Shared Decision Making in Pain Management Planning in Patients With Cancer



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:October 1, 2017
End Date:April 30, 2019
Contact:Kristy Birchard
Email:kristy.birchard@carevive.com
Phone:800-460-3760

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The goal of this project is to evaluate the effectiveness of shared-decision-making (SDM) to
manage chronic and breakthrough pain in patients with cancer. Providers will receive
evidence-based education on shared decision-making strategies and comprehensive pain
management at study start up. In addition, the information will be available on the Carevive
platform for reference at the point of care. This multisite study will enroll 105 patients
from three cancer institutions. This project will explore the SDM model using a
touchscreen-based expanded pain assessment (EPA) to evaluate the impact of the
shared-decision-making model on pain management, and explore its relationship to pain
management care planning. Patients will use the Carevive Systems software in the clinic to
answer questions regarding decision making preferences and complete a comprehensive
assessment of their pain status. Treatment recommendations and a care plan will be provided
to the patient at the time of the visit. At each clinic visit over 4 months, the patient will
again complete the pain assessment and receive appropriate treatment recommendations and a
revised care plan.

Cancer-related pain is a significant clinical challenge that impacts patient outcomes and
remains a significant problem for patients with cancer and their providers. The overall
prevalence of cancer pain is high; a recent meta-analysis of 52 studies reported cancer pain
prevalence ranging between 52%-77%. Another update reports rates of 39% after curative
treatment, 55% during treatment, and 66% in advanced, metastatic or terminal disease.
Moderate to severe pain was reported by 38% of all patients. Cancer pain may be cancer
related, due to tumor burden causing bone, nerve, and/or organ compression, and/or treatment
related, due to procedures, surgery, and side effects of chemotherapy or radiation. The
prevalence of pain after breast cancer treatment ranges from 13%-93%; women with metastatic
breast cancer often have bone pain from metastases and bisphosphonates. In a nationwide lung
cancer study (N = 450), pain was reported by 92% of patients with advanced (stage IIIB/IV)
NSCLC. Similar reports indicate pain ranges from 74% to 92%. Uncontrolled pain is the most
common chief complaint of unplanned hospitalizations and readmissions. One study reported
over half of the chief complaints provided by breast cancer patients with an emergency
department (ED) visit were related to poorly controlled pain, respiratory or gastrointestinal
symptoms. Finally, there is evidence that high symptom burden and poor management of symptoms
and side effects also leads to suboptimal adherence to therapy.

Management of cancer pain requires that the patient be screened for the presence of pain at
every clinical contact. A comprehensive assessment should be conducted if the patient is
experiencing pain, including specific questions about location, duration, severity, quality,
timing, duration, and impact on quality of life. A thorough understanding of pain also
considers the temporal characteristics of the pain experience, determining if the pain is
intermittent, that is bursts of severe pain without persistent chronic pain, persistent, with
moderate to severe pain present throughout the day, and/or breakthrough pain described as the
transient exacerbation of pain despite adequately controlled persistent pain. Breakthrough
pain is reported to occur daily in 21%-70% of patients.

The prevalence of psychosocial and physical symptom distress in cancer is so compelling that
the Commission on Cancer, the Oncology Nursing Society (ONS), American Society of Clinical
Oncology (ASCO), and the National Committee for Quality Assurance (NCQA)'s Patient-Centered
Oncology Care Standards all require distress screening that includes pain screening and
assessment as a quality mandate in their accreditation and quality certification programs. In
addition, the Centers for Medicare and Medicaid Services (CMMS)'s Oncology Care Model (OCM)
requires a care management plan that includes symptom management. Included as quality
measures are NQF384, pain intensity quantified, and NQF 383, plan of care for pain. In
addition, value based care payment models seek to decrease emergency department (ED) visits
and hospitalization days.

Carevive recently completed a project designed to improve adherence to quality metrics in
breast cancer through education plus use of a tablet-based technology to screen for and
manage identified distress, pain, and other breast cancer quality indicators available within
ASCO's Quality Oncology Practice Initiative (QOPI) program. The Breast National Quality
Standards project used QOPI metrics to evaluate outcomes of a CME intervention and use of the
Carevive CPS. Preliminary data from this project showed improvement in key areas. Provider
adherence to quality metrics was measured in 151 non-metastatic BC patients, 77 of which
served as historical controls with no CME/clinical intervention, and 74 received the
intervention after their provider participated in certified continuing medical education
(CME) activities designed to educate about evidence-based assessment, decision-making, and
management strategies for BC patients. Preliminary analysis showed that the intervention
improved provider adherence to four pain quality measures: a. pain assessed by second office
visit, b) pain intensity quantified by second office visit, c) plan of care documented, and
d) pain assessed on either of the two most recent office visits. This project will build on
that work to incorporate a comprehensive assessment and a more multi-faceted intervention
that engages the care team in a SDM process around cancer pain management.

Along with an imperative to formalize a pain management plan is the rising importance of
incorporating shared-decision-making, the cornerstone of patient centered care, into all care
decisions. When making treatment decisions, the provider must incorporate current literature,
patients' current clinical status, and patient preferences. One challenge with measuring
quality through electronic chart abstraction is the difficulty of identifying when patient
preference has influenced treatment decisions. Little data currently exist on the level of
patient engagement in decision-making for pain management and the perception of patients with
MBC, LC, or AC of shared-decision-making in developing a pain management care plan. Dr.
Jeannine Brant and colleagues have developed the Pain Care Quality Survey (PainCQ©). The
PainCQs are two tools that measure the quality of nursing and interdisciplinary care related
to pain management as perceived by hospitalized individuals. These tools will be modified in
this project to capture the variable contributions of different members in the care team,
including oncology nursing staff.

Strategies to better manage chronic and breakthrough cancer pain are critical. Many cancer
centers have incorporated distress screening using either the National Comprehensive Cancer
Network (NCCN) Distress Thermometer or the Edmonton Symptom Assessment Scale (ESAS) tools.
However, structured processes are typically lacking within the clinical workflow to
seamlessly integrate and conduct a more in-depth assessment of those patients who score
positively for pain. Processes and technologies that facilitate better integration of pain
assessment and pain management care strategies into the oncology team's clinical workflow,
while simultaneously integrating algorithms for treatment of pain have the potential to
further drive evidence-based care.

Inclusion Criteria:

- All participants must be 18 years of age or older.

- Patient participants must have a diagnosis of cancer

- Patients must have screened positive for pain per a previous clinical assessment

- All participants must be able to understand English.

Exclusion Criteria:

- Any patient who cannot understand written or spoken English.

- Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B,
C and D).
We found this trial at
1
site
801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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mi
from
Billings, MT
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