Forbedring af kommunikation om smerte og opioider
En klinikeruddannelsesintervention for at forbedre smerterelateret kommunikation, smertebehandling og opioidordination i primærpleje
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Den eneste intervention i det randomiserede kontrollerede forsøg (RCT) vil være klinikeruddannelse. Denne RCT vil ikke direkte manipulere eller påvirke patientbehandlingen. Derfor er denne undersøgelse minimal risiko. De eneste forudsigelige patientrisici vedrører datafortrolighed og privatliv.
Efterforskerne vil rekruttere cirka 48 primære klinikere til pilot-RCT. Undersøgelsens mål er at indskrive 24 beboere og 48 patienter (2 patientbesøg pr. beboer). Men baseret på tidligere erfaringer med lignende rekrutteringsmetoder i disse klinikker, vil kun omkring 50 % af de tilmeldte klinikere i sidste ende have besøg hos undersøgelsespatienter. Det vil således være nødvendigt at overtilmelde klinikere, fordi efterforskerne forventer, at en stor del af beboerne vil skulle droppes fra studiet, fordi de ikke ser nogen undersøgelsespatienter. Efter tilmelding vil klinikere udfylde et kort spørgeskema, herunder demografi og selveffektivitet vedrørende kommunikation med patienter om kroniske smerter og opioider.
Randomiseringstildeling vil finde sted, efter at alle klinikere har givet informeret samtykke og tilmeldt sig, for at forhindre randomiseringsstatus i at påvirke tilmeldingsbeslutninger. Randomiseringsopgaven vil blive udført af undersøgelsens personale, efter at alle klinikere er blevet rekrutteret. Randomisering er på klinikerniveau. På grund af interventionens karakter er det ikke muligt at blinde forsøgspersoner eller efterforskere til randomiseringsopgave. Patienter vil dog være uvidende om klinikernes randomiseringsopgave.
Interventionsklinikere vil gennemføre 2 standardiserede patientbesøg i løbet af almindelig kliniktid. Det første besøg vil omfatte visning af en 8-10 minutters video, der opsummerer de vigtigste kommunikationsevner, en 10-12 minutters roll-play-session for at øve dig i at bruge disse færdigheder og 8-10 minutters konstruktiv feedback. Den anden video vil kun have roll-play og feedback. Kontrolklinikere vil modtage et skriftligt resumé af 2016 Centers for Disease Control and Prevention (CDC) retningslinjer for ordinering af opioider, som inkluderer anbefalinger til bedste praksis for brug af opioider til behandling af kroniske smerter uden kræft. I det omfang det er muligt, vil efterforskerne bruge CDC-producerede materialer til kontrolgruppen. CDC-retningslinjer vil tjene som en opmærksomhedskontrol. Interventionsklinikere vil udfylde et kort spørgeskema, der evaluerer interventionen. Nogen tid senere vil tilmeldte klinikere se 2 patienter, som er blevet screenet og indskrevet af forskerholdet, og som har indvilget i at tillade, at et tidligere planlagt besøg hos pcp bliver lydoptaget. Data vil omfatte lydoptagelsesudskrifter, et patientspørgeskema før og efter besøg og et spørgeskema efter kliniker efter besøg.
2 måneder efter hvert patients besøg vil en forskningsassistent ringe til patienter og indhente 2-måneders opfølgningsdata (f.eks. Kort smerteopgørelse).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Family Medicine Clinic
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Internal Medicine Clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
Indbyggere i intern medicin eller familiemedicin ved UC Davis:
- gennemført ≥1 års uddannelse
- se primærplejepatienter i Ambulatory Care Center (ACC) bygningen. Klinikere vil blive rekrutteret gennem klinik-huddles, e-mails og præsentationer ved møder.
UC Davis patienter:
- 18-80 år gammel
- tager opioider (≥1 opioiddosis om dagen) ordineret af deres primære læge i >90 dage til behandling af kroniske muskuloskeletale smerter
- har en aftale planlagt med en deltagende kliniker, hvor de rapporterer, at de sandsynligvis vil diskutere smertebehandling
Ekskluderingskriterier:
- aktiv cancer
- hospice
- taler ikke engelsk
- fanger
- gravid kvinde
- ude af stand til at give samtykke
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Clinicians - Communication skills training
Intervention clinicians will receive 2 standardized patient visits.
The first visit will consist of an 8 minute video on the development of 5 key communication skills, a 10-12 minute role-play session to practice using these skills, and 8-10 minutes of constructive feedback.
The 2nd visit will include only the role-play and feedback components.
Clinicians will also get a printed pocket card and pamphlet explaining the targeted communication skills in more detail.
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Intervention components include an 8-10 minute instructional video, a pocket card and pamphlet, and 2 standardized patient visits with role-play and feedback by the standardized patient
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Aktiv komparator: Clinician Control
Control clinicians will receive a written summary of the 2016 CDC opioid prescribing guidelines, which include recommendations for best practices for use of opioids to treat chronic non-cancer pain.
CDC guidelines will serve as an attention control.
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Physician will review materials based on CDC opioid prescribing guidelines.
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Eksperimentel: Patient seeing trained clinician
Patients taking opioids for chronic pain who are established clinic patients and have an appointment with a clinician who has received the communication training will be recruited for this arm.
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patient with a scheduled visit with a clinician who received the communication training.
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Aktiv komparator: Patient seeing control clinician
Patients taking opioids for chronic pain who are established clinic patients and have an appointment with a clinician who has NOT received the communication training (Clinician control group) will be recruited for this arm.
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patient with a scheduled visit with a clinician who did not receive the communication training.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinician Number of Targeted Behaviors Per Visit
Tidsramme: Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
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Compare frequency of use of targeted communication behaviors observed per visit for residents in the Intervention vs Control arm (using coding of recorded visits to assess skill use).
We first developed a list of targeted communication behaviors that were targeted by our intervention and based on our conceptual model.
We developed a coding manual to count the number of unique behaviors in each study visit.
We analyzed audio recordings and transcripts from all study visits to count the number of targeted behaviors per each visit.
Multiple team members measured communication behaviors in each visit to ensure reliability of this measure.
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Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
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Compare Efficacy of Control vs Intervention by Measuring Changes in the Way Pain Interfered With Patients Lives Using the Brief Pain Inventory - Pain Interference Subscale Survey
Tidsramme: 8 weeks
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Brief Pain Inventory (BPI) Pain Interference subscale consists of 7 categories relating to how pain interferes with patients' lives.
Patients are asked to rate their pain on a zero (Does Not Interfere) to 10 (Completely Interferes) scale.
The 7 categories are: 1.
General Activity, 2. Mood, 3. Walking Ability, 4. Work, 5. Relationships, 6. Sleep, 7. Enjoyment of life.
Results are averaged to give an overall interference rating from 0-10, with higher scores indicating worse pain.
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8 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Compare Efficacy of Control vs Intervention by Measuring Changes in the Severity of Patients Pain Using the Brief Pain Inventory - (Short Form) Pain Severity Subscale Which Measures the Severity of the Patient's Pain.
Tidsramme: 8 weeks
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Brief Pain Inventory (BPI) Short Form -- Pain Severity subscale has 4 survey questions / categories, asking patients to rate the severity of their pain on a 0-10 scale (with 0 being No Pain and 10 being Worst Possible Pain).
The 4 Categories are, A. At it's worst in the last 24 hours, B. At it's best in the last 24 hours, C. Pain on average, D. Pain right now.
Results are averaged to give an overall score (0-10) with higher scores indicating worse outcomes.
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8 weeks
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Difficult Doctor-Patient Relationship Questionnaire
Tidsramme: Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
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Comparison of difficult doctor-patient encounter scale for Intervention vs Control physicians.
Difficult doctor-patient relationship scale has 10 items scored from 1-6.
The overall scale range is 10-60, with higher values indicating more difficult (worse) visits.
Physicians complete this measure for each study patient.
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Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
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Patient Experience Score
Tidsramme: 8 weeks
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Patient experience score for patients who saw Intervention and Control physicians, measured by post visit patient agreement with treatment plan, patient trust, and patient assessment of clinician communication skills. Patient experience is a standardized composite average of three validated scales: Consumer Assessment of Healthcare Providers and Systems (CAHPS) Adult Visit Survey communication subscale, range 0 to 12, with higher scores indicating better communication. Patient Agreement with Treatment Plan Scale, range 3 to 21, with higher scores indicating greater agreement. Brief Wake Forest Physician Trust Scale, range 5 to 25, with higher scores indicating greater trust. The three scales were standardized and averaged into a single composite score. The theoretical composite score ranges from -4.5 to 0.6, with higher scores indicating a better patient experience. Results are reported separately for each study arm as mean (standard deviation). |
8 weeks
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Physicians' Overall Appraisal of the Standardized Patient Intervention
Tidsramme: 1-3 months
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Physician reported assessment of intervention.
Investigators will ask for physicians' evaluation of the feasibility, acceptability, and utility of the intervention.
Investigators will offer 10 value statements about the intervention.
Physicians will select 1 from the following choices: strongly agree, agree, neutral, disagree, strongly disagree.
Results will be reported as the percentage who agree or strongly agree with each statement.
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1-3 months
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Physician Communication Self-efficacy
Tidsramme: Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
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Physician self-efficacy for communication skills for Intervention vs Control physicians.
These questions ask about physicians' confidence related to managing chronic non-cancer pain in primary care.
Physicians will be asked to rate how strongly they agree or disagree with 8 statements (each on 1-5 scale.
Higher values indicate greater (better) self-efficacy.
Baseline and post-visit ratings of self efficacy will be computed, and we will measure change in self efficacy (post-visit self efficacy minus baseline self efficacy) for Control vs Intervention physicians.
Overall score range will be 1-5, with higher numbers indicating better self efficacy.
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Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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High-risk Opioid Prescribing
Tidsramme: Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
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Prevalence of high-risk opioid prescribing as measured by chart review; defined either as being prescribed 90MME or more OR being prescribed opioids plus benzodiazepines 2 months after study completion based on chart review
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Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Stephen G Henry, MD, University of California, Davis
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 970014
- 5K23DA043052 (U.S. NIH-bevilling/kontrakt)
- A18-0560 (Anden identifikator: UC Davis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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