A Proactive Walking Trial to Reduce Pain in Black Veterans



Status:Recruiting
Healthy:No
Age Range:18 - 90
Updated:3/22/2019
Start Date:July 1, 2016
End Date:February 27, 2020
Contact:Diana J Burgess, PhD
Email:diana.burgess@va.gov
Phone:(612) 467-1591

Use our guide to learn which trials are right for you!

The long term goal is to improve the quality and equity of chronic pain treatment among VA
patients. The primary objective of this study is to improve pain outcomes among black VA
patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and
outcomes than their white counterparts. The work proposed is expected to result in a
non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve
functioning among black patients with MSK pain, by promoting walking. This intervention is
specifically designed to address factors that contribute to MSK pain among black Veterans;
however, the investigators expect that it will also benefit non-black Veterans. The proposed
research is innovative, in its use of proactive outreach and recent advances in
self-regulation strategies (such as Action Planning) to help black Veterans overcome
psychological, environmental, utilization-related, and provider-related barriers that
contribute to pain.

BACKGROUND/RATIONALE:

Chronic musculoskeletal (MSK) pain is one of the most common conditions among Veterans,
affecting approximately 60% of those seen in VA primary care. Although perceived
effectiveness of chronic pain treatment is low among all VA patients, black patients are less
likely than whites to perceive their treatment as effective, and are more likely to
experience functional limitations due to pain. There is growing consensus that chronic pain
is best addressed by a biopsychosocial approach that acknowledges the role of psychological
and environmental contributors to pain, some of which differ by race and hence contribute to
disparities. For example, blacks experience greater pain-related fear and lower self-efficacy
in coping with pain (psychological contributors), and neighborhoods that make physical
activity difficult (environmental contributors). However, there is a lack of effective
interventions to improve pain treatment among minority patients, particularly those that
target psychological and environmental contributors.

OBJECTIVES:

The long term goal is to improve the quality and equity of pain treatment in order to improve
pain outcomes for all Veterans. The objective of this application is to test the
effectiveness of a multi-component intervention that specifically targets known barriers to
effective pain care among black Veterans with chronic MSK pain. The primary hypothesis is
that a telephone-delivered intervention, which emphasizes walking and incorporates Action
Planning, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) techniques,
and the use of pedometers, will improve core chronic pain outcomes in black Veterans.
Secondarily, we will determine whether our intervention also benefits non-black patients with
MSK.

METHODS:

The investigators propose a randomized trial to test the effectiveness of the intervention
compared with usual care (UC) among 250 black and 250 non-black patients with chronic MSK
pain. Patients from the Atlanta VAMC will be identified using administrative data. Patients
will be screened by phone, and, if eligible, will be mailed the baseline survey to complete
and mail back. Eligible patients who complete the baseline survey will be randomly assigned
to the usual care (UC) or intervention condition (IC). Intervention participants will receive
a pedometer-mediated walking intervention that will incorporate Action Planning and the use
of MI and CBT techniques. The intervention will be delivered in 6 telephone counseling
sessions over three months. Patients in the UC condition will receive an informational
brochure and a pedometer. The study is powered to find a difference between the IC and UC
groups within the black and non-black groups. The primary outcome is chronic pain-related
physical functioning, assessed by the revised Roland and Morris Disability Questionnaire, a
measure recommended by the Initiative on Methods, Measurement, and Pain Assessment in
Clinical Trials (IMMPACT). We will also examine whether the intervention improves other
IMMPACT-recommended domains (pain intensity, emotional functioning, and ratings of overall
improvement). Secondary objectives include examining potential mediators targeted by the
intervention, exploring whether the intervention affects service utilization and use of
opioid analgesics, and exploring whether the intervention reduces racial disparities in pain
outcomes. Measures will be assessed by mail and phone survey at baseline, 3 months, and 6
months. Data analysis of primary aims will follow intent-to-treat methodology.

FINDINGS:

None at this time.

STATUS:

Focus groups were conducted at the Atlanta VAMC in September and October 2015. These focus
groups provided valuable information that led us to refine our recruitment materials. Focus
groups also yielded important information for our counselors, including potential
communication barriers and barriers to walking. During January - April 2016, we conducted a
pilot test of our intervention with 3 participants. We began the trial on July 2016, and it
is currently ongoing.

IMPACT:

The work proposed is expected to result in a non-pharmacological intervention, delivered by
telephone, designed to reduce pain and improve functioning among black patients with MSK
pain, by promoting walking.

Inclusion Criteria:

- Eligible patients must receive care at the Atlanta VAMC and

- have back, hip or knee pain for a duration of at least 6 months,

- moderate-severe pain intensity and interference with function (defined as a PEG score
of 5 or greater),

- self-reported ability to walk at least 1 block, and

- must be able to communicate effectively by telephone (no cognitive disability). The
investigators will not exclude patients who are on medication or receiving
interventions to treat their chronic pain. The investigators will include the
approximately 10% of patients who have no race data; race data will be collected on
the brief screening survey.

Exclusion Criteria:

The investigators will not include any vulnerable populations or those who meet any of the
following exclusion criteria that may interfere with the outcome assessment: a) moderately
severe cognitive impairment defined as > 2 errors on a brief cognitive screener; b)
anticipated back, knee, hip, or other major surgery within the next 6 months; c) patients
who say they are unable to walk at least a block; d) patients who say they would be
unavailable to participate in a 6 month study; e) patients with active psychotic symptoms,
suicidality, and/or active manic episode or poorly controlled bipolar disorder, as
determined by chart review.
We found this trial at
1
site
Minneapolis, Minnesota 55417
Phone: 612-467-2781
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials