Chronic Disease, Delivery Simple, Standardized & Redundant Message to Patient, Therapeutic Adherence, Training Group, Sensitivity
Conditions
Keywords
intervention study, stepped wedge study
Brief summary
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.
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.
Interventions
OTHERTrained 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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The research is multicentric and randomized. The study intervention will be implemented in a stepped-wedge design with 10 steps, 10 healthcare facilities (clusters), 12 2-month periods, 1 2-month period including wash-out and training of healthcare professionals (intervention). The wash-out will prevent contamination between the two periods.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in therapeutic adherence | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost of the intervention | 12 months | 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. |
| Satisfaction of participating healthcare professionals and reasons for refusal to participate | 12 months | 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. |
| Predictive factors of improved adherence factors predictive of therapeutic adherence | 6 months | Identification of predictive factors for improving adherence assessed by the Freedom patient self-questionnaire and known factors. |
| Improvement in therapeutic adherence estimated | 12 months | 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. |
| Costs of care according to periods (control vs. intervention) | 12 months | 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. |
| Improvement in therapeutic adherence | 12 months | 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 %. |
Countries
France
Contacts
CONTACTTiffany MARTIN
PRINCIPAL_INVESTIGATORBrigitte SABATIER, Dr
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed