Inflammatory Bowel DiseasesPAIN-SparingNCT03798405
Reactive vs. Proactive Pain Control in IBD
A study testing Proactive Analgesic Inpatient Narcotic-Sparing in people with Inflammatory Bowel Diseases and Pain, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The investigators will compare two physician behaviors for managing pain in patients with IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard of care at the institution in which the study will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Pain, Opioid Use
- What is being tested?
- Proactive Analgesic Inpatient Narcotic-Sparing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 1 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with confirmed IBD diagnosis
- Admitted for primary IBD-related sign or symptom
Who cannot join
- Admitted for primary non-IBD complaint
- Surgery in the last 30 days
- Alternative (non-IBD) GI diagnosis determined
- Age <18
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease
The investigators will compare two physician behaviors for managing pain in patients with IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard of care at the institution in which the study will be performed. The PROACTIVE strategy is an IBD-specific analgesic orderset (built into our EMR and approved by the institution's Pharmacy and Therapeutics committee), the REACTIVE strategy is a traditional "reactive" analgesic prescribing (prescribing medications only when patients have pain). The PROACTIVE IBD-specific analgesic orderset consists of medications which have evidence for use in IBD-related pain. This orderset is an educational guide, it does not force any order. The reactive prescribing habits could contain an array of pain medications depending on what the provider wants to prescribe.
Aims:
Read more
Aim 1: To assess whether there is a difference in pain scores or functional activity among hospitalized patients with IBD between reactive vs proactive physician behaviors.
Aim 2: To assess whether there is a difference in inpatient opioid-prescribing between reactive vs proactive physician behaviors.
Aim 3: To assess whether there is a difference in health care utilization, including length-of-stay and 30-day readmission, between reactive vs proactive physician behaviors.
Read the detailed description
Prospective, investigator-blinded, single-institution randomized-control trial . Consecutive adult patients with IBD (Crohn's disease or ulcerative colitis) admitted to the hospital will be screened for eligibility, and eligible patients will be approached and consented to participate. Subjects will be randomized to receive the P.A.I.N.-Sparing bundle or usual care. Patient randomization will be stratified by provider to avoid bias, using a web-based in-house system (RANDI3). Subjects will also be provided with a fitness tracker (Fitbit(R)) to measure functional status during their hospital stay.
- Conditions
- Inflammatory Bowel Diseases, Pain, Opioid Use, Crohn Disease, Ulcerative Colitis
- Being tested
- Proactive Analgesic Inpatient Narcotic-Sparing
- Keywords
- Pain, Inflammatory Bowel Disease, Opioids
- Medical subject headings
- Inflammatory Bowel Diseases, Pain, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive Analgesic Inpatient Narcotic-SparingBehavioural
Also called P.A.I.N.-Sparing Bundle
Medications suggested to the physician with enhanced ease of ordering.
| Study group | Role | What they receive |
|---|---|---|
| Proactive | Experimental | Proactive Analgesic Inpatient Narcotic-Sparing:
Pain management in patients in the proactive physician-behavior group will be based on the IBD Pain orderset in our EMR. This orderset is already in use and standard-of-care at Cedars. The orderset uses pain medications, which have evidence for use in IBD. The orderset is simply a guide to clinicians and does not force any doctor or patient to be in a "protocol". Receives: Behavioral: Proactive Analgesic Inpatient Narcotic-Sparing |
| Reactive (Control Group) | No intervention | Pain management in patients in the reactive group (control group) will follow traditional prescribing habits. As different providers vary in the way they treat pain, analgesic medication prescribing in the control group will be inherently variable in nature. The control group does not constitute a lack of treatment or placebo; rather, pain management in the control group will not be proactive as in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Pain Scores
Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))
Measured: Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.
Secondary outcomes (3)
Healthcare Utilization
Hospital length of stay (in days)
Measured: From hospital admission until hospital discharge, typically 7 days.
Functional Activity
FitBit activity (number of steps per day)
Measured: From hospital admission until hospital discharge, typically 7 days.
Opioid-Consumption
Milligram morphine-equivalents consumed per day
Measured: From hospital admission until hospital discharge, typically 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Jan 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Why it stopped: COVID-19-related restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- Consecutive patients with IBD admitted to the hospital will be screened, and eligible patients will be consented. Patients who have a pain score \> 0 and require pain control will randomly receive the reactive traditional prescribing or the proactive standard-of-care orderset guideline - all patients will receive a FitBit exercise tracker.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gil Melmed, Cedars-Sinai Medical Center
- Investigators
- Gil Y Melmed, MD, MS, Principal investigator, Cedars-Sinai Medical CenterSameer K Berry, MD, MBA, Study director, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798405
- Sponsor's protocol ID
- Pro00050742
- Acronym
- PAIN-Sparing
- Status last verified
- Jul 2022
- First submitted
- 4 Dec 2018
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berry SK, Takakura W, Patel D, Govalan R, Ghafari A, Kiefer E, Huang SC, Bresee C, Nuckols TK, Melmed GY. A randomized controlled trial of a proactive analgesic protocol demonstrates reduced opioid use among hospitalized adults with inflammatory bowel disease. Sci Rep. 2023 Dec 16;13(1):22396. doi: 10.1038/s41598-023-48126-0.
PubMed 38104145
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03798405
- Acronym / sponsor ID
- PAIN-Sparing / Pro00050742
- Conditions
- Inflammatory Bowel Diseases, Pain, Opioid Use, Crohn Disease, Ulcerative Colitis
- Keywords
- Pain, Inflammatory Bowel Disease, Opioids
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19-related restrictions
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Jan 2019 (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 investigators will compare two physician behaviors for managing pain in patients with IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard of care at the institution in which the study will be performed. The PROACTIVE strategy is an IBD-specific analgesic orderset (built into our EMR and approved by the institution's Pharmacy and Therapeutics committee), the REACTIVE strategy is a traditional "reactive" analgesic prescribing (prescribing medications only when patients have pain). The PROACTIVE IBD-specific analgesic orderset consists of medications which have evidence for use in IBD-related pain. This orderset is an educational guide, it does not force any order. The reactive prescribing habits could contain an array of pain medications depending on what the provider wants to prescribe.
Aims:
Aim 1: To assess whether there is a difference in pain scores or functional activity among hospitalized patients with IBD between reactive vs proactive physician behaviors.
Aim 2: To assess whether there is a difference in inpatient opioid-prescribing between reactive vs proactive physician behaviors.
Aim 3: To assess whether there is a difference in health care utilization, including length-of-stay and 30-day readmission, between reactive vs proactive physician behaviors.
Detailed description
Prospective, investigator-blinded, single-institution randomized-control trial . Consecutive adult patients with IBD (Crohn's disease or ulcerative colitis) admitted to the hospital will be screened for eligibility, and eligible patients will be approached and consented to participate. Subjects will be randomized to receive the P.A.I.N.-Sparing bundle or usual care. Patient randomization will be stratified by provider to avoid bias, using a web-based in-house system (RANDI3). Subjects will also be provided with a fitness tracker (Fitbit(R)) to measure functional status during their hospital stay.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Consecutive patients with IBD admitted to the hospital will be screened, and eligible patients will be consented. Patients who have a pain score > 0 and require pain control will randomly receive the reactive traditional prescribing or the proactive standard-of-care orderset guideline - all patients will receive a FitBit exercise tracker.
| Arm | Type | Receives |
|---|---|---|
| Proactive | Experimental | Behavioral: Proactive Analgesic Inpatient Narcotic-SparingProactive Analgesic Inpatient Narcotic-Sparing: Pain management in patients in the proactive physician-behavior group will be based on the IBD Pain orderset in our EMR. This orderset is already in use and standard-of-care at Cedars. The orderset uses pain medications, which have evidence for use in IBD. The orderset is simply a guide to clinicians and does not force any doctor or patient to be in a "protocol". |
| Reactive (Control Group) | No intervention | –Pain management in patients in the reactive group (control group) will follow traditional prescribing habits. As different providers vary in the way they treat pain, analgesic medication prescribing in the control group will be inherently variable in nature. The control group does not constitute a lack of treatment or placebo; rather, pain management in the control group will not be proactive as in the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with confirmed IBD diagnosis
- Admitted for primary IBD-related sign or symptom
Key exclusion criteria (5 listed)
- Admitted for primary non-IBD complaint
- Surgery in the last 30 days
- Alternative (non-IBD) GI diagnosis determined
- Age <18
- Pregnancy
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 |
|---|---|---|
| Proactive Analgesic Inpatient Narcotic-SparingAlso: P.A.I.N.-Sparing BundleMedications suggested to the physician with enhanced ease of ordering. | Behavioural | Proactive |
Primary outcome
Patient-Reported Pain Scores
Time frame: Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.
Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))
3 secondary outcomes
Healthcare Utilization
Time frame: From hospital admission until hospital discharge, typically 7 days.
Functional Activity
Time frame: From hospital admission until hospital discharge, typically 7 days.
Opioid-Consumption
Time frame: From hospital admission until hospital discharge, typically 7 days.
Results and safety
The study was stopped early (reason given: COVID-19-related restrictions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 38104145Berry SK, Takakura W, Patel D, Govalan R, Ghafari A, Kiefer E, Huang SC, Bresee C, Nuckols TK, Melmed GY. A randomized controlled trial of a proactive analgesic protocol demonstrates reduced opioid use among hospitalized adults with inflammatory bowel disease. Sci Rep. 2023 Dec 16;13(1):22396. doi: 10.1038/s41598-023-48126-0.
- Individual participant dataSharing planned: No
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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.
Gil Y Melmed, MD, MS principal investigator
Cedars-Sinai Medical Center
Sameer K Berry, MD, MBA study director
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive Analgesic Inpatient Narcotic-Sparing in people with Inflammatory Bowel Diseases and Pain, run by Cedars-Sinai Medical Center at 1 site 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 stopped early (reason given: COVID-19-related restrictions). Results are not available in the source record.
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?
Patient-Reported Pain Scores (time frame: Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798405, which also lists 1 linked publication.
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 22 Jul 2022.