Effective Screening for Pain Study

NCT01816763 | Completed Results

• 1 other identifier: CRE 12-030
• Study Type: interventional
• Target: 569
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pain; Pain Management

Keywords

Health Care Quality, Access, and Evaluation; Primary Health Care; Medical Informatics

Outcome Measures

Primary Outcomes (1)

• 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)

  pain (Numeric Rating Scale - NRS and PEG (full scale name) and Defense Veterans Pain Rating Scale - DVPRS measures) using overall pain derived from each of the three measures compared cross sectionally with the three pain intensity items and scale of the Chronic Pain Grade (CPG) questionnaire. The latter addresses pain 'now', average pain, and worst pain. All measures (NRS, PEG, DVPRS, and CPG) are scored from 0-10 where 0 equals no pain and 10 equals worst possible pain.). the NRS is a one item pain intensity measure, the PEG is a 3 item measure combining pain intensity, pain-related emotional and functional interference, and the DVPRS integrates pain intensity, pain interference, faces pain, and colormetric indicators on a 0-10 overall pain scale. The study used no subscales for the NRS, PEG, or DVPRS, and all values reported are total measure scores, computed as the average of items. We compare them to the pain intensity score of the CPG. Higher scores signify worse pain.

  Baseline (e.g., time of clinic visit) measures were cross sectionally assessed

Secondary Outcomes (2)

• Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Differences in Number of Individuals Who Failed to Complete Pain Screen

  Baseline cross sectional comparison at the time of clinic visit

• 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

  Baseline cross-sectional comparison at time of clinic visit

Study Arms (3)

tablet based NRS pain one week, followed by nurse pain screen

EXPERIMENTAL

tablet-based patient self-report of the 'NRS pain one week'

Behavioral: NRS pain one week

tablet based PEG, followed by nurse pain screen

EXPERIMENTAL

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

Behavioral: PEG

DVPRS, followed by nurse pain screen

EXPERIMENTAL

Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now

Behavioral: DVPRS

Interventions

NRS pain one week BEHAVIORAL

Eligible patients will be randomly assigned to complete a patient-reported 'NRS one week' on a tablet prior to making contact with a nursing staff vital signs screener.

tablet based NRS pain one week, followed by nurse pain screen

PEG BEHAVIORAL

Eligible 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.

tablet based PEG, followed by nurse pain screen

DVPRS BEHAVIORAL

Eligible patients will be randomly assigned to complete a patient-reported 'DVPRS' on a tablet prior to making contact with a nursing staff vital signs screener.

DVPRS, followed by nurse pain screen

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• a) no working telephone (home, office, or mobile)
• b) hearing impaired and unable to complete a phone survey

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (7)

• Giannitrapani KF, Ahluwalia SC, McCaa M, Pisciotta M, Dobscha S, Lorenz KA. Barriers to Using Nonpharmacologic Approaches and Reducing Opioid Use in Primary Care. Pain Med. 2018 Jul 1;19(7):1357-1364. doi: 10.1093/pm/pnx220.

  PMID: 29059412 BACKGROUND

• Haverfield MC, Giannitrapani K, Timko C, Lorenz K. Patient-Centered Pain Management Communication from the Patient Perspective. J Gen Intern Med. 2018 Aug;33(8):1374-1380. doi: 10.1007/s11606-018-4490-y. Epub 2018 May 29.

  PMID: 29845465 BACKGROUND

• Giannitrapani K, McCaa M, Haverfield M, Kerns RD, Timko C, Dobscha S, Lorenz K. Veteran Experiences Seeking Non-pharmacologic Approaches for Pain. Mil Med. 2018 Nov 1;183(11-12):e628-e634. doi: 10.1093/milmed/usy018.

  PMID: 29590422 BACKGROUND

• Ahluwalia SC, Giannitrapani KF, Dobscha SK, Cromer R, Lorenz KA. "It Encourages Them to Complain": A Qualitative Study of the Unintended Consequences of Assessing Patient-Reported Pain. J Pain. 2018 May;19(5):562-568. doi: 10.1016/j.jpain.2017.12.270. Epub 2018 Feb 5.

  PMID: 29421247 BACKGROUND

• Giannitrapani KF, Day RT, Azarfar A, Ahluwalia SC, Dobscha S, Lorenz KA. What Do Providers Want from a Pain Screening Measure Used in Daily Practice? Pain Med. 2019 Jan 1;20(1):68-76. doi: 10.1093/pm/pny135.

  PMID: 30085285 BACKGROUND

• Giannitrapani KF, Glassman PA, Vang D, McKelvey JC, Thomas Day R, Dobscha SK, Lorenz KA. Expanding the role of clinical pharmacists on interdisciplinary primary care teams for chronic pain and opioid management. BMC Fam Pract. 2018 Jul 3;19(1):107. doi: 10.1186/s12875-018-0783-9.

  PMID: 29970008 BACKGROUND

• Giannitrapani KF, Ahluwalia SC, Day RT, Pisciotta M, Dobscha S, Lorenz K. Challenges to teaming for pain in primary care. Healthc (Amst). 2018 Mar;6(1):23-27. doi: 10.1016/j.hjdsi.2017.06.006. Epub 2017 Jul 13. No abstract available.

  PMID: 28711504 RESULT

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Karl Lorenz MD MSHS, Principal Investigator
• Organization: VA Palo Alto

kalorenz@stanford.edu

6504935000

Study Officials

• Karl A. Lorenz, MD MSHS

  VA Palo Alto Health Care System, Palo Alto, CA

  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: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 22, 2013
• Study Start: June 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)