Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN)

Chronic Pain Clinical Trial

— OPENtext  

Official title:

Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136108
• Other study ID #: IHS -1306-02960
• Status: Completed
• Phase: N/A
• First received: May 7, 2014
• Last updated: April 16, 2018
• Start date: September 1, 2015
• Est. completion date: January 31, 2018

Study information

• Verified date: April 2018
• Source: Inflexxion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: January 31, 2018
• Est. primary completion date: September 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Enrolled in the Rhode Island Medicaid Chronic Pain Initiative program

Exclusion Criteria:

• Do not speak English

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• OPENtext
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.
• OPENnav
Particpants will be linked with a RIPN PEER Navigator who will assisted them in managing their health care

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (5)

Lead Sponsor	Collaborator
Inflexxion, Inc.	Lifespan, Patient-Centered Outcomes Research Institute, Rhode Island Hospital, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Engagement	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.	Once per month for 6 months
Primary	Readiness to Change	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.	At baseline, 3 months, and 6 months post-randomization
Primary	Change in Self-Efficacy	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).	At baseline, 3 months, and 6 months post-randomization
Secondary	Pain Severity	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.	At baseline, 3 months, and 6 months post-randomization
Secondary	Quality of Life	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.	At baseline, 3 months, and 6 months post-randomization
Secondary	Pain Medication Use	Schedule II/III opioid medication utilization will derive from the RI Department of Health (HEALTH)'s Prescription Monitoring Program (PMP) database.	At baseline, 3 months, and 6 months post-randomization
Secondary	Likelihood of Misusing Opioid Medication	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.	At baseline, 3 months, and 6 months post-randomization
Secondary	Safety and Aberrant Pain Medication Use Behaviors	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.	At baseline, 3 months, and 6 month post-randomization
Secondary	Acceptance & Satisfaction	Patients will be asked to rate intervention utility and content (relevance, interest) using 5-point Likert scales.	At 9-month follow up

External Links

•   Patient Centered Outcomes Research Institute (PCORI)