Clinical trial NCT06829589: Retrieval of Economic Incentives and Information on Quality-of-care Indicators in Primary Care
Official title: Assessment of the Retrieval of Economic Incentives and Information Provision on Quality-of-care Indicators for Primary Care Professionals
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Diabetes
Atrium; Fibrillation
Asthma
Keywords: pay-for-performance
primary care
quality-of-care indicators
feedback
healthcare policy
information provision
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Catalan Institute of Health
First posted: 2025-02-17
Enrollment: 1614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Unblinded cluster randomized clinical trial
Primary purpose: OTHER

Brief summary: Background: Information provision and economic incentives for professionals are measures aimed at improving quality-of-care in primary care. They are frequently implemented in combination, thus, there is a lack of evidence confirming their individual effectiveness. Since 2006, the Catalan Health Institute (ICS) has implemented a quality improvement system based on a) informing professionals on the result of quality-of-care indicators through an online platform, and simultaneously b) introducing economic incentives in a pay-for-performance (P4P) scheme. There is an unmet need for evidence on the specific impacts of these interventions on quality-of-care.

Aims: Overall, the main aim of the study is to analyze the impact of removing information provision and economic incentives on quality-of-care indicators. Specifically, investigators aim (1) to analyze the effect of removing an economic incentive from a quality-of-care indicator, (2) to analyze the effect of removing information provision from an indicator, (3) to evaluate such effects based on the type of indicator, (4) to evaluate potential spillover effects between indicators linked to the same health problem, and (5) to evaluate potential changes in the professionals' registry patterns.

Methods: The study will be an unblinded cluster randomized clinical trial, with 3 branches: (1) Control, with no changes in the information/incentive schemes; (2) Removal of the economic incentives from a subset of 7 indicators; (3) Removal of the economic incentives and information linked to the 7 indicators. The study duration will be from February to December 2025, with intermediate analyses at 3, 6 and 9 months. The reference population will be the 68 ICS primary care practices (PCPs) in the regions of Catalunya Central, Penedès and Girona. The primary endpoint will be the monthly quality-of-care indicator result of the 7 indicators, and secondary endpoints will include PCP, professional and patient characteristics. The analysis of the intervention effects will be carried out using mixed models and comparing the evolution of results versus the previous years (2019-2024).

Detailed description: Background

Primary care serves as the first point of contact for patients within the healthcare system, addressing key health issues through preventive, curative, and rehabilitative services. Economic incentives, such as pay-for-performance (P4P) schemes, aim to align healthcare professionals' objectives with those of health providers and society by rewarding the achievement of quality-of-care targets. In many cases, P4P is implemented alongside information provision, as seen in the UK's Quality and Outcomes Framework (QOF), where public reporting of quality indicators adds a reputational incentive. However, the interaction between financial and non-financial incentives remains complex, and their long-term effects on quality-of-care continue to be debated.

In Catalonia, the Catalan Institute of Health (ICS) has implemented a quality improvement system since 2006, using the Quality Standard of Care (EQA) framework, which includes 118 evidence-based indicators. This system combines real-time performance feedback through an online platform (information provision) with financial incentives linked to achieving specific targets. While the approach has been well established, many incentivized indicators have plateaued in performance, raising questions about the added value of financial incentives beyond information provision alone in such situations. This study aims to evaluate the impact of removing economic incentives or information on selected EQA indicators, assessing effects by indicator type and exploring interactions between related indicators. The findings will provide crucial insights to optimize incentive strategies and improve healthcare quality in Catalonia.

Aims

General aim: To study the impact of removing economic incentives and/or information provision on quality-of-care indicators among primary care professionals.

Specific aims:

1. To analyze the effect of removing a financial incentive from an indicator: to provide evidence on what happens when points from a quality-of-care indicator linked to the Catalan Health Institute's (ICS) Direcció per Objectius (DPO) are removed, meaning that a specific indicator or a set of indicators for a clinical condition is no longer financially incentivized.
2. To analyze the effect of partially removing information from an indicator: to assess the additional impact of withdrawing part of the information related to a specific indicator or a set of indicators for a particular condition.
3. To analyze the effects of objectives 1 and 2 based on indicator type: to evaluate whether the observed effects differ according to certain characteristics of the indicators: (a) indicators that have had consistently high results for years (plateaued) and have high clinical relevance; (b) indicators primarily related to data recording; (c) sets of indicators associated with a specific condition.
4. To assess potential spillover effects on other indicators: to determine whether removing incentives and/or information from an indicator affects other indicators related to the same clinical condition that remain incentivized and publicly reported.
5. To evaluate changes in professionals' recording patterns: to determine whether the presence or absence of financial incentives for indicators leads to changes in the way healthcare professionals record data.

Study design

A cluster-randomized clinical trial without blinding. The study will include the following groups (further detail provided in the Arms and Interventions section):

* Control Group: No changes in the information and incentive scheme.
* Intervention 1: Removal of the financial incentive for a selected set of indicators.
* Intervention 2: Removal of the same financial incentives as in Intervention 1, along with the removal of related information in the online platform for professionals (numeric result of the indicator, 12-month evolution lineplot, number of patients not fulfilling the indicator criteria, degree of accomplishment of the indicator in relation to specific goals using a traffic light color coding)

Study Period and Duration

The study will take place from February 2025 to December 2025. Weekly monitoring of the primary outcome variable will be conducted, with interim analyses at 3, 6, and 9 months.

Setting and Target Population

The study will be conducted in primary care practices (PCPs) of the Catalan Health Institute (ICS). To minimize interference from territorial management incentives and encourage participation, the trial will be carried out in three regional health management areas: Catalunya Central, Penedès and Girona. These regions were selected after discussions with their management teams and agreement on the study's implementation.

The trial will be conducted at the level of individual healthcare professionals (family physicians and nurses). However, randomization will be performed at the PCP level, ensuring that all professionals within the same PCP are assigned to the same arm of the study.

Statistical analysis

The analysis will be conducted at both the individual professional and EAP levels and will include all professionals from both intervention and control EAPs, regardless of whether they have used clinical decision support tools (SISAP web and/or patient lists). The analysis will follow an intention-to-treat (ITT) approach.

First, a descriptive analysis will be performed to assess the characteristics of each group, ensuring balance across different EAP and professional-level characteristics. Balance will be evaluated using the standardized mean difference (SMD), where an SMD \> 0.1 will indicate imbalance.

The primary analysis will be focused on the effect of incentive and information withdrawal. The effect of removing financial incentives and removing both incentives and information will be analyzed using mixed-effects models, which account for intra-cluster variability and EAP-level clustering effects. A linear mixed-effects model will be used, considering both fixed and random effects. Fixed effects will include the intervention and any imbalanced covariates (based on SMD \> 0.1). Random effects will account for variability within clusters (EAPs). Results will be reported as effect estimates with 95% confidence intervals (CI95%). In addition to the above, pre-post models will also be conducted to compare current vs. past performance for the same indicators.These analyses will be conducted at 3, 6, 9, and 12 months.

To assess for changes in documentation patterns (objective #5), the study will compare the distribution of systolic (SBP) and diastolic blood pressure (DBP) values recorded for patients included in blood pressure-related indicators across control and intervention groups. The descriptive statistics mean ± standard deviation (SD) and median ± interquartile range (IQR) will be reported. T-tests will be used to compare mean differences between groups.

ANOVA followed by Tukey's post-hoc test will be used for multiple comparisons. If normality or homoscedasticity assumptions are violated, non-parametric tests will be applied instead. Statistical significance (α = 0.05) will be adjusted for multiple comparisons to control for Type I errors.

Informed consent

The regional and PCP management teams have the authority to decide which indicators contribute to the P4P scheme for each professional. This system allows a certain flexibility in awarding economic incentives for professionals. Given this framework, individual informed consent from professionals is not deemed necessary. However, the study will be presented to the directors of the participating PCPs and their agreement to participate in the study will be collected with study participation acceptance forms. These stakeholders will be fully informed about the study, including the fact that their professionals will be enrolled in a randomized clinical trial, and that professionals in the intervention groups (where some indicators have their points removed) will not experience any financial penalty. As a secondary validation, professionals will implicitly confirm their consent when signing their P4P scheme agreements. If any professional disagrees with their P4P scheme, they will be excluded from the study, and no intervention will be applied to them.

Eligibility criteria: Inclusion Criteria:

* Any general practitioner or nurse working in a primary care practice.
* Having enough clinical activity to be included in the pay-for-performance schemes by the PCP director.
* Belonging to a PCP in the regions of Catalunya Central, Penedès or Girona.
* Belonging to a PCP whose director accepted to participate in the study.

Exclusion Criteria:

* PCPs with very low overall quality-of-care scores (\<60%).
* Professionals who did not sign the pay-for-performance contracts.

Primary outcomes:
measure: Monthly percentage of achievement of the 7 quality-of-care indicators
timeFrame: Evaluation will be carried out at baseline and at months 3, 6, 9 and 12 of the year
Secondary outcomes:
Other outcomes:
measure: Monthly percentage of achievement stratified by practice rurality
timeFrame: Baseline and at 1 year
measure: Monthly percentage of achievement stratified by social deprivation index
timeFrame: Baseline and at 1 year
measure: Monthly percentage of achievement stratified by PCP accessibility
timeFrame: Baseline and at 1 year
measure: Monthly percentage of achievement stratified by PCP frequentation
timeFrame: Baseline and at 1 year
measure: Monthly percentage of achievement stratified by sex of the professional
timeFrame: Baseline and at 1 year
measure: Monthly percentage of achievement stratified by specialty of the professional
timeFrame: Baseline and at 1 year
measure: Monthly percentage of achievement stratified by age of the professional
timeFrame: Baseline and at 1 year
measure: Monthly percentage of achievement stratified by years worked
timeFrame: Baseline and at 1 year
measure: Monthly percentage of achievement stratified by sex distribution in the patient panels
timeFrame: Baseline and at 1 year
measure: Monthly percentage of achievement stratified by % of immigrant population in the patient panels
timeFrame: Baseline and at 1 year
Locations:
city: Artés
country: Spain
facility: ABS Artés
state: Barcelona
city: Berga
country: Spain
facility: ABS Berga
state: Barcelona
city: Calaf
country: Spain
facility: ABS Calaf
state: Barcelona
city: Canet De Mar
country: Spain
facility: ABS Canet de Mar
state: Barcelona
city: Capellades
country: Spain
facility: ABS Capellades
state: Barcelona
city: Cardona
country: Spain
facility: ABS Cardona
state: Barcelona
city: Castellterçol
country: Spain
facility: ABS Moià
state: Barcelona
city: Cubelles
country: Spain
facility: ABS Cubelles-Cunit
state: Barcelona
city: Els Monjos
country: Spain
facility: EAP Penedès Rural Est
state: Barcelona
city: Els Monjos
country: Spain
facility: EAP Penedès Rural Oest
state: Barcelona
city: Gironella
country: Spain
facility: ABS Baix Berguedà
state: Barcelona
city: Guardiola de Berguedà
country: Spain
facility: ABS Alt Berguedà
state: Barcelona
city: Igualada
country: Spain
facility: ABS Igualada urbana
state: Barcelona
city: La Pobla de Claramunt
country: Spain
facility: ABS Anoia Rural
state: Barcelona
city: Manlleu
country: Spain
facility: ABS Manlleu
state: Barcelona
city: Manresa
country: Spain
facility: ABS Manresa-2
state: Barcelona
city: Manresa
country: Spain
facility: ABS Manresa-4
state: Barcelona
city: Monistrol De Montserrat
country: Spain
facility: ABS Montserrat
state: Barcelona
city: Navàs
country: Spain
facility: ABS Navàs/Balsareny
state: Barcelona
city: Piera
country: Spain
facility: ABS Piera
state: Barcelona
city: Pineda de Mar
country: Spain
facility: ABS Pineda de Mar
state: Barcelona
city: Prats de Lluçanès
country: Spain
facility: ABS Lluçanès
state: Barcelona
city: Roda de Ter
country: Spain
facility: EAP Roda de Ter
state: Barcelona
city: Sallent
country: Spain
facility: ABS Sallent
state: Barcelona
city: Sant Fruitós De Bages
country: Spain
facility: ABS Navarcles - Sant Fruitós de Bages
state: Barcelona
city: Sant Hipòlit De Voltregà
country: Spain
facility: ABS Sant Hipòlit de Voltregà
state: Barcelona
city: Sant Joan De Vilatorrada
country: Spain
facility: ABS Sant Joan de Vilatorrada
state: Barcelona
city: Sant Pere De Ribes
country: Spain
facility: EAP Ribes-Olivella
state: Barcelona
city: Sant Pere de Ribes
country: Spain
facility: EAP Roquetes-Canyelles
state: Barcelona
city: Sant Quirze de Besora
country: Spain
facility: ABS Sant Quirze de Besora
state: Barcelona
city: Sant Sadurní d'Anoia
country: Spain
facility: ABS Sant Sadurní d'Anoia
state: Barcelona
city: Sant Vicenç de Castellet
country: Spain
facility: ABS Sant Vicenç de Castellet
state: Barcelona
city: Santa Eugènia de Berga
country: Spain
facility: ABS Santa Eugènia de Berga
state: Barcelona
city: Santa Margarida De Montbui
country: Spain
facility: ABS Santa Margarida de Montbui
state: Barcelona
city: Santpedor
country: Spain
facility: ABS Santpedor
state: Barcelona
city: Sitges
country: Spain
facility: ABS Sitges
state: Barcelona
city: Súria
country: Spain
facility: ABS Súria
state: Barcelona
city: Tona
country: Spain
facility: ABS Tona
state: Barcelona
city: Tordera
country: Spain
facility: ABS Tordera
state: Barcelona
city: Torelló
country: Spain
facility: ABS La Vall de Ges
state: Barcelona
city: Vic
country: Spain
facility: ABS Vic-1 Nord
state: Barcelona
city: Vilafranca Del Penedès
country: Spain
facility: EAP Vilafranca del Penedès-1
state: Barcelona
city: Vilafranca Del Penedès
country: Spain
facility: EAP Vilafranca del Penedès-2
state: Barcelona
city: Vilanova del Camí
country: Spain
facility: ABS Vilanova del Camí
state: Barcelona
city: Vilanova i la Geltrú
country: Spain
facility: ABS Vilanova i la Geltrú-1
state: Barcelona
city: Vilanova I La Geltrú
country: Spain
facility: ABS Vilanova i la Geltrú-2
state: Barcelona
city: Arbúcies
country: Spain
facility: ABS Arbúcies/Sant Hilari
state: Girona
city: Besalú
country: Spain
facility: ABS Besalú
state: Girona
city: Bàscara
country: Spain
facility: EAP Bàscara
state: Girona
city: Camprodon
country: Spain
facility: ABS Camprodon
state: Girona
city: Celrà
country: Spain
facility: ABS Celrà
state: Girona
city: Figueres
country: Spain
facility: ABS Figueres
state: Girona
city: La Jonquera
country: Spain
facility: ABS La Jonquera
state: Girona
city: Llançà
country: Spain
facility: ABS Llançà
state: Girona
city: Olot
country: Spain
facility: ABS Olot
state: Girona
city: Ripoll
country: Spain
facility: ABS Ripoll
state: Girona
city: Roses
country: Spain
facility: ABS Roses
state: Girona
city: Salt
country: Spain
facility: ABS Salt
state: Girona
city: Sant Feliu De Guíxols
country: Spain
facility: ABS Sant Feliu de Guíxols
state: Girona
city: Santa Coloma de Farners
country: Spain
facility: ABS Santa Coloma de Farners
state: Girona
city: Sarrià de Ter
country: Spain
facility: ABS Sarrià de Ter
state: Girona
city: Sils
country: Spain
facility: ABS Sils-Vidreres-Maçanet de la Selva
state: Girona
city: Vilafant
country: Spain
facility: EAP Vilafant
state: Girona
city: Santa Coloma De Queralt
country: Spain
facility: ABS Santa Coloma de Queralt
state: Tarragona
city: Girona
country: Spain
facility: ABS Girona-1
city: Girona
country: Spain
facility: ABS Girona-3
city: Girona
country: Spain
facility: ABS Girona-2
city: Girona
country: Spain
facility: ABS Girona-4
Study officials:
References:
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citation: Mendelson A, Kondo K, Damberg C, Low A, Motuapuaka M, Freeman M, O'Neil M, Relevo R, Kansagara D. The Effects of Pay-for-Performance Programs on Health, Health Care Use, and Processes of Care: A Systematic Review. Ann Intern Med. 2017 Mar 7;166(5):341-353. doi: 10.7326/M16-1881. Epub 2017 Jan 10.
citation: Zaresani A, Scott A. Is the evidence on the effectiveness of pay for performance schemes in healthcare changing? Evidence from a meta-regression analysis. BMC Health Serv Res. 2021 Feb 24;21(1):175. doi: 10.1186/s12913-021-06118-8.
citation: Chauhan BF, Jeyaraman MM, Mann AS, Lys J, Skidmore B, Sibley KM, Abou-Setta AM, Zarychanski R. Behavior change interventions and policies influencing primary healthcare professionals' practice-an overview of reviews. Implement Sci. 2017 Jan 5;12(1):3. doi: 10.1186/s13012-016-0538-8.
citation: Coma E, Ferran M, Mendez L, Iglesias B, Fina F, Medina M. Creation of a synthetic indicator of quality of care as a clinical management standard in primary care. Springerplus. 2013 Dec;2(1):51. doi: 10.1186/2193-1801-2-51. Epub 2013 Feb 13.