Effective Screening for Pain Study

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 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 nurse documented NRS now, a tablet computer-based
NRS one week, and a tablet computer-based PEG.

Objectives:

1) Qualitatively evaluate Veteran and multidisciplinary provider perspectives on pain
screening and the use of the NRS vs. the PEG items, point of care vs. mobile reporting,
clinician-assessed vs. patient-reported pain, and usefulness of medical chart and
patient-derived health information in screening, assessment, management, and follow-up of
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 usual 5th vital sign (Arm 3). Also
pain, self-reported disability, and Veteran satisfaction with pain screening mode for chronic
pain detection.

2b) Informed by Aims 1 and 2a, qualitatively evaluate provider perspectives on different pain
reports and features of informatics prototypes 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') compared with the NRS
one week (Arm 3), 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 Aim 1 data collection, coding, and analyses. They have
presented some findings as conference posters and presentations at two conferences. Two
manuscripts are currently under review and others are being prepared for submission.

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.

For Aim 2b, the investigators have completed qualitative semi-structured interviews with
providers about their perspectives on pain reporting processes, and have begun analyzing
those transcripts. The investigators have conducted several interviews with patients and will
continue collecting and analyzing those interviews.

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