Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Inflexxion, Inc.
- Enrollment
- 197
- Locations
- 1
- Primary Endpoint
- Change in Engagement
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Traci Green
Deputy Director, Boston Medical Center Injury Center
Inflexxion, Inc.
Eligibility Criteria
Inclusion Criteria
- •Enrolled in the Rhode Island Medicaid Chronic Pain Initiative program
Exclusion Criteria
- •Do not speak English
Outcomes
Primary Outcomes
Change in Engagement
Time Frame: Once per month for 6 months
Investigators will capture change in engagement in the CPI program based on utilization of services per month, derived from AMI's administrative records. For the purposes of this study, engagement will be defined as having one or more visits to a CAM provider in a given month.
Readiness to Change
Time Frame: At baseline, 3 months, and 6 months post-randomization
The Pain Stages of Change Questionnaire (PSOCQ) will be used to measure change in patient's self-reported engagement in the CPI and in the intervention group.
Change in Self-Efficacy
Time Frame: At baseline, 3 months, and 6 months post-randomization
To measure patient's change in confidence of their ability to self-manage their condition, investigators will use the Chronic Pain Self Efficacy Scale (CPSS).
Secondary Outcomes
- Pain Severity(At baseline, 3 months, and 6 months post-randomization)
- Quality of Life(At baseline, 3 months, and 6 months post-randomization)
- Likelihood of Misusing Opioid Medication(At baseline, 3 months, and 6 months post-randomization)
- Safety and Aberrant Pain Medication Use Behaviors(At baseline, 3 months, and 6 month post-randomization)
- Pain Medication Use(At baseline, 3 months, and 6 months post-randomization)
- Acceptance & Satisfaction(At 9-month follow up)