N/A
N=569
Effective Screening for Pain Study
Pain · Pain Management
Bottom Line
View on ClinicalTrials.gov: NCT01816763 ↗Enrolled (actual)
569
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (Defense Veterans Pain Rating Scale (e.g.,DVPRS) Differences Baseline Overall Pain Compared With Gold Standard Chronic Pain Grade Questionnaire Intensity Subscale Items (e.g., CPG Scale, Pain Intensity) — 4.43; 4.32; 4.06 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NRS pain one week (Behavioral); PEG (Behavioral); DVPRS (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (Defense Veterans Pain Rating Scale (e.g.,DVPRS) Differences Baseline Overall Pain Compared With Gold Standard Chronic Pain Grade Questionnaire Intensity Subscale Items (e.g., CPG Scale, Pain Intensity) |
4.43; 4.32; 4.06 | — |
| SECONDARY Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Differences in Number of Individuals Who Failed to Complete Pain Screen |
4; 15; 11 | — |
| SECONDARY Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Number of Participants Who Rated Overall Functional Status Worse Relative to Peers Using the Gill Single Item Questionnaire |
50; 60; 48 | — |
Summary
In light of the importance of pain and widespread interest in patient-centeredness, the Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its management a routine feature of the health record and a focus of care. Awareness of pain and efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and practice of nursing staff routinely screening for 'pain now' at every health encounter using a 0-10 Numeric Rating Scale (NRS).
The team's previous research on VA's '5th Vital Sign' informs the specific design of this Effective Screening for Pain (ESP) study as well as the proposed research products.
Alternatives to the current pain screening approach may improve the sensitivity and specificity of screening for chronic pain. These alternatives include the nurse administered NRS with a one week look back period and a three item scale (PEG) incorporating intensity and emotional and physical interference. The PEG is very similar to the gold standard Brief Pain Inventory (BPI) from which it is derived, in its sensitivity, specificity, and sensitivity to change in detecting clinically important, functionally impairing pain.
The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for pain screening, focusing on simple, feasible measures that can be used cross-sectionally for pain screening. In the setting of a primary care clinic, the investigators plan to cross-sectionally evaluate three arms - a tablet based DVPRS, a tablet computer-based NRS one week, and a tablet computer-based PEG. All arms will be compared with the nurse administered NRS.
Eligibility Criteria
Inclusion Criteria
- All Veterans are eligible to participate in the clinical trial when presenting for routine care in the primary care clinic at all sites (VA at Palo Alto, Minneapolis, and Portland).
- All are eligible who do not opt out of participation.
- All participants in the baseline tablet intervention will also be eligible for a one week follow up telephone interview - unless they are unable to complete a phone interview (see exclusions).
- For the qualitative Veteran component, all Veterans who can hear and respond in an interview are eligible.
- Providers/staff must be clinic and facility staff including administrative clerks, regular part time or full time employees in primary care who routinely participate in the care of Veterans who have painful conditions.
Exclusion Criteria
- Veterans who meet either of the following exclusion criteria that may interfere with outcome assessment will be ineligible for the follow up telephone interview:
- a) no working telephone (home, office, or mobile)
- b) hearing impaired and unable to complete a phone survey
Data sourced from ClinicalTrials.gov (NCT01816763). 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.