Optimizing PharmacoTherapy In the Multimorbid Elderly in Primary CAre: the OPTICA Trial
- Conditions
- MultimorbidityPolypharmacy
- Interventions
- Device: STRIPA interventionOther: Sham intervention
- Registration Number
- NCT03724539
- Lead Sponsor
- University of Bern
- Brief Summary
The objective of this randomized controlled trial (RCT) is to evaluate whether the Systematic Tool to Reduce Inappropriate Prescribing (STRIP), put into practice through the STRIP Assistant (STRIPA) and implemented by general practitioners (GPs), will lead to an improvement in clinical and economic outcomes in patients aged 65 or older with multimorbidity and polypharmacy.
- Detailed Description
Background:
Policy makers face many challenges, when they plan health care systems to meet the needs of the fast growing elderly population. More than 60% of the elderly suffer from multiple chronic conditions (multimorbidity - commonly defined as ≥3 chronic diseases) and get multiple drugs (polypharmacy - commonly defined as ≥5 regular medications). Multimorbid patients are often excluded from randomized controlled trials (RCT) and consequently most prescribing guidelines address diseases in isolation. Consequently, there is inappropriate prescribing, which results in diminished health states and lower quality of life of the patients.
Older patients usually rely on their general practitioners (GPs) to manage their medications. However, GPs often have limited time to adapt polypharmacy. Reviewing medications and understanding their interactions based on a list of diagnoses and drugs is complex and time consuming. Furthermore, due to the increase of patients with multimorbidity and polypharmacy, medication review especially in patients with many drugs is often neglected. Pilot data from the Netherlands showed that a software-assisted method, called STRIPA, was effective for optimizing pharmacotherapy in primary care. Through the OPTICA trial this tool will now be tested in the Swiss primary care context.
Study design:
The OPTICA trial is a single-site cluster randomized controlled trial (RCT), which will be conducted at the Institute for Primary Health Care of the University of Bern (BIHAM). All study-related tasks will be performed centrally at the BIHAM except for patient recruitment and use of the STRIPA, as these two tasks will be performed in participating GP offices.
The GPs in the intervention group use the STRIP assistant, whereas the GPs in the control group conduct a sham intervention: usual medication review and shared-decision making with patient. STRIPA is designed to optimize drug therapy and to advise on safe and appropriate therapy using STOPP/START criteria (STOPP = 'screening tool of older people's prescriptions'; START = 'screening tool to alert to right treatment'). Patients will be followed for 1 year with follow-up phone calls after 6 and 12 months.
Study objectives:
The primary objective of this study is to assess the effect of pharmacotherapy optimization through STRIPA on the medication appropriateness, which is measured by the medication appropriateness index (MAI) for drug overuse and by the assessment of underutilization (AOU) for drug underuse.
The secondary objective of the OPTICA study is to assess the impact of pharmacotherapy optimization by STRIPA on the parameters listed below (1- 4) as well as to examine the use of the STRIP assistant by GPs (5) and to examine patients' willingness to deprescribe (6):
1. Degree of polypharmacy
2. Degree of over- and underprescribing
3. Number of falls and fractures
4. Quality of life, including pain/discomfort
5. Health economic parameters, including direct costs of the intervention and incremental cost-effectiveness
6. Enablers and barriers faced by GPs when using the STRIP assistant
7. Patients' willingness to deprescribe
Statistical considerations:
40 clusters with a cluster size of 8-10 patients will be included. The primary analysis will be an intention-to-treat (ITT) analysis, whereby all randomised patients will be included in the group they were allocated to.
There will be two co-primary outcomes, the improvement in the MAI score at 12 months, defined as decrease of the score of at least one point, and improvement in the AOU index at 12 months, defined as a reduction of at least one prescribing omission. Both outcomes will be tested separately and success claimed if either test is significant. Adjustment for multiple testing will be performed.
In the primary analysis, the investigators will assess outcomes at the patient level, accounting for the correlated nature of data among GPs by using multilevel mixed-effects models. For the co-primary outcomes, the investigators will present and compare the proportion of patients with improvement of the MAI score and AOU index in the control and intervention groups. The relative difference between groups will be assessed using a mixed-effects logistic model with a random intercept at the GP level in order to account for clustering.
Secondary binary outcomes will be evaluated like the primary outcomes. Secondary continuous outcomes will be analyzed using random-effects linear regression with a random intercept at the GP level. Models will additionally be adjusted for the baseline value as a covariate. Secondary count outcomes will be analyzed using random-effects Poisson regression with a random intercept at the GP level.
Health economic analyses will comprise the assessment i) of resource use and cost differences between the trial arms, ii) the assessment of differences in quality-adjusted lifetime between the trial arms (expressed as quality-adjusted life years \[QALYs\]), and iii) the assessment of the cost-effectiveness of the intervention in comparison with the comparator, i.e. medication review in accordance with standard care.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 323
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STRIPA intervention STRIPA intervention GPs in the intervention group will perform a STRIPA analysis for each of their 8-10 patients after the recruitment of the patient into the OPTICA trial, so that the results can be discussed in the next consultation and a shared decision-making can be performed. STRIPA is a structured method to perform pharmacotherapy optimization. The STRIPA intervention in the OPTICA trial consists of 4 steps: 1. recording medication and diagnoses in STRIPA (upload from data from the 'Family medicine ICPC Research using Electronic medical records' (FIRE) database) 2. structured drug review through the GP based on the STRIPA with the integrated STOPP/START criteria 3. shared decision-making between GP and patient with possible adaptation of the recommendation 4. follow-up through study team Sham intervention Sham intervention Patients in the control group will receive a sham intervention, which consists of a usual medication review by their GP as well as a shared decision making of the latter.
- Primary Outcome Measures
Name Time Method Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #1: change in the Medication Appropriateness Index (MAI) 12 months Medication Appropriateness Index (MAI), assessed at baseline as well as at the 6 and 12 months follow-ups for each chronic medication of the patient. The 10 item version of the MAI will be used, but the cost-effectiveness item will be excluded. The MAI score for each medication will range from 0 to 17.
Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #2: change in the Assessment of Underutilization (AOU) 12 months Assessment of Underutilization (AOU), assessed for each of the patients' chronic conditions at baseline as well as at the 6 and 12 months follow-ups. For each chronic condition of the patient, the assessors decided whether there is i) no omission, ii) marginal omission, or iii) omission of indicated medication.
- Secondary Outcome Measures
Name Time Method Cost-effectiveness of the STRIPA intervention 12 months The cost-effectiveness analysis will be performed by combining clinical data, quality of life data as well as data about the amount of formal and informal care collected within the trial, and unit costs that will stem from external sources.
Patients' degree of polypharmacy 12 months Numbers of regular long-term medications taken by patients, assessed at baseline as well as the 6 and 12 months follow-ups.
Patients' quality of life measured by 5-level version of the European Quality of Life-5 Dimensions questionnaire (EQ-5D), including pain/discomfort. 12 months Assessed by the 5-level version of the European Quality of Life - 5 Dimensions questionnaire (EQ-5D). Assessed at baseline as well as at the 6 and 12 months follow-ups. The questionnaire consists of 5 questions with 5 possible responses each and a visual analogue scale (0-100). The EQ-5D-5L index resulting from this questionnaire ranges from 0 to 1.
Amount of informal care received by patients 12 months Assessed by looking at unpaid care by e.g. family members, relatives, friends. Assessed at baseline as well as at the 6 and 12 months follow-ups.
Survival 12 months As measured by number of survivors
Patients' Quality-adjusted life years (QALYs) 12 months Assessment will be done at the end of the trial, when all data was collected.
Patients' degree of underprescribing, as measured by the Assessment of Underutilization 12 months The degree of underprescribing will be assessed at baseline as well as at the 6 and 12 months follow-ups. For each chronic condition of the patient, the assessors decided whether there is i) no omission, ii) marginal omission, or iii) omission of indicated medication.
Patients' falls and fractures 12 months Number of falls and fractures reported by the patients. Assessed at baseline as well as at the 6 and 12 months follow-ups.
Amount of formal care received by patients 12 months Assessed by looking at number of planned and unplanned care sessions received by a patient. Assessed at baseline as well as at the 6 and 12 months follow-ups.
Percentage of recommendations accepted by general practitioners (GPs) 12 months Quantification of the amount of recommendations generated by the STRIP assistant that have been accepted by GPs. Assessed after all the GPs in the intervention group have used the STRIPA.
Patient's willingness to deprescribe Baseline The willingness of patients' to deprescribe will be assessed by the "revised Patients' Attitudes Towards Deprescribing" (rPATD) questionnaire. Assessed at baseline. The score will range from 0 to 22 for the patient questionnaire and between 0 and 19 for the caregiver questionnaire.
Patients' medical costs 12 months Direct medical costs during one year. Assessment will be done at the end of the trial, when all data was collected.
Patients' degree of overprescribing, as measured by the Medication Appropriateness Index (MAI) 12 months The degree of overprescribing be assessed at baseline as well as at the 6 and 12 months follow-ups. The 10 item version of the MAI will be used. The MAI score for each medication will range from 0 to 18.
Percentage of recommendations rejected by general practitioners (GPs) 12 months Quantification of the amount of recommendations generated by the STRIP assistant that have been rejected by GPs. Assessed after all the GPs in the intervention group have used the STRIPA.
Trial Locations
- Locations (1)
Berner Institut für Hausarztmedizin, BIHAM
🇨🇭Bern, Switzerland