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

16 avril 2018 mis à jour par: Traci Green, Inflexxion, Inc.
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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

197

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02903
        • Rhode Island Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

19 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Enrolled in the Rhode Island Medicaid Chronic Pain Initiative program

Exclusion Criteria:

  • Do not speak English

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.
Comparateur actif: 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.
Autre: OPENnav
Particpants will be linked with a RIPN PEER Navigator who will assisted them in managing their health care

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Engagement
Délai: 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.
Once per month for 6 months
Readiness to Change
Délai: 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.
At baseline, 3 months, and 6 months post-randomization
Change in Self-Efficacy
Délai: 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).
At baseline, 3 months, and 6 months post-randomization

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pain Severity
Délai: 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.
At baseline, 3 months, and 6 months post-randomization
Quality of Life
Délai: 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.
At baseline, 3 months, and 6 months post-randomization
Pain Medication Use
Délai: 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.
At baseline, 3 months, and 6 months post-randomization
Likelihood of Misusing Opioid Medication
Délai: 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.
At baseline, 3 months, and 6 months post-randomization
Safety and Aberrant Pain Medication Use Behaviors
Délai: 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.
At baseline, 3 months, and 6 month post-randomization
Acceptance & Satisfaction
Délai: At 9-month follow up
Patients will be asked to rate intervention utility and content (relevance, interest) using 5-point Likert scales.
At 9-month follow up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Inflexxion, Inc.

Collaborateurs

Patient-Centered Outcomes Research Institute
The Miriam Hospital
Rhode Island Hospital
Lifespan

Les enquêteurs

  • Chercheur principal: Traci Green, PhD, MSc, Inflexxion, Inc., Brown University, and Rhode Island Hospital
  • Chaise d'étude: Megan Ranney, MD, The Miriam Hospital and Brown University
  • Chaise d'étude: Elizabeth Donovan, PhD, Independent consultant

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2015

Achèvement primaire (Réel)

14 septembre 2017

Achèvement de l'étude (Réel)

31 janvier 2018

Dates d'inscription aux études

Première soumission

7 mai 2014

Première soumission répondant aux critères de contrôle qualité

8 mai 2014

Première publication (Estimation)

12 mai 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 avril 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 avril 2018

Dernière vérification

1 avril 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IHS -1306-02960

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

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