Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN) (OPENtext)
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|ClinicalTrials.gov Identifier: NCT02136108|
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Other: OPENtext Other: OPENnav||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||197 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN)|
|Actual Study Start Date :||September 1, 2015|
|Actual Primary Completion Date :||September 14, 2017|
|Actual Study Completion Date :||January 31, 2018|
OPENtext will target cognitive, affective, and behavioral strategies through a single, brief in-person assessment, followed by 12 weeks of theoretically-informed text messages, a core set of information organized in a 'frequently asked questions' structure, interactive peer support, static resources on key patient-identified topics, and a library of peer stories accessible throughout the study period.
Participants will receive 12 weeks of daily text messages sent from an automated system. The text messages will assist participants in managing their chronic pain.
Active Comparator: OPENnav
Peer Navigation is currently offered to some individuals in this Medicaid population but not all. Peer navigators interact with patients by phone/text and at home visits. Efforts focus on drivers of a patient's ED use, and may include providing or identifying patient support, improving health literacy, assisting with transportation vouchers, health education, family support, accessing housing services, and orienting to other community support services.
Particpants will be linked with a RIPN PEER Navigator who will assisted them in managing their health care
- 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).
- Pain Severity [ Time Frame: At baseline, 3 months, and 6 months post-randomization ]To assess the severity of pain and the impact of pain on daily functions, investigators will use the Brief Pain Inventory short form (BPI), which is commonly used in clinical trials and has documented validity, reliability, and responsiveness to change.
- Quality of Life [ Time Frame: At baseline, 3 months, and 6 months post-randomization ]Investigators will use the Short Form-12 (SF-12)103, a global measure of patient quality of life with well-established psychometrically sound properties across many disease areas and populations, including chronic pain patients. The SF-12 is responsive to interventions, and is currently being used as the key CPI patient evaluation measure by AMI.
- Pain Medication Use [ Time Frame: At baseline, 3 months, and 6 months post-randomization ]Schedule II/III opioid medication utilization will derive from the RI Department of Health (HEALTH)'s Prescription Monitoring Program (PMP) database.
- Likelihood of Misusing Opioid Medication [ Time Frame: At baseline, 3 months, and 6 months post-randomization ]The SOAPP-R and COMM are quick and easy-to-use, designed to help providers evaluate the patients' relative risk for developing problems when placed on long-term opioid therapy (SOAPP-R) or to monitor chronic pain patients on opioid therapy (COMM). As a screening tool, the SOAPP-R and the COMM are recommended by SAMHSA in the treatment of chronic pain in patients with histories of or at risk of substance use disorder.
- Safety and Aberrant Pain Medication Use Behaviors [ Time Frame: At baseline, 3 months, and 6 month post-randomization ]Investigators will examine patient ED utilization from the health plans' (UH,NH) claims data and prevalence and incidence of aberrant opioid medication use (i.e.,"dr. shopping") from the RI PMP database.
- Acceptance & Satisfaction [ Time Frame: At 9-month follow up ]Patients will be asked to rate intervention utility and content (relevance, interest) using 5-point Likert scales.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136108
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Traci Green, PhD, MSc||Inflexxion, Inc., Brown University, and Rhode Island Hospital|
|Study Chair:||Megan Ranney, MD||The Miriam Hospital and Brown University|
|Study Chair:||Elizabeth Donovan, PhD||Independent Consultant|