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Task Shifting in the Care for Patients With Hand Osteoarthritis

Primary Purpose

Osteoarthritis Both Hands

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Rheumatologist-led care.
Occupational therapist-led care.
Sponsored by
National Resource Center for Rehabilitation in Rheumatology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis Both Hands

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Diakonhjemmet Hospital
  • National resource center for rehabilitation in rheumatology
  • Martina Hansens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of treatment responders
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).

Secondary Outcome Measures

Number of painful finger joints
Joint count of number of painful finger joints at each hand
Hand pain measured on a numeric rating scale
Hand pain will be measured on a numeric rating scale
Hand stiffness measured on a numeric rating scale
Hand stiffness will be measured on a numeric rating scale
Disease activity measured on a numeric rating scale
Disease activity will be measured on a numeric rating scale
Physical function measured by the Functional Index for Hand OsteoArthritis
Physical function will be measured by the Functional Index for Hand OsteoArthritis
Activity performance measured by the Measure of Activity Performance of the Hand
Activity performance will be measured by the Measure of Activity Performance of the Hand
Grip strength measured by JAMAR dynamometer
Grip strength will be measured by JAMAR dynamometer
Health related quality of life measured by EQ5D
Health related quality of life will be measured by EQ5D
Satisfaction with care measured by PASS-Opp
Satisfaction with care will be measured by PASS-Opp

Full Information

First Posted
March 31, 2017
Last Updated
March 28, 2023
Sponsor
National Resource Center for Rehabilitation in Rheumatology
Collaborators
Diakonhjemmet Hospital, Martina Hansen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03102788
Brief Title
Task Shifting in the Care for Patients With Hand Osteoarthritis
Official Title
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?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
November 14, 2020 (Actual)
Study Completion Date
November 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Resource Center for Rehabilitation in Rheumatology
Collaborators
Diakonhjemmet Hospital, Martina Hansen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Both Hands

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Rheumatologist-led care.
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Occupational therapist-led care.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of treatment responders
Description
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).
Time Frame
One year
Secondary Outcome Measure Information:
Title
Number of painful finger joints
Description
Joint count of number of painful finger joints at each hand
Time Frame
One year
Title
Hand pain measured on a numeric rating scale
Description
Hand pain will be measured on a numeric rating scale
Time Frame
One year
Title
Hand stiffness measured on a numeric rating scale
Description
Hand stiffness will be measured on a numeric rating scale
Time Frame
One year
Title
Disease activity measured on a numeric rating scale
Description
Disease activity will be measured on a numeric rating scale
Time Frame
One year
Title
Physical function measured by the Functional Index for Hand OsteoArthritis
Description
Physical function will be measured by the Functional Index for Hand OsteoArthritis
Time Frame
One year
Title
Activity performance measured by the Measure of Activity Performance of the Hand
Description
Activity performance will be measured by the Measure of Activity Performance of the Hand
Time Frame
One year
Title
Grip strength measured by JAMAR dynamometer
Description
Grip strength will be measured by JAMAR dynamometer
Time Frame
One year
Title
Health related quality of life measured by EQ5D
Description
Health related quality of life will be measured by EQ5D
Time Frame
One year
Title
Satisfaction with care measured by PASS-Opp
Description
Satisfaction with care will be measured by PASS-Opp
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore K Kvien, PhD
Organizational Affiliation
Research director, Diakohjemmet Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Diakonhjemmet Hospital
City
Oslo
ZIP/Postal Code
0319
Country
Norway
Facility Name
National resource center for rehabilitation in rheumatology
City
Oslo
ZIP/Postal Code
0319
Country
Norway
Facility Name
Martina Hansens Hospital
City
Sandvika
ZIP/Postal Code
1306
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33593307
Citation
Kjeken I, Bergsmark K, Haugen IK, Hennig T, Hermann-Eriksen M, Hornburg VT, Hove A, Proven A, Sjovold TA, Slatkowsky-Christensen B. Task shifting in the care for patients with hand osteoarthritis. Protocol for a randomized controlled non-inferiority trial. BMC Musculoskelet Disord. 2021 Feb 16;22(1):194. doi: 10.1186/s12891-021-04019-9.
Results Reference
derived
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/33593307/
Description
Published study protocol

Learn more about this trial

Task Shifting in the Care for Patients With Hand Osteoarthritis

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