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Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain

21 mars 2019 uppdaterad av: Jordan Miller, PT, PhD, Queen's University

Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial

This is a pilot cluster randomized controlled trial to determine the feasibility of a cluster randomized trial to evaluate the individual and health system impact of implementing a new physiotherapist-led primary care model for back pain in Canada.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in Ontario to evaluate the individual health outcomes and health system impact of implementing a new physiotherapist-led primary care model for people with back pain. The primary purpose of this pilot study is to determine the feasibility including recruitment and retention of primary care teams (sites) and patient participants, carrying out the assessment procedures, and implementing the physiotherapist-led primary care intervention including training the physiotherapist to adopt this role.

Studietyp

Interventionell

Inskrivning (Faktisk)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kanada
    • Ontario
      • Kingston, Ontario, Kanada, K7L 3N6
        • Queen's University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Adults (18 years and over) with back pain of any duration
  • Seeking primary care for back pain at a participating site
  • Primary care visit may be a first or repeat visit

Exclusion Criteria:

  • Patients who do not consent to participation
  • Patients who report being unable to understand, read, and write English

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Fysioterapeutledd primärvårdsmodell för ryggsmärtor
Den PT-ledda primärvårdsmodellen för ryggsmärta kommer att innebära att en PT införlivas inom primärvårdsteamet vid första kontaktpunkten för personer med ryggsmärta utan kostnad för patienten. Patienter i denna modell kommer att få välja att träffa PT eller husläkare. De kommer att uppmuntras att boka med PT förutom när den primära anledningen till besöket är för förnyade läkemedel eller när patienten har ytterligare hälsoproblem som behöver uppmärksammas av sin läkare vid samma besök. Det kommer att finnas fyra nyckelkomponenter i den PT-ledda primärvårdsinterventionen: 1) Inledande bedömning och screening; 2) Kort individualiserad intervention vid första besöket; 3) Hälsovårdsnavigering; 4) Ge ytterligare PT-vård för personer med ett otillfredsställt behov.
Beteende: Physiotherapist-led primary care model for back pain
  1. Assessment and screening: taking a history; screening for red flags, comorbidities, and risk factors of ongoing pain and disability; physical examination
  2. Brief individualized intervention at the first visit: effective communication, cognitive reassurance, a few exercises, and advice/strategies to stay active.
  3. Health services navigation: PT assistance with navigating healthcare services based on the assessment findings. First, red-flags requiring emergency or urgent referrals. Next, comorbid conditions that would benefit from care from other healthcare providers. Finally, referral to PT (if appropriate).
  4. Providing additional physiotherapy care to people with an unmet need: Additional physiotherapy care will be provided to patients who have an identified need for physiotherapy but no physiotherapy coverage through private or government health insurance plans.
Aktiv komparator: Usual care
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada. This usually includes a visit to a primary care physician, who would perform a history and physical examination, provide LBP education, and prescribe medications and/or refer based on their assessment findings and patient preferences.
Övrig: Usual care
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Recruitment of primary care teams
Tidsram: Baseline
Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
Baseline
Recruitment of patient participants
Tidsram: Baseline to 14 weeks
Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
Baseline to 14 weeks
Assessment completion
Tidsram: Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
Percentage of all assessment items completed by participants completing each assessment
Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
Retention of patient participants
Tidsram: Retention of participants at 6-week, 12-week, 6, 9, and 12-month follow-up assessments. The primary timeline for this outcome is 12-month follow-up.
Attrition rate
Retention of participants at 6-week, 12-week, 6, 9, and 12-month follow-up assessments. The primary timeline for this outcome is 12-month follow-up.
Physiotherapist confidence in carrying out the interventions
Tidsram: Baseline
The PT will rate his/her confidence in each component of the intervention after the training on a scale from 0-10 with higher scores indicating greater confidence in carrying out that component of the intervention.
Baseline
Treatment fidelity
Tidsram: 6-week follow-up
Treatment fidelity will be measured by consistency with the intervention described in the protocol measured through an intervention checklist completed by the physiotherapist and an audit of the EMR notes.
6-week follow-up

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Self-reported disability
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Self-reported pain intensity
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity (measured at rest, during walking, and during a lifting task)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health Related Quality of Life
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Global rating of change
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using an 11-point scale (-5 to +5 with negative scores indicating a worsening of physical functioning related to back pain and positive scores indicating an improvement of physical functioning related to back pain)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Satisfaction with health care
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using an 11-point scale(-5 to +5 with negative scores indicating a dissatisfaction with health care received and positive scores indicating satisfaction with health care received)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Catastrophic Thinking
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Depressive symptoms
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the 9-item Patient Health Questionnaire (PHQ-9) (0 to 27 with greater scores indicating increased depressive symptoms)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Adverse events
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using an adverse events questionnaire that asks 1) if the patient has experienced any adverse events as a result of the treatments received (yes/no); 2) how long the event lasted (hours or days); 3) how severe the adverse event was (0-10 scale); 4) what adverse events were experienced.
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care accessibility
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Percentage of patients receiving care within 48 hours.
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care accessibility
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care utilization
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
All health care visits (aggregated and dis-aggregated) including: primary care visits, emergency department visits, hospitalizations, surgeries, consultations with other health care providers, diagnostic imaging, medications, and other care received by the patient
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Costs (piloted for a cost utility analysis in a future trial)
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Includes all health care costs plus societal costs using a human capital approach for loss of productivity
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Medications prescribed
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Diagnostic imaging ordered
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
referrals to other health care providers made
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
notes made by primary care provider to employers or insurers
Tidsram: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Queen's University

Samarbetspartners

Canadian Institutes of Health Research (CIHR)

Utredare

  • Huvudutredare: Jordan Miller, PhD, Queen's University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 september 2017

Primärt slutförande (Faktisk)

15 januari 2019

Avslutad studie (Faktisk)

15 januari 2019

Studieregistreringsdatum

Först inskickad

16 oktober 2017

Först inskickad som uppfyllde QC-kriterierna

24 oktober 2017

Första postat (Faktisk)

25 oktober 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 mars 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 mars 2019

Senast verifierad

1 mars 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 6021536

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

There is no plan to share individual participant data from this pilot study. This data will be used to inform the protocol for a fully powered cluster randomized trial.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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