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Task Shifting in the Care for Patients With Hand Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03102788
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Diakonhjemmet Hospital
Martina Hansens Hospital
Information provided by (Responsible Party):
Ingvild Kjeken, National Resource Center for Rehabilitation in Rheumatology

Tracking Information
First Submitted Date  ICMJE March 31, 2017
First Posted Date  ICMJE April 6, 2017
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE September 14, 2017
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
Number of treatment responders [ Time Frame: One year ]
Number of treatment responders will be calculated as number of OMERACT/OARSI-responders. This is a composite index that presents the results of changes after treatment in the three domains of pain, function and patient's global assessment as a single variable (responder yes/no).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
  • Number of painful finger joints [ Time Frame: One year ]
    Joint count of number of painful finger joints at each hand
  • Hand pain measured on a numeric rating scale [ Time Frame: One year ]
    Hand pain will be measured on a numeric rating scale
  • Hand stiffness measured on a numeric rating scale [ Time Frame: One year ]
    Hand stiffness will be measured on a numeric rating scale
  • Disease activity measured on a numeric rating scale [ Time Frame: One year ]
    Disease activity will be measured on a numeric rating scale
  • Physical function measured by the Functional Index for Hand OsteoArthritis [ Time Frame: One year ]
    Physical function will be measured by the Functional Index for Hand OsteoArthritis
  • Activity performance measured by the Measure of Activity Performance of the Hand [ Time Frame: One year ]
    Activity performance will be measured by the Measure of Activity Performance of the Hand
  • Grip strength measured by JAMAR dynamometer [ Time Frame: One year ]
    Grip strength will be measured by JAMAR dynamometer
  • Health related quality of life measured by EQ5D [ Time Frame: One year ]
    Health related quality of life will be measured by EQ5D
  • Satisfaction with care measured by PASS-Opp [ Time Frame: One year ]
    Satisfaction with care will be measured by PASS-Opp
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • Number of painful finger joints [ Time Frame: One year ]
    Joint count of number of painful finger joints at each hand
  • Hand pain measured on a numeric rating scale [ Time Frame: One year ]
    Hand pain will be measured on a numeric rating scale
  • Hand stiffness measured on a numeric rating scale [ Time Frame: One year ]
    Hand stiffness will be measured on a numeric rating scale
  • Disease activity measured on a numeric rating scale [ Time Frame: One year ]
    Disease activity will be measured on a numeric rating scale
  • Physical function measured by the Functional Index for Hand OsteoArthritis [ Time Frame: One year ]
    Physical function will be measured by the Functional Index for Hand OsteoArthritis
  • Activity performance measured by the Measure of Activity Performance of the Hand [ Time Frame: One year ]
    Activity performance will be measured by the Measure of Activity Performance of the Hand
  • Grip strength measured by JAMAR dynamometer [ Time Frame: One year ]
    Grip strength will be measured by JAMAR dynamometer
  • Health related quality of life measured by EQ5D [ Time Frame: One year ]
    Health related quality of life will be measured by EQ5D
  • Satisfaction with care measured by PASS-Opp [ Time Frame: One year ]
    Satisfaction with care will be measured by PASS-Opp
  • Degree of osteoarthritis [ Time Frame: One year ]
    Scoring based on x-rays of both hands (frontal)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Task Shifting in the Care for Patients With Hand Osteoarthritis
Official Title  ICMJE Task Shifting in the Care for Patients With Hand Osteoarthritis: May the First Consultation in Specialist Health Care be Performed by an Occupational Therapy Specialist?
Brief Summary The main aim in this randomized controlled trial is to improve access to safe and effective care, professional practice and cost-effective utilisation of health care resources by testing if occupational therapist-led care is as effective and safe as rheumatologist-led care for people with hand osteoarthritis.
Detailed Description

Hand osteoarthritis is one of the most prevalent musculoskeletal conditions in an adult population, and may have large influences on an individual's function, health related quality of life, and participation in the society. In the absence of disease-modifying interventions, occupational therapy, comprising information, hand exercises, assistive devices and orthoses/splints, is considered as core treatment. In Norway, people with hand osteoarthritis are increasingly referred to consultation by a rheumatologist in specialist health care. At the same time a shortage of rheumatologists nationwide is stressing the healthcare system's capacity, and rheumatologists time should therefore primarily be allocated to patients in which early diagnosis and medical treatment are essential.

The World Health Organization recommend task-shifting as one method of strengthening and expanding the health workforce. Such models rely on other healthcare providers in expanded clinical roles, where physiotherapists, nurses or occupational therapists working in collaboration with physicians and other team members have their own patients for whom they provide health care services.

In this randomized controlled trial, we will test if a new model, where patients referred to consultation in specialist health care receive their first consultation by an occupational therapy specialist, is as safe and effective as the traditional model, where they receive their first consultation by a rheumatologist.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
In this randomized controlled trial, participants will be allocated to receive their first consultation in specialist health care by either an occupational therapy specialist or a rheumatologist. The occupational therapist may thereafter refer the patient to a consultation with a rheumatologist if necessary, and vice versa.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
The research assistant who will examine the participants at baseline and follow-ups and the statistician who perform the main effect analysis will be blinded for group allocation.
Primary Purpose: Health Services Research
Condition  ICMJE Osteoarthritis Both Hands
Intervention  ICMJE
  • Behavioral: Rheumatologist-led care.

    Rheumatologist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, and, for some patients, Intra-articular injection of long-acting Corticosteroid.

    The rheumatologist may also refer participants to occupational therapy if needed.

  • Behavioral: Occupational therapist-led care.
    Occupational therapist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, teaching of hand exercises and ergonomic working methods, and, for some patients, provision assistive devices and orthoses/splints. The occupational therapist will refer patients to a short rheumatologist consultation if confirmation of diagnosis or intra-articular injections of long-acting Corticosteroid are needed.
Study Arms  ICMJE
  • Active Comparator: Control
    Patients in the control group will receive their first consultation in specialist health care by a rheumatologist. Rheumatologist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, and, for some patients, Intra-articular injection of long-acting Corticosteroid. The rheumatologist may also refer participants to occupational therapy if needed.
    Intervention: Behavioral: Rheumatologist-led care.
  • Experimental: Intervention
    Patients in the intervention group will receive their first consultation in specialist health care by an occupational therapy specialist. Occupational therapist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, teaching of hand exercises and ergonomic working methods, and, for some patients, provision assistive devices and orthoses/splints. The occupational therapist will refer patients to a short rheumatologist consultation if confirmation of diagnosis or intra-articular injections of long-acting Corticosteroid are needed.
    Intervention: Behavioral: Occupational therapist-led care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2017)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hand osteoarthritis diagnosed by physician in primary care, referred for consultation in specialist health care, and ability to communicate in Norwegian.

Exclusion Criteria:

  • Exclusion criteria were cognitive or mental impairment, possible inflammatory rheumatic disease (SR>40 or CRP>20, or patient confirming having psoriasis during telephone screening).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ingvild Kjeken, PhD +4798802614 ingvild.kjeken@diakonsyk.no
Contact: Kåre B Hagen, PhD +4791858201 k.b.hagen@medisin.uio.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03102788
Other Study ID Numbers  ICMJE Project nr 97001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ingvild Kjeken, National Resource Center for Rehabilitation in Rheumatology
Study Sponsor  ICMJE National Resource Center for Rehabilitation in Rheumatology
Collaborators  ICMJE
  • Diakonhjemmet Hospital
  • Martina Hansens Hospital
Investigators  ICMJE
Study Director: Tore K Kvien, PhD Research director, Diakohjemmet Hospital
PRS Account National Resource Center for Rehabilitation in Rheumatology
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP