Trial record 2 of 1506 for:    PC trial

Inappropriate Prescription in Elderly and Polypharmacy Patients in Primary Care. PHARM-PC Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Hospital Comarcal de Inca
Sponsor:
Information provided by (Responsible Party):
Jesus Martinez Sotelo, Hospital Comarcal de Inca
ClinicalTrials.gov Identifier:
NCT02224833
First received: August 19, 2014
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Elderly
Polypharmacy
Behavioral: Pharmacist intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PHARMACIST-LED INTERVENTION TO REDUCE POTENTIALLY INAPPROPRIATE PRESCRIPTION IN ELDERLY AND POLYPHARMACY PATIENTS AT PRIMARY CARE SETTING (PHARM-PC) CLUSTER RANDOMIZED TRIAL.

Further study details as provided by Hospital Comarcal de Inca:

Primary Outcome Measures:
  • Number of patients with potentially inappropriate prescriptions (PIP) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: Yes ]

    This variable will be measured the day after intervention, when a new review of patient treatment will be performed to check acceptance by the physician of the recommendations issued by the pharmacist.

    PIP: Prescription (drug, dose, frequency of administration) that meets at least one of the following conditions: contraindication, inadequate dosing (dose, frequency and / or duration), duplication, interactions, probability of adverse drug reactions, health problem insufficiently treated, unnecessary medication; new drugs of little-no therapeutic value, drug which is not considered as first choice in the treatment of the most prevalent diseases in the outpatient setting.



Secondary Outcome Measures:
  • Mean number of PIP per patient [ Time Frame: Up to 24 hours ] [ Designated as safety issue: Yes ]
    This variable will be measured the day after intervention, when a new review of patient treatment will be performed to check acceptance by the physician of the recommendations issued by the pharmacist.

  • Morbidity [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

    Composite end-point:

    • Hospital Admissions in medical units (HA-MU) +
    • Hospital Admissions in intensive care units (HA-ICU) +
    • Visits to Hospital Emergency Department (HED) +
    • Visit to Primary Care Emergency Department (PCED) +
    • Specialized Care Consultation (SCC) +
    • Primary Care Consultations (PCC).

  • Total spending on drugs [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]

    Total monetary amount (in euros) of the drugs involved in the PIP; which is calculated as annual amount (being chronic medications), for which we will consider the invoice price (monetary amount paid by the health administration for drugs) specified in the pharmaceutical sales database from Balearic Islands and total dose diari and the total daily dose prescribed.

    This variable will be measured the day after intervention, when a new review of patient treatment will be performed to check acceptance by the physician of the recommendations issued by the pharmacist.


  • Total spending on health resources. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

    Composite end-point:

    Total monetary amount (in euros) of the following health resources used due to PIP:

    • Hospital Admissions in medical units (HA-MU) +
    • Hospital Admissions in intensive care units (HA-ICU) +
    • Visits to Hospital Emergency Department (HED) +
    • Visit to Primary Care Emergency Department (PCED) +
    • Specialized Care Consultation (SCC) +
    • Primary Care Consultations (PCC). according to the survey of prices paid by the Balearic Islands Health Service to healthcare facilities arranged by provision of healthcare resources; published in the Official Gazette of the Balearic Islands.

  • Mortality [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    Number of patients who died


Estimated Enrollment: 800
Study Start Date: October 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Behavioral: Pharmacist intervention

Systematic review of treatments:

Identification of reasons for PPI.

  • 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, review potential new prescriptions made without pharmacist recommending, and whether these new drugs lead to PIP.

No Intervention: Control

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 65 years
  • treatment with 5 or more chronic medications.

Exclusion Criteria:

  • patients not included in electronic prescription software
  • routine monitoring is carried out in private health care
  • temporary displaced persons (routine monitoring is carried out in another community).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02224833

Contacts
Contact: Jesús Martínez, Pharm D +34 646222555 jesus.martínezs2@hcin.es

Locations
Spain
Sector Sanitario Tramuntana Not yet recruiting
Inca, Baleares, Spain, 07300
Contact: Jesus Martínez, Pharm D    +34 646222555    jesus.martinezs2@hcin.es   
Principal Investigator: Jesus Martínez, Pharm D         
Sponsors and Collaborators
Hospital Comarcal de Inca
  More Information

Additional Information:
No publications provided

Responsible Party: Jesus Martinez Sotelo, Pharm D, Hospital Comarcal de Inca
ClinicalTrials.gov Identifier: NCT02224833     History of Changes
Other Study ID Numbers: PHARM-PC
Study First Received: August 19, 2014
Last Updated: August 22, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Comarcal de Inca:
appropriateness
elderly
polypharmacy
primary care

ClinicalTrials.gov processed this record on October 01, 2014