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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OPENtext
OPENnav
Sponsored by
Inflexxion, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain focused on measuring Chronic pain, Complementary and alternative therapies, Mobile health, Medicaid, Patient navigation

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Enrolled in the Rhode Island Medicaid Chronic Pain Initiative program

Exclusion Criteria:

  • Do not speak English

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OPENtext

OPENnav

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

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.
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.
Pain Medication Use
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
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
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
Patients will be asked to rate intervention utility and content (relevance, interest) using 5-point Likert scales.

Full Information

First Posted
May 7, 2014
Last Updated
April 16, 2018
Sponsor
Inflexxion, Inc.
Collaborators
Patient-Centered Outcomes Research Institute, Lifespan, Rhode Island Hospital, The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02136108
Brief Title
Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN)
Acronym
OPENtext
Official Title
Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
September 14, 2017 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inflexxion, Inc.
Collaborators
Patient-Centered Outcomes Research Institute, Lifespan, Rhode Island Hospital, The Miriam Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Complementary and alternative therapies, Mobile health, Medicaid, Patient navigation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPENtext
Arm Type
Experimental
Arm Description
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.
Arm Title
OPENnav
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
OPENtext
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
OPENnav
Intervention Description
Particpants will be linked with a RIPN PEER Navigator who will assisted them in managing their health care
Primary Outcome Measure Information:
Title
Change in Engagement
Description
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.
Time Frame
Once per month for 6 months
Title
Readiness to Change
Description
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.
Time Frame
At baseline, 3 months, and 6 months post-randomization
Title
Change in Self-Efficacy
Description
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).
Time Frame
At baseline, 3 months, and 6 months post-randomization
Secondary Outcome Measure Information:
Title
Pain Severity
Description
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.
Time Frame
At baseline, 3 months, and 6 months post-randomization
Title
Quality of Life
Description
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.
Time Frame
At baseline, 3 months, and 6 months post-randomization
Title
Pain Medication Use
Description
Schedule II/III opioid medication utilization will derive from the RI Department of Health (HEALTH)'s Prescription Monitoring Program (PMP) database.
Time Frame
At baseline, 3 months, and 6 months post-randomization
Title
Likelihood of Misusing Opioid Medication
Description
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.
Time Frame
At baseline, 3 months, and 6 months post-randomization
Title
Safety and Aberrant Pain Medication Use Behaviors
Description
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.
Time Frame
At baseline, 3 months, and 6 month post-randomization
Title
Acceptance & Satisfaction
Description
Patients will be asked to rate intervention utility and content (relevance, interest) using 5-point Likert scales.
Time Frame
At 9-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Enrolled in the Rhode Island Medicaid Chronic Pain Initiative program Exclusion Criteria: Do not speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Traci Green, PhD, MSc
Organizational Affiliation
Inflexxion, Inc., Brown University, and Rhode Island Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Megan Ranney, MD
Organizational Affiliation
The Miriam Hospital and Brown University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elizabeth Donovan, PhD
Organizational Affiliation
Independent Consultant
Official's Role
Study Chair
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.pcori.org/research-results/2013/optimizing-patient-engagement-novel-pain-management-initiative-open
Description
Patient Centered Outcomes Research Institute (PCORI)

Learn more about this trial

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

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