Trial Outcomes & Findings for Effective Screening for Pain Study (NCT NCT01816763)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

569 participants

Primary outcome timeframe

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

Results posted on

2019-07-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Tablet Based NRS Pain Now, Followed by Nurse Pain Screen tablet-based patient self-report of the 'NRS pain now' NRS pain now: Eligible patients will be randomly assigned to complete a patient-reported 'NRS now' on a tablet prior to making contact with a nursing staff vital signs screener.	Tablet Based PEG, Followed by Nurse Pain Screen tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference) 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.	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 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.
Overall Study STARTED	195	194	180
Overall Study COMPLETED	191	179	169
Overall Study NOT COMPLETED	4	15	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Tablet Based NRS Pain Now, Followed by Nurse Pain Screen tablet-based patient self-report of the 'NRS pain now' NRS pain now: Eligible patients will be randomly assigned to complete a patient-reported 'NRS now' on a tablet prior to making contact with a nursing staff vital signs screener.	Tablet Based PEG, Followed by Nurse Pain Screen tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference) 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.	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 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.
Overall Study The main reason for an incomplete survey	4	15	11

Baseline Characteristics

Effective Screening for Pain Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tablet Based NRS Pain Now, Followed by Nurse Pain Screen n=195 Participants tablet-based patient self-report of the 'NRS pain now' NRS pain now: Eligible patients will be randomly assigned to complete a patient-reported 'NRS now' on a tablet prior to making contact with a nursing staff vital signs screener.	Tablet Based PEG, Followed by Nurse Pain Screen n=194 Participants tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference) 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.	DVPRS, Followed by Nurse Pain Screen n=180 Participants Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now 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.	Total n=569 Participants Total of all reporting groups
Age, Continuous	60.5 years STANDARD_DEVIATION 15.2 • n=5 Participants	62.3 years STANDARD_DEVIATION 15.7 • n=7 Participants	59.9 years STANDARD_DEVIATION 16.0 • n=5 Participants	60 years STANDARD_DEVIATION 16 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants	74 Participants n=4 Participants
Sex: Female, Male Male	169 Participants n=5 Participants	180 Participants n=7 Participants	146 Participants n=5 Participants	495 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	174 Participants n=5 Participants	172 Participants n=7 Participants	165 Participants n=5 Participants	511 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	47 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tablet Based NRS Pain Now n=195 Participants tablet-based patient self-report of the 'NRS pain now' NRS pain now: Eligible patients will be randomly assigned to complete a patient-reported 'NRS now' on a tablet prior to making contact with a nursing staff vital signs screener.	Tablet Based PEG n=194 Participants tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference) 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.	DVPRS n=180 Participants Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now 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.
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 units on a scale Standard Deviation 2.81	4.32 units on a scale Standard Deviation 3	4.06 units on a scale Standard Deviation 2.75

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tablet Based NRS Pain Now n=190 Participants tablet-based patient self-report of the 'NRS pain now' NRS pain now: Eligible patients will be randomly assigned to complete a patient-reported 'NRS now' on a tablet prior to making contact with a nursing staff vital signs screener.	Tablet Based PEG n=194 Participants tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference) 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.	DVPRS n=180 Participants Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now 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.
Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Differences in Number of Individuals Who Failed to Complete Pain Screen	4 participants	15 participants	11 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tablet Based NRS Pain Now n=109 Participants tablet-based patient self-report of the 'NRS pain now' NRS pain now: Eligible patients will be randomly assigned to complete a patient-reported 'NRS now' on a tablet prior to making contact with a nursing staff vital signs screener.	Tablet Based PEG n=122 Participants tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference) 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.	DVPRS n=101 Participants Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now 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.
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 participants	60 participants	48 participants

Adverse Events

Tablet Based NRS Pain Now, Followed by Nurse Pain Screen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tablet Based PEG, Followed by Nurse Pain Screen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DVPRS, Followed by Nurse Pain Screen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karl Lorenz MD MSHS, Principal Investigator

VA Palo Alto

Phone: 6504935000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place