56 Clinical Trials for Various Conditions
The purpose of this study is to compare opioid prescribing practices by either routine provider prescribing practices, or with the use of a calculator, i.e., the Opioid Calculator, published by the University of Michigan (www.opioidcalculator.org), with the intent of decreasing the number of pills.
The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are: * Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal? * Do oral surgeons' beliefs about the intervention and opioid prescribing change? * Do patients that report using opioids after tooth removal have different experiences than patients that do not? Oral surgeon participants will: * Attend a 1-hour education session with a trained pharmacist * Receive patient instructions and blister packs of pain medicine to give to patients * Complete 2 surveys about feasibility and appropriateness Patient participants will complete a survey about pain and medication use after having a tooth removed. Researchers will compare the intervention to usual care to see if it reduces opioid prescribing.
This randomized controlled trial will test whether an academic detailing educational outreach intervention (referred to as "academic detailing" throughout) decreases opioid prescribing to patients aged 13-30 years among high-prescribing dentists in Southeast Michigan. The primary objective is to evaluate whether an academic detailing intervention reduces the number of dispensed opioid prescriptions to patients aged 13-30 years.
The objective of this research study is to evaluate the effect of a quality improvement initiative carried out by a health system opioid stewardship task force aiming to increase clinician post-operative prescribing adherence with procedure specific guidelines that were developed using patient reported data. The feedback compares the clinician's average number of opioid pills prescribed after a given procedure to other clinicians in the health system and to the health system guideline recommended amount based on patient reported data on opioid pills taken for that procedure. The feedback also provides historical data on mean patient reported number opioid pills taken following a given procedure and on patients' ability to manage pain among those who received guideline adherent prescriptions compared with patients who received greater than the guideline recommended amount.
This is a prospective qualitative study of obstetric clinicians examining factors which influence their approach to postpartum pain management, their perspectives and preferences of interventions aimed at reducing opioid use, and the biases which may contribute disparities in this setting.
Many prescription opioids following surgery are left unused and are at risk of being misused or diverted. Encouraging proper disposal is important, yet motivating this behavior remains challenging as patients must understand the risks of opioids, the benefits of disposal, and identify opportunities and places to dispose of them safely. Alternative disposal techniques can improve disposal rates but may be lost or forgotten. Applying behavioral economics techniques may lower the barriers and promote disposal. The objective is to test the effect of a specifically timed, mailed, at-home kit on disposal rates following surgery.
This study tests the effectiveness of two email-based behavioral nudges, one based on peer behavior and one based on best practice guidelines, in reducing excessive opioid prescriptions after surgery. It will be conducted in three surgical specialties (general surgery, orthopedic surgery, and obstetric/gynecological surgery) at 19 hospitals within one healthcare system. These specialties will each be randomized to a control group or one of two nudge groups. Each month for one year, surgeons in the nudge groups will receive emails comparing their opioid prescribing either to their peers' prescribing or to prescribing guidelines. Both types of email-based nudges are expected to reduce opioid prescribing after surgery.
Despite an enormous policy response, opioid prescribing remains well above historical levels and harms from opioids continue to mount. Nearly all states have Prescription Monitoring Programs (PMPs) to facilitate safer prescribing of opioids and other drugs, but research suggests these systems only deliver benefits when health care professionals are required to use them. Even with PMP mandates in place, providers may be unaware of the dangers of co-prescribing opioids with benzodiazepines or gabapentinoids, which include increased risk of overdose and death. Working with the Minnesota state government, the investigators will mail letters to guideline-discordant opioid prescribers that either highlight an upcoming legally mandated requirement to check the PMP before prescribing an opioid, inform and educate providers about patients filling concurrent prescriptions and the dangers of such co-prescribing, or both. Study participants will be randomized to receive no intervention or one of the three treatment letters. Using administrative data, the investigators will track effects of the letters on not only prescribing but also PMP usage and queries. Findings form the multiplicity of treatment messages and outcomes will shed light on the mechanisms driving overprescribing. Results will inform future work by state and local policymakers to make opioid prescribing safer.
The purpose of this study is to determine if an educational patient-centered presentation reduced the amount of opioid pills requested and utilized by patients compared to standard of care group.
This will be a randomized controlled clinical trial in patients who have undergone primary unilateral total knee arthroplasty at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center. Study subjects will receive either a shared decision aid (SDA) about pain management or standard of care at the time of discharge. The impact of the SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7 will be assessed.
This study will characterize patient pain and opioid use after an initial opioid prescription for acute pain.
The opioid epidemic has had a tremendous negative impact on the health of persons in the U.S. The objective of the trial 1 of Application of Economics \& Social psychology to improve Opioid Prescribing Safety (AESOPS-T1), is to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice.
The investigators will embed a developed decision support tool into the electronic health record (EHR) to individualize pain therapy in surgical patients after hospital discharge and test its performance in a pragmatic clinical trial. Preliminary data indicate that current opioid prescription practice after surgery follows a "one size fits all" pattern. In-hospital opioid use prior to discharge serves as a reliable indicator to estimate needs for analgesic medications at home. The investigators will test the hypothesis that the existing tool will enable providers to write need-based prescriptions based on prior-to-discharge opioid use, empower patients to maximize alternatives to opioids (ALTO) therapies at home, while minimizing the need for rescue prescriptions. The investigators will test this tool prospectively in a cohort of \~1,000 providers (primary subjects) and \~39,000 surgical patients (secondary subjects) in four University of Colorado Health (UCHealth) hospitals (clusters to be exposed versus (vs.) non-exposed to the intervention).
The purpose of this project is to improve quality of care for dental patients in the state of Michigan. This will be achieved through educating dentists about best practices for opioid prescribing and includes three continuing education (CE) credits and one (or two) academic detailing (AD) visits. The cohort of 90 dentists who are enrolled to the CE will be randomized into two groups upon enrollment. One of these groups, half of the cohort, will receive the academic detailing. A report will be written highlighting key findings from this project and best practices for treating patients after dental care.The quality of care for dental patients will be improved by sharing this information with both participating and non-participating dental providers statewide through reports, manuscripts, and presentations. These data will inform best practice with the potential for future academic detailing and educational interventions for dentists and oral surgeons.
The specific objective of this proposal is to evaluate pain and opioid use following a midurethral sling (MUS) under two different opioid prescribing schemes. The central hypothesis is that, in spite of the fact that opioids are often routinely prescribed by many surgeons following this procedure, most patients do not require them for pain control, and patients who are not prescribed postoperative will have similar pain scores and pain control satisfaction compared with patients who are routinely prescribed a standard amount of opioids for postoperative pain control.
The overall objective of this study is to evaluate strategies to reduce unused opioids prescribed for pediatric acute post-surgical pain management.
Analyze baseline concurrent opioid prescribing metrics at the individual prescriber level in the Duke Health System on the identified three main outcome measures. Test the impact of reports on opioid prescriber behaviors with the following primary measures: number of prescriptions with concurrent benzo within reporting period, number of prescriptions with concurrent muscle relaxants within reporting period, and number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period. Create a blueprint to implement the concurrent opioid prescribing nudge intervention in other settings.
This study aims to understand the optimal sequencing and combination of implementation strategies that specific types of clinics and prescribers need to adopt clinical guidelines for opioid prescribing. The pragmatic goal is to give health systems a tool they can use to predict which clinics and prescribers will benefit most from which sequence and combination of implementation strategies.
The investigators will utilize the electronic health record to individualize pain therapy in surgical patients after hospital discharge using last 24-hour opioid intake as the decision variable for the amount of opioid pain pills prescribed. The preliminary data indicate that current opioid prescription practice after surgery follows a "one size fits all" pattern. In-hospital opioid use 24 hours prior to discharge serves as a strong indicator to correctly estimate needs for analgesic medications at home. The investigators will test the hypothesis that this prescription estimation tool will enable providers to write need-based prescriptions based on each patient's' 24-hour prior-to-discharge opioid use. The investigators will test this tool prospectively for patients after Cesarean section who are anticipated to use about half or less of the usually prescribed amount of opioid pain pills after discharge randomized equally to prescription tool intervention or no intervention (prescription as usual).
This study examines the comparative effectiveness of opioid review programs in reducing unsafe opioid prescribing in two states: prospective prior authorization (PA) with hard stops in Washington and retrospective review (RR) with prescriber notification in Ohio.
In this study, the investigators will evaluate the effect of a health system initiative aiming to change clinician opioid prescribing behaviors using two behavioral economic interventions - individual audit feedback and peer comparison feedback of clinicians.
We would like to evaluate and optimize opioid prescribing after minimally invasive hysterectomy. Currently, our standard prescribing is 150 oral morphine equivalents. However, recent studies show that half of the opioids prescribed are not used. We would like to include the patient in the decision making of the opioid prescribing. We have designed a randomized controlled trial to prescribe standard (150 oral morphine equivalents) or patient directed (less than or equal to 150 oral morphine equivalents) for pain control. We hypothesize that with patient input, there will be a higher utilization of the opioids prescribed. Also, we anticipate a lower number of opioids used overall. This study will help us optimize opioid prescribe and evaluate whether patient input can help in this important measure.
There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. The objective of the R21 pilot phase of the Application of Economics \& Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and test novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid prescribing for persons with noncancer pain. Interventions will leverage the electronic health record (EHR) to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice.
The overarching plan for TOWER is to develop and test an algorithmic version of the Center for Disease Control Guidelines (CDCG) tailored for a specific primary care setting, the HIV primary care clinic. This CDCG intervention incorporates communication and implementation strategies tailored for the HIV primary care setting, and enabled with technology (an app for use by patients and EMR tools for providers).
The investigators will assess whether behavioral science-based interventions can "nudge" providers towards more evidence-based care for patients with acute non-cancer pain. Aim 1) Among opioid naïve primary care patients with acute non-cancer pain, compare the effect of the provider-targeted behavioral interventions (opioid justification and provider comparison), individually and in combination, on initial opioid prescription, initial use of non-opioid management, and patient-reported pain and function. Aim 2) Compare the effect of the 2 provider-targeted behavioral interventions, individually and in combination, on unsafe opioid prescribing and transition to chronic opioid therapy. Aim 3) Assess provider satisfaction and experience with the provider-targeted behavioral interventions. Hypotheses: Aim 1, H1a: Compared with the guideline (usual care) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of opioid prescription and increased proportion of non-opioid management at the initial outpatient visit for acute non-cancer pain. Aim 1, H1b: Compared with usual care (guideline) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with no difference in patient-reported pain, function, and satisfaction at 1, 6, and 12 months. Aim 2, H2: Compared with the usual care (guideline), the addition of opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of patients receiving unsafe opioid therapy and a decreased proportion of patients transitioning to chronic opioid therapy. Study Design: Pragmatic, cluster-randomized clinical trial in 48 primary care clinics. Study Population: The patient population will be 19,855 opioid naïve adults who present to clinic with acute uncomplicated musculoskeletal pain or headache. Primary and Secondary Outcomes: The primary outcome measures will be receipt of an initial opioid prescription and unsafe opioid prescribing. Secondary outcomes will be non-opioid pain management, and, in 514 patients, patient-reported pain and function. Analytic Plan: The investigators will test for differences in the primary and secondary outcomes among the 4 intervention groups. Once completed, the project will provide evidence that health systems and other stakeholders need to implement interventions to prevent unsafe opioid prescribing.
Back on Track is a quasi-experimental, mixed-methods study of a unique natural experiment that will answer the question: what is the comparative effectiveness of different payer or health-system strategies that aim to prevent unsafe opioid prescribing? The State of Oregon is enacting a Medicaid reimbursement policy to enhance access to evidence-based non-pharmacotherapeutic treatment options while restricting reimbursement for opioids for back pain. We will assess whether the policy decreases unsafe opioid prescribing and improves patient outcomes compared with usual back pain treatment practices in a comparable state, California, that is not changing Medicaid payment policy.
We aim to determine if descriptive normative feedback of peer prescribing reduces opioid analgesic prescribing by emergency medicine providers
The number of opioid overdose deaths in the United States has quadrupled in 15 years, a dramatic manifestation of the current opioid abuse epidemic. This rise parallels a sharp increase in the amount of legal prescription opioids dispensed. The abundance of prescription opioids available is a primary pathway for opioid abuse and diversion. Adjusting post- cesarean delivery opioid prescribing practices to better match actual patient need has the potential to reduce unused opioids available for diversion, nonmedical use, and development of chronic dependence, as well as reduce wasted resources.
This study seeks to investigate the prescribing patterns and patient utilization of opioid pain medication in the postpartum setting. Postpartum women will be surveyed prior to hospital discharge and again at 2-4 weeks postpartum in order to assess the number of opioid tablets they used (in relation to the number prescribed), pain satisfaction, and storage/disposal of any remaining opioid tablets.
This is a study of emergency physicians' prescribing patterns related to opioid (narcotic) medications. We are trying to determine whether giving providers access to their own prescribing data influences their prescribing patterns.