Ignite Creation Date:
2024-05-06 @ 3:10 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02224833
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2014-08-19
Brief Title:
Inappropriate Prescription in Elderly and Polypharmacy Patients in Primary Care PHARM-PC Trial
Sponsor:
Hospital Comarcal de Inca
Organization:
Hospital Comarcal de Inca
Study Overview
Official Title:
Pharmacist-led Intervention to Reduce Potentially Inappropriate Prescription in Elderly and Polypharmacy Patients at Primary Care Setting PHARM-PC Cluster Randomized Trial
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHARM-PC
Brief Summary:
PHARM-PC study is based on identify potentially inappropriate prescriptions PIP and delivery therapeutic appropriateness recommendations from the pharmacist to the physician and about drugs prescribed for elderly and polypharmacy patients in primary care Assessment of the impact of pharmacist intervention on the appropriateness of prescribing and both health outcomes and economic outcomes will be done
Detailed Description:
Main objective
To assess the effect of Pharmaceutical Intervention PI on PIP in elderly patients with polypharmacy in PC
Secondary objectives
2 a Assess baseline characteristics of elderly polypharmacy patients in PC and assess association with the possible presence of PIP
2 b Describe the main types and the reasons for PIP 3 Assess impact of PI on health outcomes morbidity and mortality 4 Estimate the effect of IF on the cost of both drugs and healthcare resources
Design and methods
Prospective multicenter open-label controlled and randomized by groups clusters clinical trail in order to prevent contamination between Intervention Group IG and Control Group CG patients seen by the same physician
Clusters unit of randomization are primary care physicians who work in public primary care health centers in Tramuntana Sector under Hospital Comarcal de Inca Different cluster were randomly assigned to Intervention Group IG or control group CG in the ratio 1 1
The study compared the effectiveness of a strategy for health care to elderly patients with polypharmacy in PC consisting of medical visit along with PI consistent in turn on identifying PIP and delivering therapeutic appropriateness recommendations against routine health care consisting solely of medical visit
Furthermore the impact of treatment on health outcomes and both drug and health service costs will also be assessed
Methodology
Intervention Group
Systematic review of treatments
Identification of reasons for PPI Causes why a pharmacological prescription drug dose route of administration duration of treatment may have both risk-benefit balance as cost-effectiveness balance unfavorable versus other alternatives such as
contraindications dosage dose frequency duration inappropriate duplication interactions risk of adverse effects health problem insufficiently treated unnecessary medication equivalent to Drug-Related Problems DRP listed in the Third Consensus of Granada To identify DRP we will use a combination of explicit criteria STOPP START and implicit criteria information from drug labels drug-surveillance alerts issued by drug regulatory agencies recommendations of scientific societies implemented in CheckTheMeds software
Drugs that have more cost-effective alternatives ranked by the Committee on Quality Indicators Prescription Health Service of the Balearic Islands as
New drugs with little or no therapeutic value drugs marketed in the past 5 years and considered by the Comité Mixto de Evaluación de Nuevos Medicamentos as little or no therapeutic value against the alternatives available in the market for the treatment of these pathologies metformin saxagliptin linagliptin metformin saxagliptin linagliptin rosuvastatin pitavastatin sinecatequin ingenol mebutate bazedoxifene silodosin degarelix denosumab hydromorphone tapentadol agomelatine desvenlafaxine indacaterol ciclesonide aclidinium bromide glycopyrronium bromide roflumilast bilastine tafluprost
Medications considered first choice in the treatment of the most prevalent diseases in the outpatient setting Omeprazole antiulcer Metformin oral antidiabetic ACE inhibitors Beta-blockers diuretics Calcium-antagonists anti-hypertensive Simvastatin statins diclofenac Diclofenac Misoprostol ibuprofen Naproxen anti-inflammatory drugs Alendronic acid osteoporosis fluoxetine citalopram paroxetine Sertraline antidepressant
Determination of recommended pharmacotherapeutic alternatives
Issue recommendations for therapeutic appropriateness to the doctor via registration on the EHR and verbal communication if deemed appropriate that will be of 4 types Add medicine discontinue medicine adjust dosage replace medicine
After the medical visit the next day New treatment review for checking acceptance or rejection of the recommendations issued and review potential new prescriptions made without pharmacist recommending and whether these new drugs lead to PIP
Control Group In the control group the same steps will be followed than intervention group excluding issue recommendations for therapeutic appropriateness to the doctor
Sample size and statistical power
The sample size was calculated by comparing proportions using the application for the determination of sample size available on Fisterra website based on the results of a pilot study not yet published which showed a difference of 15 percent in the number of patients with PIP between IG and CG and based on the study by Delgado et al which considers cost effective any screening tool that achieves at least a moderate reduction 10-20 percent of PIP For a power of 80 and assuming a loss rate of 10 percent was obtained a sample size of 153 Considering adjustment for cluster effect according to the following formula 1 m - 1 x ρ we obtain a final sample size of 214 patients
Statistics
Categorical variables qualitative Measurements of frequency and percentage The association between categorical variables will be performed by chi-square or Fischers exact test accordingly
Continuous Variables Quantitative Measures of central tendency and dispersion measures The association between continuous variables will be performed using T-Student t test ANOVA Mann-Whitney or Kruskal-Wallis as appropriate
A value of p 005 as statistically significant will be considered
Timescale
The study will begin in October 2014 and will end about April 2016 Is expected than patients will be enrolled into the study between October 2014 and April 2015 until complete sample size required
The study will last 12 more months to assess the outcomes of morbidity mortality and cost of health care resources
Ethics and safety
The Research Ethics Committee and Primary Care Research Unit of Balearic Islands have approved the project
To assess the effect of Pharmaceutical Intervention PI on PIP in elderly patients with polypharmacy in PC
Secondary objectives
2 a Assess baseline characteristics of elderly polypharmacy patients in PC and assess association with the possible presence of PIP
2 b Describe the main types and the reasons for PIP 3 Assess impact of PI on health outcomes morbidity and mortality 4 Estimate the effect of IF on the cost of both drugs and healthcare resources
Design and methods
Prospective multicenter open-label controlled and randomized by groups clusters clinical trail in order to prevent contamination between Intervention Group IG and Control Group CG patients seen by the same physician
Clusters unit of randomization are primary care physicians who work in public primary care health centers in Tramuntana Sector under Hospital Comarcal de Inca Different cluster were randomly assigned to Intervention Group IG or control group CG in the ratio 1 1
The study compared the effectiveness of a strategy for health care to elderly patients with polypharmacy in PC consisting of medical visit along with PI consistent in turn on identifying PIP and delivering therapeutic appropriateness recommendations against routine health care consisting solely of medical visit
Furthermore the impact of treatment on health outcomes and both drug and health service costs will also be assessed
Methodology
Intervention Group
Systematic review of treatments
Identification of reasons for PPI Causes why a pharmacological prescription drug dose route of administration duration of treatment may have both risk-benefit balance as cost-effectiveness balance unfavorable versus other alternatives such as
contraindications dosage dose frequency duration inappropriate duplication interactions risk of adverse effects health problem insufficiently treated unnecessary medication equivalent to Drug-Related Problems DRP listed in the Third Consensus of Granada To identify DRP we will use a combination of explicit criteria STOPP START and implicit criteria information from drug labels drug-surveillance alerts issued by drug regulatory agencies recommendations of scientific societies implemented in CheckTheMeds software
Drugs that have more cost-effective alternatives ranked by the Committee on Quality Indicators Prescription Health Service of the Balearic Islands as
New drugs with little or no therapeutic value drugs marketed in the past 5 years and considered by the Comité Mixto de Evaluación de Nuevos Medicamentos as little or no therapeutic value against the alternatives available in the market for the treatment of these pathologies metformin saxagliptin linagliptin metformin saxagliptin linagliptin rosuvastatin pitavastatin sinecatequin ingenol mebutate bazedoxifene silodosin degarelix denosumab hydromorphone tapentadol agomelatine desvenlafaxine indacaterol ciclesonide aclidinium bromide glycopyrronium bromide roflumilast bilastine tafluprost
Medications considered first choice in the treatment of the most prevalent diseases in the outpatient setting Omeprazole antiulcer Metformin oral antidiabetic ACE inhibitors Beta-blockers diuretics Calcium-antagonists anti-hypertensive Simvastatin statins diclofenac Diclofenac Misoprostol ibuprofen Naproxen anti-inflammatory drugs Alendronic acid osteoporosis fluoxetine citalopram paroxetine Sertraline antidepressant
Determination of recommended pharmacotherapeutic alternatives
Issue recommendations for therapeutic appropriateness to the doctor via registration on the EHR and verbal communication if deemed appropriate that will be of 4 types Add medicine discontinue medicine adjust dosage replace medicine
After the medical visit the next day New treatment review for checking acceptance or rejection of the recommendations issued and review potential new prescriptions made without pharmacist recommending and whether these new drugs lead to PIP
Control Group In the control group the same steps will be followed than intervention group excluding issue recommendations for therapeutic appropriateness to the doctor
Sample size and statistical power
The sample size was calculated by comparing proportions using the application for the determination of sample size available on Fisterra website based on the results of a pilot study not yet published which showed a difference of 15 percent in the number of patients with PIP between IG and CG and based on the study by Delgado et al which considers cost effective any screening tool that achieves at least a moderate reduction 10-20 percent of PIP For a power of 80 and assuming a loss rate of 10 percent was obtained a sample size of 153 Considering adjustment for cluster effect according to the following formula 1 m - 1 x ρ we obtain a final sample size of 214 patients
Statistics
Categorical variables qualitative Measurements of frequency and percentage The association between categorical variables will be performed by chi-square or Fischers exact test accordingly
Continuous Variables Quantitative Measures of central tendency and dispersion measures The association between continuous variables will be performed using T-Student t test ANOVA Mann-Whitney or Kruskal-Wallis as appropriate
A value of p 005 as statistically significant will be considered
Timescale
The study will begin in October 2014 and will end about April 2016 Is expected than patients will be enrolled into the study between October 2014 and April 2015 until complete sample size required
The study will last 12 more months to assess the outcomes of morbidity mortality and cost of health care resources
Ethics and safety
The Research Ethics Committee and Primary Care Research Unit of Balearic Islands have approved the project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None