Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
This study will (1) recruit, train and provide resources to approximately 30 Emergency Department (ED) sites throughout the U.S. using implementation facilitation strategies to provide ED-initiated buprenorphine (BUP) for patients presenting with opioid use disorder (OUD) who are not receiving medications for opioid use disorder (MOUD). Once implementation is adequately achieved, the sites will (2) conduct a randomized controlled trial (RCT) to compare the effectiveness of sublingual buprenorphine (SL-BUP) versus extended-release buprenorphine (XR-BUP) on ED patients' engagement in formal addiction treatment 7-days after their ED visit. In addition, in an ancillary component of the study, the investigators will (3) assess the use of XR-BUP in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores < 8 in a case series to potentially expand the eligibility of patients in the larger RCT to those presenting with little to no opioid withdrawal symptoms. Finally, the investigators will (4) develop and validate ED electronic health record (EHR) opioid-related phenotypes, both of which will inform the main RCT.
Description: Engagement in formal addiction treatment will be defined as enrollment and receiving formal addiction treatment on the 7th day post randomization, confirmed by contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, opioid treatment programs (OTPs), intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD at 7 days to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics Anonymous (AA) or (Narcotics Anonymous) NA alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted.
Measure: RCT Component: Patient engagement (yes/no) in formal addiction treatment at 7 days post randomization Time: 7 days post randomizationDescription: Engagement in formal addiction treatment will be defined as enrollment in formal addiction treatment on the 30th day post randomization, confirmed by direct contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, OTPs, intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD on the 30th day post randomization to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics or Narcotics Anonymous alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted.
Measure: RCT Component: Patient engagement (yes/no) in formal addiction treatment at 30 days post randomization Time: 30 days post randomizationDescription: The primary economic outcome will be the incremental cost-effectiveness ratio (ICER). The ICER will be calculated as the incremental mean cost of XR-BUP relative to SL-BUP, divided by the incremental mean effectiveness of XR-BUP relative to SL-BUP. Measures of effectiveness include: engagement in formal addiction treatment at 7 days and on the 30th day; quality-adjusted life-years (QALYs) gained; and Abstinent Years, a measure of time abstinent from opioids.
Measure: RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP at 7 days post randomization Time: 7 days post randomizationDescription: The primary economic outcome will be the incremental cost-effectiveness ratio (ICER). The ICER will be calculated as the incremental mean cost of XR-BUP relative to SL-BUP, divided by the incremental mean effectiveness of XR-BUP relative to SL-BUP. Measures of effectiveness include: engagement in formal addiction treatment at 7 days and on the 30th day; quality-adjusted life-years (QALYs) gained; and Abstinent Years, a measure of time abstinent from opioids.
Measure: RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP at 30 days post randomization Time: 30 days post randomizationDescription: self-report verified with treatment provider(s)
Measure: RCT Component: Engagement in MOUD (yes/no) at 7 days post randomization Time: 7 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids.
Measure: RCT Component: Self-reported days of illicit opioid use (past 7 days) at 7 days post randomization Time: 7 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported quantity of use of opioids.
Measure: RCT Component: Self-reported days (quantity) of illicit opioid use (past 7 days) at 7 days post randomization Time: 7 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported route of administration of use of opioids.
Measure: RCT Component: Self-reported days (route of administration) of illicit opioid use (past 7 days) at 7 days post randomization Time: 7 days post randomizationDescription: The investigators will use visual analogue scales (VAS) to assess craving, desire to use opioids and need to use opioids with a scale of 0-100.
Measure: RCT Component: Craving scores at 7 days post randomization Time: 7 days post randomizationDescription: The investigators will modify the patient satisfaction scale where overall experience is rated from 1 to 5 (1 is completely ineffective and 5 is completely effective) and treatment characteristics are rated 1 to 7 (1 is not important and 7 is extremely important) based on previous published data.
Measure: RCT Component: Patient satisfaction with BUP at 7 days post randomization Time: 7 days post randomizationDescription: self report verified with treatment provider(s)
Measure: RCT Component: Patient Engagement in MOUD (yes/no) at 30 days post randomization Time: 30 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids.
Measure: RCT Component: Self-reported days of illicit opioid use (past 7 days) at 30 days post randomization Time: 30 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported quantity of use of opioids.
Measure: RCT Component: Self-reported days (quantity) of illicit opioid use (past 7 days) at 30 days post randomization Time: 30 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported route of administration of use of opioids.
Measure: RCT Component: Self-reported days (route of administration) of illicit opioid use (past 7 days) at 30 days post randomization Time: 30 days post randomizationDescription: A brief, structured interview regarding health care utilization (inpatient and outpatient) will be used, which collects information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment and self-help sources of support (e.g., NA).
Measure: RCT Component: Healthcare services utilization (past 30 days) regarding ED visits and hospitalizations at 30 days post randomization Time: 30 days post randomizationDescription: Assessment of past 30-day overdose events will be completed at 30 days post study enrollment. In addition, Site PIs will search local electronic medical records for fatal and non-fatal overdose events.
Measure: RCT Component: Overdose Events at 30 days post randomization Time: 30 days post randomizationDescription: The investigators will use a visual analogue scale (VAS) "Desire to Use" to assess craving. Participants will be asked "At this moment I desire opioids" and indicate on the line the point that corresponds to the extent to which they desire opioids. Anchors will include 0 mm - "definitely not" to 100 mm - "definitely so". At follow up daily calls they will report a number between 0 and 100.
Measure: Ancillary Component: Desire to Use post XR-BUP injection at ED Index Visit (Day 0) Time: Pre-injection and 240 minutes post injectionDescription: The investigators will use a VAS to assess bad drug effects. Participants will be asked to respond to the statement: "At this moment, I feel bad drug effects" and place a mark across the line at the point that corresponds to the extent to which they are feeling any bad drug effects. Anchors will include 0 mm - 'not at all' to 100 mm - 'extremely'.
Measure: Ancillary Component: Bad drug effects post XR-BUP injection at ED Index Visit (Day 0) Time: Pre-injection and 240 minutes post injectionDescription: Adjective Rating Scale for Withdrawal (ARSW) - The ARSW is a 16-item self-report scale that measures subjective severity of opioid withdrawal and symptoms using a scale of 1 to 9 (1 is none and 9 is severe).
Measure: Ancillary Component: Changes in withdrawal severity at post XR-BUP injection at ED Index Visit (Day 0) Time: Pre-injection and 240 minutes post-injectionDescription: Participants will report the degree of pain at the injection site after the injection is administered using a numerical rating scale ranging from 0 - no pain to 10 - worst possible pain.
Measure: Ancillary Component: Pain at injection site post XR-BUP injection at ED Index Visit (Day 0) Time: Immediately following XR-BUP injection, 30 minutes and 240 minutes post injectionDescription: Vital signs (temperature) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (temperature) post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Vital signs (systolic blood pressure, mmHg) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (blood pressure- systolic) post XR-BUP injection at ED Index Visit- (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Vital signs (diastolic blood pressure, mmHg) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (diastolic blood pressure) post XR-BUP injection at ED Index Visit- (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Vital signs (pulse rate- beats per minute) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (pulse rate) post XR-BUP injection at ED Index Visit- (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Vital signs (respiratory rate- breaths/min) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (respiratory rate) post XR-BUP injection at ED Index Visit- (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Vital signs (oxygen saturation- collected while sitting, following a rest period of at least 3 minutes) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (oxygen saturation) post XR-BUP injection at ED Index Visit- (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Measure: Ancillary Component: Changes in withdrawal severity (COWS) at post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: The Objective Opioid Withdrawal Scale (OOWS) - The OOWS is a validated measure of the severity of opioid withdrawal that consists of 13 objective items.
Measure: Ancillary Component: Changes in withdrawal severity (OOWS) at post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Adjective Rating Scale for Withdrawal (ARSW) - The ARSW is a 16-item self-report scale that measures subjective severity of opioid withdrawal and symptoms using a scale of 1 to 9 (1 is none and 9 is severe).
Measure: Ancillary Component: Changes in withdrawal severity (ARSW) at post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: This will be assessed via pupillometry. Two measurements should be taken and if they are discrepant by >0.5mm discrepant, the Research Associate will need to repeat assessment until they achieve two consecutive readings with agreement of <0.5mm. The average of the two measurements is entered.
Measure: Ancillary Component: Pupillary diameter post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: SL-BUP and ancillary medications will be provided according to a uniform protocol. Research Associates (RAs) and nurses will document the timing and provision of all medications received before and during the 4-hour observation period in the ED. In addition, the Research Associate will review the electronic medical record to determine any additional medications or intravenous fluids were administered to the patient during their ED visit and the timing of those medications.
Measure: Ancillary Component: Provision of post Injection Medications post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Precipitated Withdrawal will be documented on the Precipitated Withdrawal Form along with time of occurrence.
Measure: Ancillary Component: Precipitated Withdrawal (yes/no) post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: The Research Associate will assess the degree of erythema and swelling at the injection site using a 4-point rating scale ranging from 0 - none to 3-severe.
Measure: Ancillary Component: Local Tolerability post XR-BUP injection at ED Index Visit (Day 0) Time: At 30 and 240 minutes post XR-BUP injectionDescription: Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Measure: Ancillary Component: Proportion of participants that experience a 5 or greater increase in COWS score within 4 hours of of XR-BUP administration Time: Within 4 hours of XR-BUP administrationDescription: Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Measure: Ancillary Component: Proportion of participants that transition to moderate withdrawal (COWS 13-24) within 4 hours of XR-BUP administration Time: Within 4 hours of XR-BUP administrationDescription: The Daily Substance Use assessment solicits participant use of substances of interest daily via a text-messaging application.
Measure: Ancillary Component: Daily Substance Use (Days 1-6 post injection) Time: Days 1-6 post injectionDescription: The investigators will use a visual analogue scale (VAS) "Desire to Use" to assess craving. Participants will be asked "At this moment I desire opioids" and indicate on the line the point that corresponds to the extent to which they desire opioids. Anchors will include 0 mm - "definitely not" to 100 mm - "definitely so". At follow up daily calls they will report a number between 0 and 100 (daily via a text-messaging application).
Measure: Ancillary Component: Desire to Use (Days 1-6 post injection) Time: Days 1-6 post injectionDescription: Urine testing will be performed for the presence of the following drugs: opioids, oxycodone, benzodiazepines, cocaine, methamphetamine, amphetamine, ecstasy (MDMA), marijuana (THC), barbiturate, methadone, buprenorphine, and fentanyl.
Measure: Ancillary Component: Presence of opioids, oxycodone, benzodiazepines, cocaine, methamphetamine, amphetamine, ecstasy (MDMA), marijuana (THC), barbiturate, methadone, buprenorphine and fentanyl (7 days post injection) Time: 7 days post injectionDescription: Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Measure: Ancillary Component: Opioid Withdrawal (7 days post injection) Time: 7 days post injectionDescription: The Daily Substance Use assessment solicits participant use of substances of interest.
Measure: Ancillary Component: Daily Substance Use (7 days post injection) Time: 7 days post injectionDescription: The investigators will use a visual analogue scale (VAS) "Desire to Use" to assess craving. Participants will be asked "At this moment I desire opioids" and indicate on the line the point that corresponds to the extent to which they desire opioids. Anchors will include 0 mm - "definitely not" to 100 mm - "definitely so". At follow up daily calls they will report a number between 0 and 100
Measure: Ancillary Component: Desire to Use (7 days post injection) Time: 7 days post injectionDescription: At 7-day follow up the participant will be queried about pain, itching, discharge and tenderness at the site. Study staff will examine the patient for erythema at the injection.
Measure: Ancillary Component: Injection Site Reactions (7 days post injection) Time: 7 days post injectionDescription: Participant satisfaction and preference will be assessed using quantitative and qualitative mixed methods at 7-day follow-up. Satisfaction will be rated on a Likert 1-5 scale by the participant, and preference order ranking to receive ongoing treatment with SL-BUP, preference to receive ongoing treatment with XR-BUP, and preference to not receive any formulation of BUP will be ranked. The investigators will use open-ended questions to explore patient satisfaction, preference and study experience.
Measure: Ancillary Component: Patient satisfaction with BUP (7 days post injection) Time: 7 days post injectionDescription: A brief, structured interview (not scored) regarding health care utilization (inpatient and outpatient) will be used, which collects information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment and self-help sources of support (e.g., NA).
Measure: Ancillary Component: Health Services Utilization (7 days post injection) Time: 7 days post injectionDescription: At 7 days post enrollment, participants will be asked to report OUD treatment received. Data will be reported on the Engagement in Treatment - Patient Survey (not scored).
Measure: Ancillary Component: Engagement in Treatment (7 days post injection) Time: 7 days post injectionDescription: Assessment of past 30-day overdose events will be completed at day 7 In addition, Site PIs will search local electronic medical records for fatal and non-fatal overdose events.
Measure: Ancillary Component: Overdose Events (7 days post injection) Time: 7 days post injectionAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports