Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02136108
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : April 18, 2018
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Lifespan
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
Traci Green, Inflexxion, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Other: OPENtext Other: OPENnav Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OPENtext
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.
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.

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in the Rhode Island Medicaid Chronic Pain Initiative program

Exclusion Criteria:

  • Do not speak English

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Inflexxion, Inc.
Patient-Centered Outcomes Research Institute
Lifespan
Rhode Island Hospital
The Miriam Hospital
Investigators
Layout table for investigator information
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

Additional Information:
Layout table for additonal information
Responsible Party: Traci Green, Deputy Director, Boston Medical Center Injury Center, Inflexxion, Inc.
ClinicalTrials.gov Identifier: NCT02136108    
Other Study ID Numbers: IHS -1306-02960
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Traci Green, Inflexxion, Inc.:
Chronic pain
Complementary and alternative therapies
Mobile health
Medicaid
Patient navigation
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms