| Primary | Recruitment Rate | Measured by a composite of the number of participants with opioid use disorder recruited (i.e., signed the informed consent form) per month, and by site and the average monthly rate of participants enrolled among potential participants who were screened. | | Posted | | Count of Participants | | Participants | | Up to six months | | | | ID | Title | Description |
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| OG000 | Pre-screened Participants | Potential study participants who were approached by research staff to assess basic study eligibility and interest in study participation. | | OG001 | Consented Participants | Participants who signed the study informed consent form and then underwent screening to determine study eligibility. |
| | | Title | Denominators | Categories |
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| Pre-screened participants consented | | | Title | Measurements |
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| - OG00076
- OG001NARow data only applies to pre-screened participants.
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| | Consented participants enrolled into study | | |
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| Primary | Treatment Retention | Number of scheduled visits completed. | The number of expected study visits for each participant is 6, based on 1 visit per month for the 6 months of the study arm. The overall number of expected study visits for all participants is 426, based on 6 visits per participant multiplied by 71 participants in the study arm. | Posted | | Count of Units | | Visits | | Up to six months | Visits | Visits | | ID | Title | Description |
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| OG000 | Pharmacist-administered Buprenorphine Maintenance Care | Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician. |
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| Primary | Number of Participants With Opioid and Other Substance Use | Measured via a composite of urine drug screen (UDS) and self-report via Timeline Follow-Back over 30 days. | Missing UDS imputed as positive | Posted | | Count of Participants | | Participants | | Up to six months | | | | ID | Title | Description |
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| OG000 | Pharmacist-administered Buprenorphine Maintenance Care | Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician. |
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| Primary | Number of Medication-Compliant Months Across All Participants | Medication compliance is defined as taking any of the dispensed medication during the past month as measured by pill count/dose reconciliation at each study visit. Medication compliance is calculated as the percentage of compliant months out of the overall number of expected study months. | | Posted | | Count of Units | | Months | | Up to six months | Months | Months | | ID | Title | Description |
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| OG000 | Pharmacist-administered Buprenorphine Maintenance Care | Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician. |
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| Secondary | Treatment Fidelity | Number of monitored study visits with physicians and pharmacists showing 80% adherence or higher to study specific tasks and responsibilities. Adherence will be calculated as the number of items completed on the Buprenorphine Visit Checklist divided by the sum of the number of complete and incomplete items. | A total of 142 study visits were monitored for adherence to study tasks and responsibilities via completion of the Buprenorphine Visit Checklist. The percentage of monitored study visits with 80% adherence out of the total number of monitored study visits was calculated. | Posted | | Count of Units | | Monitored study visits | | Up to six months | Monitored study visits | Monitored study visits | | ID | Title | Description |
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| OG000 | Pharmacist-administered Buprenorphine Maintenance Care | Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician. |
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| Secondary | Treatment Satisfaction | Indicators of satisfaction with treatment delivery measured by participants, pharmacists, and physicians using the Treatment Satisfaction Scale after each study visit. A score of 5=very satisfied, 4=satisfied, 3=neither satisfied or dissatisfied, 2=dissatisfied, and 1=very dissatisfied. | Participants who completed the study. | Posted | | Count of Participants | | Participants | | Up to six months | | | | ID | Title | Description |
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| OG000 | Pharmacist-administered Buprenorphine Maintenance Care | Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician. | | OG001 | Study Physicians and Pharmacists | Comprised of the physicians (n=6) and pharmacists (n=6) who participated in the study. |
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| Secondary | Participant Safety | A composite of self-report and medical record abstraction to measure any fatal or non-fatal opioid overdose and any opioid or other substance-related emergency department visit or hospitalization. | | Posted | | Count of Participants | | Participants | | Up to six months | | | | ID | Title | Description |
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| OG000 | Pharmacist-administered Buprenorphine Maintenance Care | Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician. |
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| Secondary | Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP) | Measured at each study visit via an action item checklist to confirm whether the PDMP was inquired to identify the following for each participant: measures of multiple buprenorphine prescriptions, any prescriptions for class II and III medications, and any other information that may be useful for the participant's treatment such as documented drug-related medical interventions or disciplinary charges. | The total number of visits (409) represent the total number of study visits attended in the maintenance phase (n=406) plus early-termination visits (n=3) that are counted separately. | Posted | | Count of Units | | Visits | | Up to six months | Visits | Visits | | ID | Title | Description |
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| OG000 | Pharmacist-administered Buprenorphine Maintenance Care | Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription from the physician. |
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