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System-wide implementation of intervention prevented randomized trial design
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The goal of the proposed study is to develop and implement a comprehensive strategy to address pain management in the inpatient setting while appropriately managing pain and optimizing patient safety in the inpatient setting. This strategy involves developing a new health Information Technology tool in the Omnicell and electronic medical record, implementing a "menu" of pain management and relaxation strategies, and developing educational materials for staff and patients to change the culture of pain management.
The goal of the proposed study is to develop and implement a comprehensive strategy to address pain management in the inpatient setting while appropriately managing pain and optimizing patient safety in the inpatient setting. This strategy involves developing a new health Information Technology tool in the Omnicell and electronic medical record, implementing a "menu" of pain management and relaxation strategies, and developing educational materials for staff and patients to change the culture of pain management.
This intervention will be implemented throughout CHS hospitals, using a stepped wedge design to guide rollout. The initial pilot will be conducted in the trauma inpatient units at Carolinas Medical Center. All patients admitted to the two primary trauma units (11A and 11 Tower) during the pilot study period will be included in the evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMPROVE Protocol | Experimental | The intervention is composed of 4 parts: 1) a multidisciplinary team that recommends, develops, approves, monitors the components of the intervention and training? 2) monitoring of medication sedation risk using established scale 3) restriction of medication dispensing via enhanced technology 4) health professional training on multimodality pain management including complementary and alternative therapies. |
|
| Usual Care | No Intervention | Treatment of patients in the usual manner based on their diagnosis and resources available at that site. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMPROVE Protocol | Other | Comprehensive pain management protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Use of Opioid Overdose Reversal Treatment | Incidence of administration of opioid reversal agent | Patient's entire length of stay in the hospital, up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Average daily pain scores (VAS) | Patient's entire length of stay in the hospital, up to 3 months |
| Oversedation without naloxone | Incidence of patient oversedation (Pasero > 2 or associated diagnosis code) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph R Hsu, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Healthcare System - Stanly | Albemarle | North Carolina | 28001 | United States | ||
| Carolinas Medical Center |
No IPD will be made available to other researchers.
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Patient's entire length of stay in the hospital, up to 3 months |
| Multimodal Therapy | Percentage of patients receiving multimodal pain management | Patient's entire length of stay in the hospital, up to 3 months |
| Average Daily MME | Morphine Milligram Equivalent Dosing for Opioid Medications | Patient's entire length of stay in the hospital, up to 3 months |
| Charlotte |
| North Carolina |
| 28203 |
| United States |
| Carolinas Healthcare System - Mercy | Charlotte | North Carolina | 28207 | United States |
| Carolinas Healthcare System - Pineville | Charlotte | North Carolina | 28210 | United States |
| Carolinas Healthcare System - University | Charlotte | North Carolina | 28262 | United States |
| Carolinas Healthcare System - NorthEast | Concord | North Carolina | 28025 | United States |
| Carolinas Healthcare System - Kings Mountain | Kings Mountain | North Carolina | 28086 | United States |
| Carolinas Healthcare System - Lincoln | Lincolnton | North Carolina | 28092 | United States |
| Carolinas Healthcare System - Union | Monroe | North Carolina | 28112 | United States |
| Carolinas Healthcare System - Blue Ridge | Morganton | North Carolina | 28655 | United States |
| Carolinas Healthcare System - Cleveland | Shelby | North Carolina | 28150 | United States |
| Carolinas Healthcare System - Anson | Wadesboro | North Carolina | 28170 | United States |