Clinical trial NCT02136108: Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN)
Official title: Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Complementary and alternative therapies
Mobile health
Medicaid
Patient navigation
Lead sponsor: Inflexxion, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Lifespan
name: Rhode Island Hospital
name: The Miriam Hospital
First posted: 2014-05-12
Enrollment: 197
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The OPEN study has two aims: The first is to identify what helps to keep patients involved with a Medicaid chronic pain management program and to identify features of an ideal text-message-based program for people enrolled in the program. The second aim is to develop the text-message-based program (OPENtext), then find out how useful this intervention is compared to a patient navigator intervention (OPENnav) for increasing patient engagement, improving patient's motivation to manage their chronic pain, and improving patient confidence in self-managing their chronic pain condition.

Detailed description: Chronic pain is a condition that affects the most fundamental aspects of quality of life. Treatment for chronic pain is challenging and usually takes the form of opioid medication therapy. But chronic opioid therapy is also associated with high rates of emergency department use, drug diversion, addiction, and unintentional overdose deaths. The new RI Medicaid Chronic Pain Initiative (CPI) targets patients who are both high emergency department users and experiencing chronic pain. In the CPI, patients can be prescribed an integrated treatment plan of massage, chiropractic, or acupuncture therapies. This is a novel approach to chronic pain care, but retention and patient engagement are low. It is important to understand why involvement in the CPI is low, how to improve the patient experience, and how to support the prescribed CAM therapies.

This study has two aims: The first is to identify what helps to keep patients involved with the CPI program and to identify features of an ideal text-message-based program for people enrolled in the CPI. The second aim is to develop the text-message-based program (OPENtext), then find out how useful this intervention is compared to a patient navigator intervention (OPENnav) for increasing patient engagement, improving patient's motivation to manage their chronic pain, and improving patient confidence in self-managing their chronic pain condition.

Investigators will conduct qualitative interviews with patients, providers, and administrators. Goals of the interviews will be: to understand the patient experience in the CPI, including experiences with the navigation approach currently in place; to identify barriers and facilitators to CPI participation; and to learn how technology-especially cell phone text-messaging-could help support pain care and CPI engagement. These interviews will help develop a text-message-based intervention and provide feedback to existing patient navigator programming. Next, investigators will develop and test the text-message patient support intervention that will contain patient-identified topics and concerns that emerge from the qualitative interviews and topic areas discussed by a stakeholder Advisory Board. Theories of behavior change will be used to help with message development, and patients will take part in helping to test and fine-tune the intervention. Last, investigators will compare the text-message and patient navigation interventions in a randomized controlled study with 200 patients over a six-month period. Investigators will see which approach helps patients increase their involvement in the CPI and better manage their chronic pain. If successful, chronic pain patients across Medicaid programs could benefit from use of the patient navigation or the text-message intervention.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the Rhode Island Medicaid Chronic Pain Initiative program

Exclusion Criteria:

* Do not speak English

Primary outcomes:
measure: Change in Engagement
timeFrame: Once per month for 6 months
measure: Readiness to Change
timeFrame: At baseline, 3 months, and 6 months post-randomization
measure: Change in Self-Efficacy
timeFrame: At baseline, 3 months, and 6 months post-randomization
Secondary outcomes:
measure: Pain Severity
timeFrame: At baseline, 3 months, and 6 months post-randomization
measure: Quality of Life
timeFrame: At baseline, 3 months, and 6 months post-randomization
measure: Pain Medication Use
timeFrame: At baseline, 3 months, and 6 months post-randomization
measure: Likelihood of Misusing Opioid Medication
timeFrame: At baseline, 3 months, and 6 months post-randomization
measure: Safety and Aberrant Pain Medication Use Behaviors
timeFrame: At baseline, 3 months, and 6 month post-randomization
measure: Acceptance & Satisfaction
timeFrame: At 9-month follow up
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Inflexxion, Inc., Brown University, and Rhode Island Hospital
name: Traci Green, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital and Brown University
name: Megan Ranney, MD
role: STUDY_CHAIR
affiliation: Independent Consultant
name: Elizabeth Donovan, PhD
role: STUDY_CHAIR
References: