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

NCT02136108 | Completed

• 1 other identifier: IHS -1306-02960
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic pain; Complementary and alternative therapies; Mobile health; Medicaid; Patient navigation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Pain Severity

  At baseline, 3 months, and 6 months post-randomization

• Quality of Life

  At baseline, 3 months, and 6 months post-randomization

• Pain Medication Use

  At baseline, 3 months, and 6 months post-randomization

• Likelihood of Misusing Opioid Medication

  At baseline, 3 months, and 6 months post-randomization

• Safety and Aberrant Pain Medication Use Behaviors

  At baseline, 3 months, and 6 month post-randomization

Study Arms (2)

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.

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.

Other: OPENnav

Interventions

OPENtext OTHER

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.

OPENtext

OPENnav OTHER

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

OPENnav

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in the Rhode Island Medicaid Chronic Pain Initiative program

You may not qualify if:

• Do not speak English

Sponsors & Collaborators

• Inflexxion, Inc.: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Lifespan: collaborator
• Rhode Island Hospital: collaborator
• The Miriam Hospital: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Traci Green, PhD, MSc

  Inflexxion, Inc., Brown University, and Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Megan Ranney, MD

  The Miriam Hospital and Brown University

  STUDY CHAIR

• Elizabeth Donovan, PhD

  Independent Consultant

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Boston Medical Center Injury Center

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 12, 2014
• Study Start: September 1, 2015
• Primary Completion: September 14, 2017
• Study Completion: January 31, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)