Effective Screening for Pain Study

Pain Clinical Trial

— ESP  

Official title:

Effective Screening for Pain Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816763
• Other study ID #: CRE 12-030
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: May 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

1) Qualitatively evaluate Veteran and multidisciplinary provider perspectives on pain screening and the use of the NRS vs. the PEG items, clinician-assessed vs. patient-reported pain 2a) Quantitatively assess, in a 3-arm randomized controlled primary care clinical team-based trial using tablets, the feasibility and completion rates, validity, and variability of pain information obtained comparing: Tablet-based vs. nurse-documented pain (e.g., 5th vital sign by tablet vs. clinician assessed) and the rate and severity of pain detected in tablet-based 'NRS one week' (Arm 1), tablet-based PEG (Arm 2), and DVPRS (Arm 3). Also pain, self-reported disability.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 569
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Pain Management

Intervention

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.
• 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
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.

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. 2017 Oct 20. doi: 10.1093/pm/pnx220. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline cross sectional comparison at the time of clinic visit
Secondary	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.	Baseline cross-sectional comparison at time of clinic visit