Clinical trial NCT04118595: Reducing the Transition From Acute to Chronic Musculoskeletal Pain Among Older Adults
Official title: Reducing the Transition From Acute to Chronic Musculoskeletal Pain Among Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Musculoskeletal Pain
Chronic Pain
Keywords: Musculoskeletal Pain
Acute Pain
Emergency Department
Elderly
Video
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Duke University
name: Indiana University
name: Yale University
name: Elon University
First posted: 2019-10-08
Enrollment: 330
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators have developed a three component intervention to support shared decision-making during the early recovery phase for older adults who present to the emergency department (ED) or orthopedic urgent care with acute musculoskeletal pain. The first component is a brief interactive video to enhance patient knowledge and self-efficacy regarding treatment options with the intent of facilitating conversations between patients and emergency providers. The second component is a protocol-guided phone conversation (telecare) between a nurse care manager and the patient at 48-72 hours following discharge to assess pain severity and interference with daily activities, review analgesic use and side effects and recovery-promoting behaviors, and discuss adjustments to the patients treatment. The third component is communication with the patient's primary care provider following the telecare call to inform them of the patient's condition and treatment plan and encourage primary care followup. The short-term objective of this project is to test the efficacy of this intervention to reduce the transition from acute to chronic musculoskeletal pain among older adults and obtain data to inform implementation. The investigators will conduct a three-arm randomized controlled trial with adults aged 50 years and older who present to the ED or orthopedic urgent care with acute musculoskeletal pain. Patients will be randomized to (1) the full intervention (video + telecare + communication with primary provider), (2) video alone, or (3) usual care. The primary outcome will be pain, measured longitudinally over the course of the year following the acute care visit. Secondary outcomes will include physical function, analgesic side effects and adverse events, opioid use, depression and anxiety symptoms, sleep duration and quality, and healthcare utilization at one, three, six, and twelve months. Secondary analyses will (1) examine whether the intervention has its effect by promoting shared decision-making, and (2) estimate the cost-effectiveness of the intervention. The long-term goal of this work is to develop, test, and implement interventions that improve long-term health outcomes for older adults with acute musculoskeletal pain.

Detailed description: Participants will be assigned to one of the three treatment arms using 1:1:1 randomization, stratified by access to a primary care provider, using randomly permuted blocks with random block sizes. (Primary care access will be determined using Source of Care questions from the Primary Care Assessment tool.) Randomization will be based on computer generated lists and allocated within subgroups based on access to a PCP using REDCap's integrated randomization module. One arm will receive the full intervention (educational video, telecare call, transmission of clinical information to the PCP), one will view the educational video only, and one will receive usual care. The investigators decided against a 2x2 factorial design, which would add a telecare only arm, because our team' s collective understanding is that a basic understanding of pain management (as provided by the educational video) is essential for effective shared decision-making (SDM) and often missing among older patients. Screening, consent, randomization, and assessments will be completed by the study coordinator.

Interventions

Educational Video: Development of the original video was funded by the John A. Hartford Foundation and used a systematic approach that included a review of literature and current pain management guidelines and input from emergency physicians, geriatricians, and experts in pharmacology, physical therapy, and risk communication. The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The actress for the 13-minute video is a 56-year-old mixed-race woman who presents herself as a healthcare provider. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.

Telecare: Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Before the call, the nurse will review the note from the index visit to obtain information about comorbidities, medications, allergies, and the patient's evaluation and treatment in the ED. Topics covered in the call will include discussion of pain management goals and priorities, current analgesic use, non-pharmacologic methods of pain management, warnings about potential side effects, and open-ended questions to address additional patient care needs. Conversations will be guided by an SDM framework in which the nurse elicits information from the patient, then discusses with the patient alternative strategies, and actively elicits feedback from the patient. Patients will be encouraged to follow-up with their PCP; uninsured patients will be referred to local free or low-cost medical clinics. The telecare call is designed to last 15 minutes and the nurse will be trained to complete the call in 15 minutes.

Correspondence with PCP: Following the telecare conversation, the nurse will enter a note in the Electronic Health Record (EHR) documenting the patient's current clinical status, information reviewed, and any recommendations or referrals made. The nurse will then share this note directly with the patient's PCP using a secure e-mail or an electronic message within the EHR if the PCP is a University of North Carolina (UNC)-affiliated provider. (If the PCP's email address is not available, the research staff will contact the PCP or their office by phone to obtain an email address or fax number.) This communication with also include: (1) The date, time, location and reason for the initial visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/recommendations; (4) A summary of and link to the video, explaining the emphasis on patient knowledge and SDM; (5) summary of the telecare conversation; and (6) encouragement for follow-up. PCPs will be asked to confirm receipt of this message.

\*Study outcome measures as described in this CT.gov report have been revised as of September 6, 2023 in order to reflect the final Master Protocol.

Eligibility criteria: Inclusion Criteria:

* Age 50 years and older
* Present to UNC ED patient with primary complaint of acute musculoskeletal pain
* Average pain score \>/= 4 on 0-10 scale
* Expected discharge from the ED

Exclusion Criteria:

* patient does not speak English
* primary pain located in the head, chest, or abdomen
* pain due to ischemia, infection, or some other cause not due to MSP (blood clot, kidney stone, etc.)
* primary pain due to self-injury
* patient is critically ill determined by an acuity score of 1 in the tracking board
* diagnosis of somatoform disorder, schizophrenia, dementia, or bipolar disorder
* patient is a prisoner or in police custody
* self-reported daily opioid use for more than 2 weeks
* resides in a nursing home or is homeless
* at-risk alcohol use
* speech, hearing, vision problems
* cognitively impaired (6-item Brief Screener)
* nonworking phone number (follow-up occurs via phone calls)

Primary outcomes:
measure: Mean Brief Pain Inventory-Short Form (BPI-SF) Combined Pain Severity and Interference Score
timeFrame: Month 1 (following ED or orthopedic urgent care visit) to Month 6
Secondary outcomes:
measure: Mean Pain Severity on the Brief Pain Inventory-Short Form (BPI-SF) Score
timeFrame: Up to 6 months
measure: Mean Pain Interference on the BPI-SF Score
timeFrame: Up to 6 months
measure: Mean Symptom Distress Score
timeFrame: 1 week & 1 month
measure: Percent of Participants With Opioid Use During the Past Week
timeFrame: 1, 3, 6, and 12 months
measure: PROMIS Measure: Mean T-score Physical Function-4
timeFrame: 1, 3, 6, and 12 months
measure: PROMIS Measure: Mean T-score Global Health-Physical 2a
timeFrame: 1, 3, 6, and 12 months
measure: Healthcare Utilization, Mean Days in the Hospital
timeFrame: Up to 12 months
measure: Healthcare Utilization, Mean Number of Visits to ED/Urgent Care
timeFrame: Up to 12 months
measure: Healthcare Utilization, Mean Number of Visits to Primary Care Provider
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michelle Meyer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Platts-Mills TF, Hollowell AG, Burke GF, Zimmerman S, Dayaa JA, Quigley BR, Bush M, Weinberger M, Weaver MA. Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older emergency department patients. Trials. 2018 Jan 5;19(1):10. doi: 10.1186/s13063-017-2403-8.
citation: Gan TJ, Joshi GP, Zhao SZ, Hanna DB, Cheung RY, Chen C. Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects. Acta Anaesthesiol Scand. 2004 Oct;48(9):1194-207. doi: 10.1111/j.1399-6576.2004.00495.x.
citation: Hurka-Richardson K, Platts-Mills TF, McLean SA, Weinberger M, Stearns SC, Bush M, Quackenbush E, Chari S, Aylward A, Kroenke K, Kerns RD, Weaver MA, Keefe FJ, Berkoff D, Meyer ML. Brief Educational Video plus Telecare to Enhance Recovery for Older Emergency Department Patients with Acute Musculoskeletal Pain: an update to the study protocol for a randomized controlled trial. Trials. 2022 May 12;23(1):400. doi: 10.1186/s13063-022-06310-z.
citation: Platts-Mills TF, McLean SA, Weinberger M, Stearns SC, Bush M, Teresi BB, Hurka-Richardson K, Kroenke K, Kerns RD, Weaver MA, Keefe FJ. Brief educational video plus telecare to enhance recovery for older emergency department patients with acute musculoskeletal pain: study protocol for the BETTER randomized controlled trial. Trials. 2020 Jul 6;21(1):615. doi: 10.1186/s13063-020-04552-3.