PainIMPROVENCT03303664
Inpatient Multimodal Path to RecOVEry
A study testing IMPROVE Protocol in people with Pain and Opioid Use, run by Wake Forest University Health Sciences at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Opioid Use
- What is being tested?
- IMPROVE Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 12 sitesUnited States
- Study dates
- 11 Jul 2017to 26 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients treated in facility as inpatient during the study period will be included in the analysis.
Who cannot join
- Patients not admitted to facility during the study period will be excluded from the analysis.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Carolinas Healthcare System - Stanly
Albemarle, North Carolina, 28001
Carolinas Medical Center
Charlotte, North Carolina, 28203
Carolinas Healthcare System - Mercy
Charlotte, North Carolina, 28207
Carolinas Healthcare System - Pineville
Charlotte, North Carolina, 28210
Carolinas Healthcare System - University
Charlotte, North Carolina, 28262
Carolinas Healthcare System - NorthEast
Concord, North Carolina, 28025
Carolinas Healthcare System - Kings Mountain
Kings Mountain, North Carolina, 28086
Carolinas Healthcare System - Lincoln
Lincolnton, North Carolina, 28092
Carolinas Healthcare System - Union
Monroe, North Carolina, 28112
Carolinas Healthcare System - Blue Ridge
Morganton, North Carolina, 28655
Carolinas Healthcare System - Cleveland
Shelby, North Carolina, 28150
Carolinas Healthcare System - Anson
Wadesboro, North Carolina, 28170
About this study
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.
Read the detailed description
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.
- Conditions
- Pain, Opioid Use
- Being tested
- IMPROVE Protocol
- Keywords
- opioid, inpatient, pain, multimodal
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPROVE ProtocolOther
Comprehensive pain management protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: IMPROVE Protocol |
| Usual Care | No intervention | Treatment of patients in the usual manner based on their diagnosis and resources available at that site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Opioid Overdose Reversal Treatment
Incidence of administration of opioid reversal agent
Measured: Patient's entire length of stay in the hospital, up to 3 months
Secondary outcomes (4)
Pain
Average daily pain scores (VAS)
Measured: 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)
Measured: Patient's entire length of stay in the hospital, up to 3 months
Multimodal Therapy
Percentage of patients receiving multimodal pain management
Measured: Patient's entire length of stay in the hospital, up to 3 months
Average Daily MME
Morphine Milligram Equivalent Dosing for Opioid Medications
Measured: Patient's entire length of stay in the hospital, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start11 Jul 2017
- Primary completion26 Feb 2018
- Study completion26 Feb 2018
Why it stopped: System-wide implementation of intervention prevented randomized trial design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph R Hsu, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303664
- Sponsor's protocol ID
- Pro00022455
- Acronym
- IMPROVE
- Status last verified
- Feb 2018
- First submitted
- 16 Aug 2017
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Multimodal Path to RecOVEry
- ClinicalTrials.gov ID
- NCT03303664
- Acronym / sponsor ID
- IMPROVE / Pro00022455
- Conditions
- Pain, Opioid Use
- Keywords
- opioid, inpatient, pain, multimodal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: System-wide implementation of intervention prevented randomized trial design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 26 Feb 2018 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMPROVE Protocol | Experimental | Other: IMPROVE ProtocolThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients treated in facility as inpatient during the study period will be included in the analysis.
Key exclusion criteria (1 listed)
- Patients not admitted to facility during the study period will be excluded from the analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPROVE ProtocolComprehensive pain management protocol | Other | IMPROVE Protocol |
Primary outcome
Use of Opioid Overdose Reversal Treatment
Time frame: Patient's entire length of stay in the hospital, up to 3 months
Incidence of administration of opioid reversal agent
4 secondary outcomes
Pain
Time frame: Patient's entire length of stay in the hospital, up to 3 months
Oversedation without naloxone
Time frame: Patient's entire length of stay in the hospital, up to 3 months
Multimodal Therapy
Time frame: Patient's entire length of stay in the hospital, up to 3 months
Average Daily MME
Time frame: Patient's entire length of stay in the hospital, up to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No. No IPD will be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph R Hsu, MD principal investigator
Wake Forest University Health Sciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPROVE Protocol in people with Pain and Opioid Use, run by Wake Forest University Health Sciences at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Opioid Overdose Reversal Treatment (time frame: Patient's entire length of stay in the hospital, up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.