Comparing Strategies to Improve Non-Pharmacologic Pain Relief for Adults With Back Pain Using the Education, Navigated Care, and Supported Self-management Pain Care Program (ENCompaSS)
Comparing Strategies to Improve Non-Pharmacologic Pain Relief for Adults With Back Pain (The ENCompaSS Trial)
The goal of this clinical trial is to help Veterans manage high-impact chronic low back pain. The trial will use a program, ENCompaSS (Education, Navigated Care, and Supported Self-Management) designed to reduce pain more than usual care alone. Researchers will assess a) the impact of ENCompaSS, b) identify which Veterans benefit the most, and c) how this program can be delivered more broadly in other clinics and health systems.
What Will Happen:
Veterans in this clinical trial will be randomly placed into one of two groups.
ENCompaSS group (intervention):
- Have at least three phone calls with a trained clinician over about 12 weeks
- Watch short online videos about managing pain
- Complete surveys before the study and again at 2, 4, 6, and 12 months
Usual care group:
- Will continue with regular care
- Complete the same surveys at the same time points
Přehled studie
Postavení
Detailní popis
ENCompaSS (Education, Navigated Care, and Supported Self-Management), is a type I hybrid effectiveness-implementation trial conducted within three Veterans Heath Administration (VHA) systems. The intervention is a patient-centered, navigator-assisted program designed to inform and guide Veterans on non-pharmacologic treatment options.
The total study duration, including enrollment and follow-up, is approximately 30 months. A total of 530 Veterans with high-impact chronic pain (HICP) due to low back pain (LBP) will be enrolled and randomized in a 1:1 ratio to receive either the ENCompaSS intervention or usual stepped care within the VA health system. In keeping with the pragmatic design, participating VHA sites will receive standardized training and implementation support but will deliver the intervention using their existing clinical staff and resources.
Patient-reported outcomes will be collected via telephone-administered REDCap surveys at baseline and at 2, 4, 6, and 12 months post-randomization. The primary outcome will be assessed at 6 months, with additional follow-up to evaluate longer-term effects 12 months post randomization.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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North Carolina
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Durham, North Carolina, Spojené státy, 27705
- Durham VA
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Be age 18 years old or older
- Have a VA outpatient clinic visit for low back pain within the previous 30 days
- Be enrolled in a participating primary care clinic
- Have high impact chronic pain per Graded Chronic Pain Scale (most days or every day on first 2 items)
- Valid telephone access
- Ability to provide informed consent
Exclusion Criteria:
- Are currently hospitalized or residing in a nursing home
- Have cognitive impairment or lack of decision-making capacity
- Have a serious mental illness (e.g., schizophrenia, bipolar disorder, recent psychiatric hospitalization, high risk suicide flag)
- Are unable to communicate by telephone or have no telephone access
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: ENCompaSS + Usual Va Care
The ENCompaSS trial builds on pain navigation and management by integrating:
Veterans randomized to ENCompaSS receive at least three structured navigator-led phone sessions over 12 weeks, delivered by trained clinicians (e.g., nurses, physical therapists, health coaches) using existing VA resources. |
The ENCompaSS pain program was designed based on the Chronic Care Model (CCM), a widely used framework for organizing care for people with chronic diseases. In this model, the care provided for a chronic condition (high impact LBP) intentionally brings together the patient, provider, and system interventions necessary to accomplish the overall goal of improving pain outcomes and related co-morbidities. Our previous experiences with navigation in a previous study were only partially represented in the CCM. ENCompaSS employs a more comprehensive blend of CCM elements, incorporating important domains such Self-Management Support, which we posit will result in better pain interference outcomes. |
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Žádný zásah: VA Usual Care
Participants randomized to usual care alone will receive standard pain treatment modalities employed within the VA Health Care System as directed by their treating providers.
VA Usual care is guided by the Stepped Care Model for Pain Management (SCM-PM) which was implemented system-wide in 2009 through VHA Directive 2009-053.
The SCM-PM is a tiered approach that begins with the least intensive and most accessible treatments, progressing to more specialized and intensive interventions as needed.
Key components include initial assessment and management in primary care, with referrals to specialists in pain medicine, physical medicine, rehabilitation, and behavioral health when primary care interventions are insufficient.
VA usual care participants will receive study materials to orient them to their treatment arm and provide assessment at multiple time points but will not receive any specific information or intervention related to LBP other than what normally would be provided.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score
Časové okno: From enrollment to 6 Months
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The validated PROMIS Pain Interference instrument measures the self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical, and recreational activities.
The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome.
Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables.
A higher score indicates greater pain interference.
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From enrollment to 6 Months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Sleep quality assessed by the PROMIS 4-item short form
Časové okno: Baseline to 6 Months
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The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with 1 representing a better outcome.
Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables.
A higher score indicates greater sleep disturbance.
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Baseline to 6 Months
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Physical function assessed by the PROMIS 4-item short form
Časové okno: Baseline to 6 Months
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The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome.
Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables.
A higher score indicates better physical function.
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Baseline to 6 Months
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Pain intensity assessed by the PROMIS short form
Časové okno: Baseline to 6 Months
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Pain intensity is a standardized, 3-question survey used to quantify how much a patient is hurting.
It evaluates three parameters: average pain in the past 7 days, worst pain in the past 7 days, and current pain.
Patients receive a raw total score ranging from 3 to 15, where higher scores indicate greater pain severity.
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Baseline to 6 Months
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Depression assessed by the PROMIS 4-item short form
Časové okno: Baseline to 6 Months
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The depression form measures self-reported negative mood, feelings of worthlessness, and loss of interest over the past seven days on a scale of 1-5 with 1 representing a better outcome.
Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables.
A higher score indicates more depression.
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Baseline to 6 Months
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Anxiety assessed by the PROMIS 4-item short form
Časové okno: Baseline to 6 Months
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The anxiety form measures self-reported anxiety, fear, and hyperarousal over the past seven days on a scale of 1-5 with 1 representing a better outcome.
Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables.
A higher score indicates more anxiety.
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Baseline to 6 Months
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Pain-related ED visits by the VA electronic health record (EHR)
Časové okno: 12 Months post randomization
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Emergency Department (ED) visits for pain measured using ICD coding for VA and Non-VA visits.
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12 Months post randomization
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Non-pharmacologic pain care visits by the VA EHR
Časové okno: 6 Months and 12 Months post randomization
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Visits for pain with non-prescribing providers using ICD coding.
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6 Months and 12 Months post randomization
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Susan Hastings, MD, Duke University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Pro00120495
- BPS-2024-40339 (Jiné číslo grantu/financování: Patient-Centered Outcomes Research Institute (PCORI))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Study data sets will be shared a timely manner with privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website. To enable broad resource sharing, the study statistician will create de-identified, publication-specific datasets including all variables presented in the publication.
The PIs hold responsibility for ensuring that the individuals cannot be re-identified. No data or code that could lead to re-identification of individuals will be released. The analytical datasets and statistical code used will be retained in accordance with VA record retention policy. If successful outcomes justify broader dissemination, we will seek to do so by placing relevant materials into the public domain.
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
We plan on using a de-identified dataset and is not subject to HIPAA's minimum necessary standards and would not require a data use agreement. Typically, datasets will be provided in SAS transport files using CDISC standards via a website. Requesters will have to enter a valid email, phone number and address to request data. The data provided will be made available under certain requirements and approved on a case-by-case basis.
Requirements include:
- Data will be used for research purposes and not to identify subjects
- Data must be secured using appropriate computer technology
- Data must be destroyed or returned after any analysis are complete authors of any manuscript resulting from this data must acknowledge the source of the data
- Analyses for the purpose of presentations, abstracts, and/or publications must be coordinated through the Publications Committee, to avoid overlap
- Coauthors must be given a chance for review and approval of a draft manuscript prior to submission
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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