Systemic Lupus ErythematosusNCT03537638

Multicomponent Strategy to Implement a Clinical Practice Guideline and Improve Health Outcomes in People With SLE

A study testing Multicomponent intervention in people with Systemic Lupus Erythematosus, run by Servicio Canario de Salud at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: Multicomponent intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 237 participants
Where: 1 siteSpain
Study dates: 16 Apr 2018to 31 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients:
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.
Health professionals:
Physicians specialized in rheumatology or internal medicine that include in their quotas a minimum of 30 patients with eligible SLE.

Who cannot join

Patients:
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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Servicio de Evaluación del Servicio Canario de la Salud
Santa Cruz de Tenerife, 38004

Other trials in Spain

About this study

Official title: Effectiveness and Cost-effectiveness of a Multicomponent Strategy to Implement a Clinical Practice Guideline and Improve Health Outcomes in People With Systemic Lupus Erythematosus

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.

Conditions: Systemic Lupus Erythematosus
Being tested: Multicomponent intervention
Keywords: Lupus, Quality of life, Multicomponent intervention, Clinical Practice Guideline, Computerized clinical decision support system, Activity
Medical subject headings: Lupus Erythematosus, Systemic, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multicomponent interventionBehavioural
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.

Study groups in NCT03537638
Study group	Role	What they receive
Multicomponent Intervention	Experimental	Rheumatologist and internist receive a multicomponent intervention Receives: Behavioral: Multicomponent intervention
Control	No intervention	Rheumatologist and internist provide the usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of self-perceived activity of the SLE
Disease activity self-reported by the patient using the Systemic Lupus Erythematosus Activity (SLAQ) Questionnaire
Measured: 18 months

Secondary outcomes (6)

Change in professional's knowledge about SLE management
Acquired knowledges assessed by a questionnaire designed ad hoc
Measured: 18 months
Change in self-perceived health-related quality of life
Self-perceived health-related quality of life using EQ-5D - 5L questionnaire
Measured: 18 months
Change in self-perceived health-related quality of life
Self-perceived health-related quality of life using LupusQol questionnaire
Measured: 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
Measured: 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)
Measured: 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
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 201831 Dec 2020

First posted25 May 2018
Study start16 Apr 2018
Primary completion19 Oct 2020
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 237 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03537638
Sponsor's protocol ID: PI15/01377
Status last verified: Oct 2020
First submitted: 16 Apr 2018
Last updated: 22 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 22188790
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.
PubMed 15928223
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.
PubMed 21557530
Lerang K, Gilboe IM, Gran JT. Differences between rheumatologists and other internists regarding diagnosis and treatment of systemic lupus erythematosus. Rheumatology (Oxford). 2012 Apr;51(4):663-9. doi: 10.1093/rheumatology/ker318. Epub 2011 Dec 7.
PubMed 22157467
Bertsias G, Ioannidis JP, Boletis J, Bombardieri S, Cervera R, Dostal C, Font J, Gilboe IM, Houssiau F, Huizinga T, Isenberg D, Kallenberg CG, Khamashta M, Piette JC, Schneider M, Smolen J, Sturfelt G, Tincani A, van Vollenhoven R, Gordon C, Boumpas DT; Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics. EULAR recommendations for the management of systemic lupus erythematosus. Report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics. Ann Rheum Dis. 2008 Feb;67(2):195-205. doi: 10.1136/ard.2007.070367. Epub 2007 May 15.
PubMed 17504841
Sidorenkov G, Haaijer-Ruskamp FM, de Zeeuw D, Denig P. A longitudinal study examining adherence to guidelines in diabetes care according to different definitions of adequacy and timeliness. PLoS One. 2011;6(9):e24278. doi: 10.1371/journal.pone.0024278. Epub 2011 Sep 8.
PubMed 21931669
Perez X, Wisnivesky JP, Lurslurchachai L, Kleinman LC, Kronish IM. Barriers to adherence to COPD guidelines among primary care providers. Respir Med. 2012 Mar;106(3):374-81. doi: 10.1016/j.rmed.2011.09.010. Epub 2011 Oct 13.
PubMed 22000501
Kastner M, Bhattacharyya O, Hayden L, Makarski J, Estey E, Durocher L, Chatterjee A, Perrier L, Graham ID, Straus SE, Zwarenstein M, Brouwers M. Guideline uptake is influenced by six implementability domains for creating and communicating guidelines: a realist review. J Clin Epidemiol. 2015 May;68(5):498-509. doi: 10.1016/j.jclinepi.2014.12.013. Epub 2015 Jan 10.
PubMed 25684154
Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999 Oct 20;282(15):1458-65. doi: 10.1001/jama.282.15.1458.
PubMed 10535437
Jacobs SR, Weiner BJ, Bunger AC. Context matters: measuring implementation climate among individuals and groups. Implement Sci. 2014 Apr 17;9:46. doi: 10.1186/1748-5908-9-46.
PubMed 24742308
Francke AL, Smit MC, de Veer AJ, Mistiaen P. Factors influencing the implementation of clinical guidelines for health care professionals: a systematic meta-review. BMC Med Inform Decis Mak. 2008 Sep 12;8:38. doi: 10.1186/1472-6947-8-38.
PubMed 18789150
Grimshaw JM, Eccles MP, Lavis JN, Hill SJ, Squires JE. Knowledge translation of research findings. Implement Sci. 2012 May 31;7:50. doi: 10.1186/1748-5908-7-50.
PubMed 22651257
Sketris IS, Langille Ingram EM, Lummis HL. Strategic opportunities for effective optimal prescribing and medication management. Can J Clin Pharmacol. 2009 Winter;16(1):e103-25. Epub 2009 Jan 30.
PubMed 19182305
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.
PubMed 23076904
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.
PubMed 19588323

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
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RecruitingObservational study
Pakistan Arthritis and Connective Tissue Disease Network - Systemic Lupus Erythematosus
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Not yet recruitingPhase 1/2
CD19-Directed CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus
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All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Cost-effectiveness of a Multicomponent Strategy to Implement a Clinical Practice Guideline and Improve Health Outcomes in People With Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT03537638
Acronym / sponsor ID: PI15/01377
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus, Quality of life, Multicomponent intervention, Clinical Practice Guideline, Computerized clinical decision support system, Activity
Study type: Interventional
Recruitment status: Completed
Enrolment: 237 participants (actual)
Lead sponsor: Servicio Canario de SaludUniversity, hospital or other
Collaborators: Instituto de Salud Carlos III
Study start: 16 Apr 2018 (actual)
Primary completion: 19 Oct 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 25 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Multicomponent Intervention	Experimental	Behavioral: Multicomponent interventionRheumatologist and internist receive a multicomponent intervention
Control	No intervention	–Rheumatologist and internist provide the usual care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients:
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.
Health professionals:
Physicians specialized in rheumatology or internal medicine that include in their quotas a minimum of 30 patients with eligible SLE.

Key exclusion criteria (2 listed)

Patients:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multicomponent interventionIntervention 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.	Behavioural	Multicomponent Intervention

Primary outcome

Change of self-perceived activity of the SLE
Time frame: 18 months
Disease activity self-reported by the patient using the Systemic Lupus Erythematosus Activity (SLAQ) Questionnaire

6 secondary outcomes

Change in professional's knowledge about SLE management
Time frame: 18 months
Change in self-perceived health-related quality of life
Time frame: 18 months
Change in self-perceived health-related quality of life
Time frame: 18 months
Patient's perception of their participation in decision making
Time frame: 18 months
Professional's attitude to partnership with the patient for shared decision making
Time frame: 18 months
Professionals' adherence to CPG-SLE recommendations
Time frame: 18 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
Background: PubMed 22188790Serrano-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.
Background: PubMed 15928223Ostbye 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.
Background: PubMed 21557530Zhu 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.
Background: PubMed 22157467Lerang K, Gilboe IM, Gran JT. Differences between rheumatologists and other internists regarding diagnosis and treatment of systemic lupus erythematosus. Rheumatology (Oxford). 2012 Apr;51(4):663-9. doi: 10.1093/rheumatology/ker318. Epub 2011 Dec 7.
Background: PubMed 17504841Bertsias G, Ioannidis JP, Boletis J, Bombardieri S, Cervera R, Dostal C, Font J, Gilboe IM, Houssiau F, Huizinga T, Isenberg D, Kallenberg CG, Khamashta M, Piette JC, Schneider M, Smolen J, Sturfelt G, Tincani A, van Vollenhoven R, Gordon C, Boumpas DT; Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics. EULAR recommendations for the management of systemic lupus erythematosus. Report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics. Ann Rheum Dis. 2008 Feb;67(2):195-205. doi: 10.1136/ard.2007.070367. Epub 2007 May 15.
Background: PubMed 21931669Sidorenkov G, Haaijer-Ruskamp FM, de Zeeuw D, Denig P. A longitudinal study examining adherence to guidelines in diabetes care according to different definitions of adequacy and timeliness. PLoS One. 2011;6(9):e24278. doi: 10.1371/journal.pone.0024278. Epub 2011 Sep 8.
Background: PubMed 22000501Perez X, Wisnivesky JP, Lurslurchachai L, Kleinman LC, Kronish IM. Barriers to adherence to COPD guidelines among primary care providers. Respir Med. 2012 Mar;106(3):374-81. doi: 10.1016/j.rmed.2011.09.010. Epub 2011 Oct 13.
Background: PubMed 25684154Kastner M, Bhattacharyya O, Hayden L, Makarski J, Estey E, Durocher L, Chatterjee A, Perrier L, Graham ID, Straus SE, Zwarenstein M, Brouwers M. Guideline uptake is influenced by six implementability domains for creating and communicating guidelines: a realist review. J Clin Epidemiol. 2015 May;68(5):498-509. doi: 10.1016/j.jclinepi.2014.12.013. Epub 2015 Jan 10.
Background: PubMed 10535437Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999 Oct 20;282(15):1458-65. doi: 10.1001/jama.282.15.1458.
Background: PubMed 24742308Jacobs SR, Weiner BJ, Bunger AC. Context matters: measuring implementation climate among individuals and groups. Implement Sci. 2014 Apr 17;9:46. doi: 10.1186/1748-5908-9-46.
Background: PubMed 18789150Francke AL, Smit MC, de Veer AJ, Mistiaen P. Factors influencing the implementation of clinical guidelines for health care professionals: a systematic meta-review. BMC Med Inform Decis Mak. 2008 Sep 12;8:38. doi: 10.1186/1472-6947-8-38.
Background: PubMed 22651257Grimshaw JM, Eccles MP, Lavis JN, Hill SJ, Squires JE. Knowledge translation of research findings. Implement Sci. 2012 May 31;7:50. doi: 10.1186/1748-5908-7-50.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

María de Mar Trujillo Martin, PhD principal investigator

Servicio de Evaluación del Servicio Canario de la Salud

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent intervention in people with Systemic Lupus Erythematosus, run by Servicio Canario de Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of self-perceived activity of the SLE (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03537638, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.