N/A
Completed N=333
Life Care Specialists (LCS) With a Focus on Patient Pain Management and Prevention of Substance Misuse
Source: ClinicalTrials.gov NCT04154384 ↗Enrolled (actual)
333
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Numeric Rating Scale Average Pain Score — 7.62; 7.94; 8.43; 5.88 units on a scale
Summary
The overall hypothesis of this randomized-controlled trial is that the introduction of a Life Care Specialist (LCS) as a novel member of the clinical care team will help reduce opioid utilization, decrease pain scores, and improve patient understanding of their addiction risk in the aftermath of orthopaedic trauma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale Average Pain Score |
7.62; 7.94; 8.43; 5.88; 5.64; 4.74 | — |
| PRIMARY Number of Participants With Improvement in the Numeric Rating Scale (NRS) Average Pain Score |
64; 42 | 0.035 sig |
| PRIMARY Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score |
52.89; 51.57; 60.16; 58.85; 54.74; 53.81 | — |
| PRIMARY PROMIS Pain Interference - Short Form Score |
54.14; 56.24; 65.19; 65.99; 62.28; 59.36 | — |
| PRIMARY PROMIS Physical Function - Short Form Score |
42.85; 42.31; 26.56; 26.82; 30.33; 33.59 | — |
| SECONDARY Opioid Utilization |
22.52; 30.00; 39.77 | — |
| SECONDARY Opioid Literacy Tool (OLT) Score |
32.02; 32.69; 33.20; 31.25 | — |
| SECONDARY Total Sleep Time |
267.34; 236.95 | — |
| SECONDARY Percentage of Sleep Fragmentation |
33.77; 32.68 | — |
| SECONDARY Patient Satisfaction Survey |
7.77; 7.23 | — |
| SECONDARY Number of Pilot Study Participants Reporting Satisfaction With Clinical Care |
79 | — |
| SECONDARY Patient Assessment of Constipation-Symptoms (PAC-SYM) Score |
0.49; 0.79 | — |
| SECONDARY Defense and Veterans Pain Rating Scale Score |
6.84; 7.49; 5.35; 5.54; 4.13; 4.02 | — |
Eligibility Criteria
Inclusion Criteria for Single-Arm Pilot Portion of this Study:
- Orthopaedic trauma patients with planned surgical procedure
- Informed consent obtained
Exclusion Criteria for Single-Arm Pilot Portion of this Study:
- Enrolled in a study that does not permit co-enrollment
- Unlikely to comply with the follow-up schedule
- Unable to converse, read or write English or Spanish at elementary school level
Inclusion Criteria for Clinical Trial Portion of this Study:
- Orthopaedic trauma patients with an isolated injury requiring surgery
- Informed consent obtained
- Functioning cellphone
Exclusion Criteria for Clinical Trial Portion of this Study:
- Enrolled in a study that does not permit co-enrollment
- Unlikely to comply with the follow-up schedule
- Unable to converse, read or write English or Spanish at elementary school level
- Unlikely to complete surveys at home, access to phone
- Unlikely to respond to opioid utilization text messaging (SMS)
- Incarcerated
- Pregnant
Data sourced from ClinicalTrials.gov (NCT04154384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.