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Pain | Effective Screening for Pain Study

Pain research study

What is the primary objective of this study?

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 nurse documented NRS now, a tablet computer-based NRS one week, and a tablet computer-based PEG.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Pain Management

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:NRS pain nowEligible patients will be randomly assigned to complete a patient-reported 'NRS now' on a kiosk prior to making contact with a nursing staff vital signs screener.

Behavioral:PEGEligible patients will be assigned to complete a patient-reported enhanced pain screening with the PEG on a tablet prior to making contact with a nursing staff vital signs screener.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

tablet based NRS pain now, followed by nurse pain screentablet-based patient self-report of the 'NRS pain now'

tablet based PEG, followed by nurse pain screentablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference)

tablet based health reminder, followed by nurse pain screenUnrelated health reminder on tablet followed by usual nursing staff documented pain screening with NRS pain now

Study Status

Enrolling by invitation

Start Date: June 2015

Completed Date: December 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Arm 1 (NRS now), to arm 2 (PEG), to arm 3 (usual care) pairwise difference scores in baseline and pain disability detection at one week, and satisfaction with pain management at one week

Secondary Outcome: Arm 1 (NRS now), to arm 2 (PEG), to arm 3 (usual care) pairwise differences in pain missingness and rating variability

Study sponsors, principal investigator, and references

Principal Investigator: Karl A. Lorenz, MD MSHS

Lead Sponsor: VA Office of Research and Development

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01816763

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