HypertensionNCT06829589
Retrieval of Economic Incentives and Information on Quality-of-care Indicators in Primary Care
A study testing Removal of economic incentives linked to 7 quality-of-care indicators and Removal of information provision linked to 7 quality-of-care indicators in people with Hypertension and Diabetes, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 68 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabetes, Atrium; Fibrillation
- What is being tested?
- Removal of economic incentives linked to 7 quality-of-care indicators and Removal of information provision linked to 7 quality-of-care indicators
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,614 participants
- Where
- 68 sitesSpain
- Study dates
- 3 Feb 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- PCPs with very low overall quality-of-care scores (<60%).
- Professionals who did not sign the pay-for-performance contracts.
Trial locations and contacts
68 sites in 1 country.
68 sites in 1 country
Spain68 sites
ABS Arbúcies/Sant Hilari
Arbúcies, Girona, 17401
ABS Artés
Artés, Barcelona, 08271
EAP Bàscara
Bàscara, Girona, 17483
ABS Berga
Berga, Barcelona, 08600
ABS Besalú
Besalú, Girona, 17850
ABS Calaf
Calaf, Barcelona, 08280
ABS Camprodon
Camprodon, Girona, 17867
ABS Canet de Mar
Canet de Mar, Barcelona, 08360
ABS Capellades
Capellades, Barcelona, 08786
ABS Cardona
Cardona, Barcelona, 08261
ABS Moià
Castellterçol, Barcelona, 08183
ABS Celrà
Celrà, Girona, 17460
ABS Cubelles-Cunit
Cubelles, Barcelona, 08880
EAP Penedès Rural Est
Els Monjos, Barcelona, 08730
EAP Penedès Rural Oest
Els Monjos, Barcelona, 08730
ABS Figueres
Figueres, Girona, 17600
ABS Girona-1
Girona, 17001
ABS Girona-3
Girona, 17003
ABS Girona-2
Girona, 17006
ABS Girona-4
Girona, 17007
ABS Baix Berguedà
Gironella, Barcelona, 08680
ABS Alt Berguedà
Guardiola de Berguedà, Barcelona, 08694
ABS Igualada urbana
Igualada, Barcelona, 08700
ABS La Jonquera
la Jonquera, Girona, 17700
ABS Anoia Rural
La Pobla de Claramunt, Barcelona, 08787
ABS Llançà
Llançà, Girona, 17490
ABS Manlleu
Manlleu, Barcelona, 08560
ABS Manresa-2
Manresa, Barcelona, 08242
ABS Manresa-4
Manresa, Barcelona, 08243
ABS Montserrat
Monistrol de Montserrat, Barcelona, 08691
ABS Navàs/Balsareny
Navàs, Barcelona, 08670
ABS Olot
Olot, Girona, 17800
ABS Piera
Piera, Barcelona, 08784
ABS Pineda de Mar
Pineda de Mar, Barcelona, 08397
ABS Lluçanès
Prats de Lluçanès, Barcelona, 08513
ABS Ripoll
Ripoll, Girona, 17500
EAP Roda de Ter
Roda de Ter, Barcelona, 08510
ABS Roses
Roses, Girona, 17480
ABS Sallent
Sallent, Barcelona, 08650
ABS Salt
Salt, Girona, 17190
ABS Sant Feliu de Guíxols
Sant Feliu de Guíxols, Girona, 17220
ABS Navarcles - Sant Fruitós de Bages
Sant Fruitós de Bages, Barcelona, 08272
ABS Sant Hipòlit de Voltregà
Sant Hipòlit de Voltregà, Barcelona, 08512
ABS Sant Joan de Vilatorrada
Sant Joan de Vilatorrada, Barcelona, 08250
EAP Ribes-Olivella
Sant Pere de Ribes, Barcelona, 08810
EAP Roquetes-Canyelles
Sant Pere de Ribes, Barcelona, 08810
ABS Sant Quirze de Besora
Sant Quirze de Besora, Barcelona, 08580
ABS Sant Sadurní d'Anoia
Sant Sadurní d'Anoia, Barcelona, 08770
ABS Sant Vicenç de Castellet
Sant Vicenç de Castellet, Barcelona, 08295
ABS Santa Coloma de Farners
Santa Coloma de Farners, Girona, 17430
ABS Santa Coloma de Queralt
Santa Coloma de Queralt, Tarragona, 43420
ABS Santa Eugènia de Berga
Santa Eugènia de Berga, Barcelona, 08507
ABS Santa Margarida de Montbui
Santa Margarida de Montbui, Barcelona, 08710
ABS Santpedor
Santpedor, Barcelona, 08251
ABS Sarrià de Ter
Sarrià de Ter, Girona, 17840
ABS Sils-Vidreres-Maçanet de la Selva
Sils, Girona, 17410
ABS Sitges
Sitges, Barcelona, 08870
ABS Súria
Súria, Barcelona, 08260
ABS Tona
Tona, Barcelona, 08551
ABS Tordera
Tordera, Barcelona, 08490
ABS La Vall de Ges
Torelló, Barcelona, 08570
ABS Vic-1 Nord
Vic, Barcelona, 08500
EAP Vilafant
Vilafant, Girona, 17740
EAP Vilafranca del Penedès-1
Vilafranca del Penedès, Barcelona, 08720
EAP Vilafranca del Penedès-2
Vilafranca del Penedès, Barcelona, 08720
ABS Vilanova del Camí
Vilanova del Camí, Barcelona, 08788
ABS Vilanova i la Geltrú-1
Vilanova i la Geltrú, Barcelona, 08800
ABS Vilanova i la Geltrú-2
Vilanova i la Geltrú, Barcelona, 08800
About this study
Official title: Assessment of the Retrieval of Economic Incentives and Information Provision on Quality-of-care Indicators for Primary Care Professionals
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).
Read the 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Hypertension, Diabetes, Atrium; Fibrillation, Asthma
- Being tested
- Removal of economic incentives linked to 7 quality-of-care indicators, Removal of information provision linked to 7 quality-of-care indicators
- Keywords
- pay-for-performance, primary care, quality-of-care indicators, feedback, healthcare policy, information provision
- Medical subject headings
- Hypertension, Diabetes Mellitus, Atrial Fibrillation, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of economic incentives linked to 7 quality-of-care indicatorsOther
The 7 intervened indicators will be the following:
- Blood pressure (BP) control in type-2 diabetes mellitus.
- BP control in ischemic cardiopathy/cerebrovascular accident.
- Hypertension: BP control in chronic renal insufficiency.
- Hypertension: BP control.
- Diagnostic adequacy of hypertension.
- Correct treatment of atrial fibrillation.
- Inhaler verification.
Professionals randomized to an arm with this intervention will no longer receive an economic reward for reaching a specific goal in the results of these 7 indicators.
The study guarantees no financial loss since the amount of money linked to these incentives will be automatically given to professionals under the concept of participating in the study.
Removal of information provision linked to 7 quality-of-care indicatorsOther
The 7 indicators will be the same as the previous intervention.
Professionals randomized to an arm with this intervention will no longer see the following in the online platform:
- Numeric result of the indicator.
- Color coding to represent indicator result in relation to the yearly goal.
- 12-month evolution graph.
Next to the 7 indicator names, only the link to a list of patients that are not fulfilling the indicator criteria will be presented (identifying the patients missing a treatment, a control or any other intervention), since this is considered a tool to support clinical practice beyond informing on the result of an indicator.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the Control group will not have any change in their information and incentives schemes. |
| Incentive removal | Experimental | Participants will no longer have the economic incentives linked to 7 quality-of-care indicators. Receives: Other: Removal of economic incentives linked to 7 quality-of-care indicators |
| Incentive and information removal | Experimental | Participants will no longer have the economic incentives linked to 7 quality-of-care indicators (like in the Incentive removal arm). In addition to this, the information on the indicator results from the online platform for health professionals will be removed. Receives: Other: Removal of economic incentives linked to 7 quality-of-care indicators; Other: Removal of information provision linked to 7 quality-of-care indicators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly percentage of achievement of the 7 quality-of-care indicators
The result of the quality-of-care indicators is calculated as the % of achievement. This is routinely computed by the Catalan Health Institute Information Systems using the electronic health records.
Measured: Evaluation will be carried out at baseline and at months 3, 6, 9 and 12 of the year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start3 Feb 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded cluster randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 1,614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Catalan Institute of Health
- Responsible party
- Principal investigator, Josep Vidal-Alaball, MD, PhD, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829589
- Sponsor's protocol ID
- 24/262-P
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roland M, Guthrie B. Quality and Outcomes Framework: what have we learnt? BMJ. 2016 Aug 4;354:i4060. doi: 10.1136/bmj.i4060.
PubMed 27492602Roland M, Dudley RA. How Financial and Reputational Incentives Can Be Used to Improve Medical Care. Health Serv Res. 2015 Dec;50 Suppl 2(Suppl 2):2090-115. doi: 10.1111/1475-6773.12419. Epub 2015 Nov 17.
PubMed 26573887Allen T, Whittaker W, Kontopantelis E, Sutton M. Influence of financial and reputational incentives on primary care performance: a longitudinal study. Br J Gen Pract. 2018 Dec;68(677):e811-e818. doi: 10.3399/bjgp18X699797. Epub 2018 Nov 5.
PubMed 30397016Eijkenaar F, Emmert M, Scheppach M, Schoffski O. Effects of pay for performance in health care: a systematic review of systematic reviews. Health Policy. 2013 May;110(2-3):115-30. doi: 10.1016/j.healthpol.2013.01.008. Epub 2013 Feb 4.
PubMed 23380190Roland M, Campbell S. Successes and failures of pay for performance in the United Kingdom. N Engl J Med. 2014 May 15;370(20):1944-9. doi: 10.1056/NEJMhpr1316051. No abstract available.
PubMed 24827040Wagenschieber E, Blunck D. Impact of reimbursement systems on patient care - a systematic review of systematic reviews. Health Econ Rev. 2024 Mar 16;14(1):22. doi: 10.1186/s13561-024-00487-6.
PubMed 38492098Mendelson 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.
PubMed 28114600Zaresani 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.
PubMed 33627112Chauhan 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.
PubMed 28057024Coma 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.
PubMed 23450738
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Retrieval of Economic Incentives and Information Provision on Quality-of-care Indicators for Primary Care Professionals
- ClinicalTrials.gov ID
- NCT06829589
- Acronym / sponsor ID
- 24/262-P
- Conditions
- Hypertension, Diabetes, Atrium; Fibrillation, Asthma
- Keywords
- pay-for-performance, primary care, quality-of-care indicators, feedback, healthcare policy, information provision
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,614 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Catalan Institute of Health
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 17 Feb 2025 (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.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Unblinded cluster randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the Control group will not have any change in their information and incentives schemes. |
| Incentive removal | Experimental | Other: Removal of economic incentives linked to 7 quality-of-care indicatorsParticipants will no longer have the economic incentives linked to 7 quality-of-care indicators. |
| Incentive and information removal | Experimental | Other: Removal of economic incentives linked to 7 quality-of-care indicators, Other: Removal of information provision linked to 7 quality-of-care indicatorsParticipants will no longer have the economic incentives linked to 7 quality-of-care indicators (like in the Incentive removal arm). In addition to this, the information on the indicator results from the online platform for health professionals will be removed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- PCPs with very low overall quality-of-care scores (<60%).
- Professionals who did not sign the pay-for-performance contracts.
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 |
|---|---|---|
| Removal of economic incentives linked to 7 quality-of-care indicatorsThe 7 intervened indicators will be the following: * Blood pressure (BP) control in type-2 diabetes mellitus. * BP control in ischemic cardiopathy/cerebrovascular accident. * Hypertension: BP control in chronic renal insufficiency. * Hypertension: BP control. * Diagnostic adequacy of hypertension. * Correct treatment of atrial fibrillation. * Inhaler verification. Professionals randomized to an arm with this intervention will no longer receive an economic reward for reaching a specific goal in the results of these 7 indicators. The study guarantees no financial loss since the amount of money linked to these incentives will be automatically given to professionals under the concept of participating in the study. | Other | Incentive and information removal, Incentive removal |
| Removal of information provision linked to 7 quality-of-care indicatorsThe 7 indicators will be the same as the previous intervention. Professionals randomized to an arm with this intervention will no longer see the following in the online platform: * Numeric result of the indicator. * Color coding to represent indicator result in relation to the yearly goal. * 12-month evolution graph. Next to the 7 indicator names, only the link to a list of patients that are not fulfilling the indicator criteria will be presented (identifying the patients missing a treatment, a control or any other intervention), since this is considered a tool to support clinical practice beyond informing on the result of an indicator. | Other | Incentive and information removal |
Primary outcome
Monthly percentage of achievement of the 7 quality-of-care indicators
Time frame: Evaluation will be carried out at baseline and at months 3, 6, 9 and 12 of the year
The result of the quality-of-care indicators is calculated as the % of achievement. This is routinely computed by the Catalan Health Institute Information Systems using the electronic health records.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 27492602Roland M, Guthrie B. Quality and Outcomes Framework: what have we learnt? BMJ. 2016 Aug 4;354:i4060. doi: 10.1136/bmj.i4060.
- Background: PubMed 26573887Roland M, Dudley RA. How Financial and Reputational Incentives Can Be Used to Improve Medical Care. Health Serv Res. 2015 Dec;50 Suppl 2(Suppl 2):2090-115. doi: 10.1111/1475-6773.12419. Epub 2015 Nov 17.
- Background: PubMed 30397016Allen T, Whittaker W, Kontopantelis E, Sutton M. Influence of financial and reputational incentives on primary care performance: a longitudinal study. Br J Gen Pract. 2018 Dec;68(677):e811-e818. doi: 10.3399/bjgp18X699797. Epub 2018 Nov 5.
- Background: PubMed 23380190Eijkenaar F, Emmert M, Scheppach M, Schoffski O. Effects of pay for performance in health care: a systematic review of systematic reviews. Health Policy. 2013 May;110(2-3):115-30. doi: 10.1016/j.healthpol.2013.01.008. Epub 2013 Feb 4.
- Background: PubMed 24827040Roland M, Campbell S. Successes and failures of pay for performance in the United Kingdom. N Engl J Med. 2014 May 15;370(20):1944-9. doi: 10.1056/NEJMhpr1316051. No abstract available.
- Background: PubMed 38492098Wagenschieber E, Blunck D. Impact of reimbursement systems on patient care - a systematic review of systematic reviews. Health Econ Rev. 2024 Mar 16;14(1):22. doi: 10.1186/s13561-024-00487-6.
- Background: PubMed 28114600Mendelson 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.
- Background: PubMed 33627112Zaresani 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.
- Background: PubMed 28057024Chauhan 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.
- Background: PubMed 23450738Coma 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
68 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removal of economic incentives linked to 7 quality-of-care indicators and Removal of information provision linked to 7 quality-of-care indicators in people with Hypertension and Diabetes, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 68 sites 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Monthly percentage of achievement of the 7 quality-of-care indicators (time frame: Evaluation will be carried out at baseline and at months 3, 6, 9 and 12 of the year). 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 NCT06829589, which also lists 10 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 17 Feb 2025.