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

September 21, 2021 updated by: Servicio Canario de Salud

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multicomponent Intervention
Rheumatologist and internist receive a multicomponent intervention
Behavioral: Multicomponent intervention
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.
No Intervention: Control
Rheumatologist and internist provide the usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in professional's knowledge about SLE management
Time Frame: 18 months
Acquired knowledges assessed by a questionnaire designed ad hoc
18 months
Change in self-perceived health-related quality of life
Time Frame: 18 months
Self-perceived health-related quality of life using EQ-5D - 5L questionnaire
18 months
Change in self-perceived health-related quality of life
Time Frame: 18 months
Self-perceived health-related quality of life using LupusQol questionnaire
18 months
Patient's perception of their participation in decision making
Time Frame: 18 months
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
Time Frame: 18 months
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
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servicio Canario de Salud

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: María de Mar Trujillo Martin, PhD, Servicio de Evaluación del Servicio Canario de la Salud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2018

Primary Completion (Actual)

October 19, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 16, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI15/01377

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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