Evaluation Of The Clinical Benefit Obtained In Patients With Knee And/Or Hip Osteoarthritis After A Proactive Intervention On The Primary Care Physician

ISRCTN ISRCTN27865285
DOI https://doi.org/10.1186/ISRCTN27865285
Secondary identifying numbers N/A
Submission date
04/02/2010
Registration date
19/02/2010
Last edited
22/02/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Agustín Gómez de la Cámara
Scientific

Hospital Universitario 12 de Octubre
Clinical Epidemiology Research Unit
Mother and Child Building
Basement -2
Avenida de Córdoba s/n
Madrid
28041
Spain

acamara@h12o.es

Study information

Study designMulticentre prospective cluster randomised controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleStudy of the clinical benefit and quality of life perception in patients with osteoarthritis of the hip and the knee. Evaluation based on a proactive follow-up intervention made by primary care physicians. Experimental open, randomized and controlled study.
Study acronymARTRO-pro_AP
Study objectivesDespite the availability of evidence-based guidelines for the management of asymptomatic chronic diseases such as osteoarthritis, physicians often do not initiate, intensify or optimize therapy when indicated, so that patients are not treated effectively. This phenomenon is known as clinical inertia. The main objective of this study was to evaluate whether an intervention on primary care physicians to avoid clinical inertia, could improve the perception of pain, functionality and quality of life in patients with hip and/or knee osteoarthritis (OA).
Ethics approval(s)The Ethical Committee of Hospital Universitario 12 de Octubre approved on August 1st, 2007. Notification was sent to the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios [AEMPS]) on November 20th, 2007.
Health condition(s) or problem(s) studiedHip and Knee Arthritis
InterventionClusters of primary care physicians working at the same healthcare centre for more than 6 months were randomly assigned to 1 of 2 study groups.
1. Group 1 (Proactive Intervention): Physicians in this group received a 45-60 minute training session on the latest European League Against Rheumatism (EULAR) recommendations on OA management, therapeutic goals, motivational techniques, and the Visual Analogue Scale (VAS), Western Ontario and McMaster Universities (WOMAC) and Short Form-12 (SF-12) questionnaires.
2. Group 2 (Control): Physicians in this group received only a brief description of the study.
Each physician includes the first three patients with knee and/or hip OA who fulfil the eligibility criteria. Both groups were given the same Case Report Forms. All patients were scheduled for two visits (Visit 1 and Visit 2), six-months apart, during which a complete medical evaluation was carried out and VAS, WOMAC and SF-12 questionnaires were completed.
Intervention typeOther
Primary outcome measureEvaluation of the clinical benefit of an educational intervention for primary care physicians, proposing a proactive approach to care (defined as a focus on updated treatment recommendations) in patients with arthritis. The primary outcome was measured by comparing results from visit 1 with those of visit 2.
Secondary outcome measures1. Clinical characteristics, and progression of pain and functional capacity, in patients with knee and/or hip OA in Primary Care practice
2. identification of additional factors related with clinical inertia that, when modified, could result in clinical benefit for the patient
3. Description of characteristics of usual clinical practice carried out by primary care physicians
Overall study start date01/10/2007
Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target number of participants1,925 Primary Care Physicians
Key inclusion criteriaPhysicians:
1. Belong to reselected Primary Care health centre
2. Have a daily clinical activity
3. Able to demonstrate a permanency up to 9 months in a clinical job
4. Commitment to follow all study criteria and recommendations
Patients:
1. Known diagnosis of hip and/or knee osteoarthritis fulfilling American College of Rheumatology (ACR) criteria.
2. Selected by physician (study subject) and gives informed consent to participate in this trial.
Key exclusion criteriaPhysicians:
1. Unable to ensure job stability at Primary Care health centre over 9 months
2. Does not accept study criteria and recommendations
3. Already involved in improvement effort programs regarding clinical support for patients affected by joint disease
Patients:
1. Clinical antecedents of actual arthritic disease with prosthesis implanted
2. Arthritic disease involving exclusively or predominantly the spine (all locations) or upper limbs
3. Severe concomitant pathology with a short term life expectancy
4. Existence of non-arthritic rheumatic condition (fibromyalgia, rheumatoid arthritis, psoriasis, collagen diseases)
5. Psychological or sensorial impairment that prevents study participation
6. Existence of any absolute contraindication for anti-arthritic medications (Non-Steroidal Anti-Inflammatory Drugs [NSAIDs], etc.)
7. Does not wish to participate
8. Potential surgical intervention (next 6 months)
9. Additionally, any patients considered by his/her physician to be clinically inappropriate for participation and clinical data collection in this study
Date of first enrolment01/10/2007
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • Spain

Study participating centre

Hospital Universitario 12 de Octubre
Madrid
28041
Spain

Sponsor information

Funders

Funder type

Industry

Merck, Sharp & Dohme de España S.A. (Spain) - educational grant

No information available

Family and Community Spanish Medical Society (SEMFyC) (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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