Chronic PainOPENtextNCT02136108
Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN)
A study testing OPENtext and OPENnav in people with Chronic Pain, run by Inflexxion, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- OPENtext and OPENnav
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in the Rhode Island Medicaid Chronic Pain Initiative program
Who cannot join
- Do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- OPENtext, OPENnav
- Keywords
- Chronic pain, Complementary and alternative therapies, Mobile health, Medicaid, Patient navigation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPENtextOther
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.
OPENnavOther
Particpants will be linked with a RIPN PEER Navigator who will assisted them in managing their health care
| Study group | Role | What they receive |
|---|---|---|
| OPENtext | Experimental | 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. Receives: Other: OPENtext |
| OPENnav | Active comparator | 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. Receives: Other: OPENnav |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once per month for 6 months
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.
Measured: At baseline, 3 months, and 6 months post-randomization
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).
Measured: At baseline, 3 months, and 6 months post-randomization
Secondary outcomes (6)
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.
Measured: At baseline, 3 months, and 6 months post-randomization
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.
Measured: At baseline, 3 months, and 6 months post-randomization
Pain Medication Use
Schedule II/III opioid medication utilization will derive from the RI Department of Health (HEALTH)'s Prescription Monitoring Program (PMP) database.
Measured: At baseline, 3 months, and 6 months post-randomization
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.
Measured: At baseline, 3 months, and 6 months post-randomization
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.
Measured: At baseline, 3 months, and 6 month post-randomization
Acceptance & Satisfaction
Patients will be asked to rate intervention utility and content (relevance, interest) using 5-point Likert scales.
Measured: At 9-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study start1 Sep 2015
- Primary completion14 Sep 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflexxion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Patient-Centered Outcomes Research Institute, Lifespan, Rhode Island Hospital, The Miriam Hospital
- Responsible party
- Principal investigator, Traci Green, Inflexxion, Inc.
- Investigators
- Traci Green, PhD, MSc, Principal investigator, Inflexxion, Inc., Brown University, and Rhode Island HospitalMegan Ranney, MD, Study chair, The Miriam Hospital and Brown UniversityElizabeth Donovan, PhD, Study chair, Independent Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136108
- Sponsor's protocol ID
- IHS -1306-02960
- Acronym
- OPENtext
- Status last verified
- Apr 2018
- First submitted
- 7 May 2014
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN)
- ClinicalTrials.gov ID
- NCT02136108
- Acronym / sponsor ID
- OPENtext / IHS -1306-02960
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Complementary and alternative therapies, Mobile health, Medicaid, Patient navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Inflexxion, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Patient-Centered Outcomes Research Institute, Lifespan, Rhode Island Hospital, The Miriam Hospital
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPENtext | Experimental | Other: OPENtextOPENtext 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. |
| OPENnav | Active comparator | Other: OPENnavPeer 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolled in the Rhode Island Medicaid Chronic Pain Initiative program
Key exclusion criteria (1 listed)
- Do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPENtextParticipants will receive 12 weeks of daily text messages sent from an automated system. The text messages will assist participants in managing their chronic pain. | Other | OPENtext |
| OPENnavParticpants will be linked with a RIPN PEER Navigator who will assisted them in managing their health care | Other | OPENnav |
Primary outcome
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).
6 secondary outcomes
Pain Severity
Time frame: At baseline, 3 months, and 6 months post-randomization
Quality of Life
Time frame: At baseline, 3 months, and 6 months post-randomization
Pain Medication Use
Time frame: At baseline, 3 months, and 6 months post-randomization
Likelihood of Misusing Opioid Medication
Time frame: At baseline, 3 months, and 6 months post-randomization
Safety and Aberrant Pain Medication Use Behaviors
Time frame: At baseline, 3 months, and 6 month post-randomization
Acceptance & Satisfaction
Time frame: At 9-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Traci Green, PhD, MSc principal investigator
Inflexxion, Inc., Brown University, and Rhode Island Hospital
Megan Ranney, MD study chair
The Miriam Hospital and Brown University
Elizabeth Donovan, PhD study chair
Independent Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPENtext and OPENnav in people with Chronic Pain, run by Inflexxion, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Engagement (time frame: Once per month for 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.