Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery
4. mai 2022 oppdatert av: Lucid Lane, Inc
Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids.
The quality of recovery after surgery is multi-factorial and includes both physical and mental factors.
Persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use.
The investigators will be evaluating if the addition of a pain coach/councilor before and after surgery, through a tele health platform (LucidLane) can improve participant's recovery from major joint surgery.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
103
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Palo Alto, California, Forente stater, 94304
- Rekruttering
- Palo Alto Division - VA Palo Alto Health Care System
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Ta kontakt med:
- Kyle T Harrison, MD
- Telefonnummer: 650-996-6532
- E-post: kharriso@stanford.edu
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Ta kontakt med:
- Nithya Vijayakumar, MS
- Telefonnummer: 6505146117
- E-post: NVijayakumar@pavir.org
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Hovedetterforsker:
- Kyle T Harrison, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or female patients between the ages of 21-90 years old
- Patient is opioid naive i.e hasn't used opioid medication for 30 days prior to surgery
- Patient willing to use Lucid Lane program to provide behavioral health support for up to 4 weeks before surgery and 4 weeks after surgery.
- Patient is willing to discuss Lucid Lane progress with Palo Alto VA's medical team and prescribing clinicians.
- Patient is willing to sign a Lucid Lane Client Agreement.
- Patient is willing to sign an informed consent form
Exclusion Criteria:
- Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression.
- Active suicidal ideations
- Patient is on methadone or buprenorphine for treatment of opioid use disorder(i.e. for treatment of addiction, and not for treatment of pain)
- Patient unwilling to use or not possessing access to a device that allows for video visits(e.g. a smart phone, tablet, or computer)
- Patients who are in palliative care
- Unable to use English to participate in the consent process, the intervention or study assessments.
- Unable to provide informed consent to participate
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Treatment
Patients participate in the Lucid Lane therapy program including working with a mental health pain coach for up to 4 weeks before surgery and 4 weeks after surgery. All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery |
This intervention is designed to aid participants with pre-surgery anxiety management and surgery prep and pain management post-surgery.
Participants will be assigned a Lucid Lane pain coach who will utilize mindfulness, cognitive behavioral therapy, group therapy, and mind-body therapies, to accomplish those goals.
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Aktiv komparator: Control
Patients will participate in a a surgery preparedness course provided by the VA before surgery (Standard of Care) and Lucid Lane therapy after surgery All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery |
This intervention is designed to aid participants with pre-surgery anxiety management and surgery prep and pain management post-surgery.
Participants will be assigned a Lucid Lane pain coach who will utilize mindfulness, cognitive behavioral therapy, group therapy, and mind-body therapies, to accomplish those goals.
This intervention is designed to help the participant prepare for their upcoming surgery.
Classes will include discussions around managing chronic pain before surgery, building mental resilience, dealing with the uncertainty of a new diagnosis or treatment plan, questions to ask their anesthesiologist before and on the day of surgery, what to expect during their potential stay at the hospital, and how to optimize their recovery after surgery.
Sessions will often include expert doctors who focus on surgery and medical management around it.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Injury and Osteoarthritis Outcome Score (HOOS) and
Tidsramme: Up to 4 months
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The KOOS and HOOS are questionnaires designed to assess short and long-term patient-relevant outcomes following knee/hip injury.
They are self-administered and assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee/hip-related quality of life.
The scores are normalized on a scale of 0 to 100, where 0 indicates severe problems and 100 indicates no problems.
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Up to 4 months
|
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Change in Pain Catastrophizing scale
Tidsramme: Up to 4 months
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The Pain catastrophizing scale (PCS) is a self administered, 13-item questionnaire, used to assess a patient's tendency to magnify the threat value of a pain stimulus.
It assess rumination, magnification and helplessness.
Responses are recorded on a scale of 0-4, where 0 represents absence of the thought and 4 represents the presence of the thought all the time.
The scale has a min score of 0 and a max score of 52.
A higher score indicates more pain catastrophizing .
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Up to 4 months
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Change in Depression Scores
Tidsramme: Up to 4 months
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The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self administered questionnaire used to screen and monitor the severity of depressive symptoms.
It inquires about depressive features, that align with the diagnostic and statistical manual of mental disorders, over the course of 2 weeks.
Responses are recorded on a scale of 0-3, where 0 represents absence of the symptom and 3 represents its presence nearly every day.
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Up to 4 months
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Change in Anxiety Scores
Tidsramme: Up to 4 months
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The General Anxiety Disorder-7 (GAD-7) is a self administered, 7-item questionnaire used to measure general anxiety disorder and its severity.
Responses are recorded on a scale of 0-3, where 0 represents an absence of the symptom and 3 represents presence nearly every day.
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Up to 4 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percent tapered off opioid (50% MME)
Tidsramme: 4 weeks after surgery
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4 weeks after surgery
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. mai 2021
Primær fullføring (Forventet)
1. april 2023
Studiet fullført (Forventet)
1. april 2023
Datoer for studieregistrering
Først innsendt
22. april 2022
Først innsendt som oppfylte QC-kriteriene
4. mai 2022
Først lagt ut (Faktiske)
10. mai 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. mai 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mai 2022
Sist bekreftet
1. mai 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 56984
Legemiddel- og utstyrsinformasjon, studiedokumenter
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