Reducing the Transition From Acute to Chronic Musculoskeletal Pain Among Older Adults

NCT04118595 | Completed Results

• 2 other identifiers: 19-0204R01AG058702
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Musculoskeletal Pain; Chronic Pain

Keywords

Musculoskeletal Pain; Acute Pain; Emergency Department; Elderly; Video

Outcome Measures

Primary Outcomes (1)

• Mean Brief Pain Inventory-Short Form (BPI-SF) Combined Pain Severity and Interference Score

  The Brief Pain Inventory-Short Form (BPI-SF) is an 11-item measure of pain severity and pain interference. Patients will rate their pain severity and interference over the past week on a 0-10 numeric scale at 3 discrete time periods (1, 3, and 6 months). End points for the severity items include 0 which equals "no pain" and 10 which equals "pain as bad as you can imagine." End points for the interference items include 0 which equals "does not interfere" and 10 "completely interferes." Higher scores reflect more pain severity and more pain interference. A composite score will be calculated by averaging scores from both the pain severity and interference items (all 11-items). Results from the 3 time periods will be analyzed longitudinally.

  Month 1 (following ED or orthopedic urgent care visit) to Month 6

Secondary Outcomes (9)

• Mean Pain Severity on the Brief Pain Inventory-Short Form (BPI-SF) Score

  Up to 6 months

• Mean Pain Interference on the BPI-SF Score

  Up to 6 months

• Mean Symptom Distress Score

  1 week & 1 month

• Percent of Participants With Opioid Use During the Past Week

  1, 3, 6, and 12 months

• PROMIS Measure: Mean T-score Physical Function-4

  1, 3, 6, and 12 months

Study Arms (3)

Full Intervention (Video + Telecare + PCP communication)

EXPERIMENTAL

Patients in this arm will watch an interactive pain management video; receive a pain assessment phone call and be given medication and behavioral pain management strategy recommendations; and an index visit and telecare summary will be shared with patient's primary care provider.

Behavioral: Educational Video; Behavioral: Telecare; Behavioral: Correspondence with Primary Care Provider

Video-only Intervention

EXPERIMENTAL

Patients in this arm will watch an interactive pain management video.

Behavioral: Educational Video

Usual Care

NO INTERVENTION

Patients will receive the typical care provided by medical personnel for their acute pain.

Interventions

Educational Video BEHAVIORAL

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.

Full Intervention (Video + Telecare + PCP communication); Video-only Intervention

Telecare BEHAVIORAL

Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Topics covered in the call will include discussion of goals and priorities the patient has for their pain management, current prescriptions and analgesic use (and adjustments if needed), non-pharmacologic methods of pain management, warnings about potential side effects, current healthcare utilization, and open-ended questions to address additional patient care needs. Conversations will be guided by a shared decision making framework in which the nurse suggests pain management options, discusses their pros and cons, and actively elicits feedback from the patient. The telecare call is designed to last 15 minutes.

Full Intervention (Video + Telecare + PCP communication)

Correspondence with Primary Care Provider BEHAVIORAL

Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email or an electronic message that includes: 1) The date, time, location and reason for the index 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) A summary of the telecare conversation; and (6) Encouragement for follow-up. PCPs will be asked to confirm receipt of this message.

Full Intervention (Video + Telecare + PCP communication)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Aging (NIA): collaborator
• Duke University: collaborator
• Indiana University: collaborator
• Yale University: collaborator
• Elon University: collaborator

Study Sites (1)

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (4)

• 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.

  PMID: 29304831 BACKGROUND

• 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.

  PMID: 15352969 BACKGROUND

• 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.

  PMID: 35550175 BACKGROUND

• 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.

  PMID: 32631400 DERIVED

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Acute Pain; Emergencies

Interventions

Telemedicine; Physicians, Primary Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Physicians; Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Michelle Meyer, PhD
• Organization: University of North Carolina at Chapel Hill

mlmeyer@unc.edu

919-966-6539

Study Officials

• Michelle Meyer, PhD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 8, 2019
• Study Start: February 3, 2020
• Primary Completion: December 27, 2022
• Study Completion: June 22, 2023
• Last Updated: November 21, 2023
• Results First Posted: November 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
• Access Criteria: Investigator who proposes data use has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)