NCT06829589

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,614

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

68 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

February 5, 2025

Last Update Submit

February 11, 2025

Conditions

Keywords

pay-for-performanceprimary carequality-of-care indicatorsfeedbackhealthcare policyinformation provision

Outcome Measures

Primary Outcomes (1)

  • 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.

    Evaluation will be carried out at baseline and at months 3, 6, 9 and 12 of the year

Other Outcomes (10)

  • Monthly percentage of achievement stratified by practice rurality

    Baseline and at 1 year

  • Monthly percentage of achievement stratified by social deprivation index

    Baseline and at 1 year

  • Monthly percentage of achievement stratified by PCP accessibility

    Baseline and at 1 year

  • +7 more other outcomes

Study Arms (3)

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.

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.

Other: Removal of economic incentives linked to 7 quality-of-care indicatorsOther: Removal of information provision linked to 7 quality-of-care indicators

Interventions

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.

Incentive and information removalIncentive removal

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.

Incentive and information removal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (68)

ABS Artés

Artés, Barcelona, 08271, Spain

Location

ABS Berga

Berga, Barcelona, 08600, Spain

Location

ABS Calaf

Calaf, Barcelona, 08280, Spain

Location

ABS Canet de Mar

Canet de Mar, Barcelona, 08360, Spain

Location

ABS Capellades

Capellades, Barcelona, 08786, Spain

Location

ABS Cardona

Cardona, Barcelona, 08261, Spain

Location

ABS Moià

Castellterçol, Barcelona, 08183, Spain

Location

ABS Cubelles-Cunit

Cubelles, Barcelona, 08880, Spain

Location

EAP Penedès Rural Est

Els Monjos, Barcelona, 08730, Spain

Location

EAP Penedès Rural Oest

Els Monjos, Barcelona, 08730, Spain

Location

ABS Baix Berguedà

Gironella, Barcelona, 08680, Spain

Location

ABS Alt Berguedà

Guardiola de Berguedà, Barcelona, 08694, Spain

Location

ABS Igualada urbana

Igualada, Barcelona, 08700, Spain

Location

ABS Anoia Rural

La Pobla de Claramunt, Barcelona, 08787, Spain

Location

ABS Manlleu

Manlleu, Barcelona, 08560, Spain

Location

ABS Manresa-2

Manresa, Barcelona, 08242, Spain

Location

ABS Manresa-4

Manresa, Barcelona, 08243, Spain

Location

ABS Montserrat

Monistrol de Montserrat, Barcelona, 08691, Spain

Location

ABS Navàs/Balsareny

Navàs, Barcelona, 08670, Spain

Location

ABS Piera

Piera, Barcelona, 08784, Spain

Location

ABS Pineda de Mar

Pineda de Mar, Barcelona, 08397, Spain

Location

ABS Lluçanès

Prats de Lluçanès, Barcelona, 08513, Spain

Location

EAP Roda de Ter

Roda de Ter, Barcelona, 08510, Spain

Location

ABS Sallent

Sallent, Barcelona, 08650, Spain

Location

ABS Navarcles - Sant Fruitós de Bages

Sant Fruitós de Bages, Barcelona, 08272, Spain

Location

ABS Sant Hipòlit de Voltregà

Sant Hipòlit de Voltregà, Barcelona, 08512, Spain

Location

ABS Sant Joan de Vilatorrada

Sant Joan de Vilatorrada, Barcelona, 08250, Spain

Location

EAP Ribes-Olivella

Sant Pere de Ribes, Barcelona, 08810, Spain

Location

EAP Roquetes-Canyelles

Sant Pere de Ribes, Barcelona, 08810, Spain

Location

ABS Sant Quirze de Besora

Sant Quirze de Besora, Barcelona, 08580, Spain

Location

ABS Sant Sadurní d'Anoia

Sant Sadurní d'Anoia, Barcelona, 08770, Spain

Location

ABS Sant Vicenç de Castellet

Sant Vicenç de Castellet, Barcelona, 08295, Spain

Location

ABS Santa Eugènia de Berga

Santa Eugènia de Berga, Barcelona, 08507, Spain

Location

ABS Santa Margarida de Montbui

Santa Margarida de Montbui, Barcelona, 08710, Spain

Location

ABS Santpedor

Santpedor, Barcelona, 08251, Spain

Location

ABS Sitges

Sitges, Barcelona, 08870, Spain

Location

ABS Súria

Súria, Barcelona, 08260, Spain

Location

ABS Tona

Tona, Barcelona, 08551, Spain

Location

ABS Tordera

Tordera, Barcelona, 08490, Spain

Location

ABS La Vall de Ges

Torelló, Barcelona, 08570, Spain

Location

ABS Vic-1 Nord

Vic, Barcelona, 08500, Spain

Location

EAP Vilafranca del Penedès-1

Vilafranca del Penedès, Barcelona, 08720, Spain

Location

EAP Vilafranca del Penedès-2

Vilafranca del Penedès, Barcelona, 08720, Spain

Location

ABS Vilanova del Camí

Vilanova del Camí, Barcelona, 08788, Spain

Location

ABS Vilanova i la Geltrú-1

Vilanova i la Geltrú, Barcelona, 08800, Spain

Location

ABS Vilanova i la Geltrú-2

Vilanova i la Geltrú, Barcelona, 08800, Spain

Location

ABS Arbúcies/Sant Hilari

Arbúcies, Girona, 17401, Spain

Location

EAP Bàscara

Bàscara, Girona, 17483, Spain

Location

ABS Besalú

Besalú, Girona, 17850, Spain

Location

ABS Camprodon

Camprodon, Girona, 17867, Spain

Location

ABS Celrà

Celrà, Girona, 17460, Spain

Location

ABS Figueres

Figueres, Girona, 17600, Spain

Location

ABS La Jonquera

la Jonquera, Girona, 17700, Spain

Location

ABS Llançà

Llançà, Girona, 17490, Spain

Location

ABS Olot

Olot, Girona, 17800, Spain

Location

ABS Ripoll

Ripoll, Girona, 17500, Spain

Location

ABS Roses

Roses, Girona, 17480, Spain

Location

ABS Salt

Salt, Girona, 17190, Spain

Location

ABS Sant Feliu de Guíxols

Sant Feliu de Guíxols, Girona, 17220, Spain

Location

ABS Santa Coloma de Farners

Santa Coloma de Farners, Girona, 17430, Spain

Location

ABS Sarrià de Ter

Sarrià de Ter, Girona, 17840, Spain

Location

ABS Sils-Vidreres-Maçanet de la Selva

Sils, Girona, 17410, Spain

Location

EAP Vilafant

Vilafant, Girona, 17740, Spain

Location

ABS Santa Coloma de Queralt

Santa Coloma de Queralt, Tarragona, 43420, Spain

Location

ABS Girona-1

Girona, 17001, Spain

Location

ABS Girona-3

Girona, 17003, Spain

Location

ABS Girona-2

Girona, 17006, Spain

Location

ABS Girona-4

Girona, 17007, Spain

Location

Related Publications (10)

  • Roland M, Guthrie B. Quality and Outcomes Framework: what have we learnt? BMJ. 2016 Aug 4;354:i4060. doi: 10.1136/bmj.i4060.

    PMID: 27492602BACKGROUND
  • Roland 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.

    PMID: 26573887BACKGROUND
  • Allen 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.

    PMID: 30397016BACKGROUND
  • Eijkenaar 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.

    PMID: 23380190BACKGROUND
  • Roland 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.

    PMID: 24827040BACKGROUND
  • Wagenschieber 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.

    PMID: 38492098BACKGROUND
  • 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.

    PMID: 28114600BACKGROUND
  • 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.

    PMID: 33627112BACKGROUND
  • 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.

    PMID: 28057024BACKGROUND
  • 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.

    PMID: 23450738BACKGROUND

MeSH Terms

Conditions

HypertensionDiabetes MellitusAtrial FibrillationAsthma

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Unblinded cluster randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research, Innovation and Data Analysis

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 17, 2025

Study Start

February 3, 2025

Primary Completion

December 31, 2025

Study Completion

April 30, 2026

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations