 Participants | 20 Participants | 13 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 7 Participants | 4 Participants | 10 Participants | 29 Participants |
| Race (NIH/OMB) White | 154 Participants | 155 Participants | 145 Participants | 151 Participants | 605 Participants |
| Region of Enrollment United States | 179 participants | 179 participants | 176 participants | 177 participants | 711 participants |
| Sex: Female, Male Female | 114 Participants | 108 Participants | 110 Participants | 123 Participants | 455 Participants |
| Sex: Female, Male Male | 65 Participants | 71 Participants | 66 Participants | 54 Participants | 256 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 148 | 1 / 152 | 0 / 155 | 0 / 151 |
| other Total, other adverse events | 2 / 148 | 1 / 152 | 0 / 155 | 0 / 151 |
| serious Total, serious adverse events | 11 / 148 | 12 / 152 | 8 / 155 | 11 / 151 |
Outcome results
Primary
Cumulative Weekly Opioid Intake After Discharge
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).
Time frame: Baseline (discharge), weekly for four weeks
Population: Participants who completed at least one week of surveys were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UControlPain Educational App | Cumulative Weekly Opioid Intake After Discharge | 30 Morphine milligram equivalents |
| UControlPain App With Only Data Collection | Cumulative Weekly Opioid Intake After Discharge | 30 Morphine milligram equivalents |
| UControlPain App and Provider Facing Tool | Cumulative Weekly Opioid Intake After Discharge | 20 Morphine milligram equivalents |
| UControlPain App With Only Data Collection and Provider Facing Tool | Cumulative Weekly Opioid Intake After Discharge | 10 Morphine milligram equivalents |
Secondary
Number of Participants Who Disposed of Opioids
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.
Time frame: Baseline (discharge), weekly for four weeks
Population: Participants who answered they had opioids left over were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| UControlPain Educational App | Number of Participants Who Disposed of Opioids | 3 Participants |
| UControlPain App With Only Data Collection | Number of Participants Who Disposed of Opioids | 2 Participants |
| UControlPain App and Provider Facing Tool | Number of Participants Who Disposed of Opioids | 3 Participants |
| UControlPain App With Only Data Collection and Provider Facing Tool | Number of Participants Who Disposed of Opioids | 6 Participants |
Secondary
Number of Participants With Opioids Prescribed From Day of Discharge + 1 Until 28 Days After Discharge
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.
Time frame: Baseline (discharge) +1 day until day 28, up to 27 days total
Population: Subjects who completed at least one week of surveys were included in the data analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| UControlPain Educational App | Number of Participants With Opioids Prescribed From Day of Discharge + 1 Until 28 Days After Discharge | 23 Participants |
| UControlPain App With Only Data Collection | Number of Participants With Opioids Prescribed From Day of Discharge + 1 Until 28 Days After Discharge | 21 Participants |
| UControlPain App and Provider Facing Tool | Number of Participants With Opioids Prescribed From Day of Discharge + 1 Until 28 Days After Discharge | 31 Participants |
| UControlPain App With Only Data Collection and Provider Facing Tool | Number of Participants With Opioids Prescribed From Day of Discharge + 1 Until 28 Days After Discharge | 25 Participants |
Secondary
Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge
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).
Time frame: Baseline (discharge)
Population: Subjects who completed at least one week of surveys were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UControlPain Educational App | Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge | 90 Morphine milligram equivalents |
| UControlPain App With Only Data Collection | Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge | 77.5 Morphine milligram equivalents |
| UControlPain App and Provider Facing Tool | Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge | 75.0 Morphine milligram equivalents |
| UControlPain App With Only Data Collection and Provider Facing Tool | Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge | 75.0 Morphine milligram equivalents |
Secondary
Pain Assessment-Pain Intensity
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 \[mean=50, standard deviation (SD) =10\].
Time frame: Weekly for four weeks after discharge
Population: Subjects who completed at least one week of surveys were included in the analysis.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| UControlPain Educational App | Pain Assessment-Pain Intensity | 52.5 T-score | Standard Deviation 9.89 |
| UControlPain App With Only Data Collection | Pain Assessment-Pain Intensity | 51.24 T-score | Standard Deviation 9.37 |
| UControlPain App and Provider Facing Tool | Pain Assessment-Pain Intensity | 52.51 T-score | Standard Deviation 9.48 |
| UControlPain App With Only Data Collection and Provider Facing Tool | Pain Assessment-Pain Intensity | 51.29 T-score | Standard Deviation 9.06 |
Secondary
Pain Assessment-Pain Interference
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 \[mean=50, standard deviation (SD) =10\].
Time frame: Weekly for four weeks after discharge
Population: Subjects who completed at least one week of surveys were included in the analysis.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| UControlPain Educational App | Pain Assessment-Pain Interference | 55.28 T-score | Standard Deviation 9.79 |
| UControlPain App With Only Data Collection | Pain Assessment-Pain Interference | 54.17 T-score | Standard Deviation 9.95 |
| UControlPain App and Provider Facing Tool | Pain Assessment-Pain Interference | 55.13 T-score | Standard Deviation 9.34 |
| UControlPain App With Only Data Collection and Provider Facing Tool | Pain Assessment-Pain Interference | 53.43 T-score | Standard Deviation 9.62 |