An interventional study of NRS pain one week and PEG in Pain and Pain Management, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-19.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
Background:
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 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 pain now.
Objectives:
2b) Informed by Aims 1 and 2a, qualitatively evaluate provider perspectives on different pain reports to facilitate better pain management.
Methods:
The investigators are conducting a two phase mixed method study that will build on prior work to develop and test enhanced pain screening approaches for primary care and Patient Aligned Care Teams (PACTs). In the first (development) phase of the study, the investigators will conduct semi-structured qualitative interviews and focus groups with primary care clinicians, other primary care team members including non-provider staff, and primary care Veteran patients, to understand what patient-reported pain assessment data are most useful for clinical decision-making and how this pain information can best be integrated into primary care team processes, including the role of informatics to optimize primary care pain management and link pain screening to management. This will inform the development of the enhanced pain screening approaches used in the Aim 2 randomized controlled trial (RCT). The investigators will also submit the enhanced tablet-based pain screening approaches to usability testing by the University of California Office of Information Technology.
The second (testing) phase of the study will include a multisite RCT to test the final enhanced pain screening approaches (Arm 1 PEG; Arm 2 NRS 'pain now', Arm 3 DVPRS) compared with the NRS one week (all Arms), on patient and primary care clinician outcomes. The investigators will assess whether the approaches improve detection of pain-related impairment, and also the feasibility, acceptability, and provider and patient experience with enhanced screening.
Status:
The investigators have completed data collection, coding, and analyses for all Aims. They have presented some findings as conference posters and presentations and published several manuscripts.
Findings from Aim 1 were used to guide the development of a tablet-based pain screening survey that the investigators tested in Aim 2a as a randomized control trial. The investigators have have completed data collection, and are currently analyzing results.
VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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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:
tablet-based patient self-report of the 'NRS pain one week'
Behavioral: NRS pain one week
tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference)
Behavioral: PEG
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 'NRS one week' on a tablet prior to making contact with a nursing staff vital signs screener.
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.
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.
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.
Time frame: Baseline (e.g., time of clinic visit) measures were cross sectionally assessed
Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Differences in Number of Individuals Who Failed to Complete Pain Screen
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.
Time frame: 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
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.
Time frame: Baseline cross-sectional comparison at time of clinic visit
Research Assistants approached patients in the waiting rooms of primary care clinics (including women's health primary care clinics) at VA Palo Alto, Minneapolis, and Portland and queried them about their eligibility.
| Milestone | Tablet Based NRS Pain Now, Followed by Nurse Pain Screen | Tablet Based PEG, Followed by Nurse Pain Screen | DVPRS, Followed by Nurse Pain Screen |
|---|---|---|---|
| Started | 195 | 194 | 180 |
| Completed | 191 | 179 | 169 |
| Not completed | 4 | 15 | 11 |
| Withdrew: The main reason for an incomplete survey | 4 | 15 | 11 |
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.
| units on a scale | Tablet Based NRS Pain Now | Tablet Based PEG | DVPRS |
|---|---|---|---|
| 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 ± 2.81 | 4.32 ± 3 | 4.06 ± 2.75 |
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.
| participants | Tablet Based NRS Pain Now | Tablet Based PEG | DVPRS |
|---|---|---|---|
| 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 |
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.
| participants | Tablet-based NRS Pain Now | Tablet-based PEG | DVPRS |
|---|---|---|---|
| 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 |
Collected over During baseline data collection for each participant. There was no study observation period or followup because the intervention was a screening tool administered as part of the baseline interview.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tablet Based NRS Pain Now, Followed by Nurse Pain Screen | 0/195 (0%) | 0/195 (0%) | 0/195 (0%) |
| Tablet Based PEG, Followed by Nurse Pain Screen | 0/194 (0%) | 0/194 (0%) | 0/194 (0%) |
| DVPRS, Followed by Nurse Pain Screen | 0/180 (0%) | 0/180 (0%) | 0/180 (0%) |
| Age, Continuous(years) | Tablet Based NRS Pain Now, Followed by Nurse Pain Screen | Tablet Based PEG, Followed by Nurse Pain Screen | DVPRS, Followed by Nurse Pain Screen | Total |
|---|---|---|---|---|
| Mean | 60.5 ± 15.2 | 62.3 ± 15.7 | 59.9 ± 16.0 | 60 ± 16 |
| Sex: Female, Male(Participants) | Tablet Based NRS Pain Now, Followed by Nurse Pain Screen | Tablet Based PEG, Followed by Nurse Pain Screen | DVPRS, Followed by Nurse Pain Screen | Total |
|---|---|---|---|---|
| Female | 26 | 14 | 34 | 74 |
| Male | 169 | 180 | 146 | 495 |
| Ethnicity (NIH/OMB)(Participants) | Tablet Based NRS Pain Now, Followed by Nurse Pain Screen | Tablet Based PEG, Followed by Nurse Pain Screen | DVPRS, Followed by Nurse Pain Screen | Total |
|---|---|---|---|---|
| Hispanic or Latino | 5 | 5 | 1 | 11 |
| Not Hispanic or Latino | 174 | 172 | 165 | 511 |
| Unknown or Not Reported | 16 | 17 | 14 | 47 |
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