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

21. März 2019 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Physiotherapeutengeführtes Grundversorgungsmodell für Rückenschmerzen
Das PT-geführte Primärversorgungsmodell für Rückenschmerzen beinhaltet die Einbeziehung eines PT in das Primärversorgungsteam als erste Anlaufstelle für Menschen mit Rückenschmerzen ohne Kosten für den Patienten. Patienten in diesem Modell haben die Wahl, den PT oder den Hausarzt aufzusuchen. Sie werden ermutigt, beim PT zu buchen, es sei denn, der Hauptgrund für den Besuch ist die Erneuerung der Medikation oder wenn der Patient zusätzliche gesundheitliche Bedenken hat, die bei demselben Besuch von seinem Arzt behandelt werden müssen. Es wird 4 Schlüsselkomponenten der PT-geführten Primärversorgungsintervention geben: 1) Eingangsbeurteilung und Screening; 2) Kurzer individueller Eingriff beim ersten Besuch; 3) Navigation im Gesundheitswesen; 4) Bereitstellung zusätzlicher PT-Versorgung für Menschen mit ungedecktem Bedarf.
  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.
Aktiver 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.
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Recruitment of primary care teams
Zeitfenster: Baseline
Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
Baseline
Recruitment of patient participants
Zeitfenster: Baseline to 14 weeks
Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
Baseline to 14 weeks
Assessment completion
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Self-reported disability
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. September 2017

Primärer Abschluss (Tatsächlich)

15. Januar 2019

Studienabschluss (Tatsächlich)

15. Januar 2019

Studienanmeldedaten

Zuerst eingereicht

16. Oktober 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Oktober 2017

Zuerst gepostet (Tatsächlich)

25. Oktober 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. März 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. März 2019

Zuletzt verifiziert

1. März 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 6021536

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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