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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UControlPain App With Only Data Collection Function (Control) | No Intervention | UControlPain App with only data collection function. No provider-facing prescription intervention. | |
| UControlPain Educational App Only | Active Comparator | UControlPain app with education components. No provider-facing prescription intervention. |
|
| UControlPain App and Provider Facing Tool | Active Comparator | UControlPain app with education components and provider-facing prescription intervention. Once half of the subjects are enrolled, the provider-facing tool will be turned on. Participants will be masked to when the provider-facing tool is activated. |
|
| Provider Facing Tool Only | Active Comparator | UControlPain App with only data collection function. Provider-facing prescription intervention. Once half of the subjects are enrolled, the provider-facing tool will be turned on. Participants will be masked to when the provider-facing tool is activated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empowering Patient to Steer Their Pain Management After Surgery | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (discharge), weekly for four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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]. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karsten Bartels, MD, PhD, MBA | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28683056 | Background | Guy GP Jr, Zhang K, Bohm MK, Losby J, Lewis B, Young R, Murphy LB, Dowell D. Vital Signs: Changes in Opioid Prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017 Jul 7;66(26):697-704. doi: 10.15585/mmwr.mm6626a4. | |
| 30605448 | Background | Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 4;67(5152):1419-1427. doi: 10.15585/mmwr.mm675152e1. |
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Participants were recruited from May 2, 2022 to December 10, 2023. Participants were enrolled in the hospital setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | UControlPain App With Only Data Collection | UControlPain App with only data collection function. No provider-facing tool. |
| FG001 | UControlPain Educational App | UControlPain app with education components. No provider-facing tool. |
| FG002 | 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). |
| FG003 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 711 participants consented to the trial, and 606 completed the research.
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| ID | Title | Description |
|---|---|---|
| BG000 | UControlPain App With Only Data Collection Function | UControlPain App with only data collection function. No provider-facing tool. |
| BG001 | UControlPain Educational App Only | UControl Pain App with education components only. No provider-facing tool. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Participants who completed at least one week of surveys were included in the analysis. | Posted | Median | Inter-Quartile Range | Morphine milligram equivalents | Baseline (discharge), weekly for four weeks |
|
Adverse event data was collected from Discharge to Day 28.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UControl Pain App Educational App | UControl Pain App with education components. No provider-facing tool. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Re-hospitalization (any reason) | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Requiring greater than 2 additional opioid prescriptions within 2 weeks of discharge | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karsten Bartels | University of Nebraska Medical Center | 402-559-4081 | anesthesiology.research@unmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2022 | Mar 17, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 20, 2023 | Mar 17, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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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.
|
| Provider-facing Prescription Aid | Behavioral | 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. |
|
| Weekly for four weeks after discharge |
| 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]. | Weekly for four weeks after discharge |
| 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). | Baseline (discharge) |
| 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. | Baseline (discharge) +1 day until day 28, up to 27 days total |
| 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. | Baseline (discharge), weekly for four weeks |
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| Physician Decision |
|
| Lost to Follow-up |
|
| Discharge plan revised; app compatibility issue or chronic opioid use discovered post-enrollment. |
|
| BG002 | 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). |
| BG003 | 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). |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
UControlPain App with only data collection function. No provider-facing tool. |
| OG002 | 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). |
| OG003 | 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). |
|
|
| 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]. | Subjects who completed at least one week of surveys were included in the analysis. | Posted | Median | Standard Deviation | T-score | Weekly for four weeks after discharge |
|
|
|
| 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]. | Subjects who completed at least one week of surveys were included in the analysis. | Posted | Median | Standard Deviation | T-score | Weekly for four weeks after discharge |
|
|
|
| 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). | Subjects who completed at least one week of surveys were included in the analysis. | Posted | Median | Inter-Quartile Range | Morphine milligram equivalents | Baseline (discharge) |
|
|
|
| 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. | Subjects who completed at least one week of surveys were included in the data analysis. | Posted | Count of Participants | Participants | Baseline (discharge) +1 day until day 28, up to 27 days total |
|
|
|
| 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. | Participants who answered they had opioids left over were included in this analysis. | Posted | Count of Participants | Participants | Baseline (discharge), weekly for four weeks |
|
|
|
| 0 |
| 148 |
| 11 |
| 148 |
| 2 |
| 148 |
| EG001 | UControlPain App With Only Data Collection | Control UControl Pain App with data collection only. No provider-facing tool. | 1 | 152 | 12 | 152 | 1 | 152 |
| EG002 | 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). | 0 | 155 | 8 | 155 | 0 | 155 |
| EG003 | 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). | 0 | 151 | 11 | 151 | 0 | 151 |
|
Not provided
Not provided