Acupuncture, Acute Pain, Emergency Department, Pain Management
Conditions
Brief summary
Our goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a \ 9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (\ 10 per site) and acupuncture patients (\ 15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).
Detailed description
The goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will include the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), the investigators will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. Prior to the start of the RCT at all sites, study investigator meetings will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), the investigators will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a \ 9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Study outcomes include responsive manualization of acupuncture intervention, recruitment, retention, patient adoption, patient acceptability, and provider acceptability. Measures will be collected including pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (\ 10 per site) and acupuncture patients (\ 15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).
Interventions
PROCEDUREAcupuncture for pain management
A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.
OTHERUsual care for pain management
Patient will receive usual care for pain management.
Sponsors
Vanderbilt University Medical Center
University of California, San Diego
Albert Einstein College of Medicine
University of Massachusetts, Worcester
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Data collector will be masked to study outcomes via electronic data collection
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years of age * Ability to communicate in English. * Level 3, 4, 5 on triage rate scale * Presentation with acute non-emergent (musculoskeletal, back, pelvic, non-cardiac chest, abdominal, flank or head) pain ≥4 on a 0-10-point NRS due to non-penetrating injury.
Exclusion criteria
* Fever exceeding 100° F * Presenting with a chief complaint of a psychological / psychiatric concern * Presenting with chief complaint of Migraine * Patient arriving via ambulance or skipping triage * Current Pregnancy * Self-reported opioid medication taken orally within 4 hours * Presenting with chief complaint of Joint Dislocation * Presenting with chief complaint of Bone Fracture * Confirmed or suspected COVID-19
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Recruitment of Participants Into the Study. | At Enrollment | The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Retained at 1-week Follow up | One-week after the participant was discharged from the ED | Retained patients will be defined as those providing patient reported outcomes scores at 1 week. Separate retention rates (# retained / # enrolled) will be assessed overall and by site. |
| Patient Satisfaction Question 1 at Post-treatment | At post-treatment (45-60 minutes after baseline) | Question 1: How satisfied are you with how your pain was managed during your ED visit on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). |
| Patient Satisfaction Question 2 at Post-treatment | At post-treatment (45-60 minutes after baseline) | Overall how satisfied are you with your treatment during your ED visit? on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). |
| Patient Satisfaction Question 1 at 1-Week | One week after participant was discharged from the ED | How satisfied are you with how your pain was managed during your ED visit on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). |
| Percentage of Participants Retained in the Study at Post Treatment | At post treatment (45-60 minutes) | Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at post-treatment. Separate retention rates (# retained / # enrolled) will be assessed overall and by site. |
| Provider Satisfaction Question1 | After enrollment at the provider's site completed (~6 months after first enrollee). | Do you view acupuncture in general as an appropriate intervention for the ED setting? on a 5 point scale (0: Very inappropriate; 1: Inappropriate; 2: Neutral; 4: Appropriate; 4: Very appropriate). Higher scores are better. |
| Provider Satisfaction Question 2 | After enrollment at the provider's site completed (~6 months after first enrollee). | Do you view acupuncture in general as helpful in managing patient pain in the ED? on a 5 point scale (0: Not at all helpful; 1: Somewhat Unhelpful; 2: Neutral; 3: Somewhat Helpful; 4: Very Helpful). Higher scores are better. |
| Provider Satisfaction Question 3 | After enrollment at the provider's site completed (~6 months after first enrollee). | How satisfied are you with the way that the acupuncture intervention was implemented in your setting on the 5-point Likert scale (4-Very Satisfied; 3-Satisfied; 2-Neither Satisfied nor Dissatisfied; 1-Dissatisfied; 0-Very Dissatisfied). Higher scores are better |
| Provider Satisfaction Que4 | After enrollment at the provider's site completed (~6 months after first enrollee). | Did the ACUITY project impose a burden on ED staff in your setting? on the 4-point Likert scale (0-Not at all a burden; 1-Somewhat of a burden; 2-Moderate burden 3-Extreme burden). Lower scores are better |
| Patient Satisfaction Question 2 at 1 Week | One week after participant was discharged from the ED | Overall how satisfied are you with your treatment during your ED visit? on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied). |
Countries
United States
Participant flow
Recruitment details
Recruitment period: May 3, 2021 - September 24, 2022 from three Emergency Departments
Pre-assignment details
At the moment of consent,165 patients were randomized to group. However, 14 (7 per group) did not provide outcomes as detailed below. Complete participants were 151 at Post-Treatment. A sample of ED providers at the sites answered 2 questions on the appropriateness and helpfulness of acupuncture being provided in the Emergency Department. Individuals with direct exposure to ACUITY answered 2 more questions on satisfaction and burden of conducting ACUITY in their ED.
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture.
Acupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.
Usual care for pain management: Patient will receive usual care for pain management. | 76 |
| Usual Care This arm will receive usual care for pain management.
Usual care for pain management: Patient will receive usual care for pain management. | 75 |
| ED Staff/Providers ED Staff and Providers were asked complete 2 questions about their perceptions of acupuncture in the ED.
If the ED staff or providers had direct contact with the ACUITY study in their ED, then they were asked to complete 2 additional questions inquiring about how ACUITY may have impacted the ED. | 125 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| ED Staff/Providers 6 Month Assessment | Skipped question 2 | 0 | 0 | 1 |
| Participants in the RCT (Overall Study) | Data collection issue | 3 | 5 | 0 |
| Participants in the RCT (Overall Study) | Delay due to ED imaging | 1 | 0 | 0 |
| Participants in the RCT (Overall Study) | Early discharge | 0 | 1 | 0 |
| Participants in the RCT (Overall Study) | Withdrawal by Subject | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | Acupuncture | Usual Care | ED Staff/Providers | Total |
|---|---|---|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 16.9 | 43.9 years STANDARD_DEVIATION 17.4 | 37.6 years STANDARD_DEVIATION 9.35 | 44.4 years STANDARD_DEVIATION 17.1 |
| Anxiety- acute | 4.5 units on a scale STANDARD_DEVIATION 3.4 | 4.1 units on a scale STANDARD_DEVIATION 3.4 | — | 4.3 units on a scale STANDARD_DEVIATION 3.4 |
| Education College degree | 17 Participants | 17 Participants | — | 34 Participants |
| Education Decline to answer | 1 Participants | 0 Participants | — | 1 Participants |
| Education Graduate or professional degree | 5 Participants | 3 Participants | — | 8 Participants |
| Education High school or equivalent | 26 Participants | 23 Participants | — | 49 Participants |
| Education No high school diploma | 1 Participants | 4 Participants | — | 5 Participants |
| Education Some college | 26 Participants | 28 Participants | — | 54 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 11 Participants | 0 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants | 64 Participants | 0 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Income $100,001 to $150,000 | 4 Participants | 4 Participants | — | 8 Participants |
| Income $20,000 - $50,000 | 21 Participants | 23 Participants | — | 44 Participants |
| Income $50,001 to $100,000 | 9 Participants | 6 Participants | — | 15 Participants |
| Income Decline to answer | 17 Participants | 11 Participants | — | 28 Participants |
| Income Less than $20,000 | 22 Participants | 27 Participants | — | 49 Participants |
| Income More than $150,000 | 3 Participants | 4 Participants | — | 7 Participants |
| Insurance Decline to answer | 1 Participants | 4 Participants | — | 5 Participants |
| Insurance Medicaid | 16 Participants | 23 Participants | — | 39 Participants |
| Insurance Medicare | 25 Participants | 19 Participants | — | 44 Participants |
| Insurance No insurance | 2 Participants | 6 Participants | — | 8 Participants |
| Insurance Private insurance | 32 Participants | 23 Participants | — | 55 Participants |
| Location of Pain Abdomen | 14 Participants | 14 Participants | — | 28 Participants |
| Location of Pain Back | 25 Participants | 27 Participants | — | 52 Participants |
| Location of Pain Chest | 2 Participants | 2 Participants | — | 4 Participants |
| Location of Pain Extremity | 16 Participants | 22 Participants | — | 38 Participants |
| Location of Pain Flank | 3 Participants | 2 Participants | — | 5 Participants |
| Location of Pain Head | 7 Participants | 6 Participants | — | 13 Participants |
| Location of Pain Multiple | 6 Participants | 1 Participants | — | 7 Participants |
| Location of Pain Neck | 1 Participants | 0 Participants | — | 1 Participants |
| Location of Pain Other | 2 Participants | 1 Participants | — | 3 Participants |
| Pain Intensity | 7.4 units on a scale STANDARD_DEVIATION 2.2 | 7.1 units on a scale STANDARD_DEVIATION 2.3 | — | 7.3 units on a scale STANDARD_DEVIATION 2.2 |
| Prior Acupuncture | 19 Participants | 17 Participants | — | 36 Participants |
| Race/Ethnicity, Customized Black/AA | 34 individuals | 33 individuals | — | 67 individuals |
| Race/Ethnicity, Customized Other | 5 individuals | 14 individuals | — | 19 individuals |
| Race/Ethnicity, Customized White | 37 individuals | 28 individuals | — | 65 individuals |
| Sex: Female, Male Female | 39 Participants | 47 Participants | 65 Participants | 151 Participants |
| Sex: Female, Male Male | 37 Participants | 28 Participants | 60 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 83 | 0 / 82 | 0 / 125 |
| other Total, other adverse events | 0 / 83 | 0 / 82 | 0 / 125 |
| serious Total, serious adverse events | 1 / 83 | 1 / 82 | 0 / 125 |
Outcome results
Primary
Successful Recruitment of Participants Into the Study.
The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.
Time frame: At Enrollment
Population: Patients who were eligible AND approached.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Approached | Successful Recruitment of Participants Into the Study. | 26.1 Percentage of participants enrolled |
| University Hospitals/Case Western | Successful Recruitment of Participants Into the Study. | 27.7 Percentage of participants enrolled |
| VUMC | Successful Recruitment of Participants Into the Study. | 16.3 Percentage of participants enrolled |
| UCSD | Successful Recruitment of Participants Into the Study. | 49.1 Percentage of participants enrolled |
Secondary
Patient Satisfaction Question 1 at 1-Week
How satisfied are you with how your pain was managed during your ED visit on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Time frame: One week after participant was discharged from the ED
Population: Participants who has Post-treatment scores and answered satisfaction question 1 at 1-week FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Approached | Patient Satisfaction Question 1 at 1-Week | 3.95 units on a scale | Standard Deviation 1.27 |
| University Hospitals/Case Western | Patient Satisfaction Question 1 at 1-Week | 4.16 units on a scale | Standard Deviation 1.21 |
| VUMC | Patient Satisfaction Question 1 at 1-Week | 3.73 units on a scale | Standard Deviation 1.3 |
Secondary
Patient Satisfaction Question 1 at Post-treatment
Question 1: How satisfied are you with how your pain was managed during your ED visit on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Time frame: At post-treatment (45-60 minutes after baseline)
Population: Participants who has Post-treatment scores and answered satisfaction question 1 at post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Approached | Patient Satisfaction Question 1 at Post-treatment | 3.91 units on a scale | Standard Deviation 1.23 |
| University Hospitals/Case Western | Patient Satisfaction Question 1 at Post-treatment | 4.36 units on a scale | Standard Deviation 1.06 |
| VUMC | Patient Satisfaction Question 1 at Post-treatment | 3.46 units on a scale | Standard Deviation 1.23 |
Secondary
Patient Satisfaction Question 2 at 1 Week
Overall how satisfied are you with your treatment during your ED visit? on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Time frame: One week after participant was discharged from the ED
Population: Participants who has Post-treatment scores and answered satisfaction question 2 at 1-week FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Approached | Patient Satisfaction Question 2 at 1 Week | 3.98 units on a scale | Standard Deviation 1.23 |
| University Hospitals/Case Western | Patient Satisfaction Question 2 at 1 Week | 4.19 units on a scale | Standard Deviation 1.16 |
| VUMC | Patient Satisfaction Question 2 at 1 Week | 3.75 units on a scale | Standard Deviation 1.27 |
Secondary
Patient Satisfaction Question 2 at Post-treatment
Overall how satisfied are you with your treatment during your ED visit? on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Time frame: At post-treatment (45-60 minutes after baseline)
Population: Participants who has Post-treatment scores and answered satisfaction question 2 at post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Approached | Patient Satisfaction Question 2 at Post-treatment | 4.13 units on a scale | Standard Deviation 1.12 |
| University Hospitals/Case Western | Patient Satisfaction Question 2 at Post-treatment | 4.57 units on a scale | Standard Deviation 0.78 |
| VUMC | Patient Satisfaction Question 2 at Post-treatment | 3.70 units on a scale | Standard Deviation 1.22 |
Secondary
Percentage of Participants Retained in the Study at Post Treatment
Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at post-treatment. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.
Time frame: At post treatment (45-60 minutes)
Population: Participants who enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Approached | Percentage of Participants Retained in the Study at Post Treatment | 91.5 percentage of patients retained at post |
| University Hospitals/Case Western | Percentage of Participants Retained in the Study at Post Treatment | 98.4 percentage of patients retained at post |
| VUMC | Percentage of Participants Retained in the Study at Post Treatment | 95.5 percentage of patients retained at post |
| UCSD | Percentage of Participants Retained in the Study at Post Treatment | 80 percentage of patients retained at post |
Secondary
Percentage of Patients Retained at 1-week Follow up
Retained patients will be defined as those providing patient reported outcomes scores at 1 week. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.
Time frame: One-week after the participant was discharged from the ED
Population: Participants who enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Approached | Percentage of Patients Retained at 1-week Follow up | 77.6 percentage of patients retained at 1-wk |
| University Hospitals/Case Western | Percentage of Patients Retained at 1-week Follow up | 82.0 percentage of patients retained at 1-wk |
| VUMC | Percentage of Patients Retained at 1-week Follow up | 81.6 percentage of patients retained at 1-wk |
| UCSD | Percentage of Patients Retained at 1-week Follow up | 69.1 percentage of patients retained at 1-wk |
Secondary
Provider Satisfaction Que4
Did the ACUITY project impose a burden on ED staff in your setting? on the 4-point Likert scale (0-Not at all a burden; 1-Somewhat of a burden; 2-Moderate burden 3-Extreme burden). Lower scores are better
Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).
Population: Providers who responded to the survey and were exposed to ACUITY
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Approached | Provider Satisfaction Que4 | 0.38 score on a scale | Standard Deviation 0.66 |
Secondary
Provider Satisfaction Question1
Do you view acupuncture in general as an appropriate intervention for the ED setting? on a 5 point scale (0: Very inappropriate; 1: Inappropriate; 2: Neutral; 4: Appropriate; 4: Very appropriate). Higher scores are better.
Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).
Population: Providers who responded to the survey after their site completed enrollment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Approached | Provider Satisfaction Question1 | 2.19 score on a scale | Standard Deviation 1.07 |
Secondary
Provider Satisfaction Question 2
Do you view acupuncture in general as helpful in managing patient pain in the ED? on a 5 point scale (0: Not at all helpful; 1: Somewhat Unhelpful; 2: Neutral; 3: Somewhat Helpful; 4: Very Helpful). Higher scores are better.
Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).
Population: Providers who responded to the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Approached | Provider Satisfaction Question 2 | 2.50 score on a scale | Standard Deviation 1.11 |
Secondary
Provider Satisfaction Question 3
How satisfied are you with the way that the acupuncture intervention was implemented in your setting on the 5-point Likert scale (4-Very Satisfied; 3-Satisfied; 2-Neither Satisfied nor Dissatisfied; 1-Dissatisfied; 0-Very Dissatisfied). Higher scores are better
Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).
Population: Providers who responded to the survey and were exposed to ACUITY
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Approached | Provider Satisfaction Question 3 | 3.03 score on a scale | Standard Deviation 0.9 |