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Effective Screening for Pain Study (ESP)

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ClinicalTrials.gov Identifier: NCT01816763
Recruitment Status : Completed
First Posted : March 22, 2013
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease Intervention/treatment Phase
Pain Pain Management Behavioral: NRS pain one week Behavioral: PEG Behavioral: DVPRS Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 569 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effective Screening for Pain Study
Study Start Date : June 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Arm Intervention/treatment
Experimental: tablet based NRS pain one week, followed by nurse pain screen
tablet-based patient self-report of the 'NRS pain one week'
Behavioral: NRS pain one week
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.

Experimental: tablet based PEG, followed by nurse pain screen
tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference)
Behavioral: PEG
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.

Experimental: DVPRS, followed by nurse pain screen
Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now
Behavioral: DVPRS
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.




Primary Outcome Measures :
  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) [ Time Frame: Baseline (e.g., time of clinic visit) measures were cross sectionally assessed ]
    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.


Secondary Outcome Measures :
  1. Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Differences in Number of Individuals Who Failed to Complete Pain Screen [ Time Frame: Baseline cross sectional comparison at the time of clinic visit ]
    Number of persons who failed to complete (NRS and PEG and DVPRS measures). the measures vary in complexity as the NRS is one item, the PEG 3 items, and the DVPRS includes 10 items integrating color, faces pain, function, and intensity descriptions of pain. Measures are fully described in Outcome 1 description.

  2. 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 [ Time Frame: Baseline cross-sectional comparison at time of clinic visit ]
    descriptive analysis comparing overall pain rated by the three measures at Baseline (NRS, PEG, DVPRS), two of which include function (PEG and DVPRS), using the outcome of pre-specified single item of self-reported function compared to one's peers as validated by Gill et. al.. All pain outcome measures (NRS, PEG, DVPRS) are described fully in Outcome 1. Gill single item is not otherwise formally named. It is a 3 item scale querying "self rated activity level relative to peers" where the categories include "less active, about as active, and more active" and is scored as a categorical 0-2 rating where 2 is optimal and 0 is worst relative function.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816763


Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, Oregon
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Karl A. Lorenz, MD MSHS VA Palo Alto Health Care System, Palo Alto, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol  [PDF] July 1, 2018
Statistical Analysis Plan  [PDF] July 1, 2018


Publications of Results:
Other Publications:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01816763     History of Changes
Other Study ID Numbers: CRE 12-030
First Posted: March 22, 2013    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VA Office of Research and Development:
Health Care Quality, Access, and Evaluation
Primary Health Care
Medical Informatics