Clinical trial NCT04188470: Optimising Drug Therapy in Polymedicated Patients According to the Person-centered Care Model
Official title: Open Randomised Multicentric Controlled Trial to Evaluate the Impact of an Intervention to Improve Drug Appropriateness in Polymedicated Patients According to the Person-centered Care Model by a Multidisciplinary Team At Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chronic Conditions
End Stage Disease
Keywords: Polypharmacy
deprescriptions
patient-centered care
frail elderly
interprofessional relations
decision making
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 208
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction: In recent years, multi-aging has increased by 25%. This is related to plutipatology, frailty, polymedications, elevated sanitary cost, low quality of life, adverse events and mortality. To improve this it is necessary to apply the people-centered care model that includes and individualized therapeutic plan taking into account medication appropriateness, frailty, complexity and patient preferences. A collaborative model by a multidisciplinary team is proposed to make decisions to optimize drug therapy.

Hypothesis: person-centered care model by a multidisciplinary team at primary care improve drug appropriateness in polymedicated elderly patients Material and Method: Design: Randomized (1:1), open-label, multicentre, parallel-arm clinical trial with 1-year follow-up. Study population: community-dwelling polymedicated (≥8 drugs) elderly (≥75 years old) people at 11 primary healthcare team in Bages, Osona and Anoia (Catalonian region). Period: May 2020 and ends at 12 months of follow-up of the last included subject. Method: 11 primary healthcare team will be randomized to control or intervention group, then volunteers basic healthcare team will participate in the study and they will be assigned to control or intervention group depending on which team they work, then the subjects assigned to theses basic healthcare teams that meet the inclusion criteria and not exclusion criteria will be selected and finally the informed consent of these will be obtained. In the intervention group the multidisciplinary work team comprised by the clinical pharmacist, expert collaborator doctor and the basic healthcare team will meet periodically to review subjects, a multidimensional review will be carried out by assessing the frailty, complexity, morbidity and the appropriateness drug therapy, if proposed changes in the therapeutic plan will have to be agreed with the patient taking into account their preferences. At 6 and 12 months or when their basic healthcare team requests it they will be reviewed again. In the control group the necessary study data collection will be carry out at the beginning and at 6 and 12 months, and the routine clinical practice in relation to the use of medication will be carried out. Measurements: variation of the mean of incidents (potencially prescription inadequate) per patient, variation of the number of prescribed drugs per patient, changes in the therapeutic plans implemented and variation of the number of hospitalizations.

Detailed description: JUSTIFICATION:

The proposed project focuses on the clinical review from primary care because the healthcare team are close to the community-dwelling people and therefore offer integral care. The added value is given by the participation of a multidisciplinary team, in addition to the reference healthcare team, an expert chronicity physician and the primary care pharmacist are also involved, thus offer a greater amplitude in the centered vision and care in the patient and in the process of therapeutic appropriateness.

The Primary Care Pharmacist (FAP) in the Project ENAPISC, defined in Catalonia, positions itself as a necessary healthcare professional in the healthcare teams to ensure adequacy use of the medication.

Although the evidence published on the result of the implementation of these interventions in the primary care environment is multiple, its application is still scarce, which gives added value to the realization of the project.

OBJECTIVES:

GENERAL: To evaluate the effectiveness of the intervention to improve the therapeutic appropriateness of the elderly polymedicated patients by the application of person-centered prescription review method.

SPECIFIC:

* Describe the characteristics of the sample
* Decrease the number of detected incidents in the prescription
* Decrease the number of prescribed medications
* -decrease the numer of hospitalizations
* Detect if there are incidents related to the medication derived from the intervention done.
* Know the changes produced in the medication plan of the intervention group after one year after the intervention has finished.

METHODS:

Study design: Randomized (1:1), open-label, multicentre, parallel-arm clinical trial with 1-year follow-up Study period: May 2020-May 2024. Study population: polymedicated patients with the condition of complex chronic patient or patient with advanced chronic disease and / or ≥ 75 years old assigned to 11 primary healthcare teams in Bages, Osona and Anoia.

Selection of the primary care center, the basic healthcare team and the subjects: Of the 11 primary care center that belong to the scope of work of the FAP, volunteer basic healthcare team will participate, these will be randomized and then the possible subjects that meet the criteria of the study population are selected, taking into account the inclusion and exclusion criteria with the calculation of the size of the study population and the sampling procedure we obtain the selection of participants.

Randomization and distribution of subjects: the 11 primary care team will be graded in a 1:1 proportion, then basic healthcare team will be assigned to control or intervention group depending on which team they will work, to prioritize study subjects, those that are in the list of possible subjects will be selected, and finally the informed consent will be obtained. It is an open study, therefore, the subjects and the basic healthcare team will be aware of what group of study they belong to.

Sample size and sampling procedure:

The sample size has been calculated using the GRANMO v.7.12 program for two independent proportions. With an alpha risk of 0.05, a beta of 0.20 with a loss ratio of 0.15.

146 subjects are needed in the first group and 146 in the second group to detect how statistically significant the difference between two proportions of the average reduction in the number of medications per patient, which for group 1 is expected to be 0.23 and for group 2 of 0.10 . Approximation of ARCSINUS has been used.

Collection of data and sources of information:

The list of patients defined as study population and who meet criteria of inclusion and no exclusion criteria will be requested from the information systems of the company, the subjects will be recruited through a telephone visit and in case of acceptance of the participation the subjects must sign the informed consent that will be offered to them through a visit with nursing to the center or at home if necessary. The control group or the intervention group will be assigned according to the basic healthcare team to which they are assigned.

The data necessary to carry out the study and defined in the data collection sheets, should be obtained from electronic clinical history.

Data analysis:

A description of the variables will be made by calculating proportions in the case of qualitative variables and representation with the corresponding graphs and a median calculation in the case of normal or median distribution if this is not the case for quantitative variables.

Bivariate inferential analysis with a parametric test in the case of normal distribution of comparison of means (t-STUDENT), and in the case of non-normal distribution a non-parametric equivalent test, in particular, the Mann-Whitney U will be used. And in the case of comparison between categorical variables we will use the Ji-cuadrado to determine the relation between variables and the Cramer V test to determine the intensity of the association in case there is one.

Multiple regression to analyze the effect of the confusing variables on the main result variable.

The statistical program SPSS v24.0 will be used to analyze the data.

WORK PLAN:

Basic healthcare team will be randomized and the subjects of study will be control or intervention depending on the assigned basic healthcare team.

In the intervention group, the work group formed by the primary care pharmacist and the physician and nurse assigned to the patients, will meet periodically to analyze 2-4 patients each meeting, a multidimensional patient review will be carried out to evaluate the frailty, complexity, health problems, control of clinical variables to assess the appropriateness of the medication by means of the detection of incidents, the group will propose changes in the therapeutic plan which will have to be finally agreed with the patient or caregiver. They will be reviewed again at 6 and 12 months. Nursing will schedule visit 0 with the patient or caregiver and the data be collected. At the same time, in a bi-annual manner, meetings with the work group will be scheduled. Once reviewed the basic healthcare team will schedule visits with the patient:

* Visit 1 to 15 days after the group meeting
* visit at 3 months to keep track of agreed changes
* Visit at 6 and 12 months prior to the work group meeting about 15 days before In the case of need for support from the community pharmacist or the social worker or other physicians, an individualized work plan will be agreed with them.

At 6 months or earlier, if a member of the group requires it, the patient's therapeutic plan will be reviewed again to monitor the clinical follow-up of the patient, to review whether there has been any incidence in the therapeutic plan adaptation process, and / or make more changes.

In the subjects of the control group the necessary data will be collected to carry out the study at the beginning and at 6 and 12 months, and the usual clinical practice will be done in relation to the use of medication. Nursing will program 3 visits (0, 6 and 12 months) in the center or at home to perform data collection, and the pharmaceutical will review the therapeutic plan.

Finally, the data of each patient included in the study will be introduced on the file created to track and evaluate results.

DIFFICULTIES AND LIMITATIONS OF THE STUDY:

The beliefs of healthcare professionals who treat patients may make it difficult to improve the adaptation of the therapeutic plan but it is considered that the design of the project (randomized trial), the multidisciplinary team work, the participation of an expert in the use of the medication can help reduce the impact of this factor and redirect some beliefs; The management of the time is also a limitation because the exhaustive review of the patient's therapeutic plan requires some time, but in this case, the health benefit that the project can generate can make the investment of time efficient. The results can be biased by the effect of the professionals on the control group and on the part of the patients knowing that they participate in the study (open study). Finally, the knowledge and beliefs of patients regarding medication and health can also be a factor that hinders changes in the therapeutic plan but with an appropriate process of shared decisions where quality information is worked for the patient, the autonomy and the decision-making capacity may reduce the impact of this limitation.

APPLICABILITY AND PRACTICAL USE OF THE RESULTS:

The proposed model proposes a systematic work in the process of medication review and teamwork with the approach from different points of view and degrees of knowledge of the subject. Until now, the medication review is done without applying a systematic process and without taking into account the technical knowledge of other skilled professionals.

Considering as a general and last objective to improve the therapeutic appropriateness of polymedicated patients, this is an innovative model, since it is characterized by:

* multidisciplinary team work: each professional provides different knowledge and perspectives regarding the use of the medication and the patient's knowledge, and the sum of all contributes the added value of the person-centered care model.
* incorporation of the primary care pharmacist as a reference in the safe and quality use of the medication in the person-centered care assistance process.

ETHICAL ASPECTS:

The project will be presented to the Committee of Ethics and Research (CEI) of the IDIAP and the Bioethics Committee of the University of Barcelona (CBUB) to request approval.

The project will be explained to the patients selected, the patient information sheet will be delivered, and the informed consent will be requested to participate in the study, which must be signed. In the case of a patient with moderate-advanced dementia the consent of both patients and caregivers will be required, and in the case of an invalid patient the consent must be signed by the legal guardian.

The participation in the investigation is voluntary and the subjects will be able to exercise the rights of access, rectification, suppression, right to the limitation of the treatment, as well as to the portability and opposition, whenever the exercise of these rights does not affect the purposes of the investigation.

The ethical principles for biomedical research on human subjects are fulfilled. In accordance with the provisions of Organic Law 3/2018, of December 5, on the protection of personal data and the guarantee of digital rights, personal information will always be treated through codes. The information recorded is encrypted for transfer to the database of the study. All servers have antivirus protection, firewalls, controlled access, permanent surveillance, alarms, as well as other relevant security measures to ensure the protection of information.

The study will generate several files with personal data. These will be kept only for the duration of the study and will be stored under the custody of the principal investigator in the directory of the shared unit of the company where she's working (SAPDIRASSIST \\ Medication Area \\ CAROL ROVIRA \\). However, these files will be password protected despite being stored in a private directory. The data collected already consists of the authorization of the people whose data will be part of this study, complying with the applicable laws on data protection (LOPD-GDD and RGPD).

The subjects of the study may exercise their rights of access, rectification, deletion, right to limit the treatment of their data, as well as portability and opposition, provided that the exercise of these rights does not affect the purposes of investigation for which they were collected.

Eligibility criteria: Inclusion Criteria:

* Polimedicated patients (\>7 drugs of \>1 month treatment duration, exclude topical drugs, ophtalmologic drugs, diaper and cure products)
* Multiple chronic conditions
* Advanced cronic disease with short life expectancy

Exclusion Criteria:

* Subjects do not want participate at the study
* \<2 visits in the last year with the basic healthcare team
* palliative care by PADES

Primary outcomes:
measure: average number ofdetected incidents
timeFrame: 0 and 12 months
measure: average on number of drugs per patient
timeFrame: 0 and 12 months
measure: average of medication changes
timeFrame: 6 and 12 months
measure: average of hospitalizations
timeFrame: 0 and 12 months
Secondary outcomes:
measure: Number of adverse events caudes by medication changes
timeFrame: 6 and 12 months
measure: Number of changes at the end of the study
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Igualada
country: Spain
facility: Mar Casanovas
state: Barcelona
city: Manresa
country: Spain
facility: Rovira
state: Barcelona
Study officials:
affiliation: ICS
name: Carol Rovira
role: PRINCIPAL_INVESTIGATOR
affiliation: ICS
name: Joan Armengol
role: STUDY_CHAIR
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