Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics, Opioid

Narcotics

Reduction of opioid prescription based on Pre-Intervention data, implementation of a discharge sheet and nursing education.

Patient education discharge sheet, nursing education, opioid prescription reduction based on Pre-Intervention data

Opioid Reduction Intervention

Current unchanged care provided; unchanged provider prescribing and unchanged education of patients prior to intervention

Current Care

Amin S Herati, MD

ORIOLES is a non-randomized, pre-post intervention study designed to improve quality of opioid prescribing and use after discharge for patients undergoing urologic surgery. The study will initially focus on a pre-defined cohort of patients undergoing radical prostatectomy. After the predefined study period for the pre-intervention arm, a three-part intervention is employed to assess the effect on opioid prescribing and use in the post-intervention arm. Pending results, the intervention may be applied to all surgeries in the department for routine clinical care.

The goal of the study is to reduce the amount of opioid analgesia prescribed after urologic surgery in the Department of Urology at Johns Hopkins. The initiative focuses on patients undergoing surgery for prostate cancer with radical prostatectomy including patients enrolled in IRB00123618/NCT03006562. The pre-intervention arm will consist of patients enrolled August 2017 to January 2018. The intervention arm will consist of patient enrolled January 2018 to completion of the study.

The intervention consists of a information discharge sheet, a standardized prescribing guideline at discharge, and nurses providing improved education for patients at discharge about appropriate use of opioid medication, routes for disposal, and potential side effects. Data on prescriptions written (amount and type of mediation) and use of opioid and other pain medication after surgery will be compared before and after the quality improvement initiative is started. Outcomes are assessed via 30-day phone call follow-up with data on perioperative outcomes, postoperative medication use, and symptoms already assessed in IRB00123618/NCT03006562. At the completion of the pre-intervention arm, providers in the urology department are informed about the average and distribution of usage of post-discharge opioids. Education and standardized prescribing (allowing for provider judgment) may help reduce/personalize the amount of opioids prescribed at discharge to reduce wasted medication entering circulation. The initiative may then be expanded to encompass all surgeries in the department to reduce opioid prescribing and use for routine clinical care.

Pre-Post Study Design with Non-Pharmacologic Intervention

Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery

Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery (ORIOLES): A Quality Improvement Study of Prescribing Habits and Patient Education

The total oral morphine equivalents (OMEQ) used by the patient up to 30 days after discharge from the hospital

The total oral morphine equivalents (OMEQ) prescribed by the inpatient provider to the patient at discharge after surgery

Method of disposal (if any) by the patient of opioid medication prescribed for post-discharge use

Patient obtaining any additional opioid medication for post-surgical pain within 30 days after discharge from the hospital

Johns Hopkins University

Symptoms and General Pathology

Pain

Anesthetics

Vaccines

Practice A will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice A will be assigned to receive the current care intervention. in the second step, Practice A will be assigned to receive the current care intervention. In the third step, Practice A will receive the reminder-recall intervention. In the fourth step, Practice A will receive the combined reminder-recall and audit-and-feedback intervention.

Practice B will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice B will be assigned to receive the current care intervention. In the second step, Practice B will be assigned to receive the reminder-recall intervention. In the third step, Practice B will receive the combined reminder-recall and audit-and-feedback intervention. In the fourth step, Practice A will receive the combined reminder-recall and audit-and-feedback intervention.

Practice C will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice C will be assigned to receive the current care intervention. In the second step, Practice C will be assigned to receive the audit-and-feedback intervention. In the third step, Practice C will receive the audit-and-feedback intervention. In the fourth step, Practice C will receive the combined reminder-recall and audit-and-feedback intervention.

Practice D will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice D will be assigned to receive the current care intervention. In the second step, Practice D will be assigned to receive the current care intervention. In the third step, Practice D will receive the audit-and-feedback intervention. In the fourth step, Practice D will receive the combined reminder-recall and audit-and-feedback intervention.

Practice E will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice E will be assigned to receive the current care intervention. In the second step, Practice E will be assigned to receive the reminder-recall intervention. In the third step, Practice E will receive the reminder-recall intervention. In the fourth step, Practice E will receive the combined reminder-recall and audit-and-feedback intervention.

Practice F will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice F will be assigned to receive the current care intervention. In the second step, Practice F will be assigned to receive the audit-and-feedback intervention. In the third step, Practice F will receive the combined reminder-recall and audit-and-feedback intervention. In the fourth step, Practice F will receive the combined reminder-recall and audit-and-feedback intervention.

The current care arm consists of the contemporary efforts now in practice to support provider recommendation including a shared, standard immunization schedule, a shared rooming process, a shared well child visit schedule, a shared electronic prompt at point-of-care of vaccines due.

Current care

The communication will use expectant (announcement-style or presumptive) language noting the child's HPV vaccination status and stating that the child's provider strongly recommends the child receive the HPV vaccination now. The communication will also describe availability of topical anesthetics (less pain), indicate the availability and convenience of nurse visits for HPV vaccination (less fuss), and describe the immunological and logistical benefits of early vaccination (right now).

Reminder-recall

The intervention includes two components. The first is a missed opportunities audit-and-feedback. The second is a provision of a strong recommendation provider-toolkit, along with a broad education of the practice staff-nurses, medical secretaries, receptionists, and clinical assistants-regarding the nature of the intervention, its goals, and its likely impact on the practice. The broad education will be conducted through supervisory communications only to practice staff in practices allocated to the intervention at the beginning of the step.

Audit-and-feedback

The combination reminder-and-audit arm consists of a simultaneous application of the intervention tested in the reminder-recall arm and the intervention tested in the audit-and-feedback arm.

Combined reminder-recall and audit-and-feedback

Robert M Jacobson, MD

Joan M Griffin, PhD

Each year the human papillomavirus (HPV) causes 30,000 cancers in the United States despite the availability of very effective and safe vaccines. Uptake of the HPV vaccine has been disappointingly low and lags behind other adolescent vaccines. This study seeks to test interventions targeting health care system, provider, and patient factors to improve the population uptake of the HPV vaccine.

The broad, long-term objective is to substantially increase human papillomavirus (HPV) vaccination rates by deploying effective population-health interventions in clinical practices across the United States. As part of this effort, the investigators intend to evaluate two evidence-based interventions with innovative enhancements at six Mayo Clinic primary care practices (PCP) to evaluate their individual and combined impact on rates of HPV vaccination among female and male patients. Aim 1, "Less Pain, Less Fuss, Right Now!", will test the hypothesis that, as compared to no intervention (current practice), a practice-level intervention utilizing reminder-recalls featuring the availability of non-medication and medication anesthetics, the convenience of nurse-only visits, and the use of persuasive language for early, on-time vaccinations will improve HPV vaccine delivery rates. Aim 2, "Make It Count!", will test the hypothesis that, as compared to no intervention, a provider level intervention utilizing a missed-opportunities assessment and feedback intervention applying social pressure (specific peer-performance comparisons) and equipping providers with a strong-recommendation toolkit will improve HPV vaccine delivery rates. Aim 3 will test the hypothesis that simultaneous implementation of interventions targeting individual, interpersonal, and organizational factors will have a synergistic effect on HPV vaccine delivery rates. To accomplish Aims 1-3, the investigators will use a stepped-wedge cluster randomized trial with an integrated process evaluation. The cluster approach prevents cross-contamination between patients or providers as we allocate two separate interventions (Aims 1 and 2) in the six PCPs. The stepped-wedge design, which ensures all practices eventually receive the same set of interventions, permits the single institutional review board overseeing all six PCPs to approve the study without requiring recruitment and consent of individual patients or providers. The stepped-wedge approach also permits the investigators to test the presence of each of the interventions in each PCP, making trial participation more attractive, while also allowing each practice to serve as its own control, reducing the bias due to imbalanced risk factors across practices. The factorial design allows the investigators to use a single trial to test two interventions and assess each individually and in combination. The design also conserves sample size while maintaining power. The investigators will measure the impact separately in females and males, 11-12 years of age for the rates of receipt of HPV vaccine doses due. Rigorously tested, highly effective, population-level interventions are essential if the US is to reach the Healthy People 2020 goal for HPV vaccination. The rigor, design, and high likelihood of success of this study will provide key evidence regarding practice- and provider-level interventions to improve HPV vaccination rates. Mayo Clinic's best practices inform not only its own 70 practices across five states but its Mayo Clinic Care Network, which consists of nearly 40 health-care organizations across 26 states and Puerto Rico.

A factorial, stepped-wedge cluster randomized trial with process evaluation

The data analyst will conduct the measurement of the patients eligible and vaccinated and the calculations of the outcomes. The investigators will blind the data analyst to which intervention(s) each practice was assigned to receive. However that only masks the practices' interventions for Step 2 and Step 3 as all practices receive the same interventions in Step 1 (current care) and Step 4 (combined reminder-audit).

Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination

"Less Pain, Less Fuss, Right Now!" and "Make It Count!"--Multilevel Interventions for Patient, Parent, and Practice to Enhance Provider Recommendations for HPV Vaccination

Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice, measured each month for the 12 months of each step.

Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible males at each practice, measured each month for the 12 months of each step.

Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible 11-year-old males and females at each practice, measured each month for the 12 months of each step.

Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible 12-year-old males and females at each practice, measured each month for the 12 months of each step.

Rates of receipt of the first dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice, measured each month for the 12 months of each step.

Rates of receipt of a second valid dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice, measured each month for the 12 months of each step.

Rates of receipt of a third valid dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice, measured each month for the 12 months of each step.

Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to family physicians, measured each month for the 12 months of each step.

Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to pediatricians, measured each month for the 12 months of each step.

Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to family medicine nurse practitioners, measured each month for the 12 months of each step.

Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to pediatric nurse practitioners, measured each month for the 12 months of each step.

Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to family medicine residents, measured each month for the 12 months of each step.

Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to pediatric residents, measured each month for the 12 months of each step.

By provider, rates of encounters of patients seen in the preceding month who were 9 to 26 years of age and due for a dose of HPV vaccine and received an HPV vaccine the day of that encounter.

Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible males and females at each practice, measured each month for the 12 months of each step.

Rates of receipt of the first valid dose for the initiation of the HPV vaccine series for empaneled, vaccine-eligible males and females at each practice, measured each month for the 12 months of each step.

Rates of receipt of the last valid dose for the completion of the HPV vaccine series for empaneled, vaccine-eligible males and females at each practice, measured each month for the 12 months of each step.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery	NCT03536065	Prostate Cancer Opioid Use	Opioid Reductio... Current Care	18 Years - 100 Years	Johns Hopkins University
Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination	NCT03501992	Papillomavirus ...	Current care Reminder-recall Audit-and-feedb... Combined remind...	11 Years - 12 Years	Mayo Clinic
Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination	NCT03501992	Papillomavirus ...	Current care Reminder-recall Audit-and-feedb... Combined remind...	11 Years - 12 Years	Mayo Clinic

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