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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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Principal objective: To produce scientific knowledge on the effectiveness and cost-effectiveness of a multicomponent intervention for knowledge transfer and implementing a Clinical Practice Guideline (CPG) for Systemic Lupus Erythematosus (SLE), formed by an educative intervention, an computerized clinical decision support system (SADC), complemented by an automated feedback built into the electronic clinical record.
Secondary objectives will be previously developed: 1) the analysis of medical practice variations along the care of SLE patients in the Canary Islands Health Service (SCS); 2) the best available scientific evidence to support the optimal development of the SADC; 3) the context and the barriers to innovation implementation in the SCS; and 4) the development of the contents for the implementation strategy, including the SADC and the automated feedback.
Methods for the main objective: The main objective will be assessed under an open, multicentric and randomized (by clusters) clinical trial, in the SCS. The multicomponent intervention will be compared to the usual procedures for CPG dissemination. The main measure will be the self-perceived activity of SLE rated by the SLAQ scale. Self-perceived health related quality of life (HRQoL) data will be obtained by means of the questionnaire EQ-5D-5L , to estimate a cost-effectiveness ratio.
Methods for secondary objectives: The rest of the objectives will be developed by a mix of quantitative and qualitative research methods to allow adapting the design, development and execution of the intervention to the characteristics of the context.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent Intervention | Experimental | Rheumatologist and internist receive a multicomponent intervention |
|
| Control | No Intervention | Rheumatologist and internist provide the usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent intervention | Behavioral | Intervention to rheumatologist and internist responsible for the care of patients with SLE. Implementation multicomponent intervention consisting of: educational component, a computerized clinical decision support system developed from the clinical practice guide - SLE and automated feedback integrated into the electronic medical record system. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of self-perceived activity of the SLE | Disease activity self-reported by the patient using the Systemic Lupus Erythematosus Activity (SLAQ) Questionnaire | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in professional's knowledge about SLE management | Acquired knowledges assessed by a questionnaire designed ad hoc | 18 months |
| Change in self-perceived health-related quality of life | Self-perceived health-related quality of life using EQ-5D - 5L questionnaire |
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Inclusion Criteria:
Adults (older than 18 years) diagnosed with SLE of any seriousness and situation (active, remission or clinically quiescent and serologically active), who agree to participate and sign informed consent.
Physicians specialized in rheumatology or internal medicine that include in their quotas a minimum of 30 patients with eligible SLE.
Exclusion Criteria:
SLE limited to the skin, advanced chronic kidney disease (dialysis or renal transplant); Mental illnesses and / or sensory or cognitive deficits; or participating in extension or follow-up studies of another RCT (possible change in follow-up guidelines). Participants in observational studies may be included as they do not change usual practice.
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa de Mar Trujillo Martin, PhD | Servicio de Evaluación del Servicio Canario de la Salud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de Evaluación del Servicio Canario de la Salud | Santa Cruz de Tenerife | 38004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22188790 | Background | Serrano-Aguilar P, Kovacs FM, Cabrera-Hernandez JM, Ramos-Goni JM, Garcia-Perez L. Avoidable costs of physical treatments for chronic back, neck and shoulder pain within the Spanish National Health Service: a cross-sectional study. BMC Musculoskelet Disord. 2011 Dec 21;12:287. doi: 10.1186/1471-2474-12-287. | |
| 15928223 | Background |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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|
| 18 months |
| Change in self-perceived health-related quality of life | Self-perceived health-related quality of life using LupusQol questionnaire | 18 months |
| Patient's perception of their participation in decision making | Patient's perception of clinician facilitation and decision-making process using the Shared Decision-Making (SDM-Q-9) Questionnaire | 18 months |
| Professional's attitude to partnership with the patient for shared decision making | Professionals' attitudes towards shared decision making assessed by the Leeds Attitude Towards Concordance II Scale (LATCon II) | 18 months |
| Professionals' adherence to CPG-SLE recommendations | Degree of professional adherence to recommendations will be determined through data collection from clinical records in terms of percentage of patients with adequate treatment according to SLE-CPG recommendations | 18 months |
| Ostbye T, Yarnall KS, Krause KM, Pollak KI, Gradison M, Michener JL. Is there time for management of patients with chronic diseases in primary care? Ann Fam Med. 2005 May-Jun;3(3):209-14. doi: 10.1370/afm.310. |
| 21557530 | Background | Zhu TY, Tam LS, Li EK. Cost-of-illness studies in systemic lupus erythematosus: A systematic review. Arthritis Care Res (Hoboken). 2011 May;63(5):751-60. doi: 10.1002/acr.20410. |
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| 23076904 | Background | Giguere A, Legare F, Grimshaw J, Turcotte S, Fiander M, Grudniewicz A, Makosso-Kallyth S, Wolf FM, Farmer AP, Gagnon MP. Printed educational materials: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004398. doi: 10.1002/14651858.CD004398.pub3. |
| 19588323 | Background | Shojania KG, Jennings A, Mayhew A, Ramsay CR, Eccles MP, Grimshaw J. The effects of on-screen, point of care computer reminders on processes and outcomes of care. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD001096. doi: 10.1002/14651858.CD001096.pub2. |
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| Background | Panzarasa S, et al.Technical Solutions for Integrating Clinical Practice Guidelines with Electronic Patient Records. Volume 5943 of LNAI. Springer-Verlag 2010;141 -154 |
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| 31675957 | Derived | Trujillo-Martin MM, Ramallo-Farina Y, Del Pino-Sedeno T, Rua-Figueroa I, Trujillo-Martin E, Vallejo-Torres L, Imaz-Iglesia I, Sanchez-de-Madariaga R, de Pascual-Medina AM, Serrano-Aguilar P; SLE-CPG-Implementation Group. Effectiveness and cost-effectiveness of a multicomponent intervention to implement a clinical practice guideline for systemic lupus erythematosus: protocol for a cluster-randomized controlled trial. BMC Health Serv Res. 2019 Nov 1;19(1):783. doi: 10.1186/s12913-019-4589-9. |
| D001519 | Behavior |