Improving Patients' Adherence to Their Chronic Treatments by Implementing a Simple, Standardized and Redundant Message Delivered by Healthcare Professionals. (MAPS)

Improving Patients' Adherence to Their Chronic Treatments by Implementing a Simple, Standardized and Redundant Message Delivered by Healthcare Professionals: a Stepped-wedge Multicenter Randomized Trial

The primary objective in this study is to achieve a 15% 6-month improvement in therapeutic adherence among patients with chronic pathologies, thanks to a simple, standardized and redundant message delivered by healthcare professionals during consultations/interviews Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action concerning therapeutic adherence. This message is delivered with the aim of modifying the patient's behavior with regard to treatment intake.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Disease; Training Group, Sensitivity; Therapeutic Adherence; Delivery Simple, Standardized & Redundant Message to Patient
• Intervention / Treatment: Other: Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence.

Detailed Description

This project will enable us to adapt or even modify the practices of healthcare professionals, by making management recommendations to improve patients' adherence to treatment during their consultations/interviews, and throughout their entire course of care. This project will increase the benefit/risk ratio of treatments and reduce the waste of healthcare resources.

For patients, their participation by filling in the therapeutic adherence self-questionnaire will enable them to become active players in the management of their treatment.

If the results of our study prove positive, this will lead to a new, optimized organization of patient care.

• Study Type: Interventional
• Enrollment (Estimated): 1210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiffany MARTIN; Phone Number: +33 1 44 84 17 92; Email: tiffany.martin@aphp.fr

Study Locations

• France
  • Angers, France, 49933
    • CHU d'Angers
    • Contact: Laurence SPIESSER-ROBELET, Dr; Phone Number: +33 2 41 35 35 44; Email: laspiesser-robelet@chu-angers.fr
  • Antibes, France, 06606
    • CH d'Antibes
    • Contact: Benjamin VERRIERE, Dr; Phone Number: +33 4 97 24 77 41; Email: benjamin.verriere@ch-antibes.fr
  • Issy-les-Moulineaux, France, 92133
    • Hôpital Corentin Celton
    • Contact: Yann ORVEN, Dr; Phone Number: +33 1 58 00 46 30; Email: yann.orven@aphp.fr
  • Marseille, France, 13005
    • Hôpital la Timone
    • Contact: Guillaume HACHE, Dr; Phone Number: +33 4 91 38 70 66; Email: guillaume.hache@ap-hm.fr
  • Marseille, France, 13005
    • Hôpital de la Conception
    • Contact: Florian CORREARD, Dr; Phone Number: +33 4 91 38 43 97; Email: florian.correard@ap-hm.fr
  • Nantes, France, 44000
    • CHU de Nantes
    • Contact: Jean-François HUON, Dr; Phone Number: +33 2 44 76 80 74; Email: jeanfrancois.huon@chu-nantes.fr
  • Paris, France, 75015
    • Hopital Europeen Georges-Pompidou
    • Contact: Brigitte SABATIER, Dr; Phone Number: +33 1 56 09 31 54; Email: brigitte.sabatier@aphp.fr
  • Paris, France, 94270
    • Hôpital Bicêtre
    • Contact: Marie-Camille CHAUMAIS, Dr; Phone Number: +33 1 45 21 71 72; Email: marie-camille.chaumais@aphp.fr
  • Toulouse, France, 31059
    • CHU de Toulouse
    • Contact: Philippe CESTAC, Dr; Phone Number: +33 5 67 77 11 59; Email: cestac.p@chu-toulouse.fr
  • Tours, France, 37000
    • CHU de Tours
    • Contact: Laura FOUCAULT-FRUCHARD, Dr; Phone Number: +33 2 47 47 38 89; Email: l.foucaultfruchard@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (age ≥ 18 years)
• Affiliated to the French social security system
• Followed in hospital for a chronic pathology within a formalized care pathway
• Having signed a consent form to participate in the study.

Exclusion Criteria:

• Patients included in the control period.
• Patients under guardianship.
• Pregnant or breast-feeding patients.
• Patients taking part in research on compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention period; Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence. During this period, the message will be delivered to the patient by each of the healthcare professionals involved in his or her hospital care. It will be formalized by a checklist that will enable them to reformulate the 3 points defined as key elements of therapeutic adherence. Each healthcare professional is free to deliver this message at any time during their consultation/interview with the patient. They will be asked to note the date and tick off each point on the checklist. The intervention period will take place after the control and wash-out periods, and after healthcare professionals have been trained in the intervention.	Other: Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence.; This message is delivered with the aim of modifying the patient's behavior with regard to treatment intake. The research does not anticipate any change in the patient's medical prescriptions.; Other Names: Intervention period
No Intervention: Control period; The control period is the period before healthcare professionals are trained in the intervention. Patients included during this period will not receive the simple, standardized and redundant message.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in therapeutic adherence	The medication possession ratio (MPR), calculated as the ratio between the sum of treatment days delivered over the period of interest x 100, expressed as a %. In the literature, an MPR ≥ 80% corresponds to good therapeutic adherence.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in therapeutic adherence	The medication possession ratio (MPR), calculated as the ratio between the sum of treatment days delivered over the period of interest x 100, expressed as a %.	12 months
Predictive factors of improved adherence factors predictive of therapeutic adherence	Identification of predictive factors for improving adherence assessed by the Freedom patient self-questionnaire and known factors.	6 months
Improvement in therapeutic adherence estimated	patient adherence self-questionnaire, taking into account what the patient says between M0 and M3, M3 and M6; and between M0 and M12, M6 and M12 (11 questions formulated using a 5-point Likert scale), which classifies patients' therapeutic adherence into 3 classes: "low therapeutic adherence / average / high". Improvement in adherence will be assessed by changing the adherence category.	12 months
Costs of care according to periods (control vs. intervention)	The number of consultations (general practitioner, specialist, nurse), hospital admissions (day and conventional), emergency room visits, and the number and duration of days off work will be collected prospectively via a questionnaire on the evaluation of healthcare use given to the patient at M0, M3, M6 and M12. Costs will then be evaluated using the official tariffs for each procedure or hospitalization. Treatment costs will be evaluated on the basis of data from copies of prescriptions collected by pharmacists at each center.	12 months
Cost of the intervention	a comparison of the cost of the intervention in terms of time spent on training by healthcare professionals and delivery of the 3-point message for each patient will be carried out, compared with the control group.	12 months
Satisfaction of participating healthcare professionals and reasons for refusal to participate	Numbers and percentages will be reported for each question of the professional satisfaction self-questionnaire adapted from Jean-Marc Palm questionnaire. The questionnaire contains six questions. The answers range from totally disagree to totally agree.	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Brigitte SABATIER, Dr, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: intervention study; stepped wedge study
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: APHP230810; PREPS-22-0004 (Other Grant/Funding Number: French Ministry of Health); DR-2024-271 (Other Identifier: Commission Nationale de l'Informatique et des Libertés); 2024-A00701-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
• IPD Sharing Time Frame: Two years after the last publication
• IPD Sharing Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No