Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02665429
Other study ID # H00009241
Secondary ID
Status Completed
Phase N/A
First received January 20, 2016
Last updated June 23, 2017
Start date February 1, 2016
Est. completion date March 1, 2017

Study information

Verified date June 2017
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Opioid misuse is a known public safety threat and public health problem, both nationwide and in the Commonwealth of Massachusetts. As a part of these efforts, Emergency Department (ED) outpatient prescriptions have been identified as a potential area for improvement. The Massachusetts Hospital Association (MHA), in conjunction with other stakeholders, developed a set of recommendations to address opioid management and prescribing within the ED setting.

This study is timed to coincide with the rollout by UMassMemorial Health Care of a system-wide opioid prescribing practice guideline/policy which mirrors the Massachusetts Hospital Association's guideline. This rollout provides a unique opportunity for a natural experiment related to provider prescribing practices.

This is a quality improvement project with two primary objectives:

- Improve understanding of physician practice patterns related to emergency department (ED) opioid prescribing

- Evaluate the effectiveness of providing individual clinician profile data in influencing behavior change among ED providers, as it relates to their opioid prescribing patterns

There are two corresponding specific aims:

- Quantitatively describe the current state of opioid prescribing by ED clinicians at four UMass Memorial EDs (using prescriptions generated within the ED electronic health information system between February 2014 and the study implementation date). Descriptive statistics being considered for feasibility of study include:

- Number of opioid prescriptions per hundred patients seen

- Percentage of total prescriptions written that are opioids

- Mean or median quantity of pills dispensed per opioid prescription

- Number of prescriptions for long-acting opioid formulations

- Evaluate the effect on prescribing practices of providing individual clinicians with their profile data to illustrate their personal opioid prescribing patterns, relative to the de-identified distribution for all other clinicians in the ED group

This project is timed to coincide with the separately planned implementation of a system-wide opioid prescribing guideline. The guideline implementation is an independent event, but we feel that it presents a unique opportunity for a simultaneous experimental intervention to assess whether providing clinicians with their individual data alters their prescribing practices beyond any effect achieved simply by being subject to the new guideline. Data collected from the electronic medical record and clinician self-reported data about their perceptions of their prescribing practices will be used to evaluate both the effect of the guideline implementation (i.e. comparison of prescribing patterns for all clinicians before and after guideline implementation) and the combined effect of guideline implementation plus individual profile intervention (i.e. comparisons across intervention versus control groups).


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date March 1, 2017
Est. primary completion date March 1, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Provider who practices Emergency Medicine in one or more of four UMass-affiliated EDs (UMassMemorial Medical Center, Marlborough Hospital, and Clinton Hospital), including attending physicians, resident physicians, and advanced practice providers (PAs and NPs).

- Have placed at least one electronic prescription for a medication of interest (namely opioids) in the PulseCheck electronic medical record system during the 12 months prior to the implementation of the opioid guidelines

- Be actively practicing in a UMass-affiliated ED at time of implementation of the guidelines

Exclusion Criteria:

Study Design


Intervention

Behavioral:
Individual prescribing data profile and self-assessment
Prior to receiving his or her individual data profile, each provider in the intervention group will be asked to identify his or her self-assessment of his or her own opioid prescribing practices. Immediately after providing self-perception data, providers will be provided with their true profile data with a visual display of where they fall within the distribution of their peers. All peer data are de-identified.

Locations

Country Name City State
United States UMass Clinton Hospital Clinton Massachusetts
United States UMass Memorial Marlborough Hospital Marlborough Massachusetts
United States UMass Memorial Medical Center Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
University of Massachusetts, Worcester UMass Memorial Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Self-assessment of decile for number of opioid prescriptions per hundred patients seen The provider's self-assessment of their decile of number of opioid prescriptions per hundred patients seen, compared to their peers Once, at time of enrollment
Other Self-assessment of decile for percentage of total prescriptions written that are opioids The provider's self-assessment of their decile of their percentage of total prescriptions written that are opioids, compared to their peers Once, at time of enrollment
Other Self-assessment of decile for median quantity of pills dispensed per opioid prescription The provider's self-assessment of their decile of their median quantity of pills dispensed per opioid prescription, compared to their peers Once, at time of enrollment
Other Self-assessment of decile for number of prescriptions for long-acting opioid formulations The provider's self-assessment of their decile of their number of prescriptions for long-acting opioid formulations, compared to their peers Once, at time of enrollment
Primary Change in number of opioid prescriptions per hundred patients seen Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Secondary Change in percentage of total prescriptions written that are opioids Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Secondary Change in median quantity of pills dispensed per opioid prescription Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
Secondary Change in number of prescriptions for long-acting opioid formulations Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
See also
  Status Clinical Trial Phase
Completed NCT03380533 - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair Phase 2/Phase 3
Completed NCT05004519 - Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass N/A
Not yet recruiting NCT04836169 - Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy N/A
Completed NCT02987985 - Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy Phase 3
Active, not recruiting NCT03366805 - A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery N/A
Completed NCT04818086 - Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder Phase 1/Phase 2
Recruiting NCT04144933 - Effect of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery Phase 3
Completed NCT04369950 - Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine Phase 4
Recruiting NCT05842928 - Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy N/A
Recruiting NCT03485430 - Tapering From Long-term Opioid Therapy in Chronic Pain Population. Randomized Controlled Trial With 12 Months Follow up N/A
Completed NCT05099055 - Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study Phase 3
Completed NCT03858621 - Comparison of Postoperative Nociception Between NOL-guided and Standard Intraoperative Analgesia Based on Fentanyl N/A
Recruiting NCT06390046 - Opioid-free Anesthesia, Optimization of Anesthesia After Bariatric Surgery N/A
Recruiting NCT06380244 - Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery N/A
Completed NCT03991546 - Pain and Narcotic Usage After Orthopaedic Surgery N/A
Withdrawn NCT02985177 - A RCT of a Combination of Analgesics for Pain Management in Children With a Suspected Fracture Phase 4
Completed NCT05581901 - Perioperative Methadone in Hip Fracture Patients Phase 4
Withdrawn NCT04397458 - Rescue Quadratus Lumborum Blocks for Post-cesarean Pain Phase 4
Completed NCT03294109 - Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy Phase 4
Completed NCT04204967 - Totally Transdermal Sedation in the Weaning From Remifentanil Infusion Phase 2