NCT02224833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
549

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

August 19, 2014

Last Update Submit

July 26, 2016

Conditions

Elderly (People Aged 65 or More)Polypharmacy (People Under Treatment With 5 or More Drugs)

Keywords

appropriatenesselderlypolypharmacyprimary care

Outcome Measures

Primary Outcomes (2)

  • Number of patients with potentially inappropriate prescriptions (PIP)

    This variable will be measured six months 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.

    Up to 6 months

  • Mean number of PIP per patient

    This variable will be measured six months 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.

    Up to 6 months

Secondary Outcomes (4)

  • Morbidity

    Up to 12 months

  • Total spending on drugs

    Up to 6 months

  • Total spending on health resources.

    Up to 12 months

  • Mortality

    Up to 12 months

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Pharmacist intervention

Control

NO INTERVENTION

Interventions

Pharmacist interventionBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • routine monitoring is carried out in private health care
  • temporary displaced persons (routine monitoring is carried out in another community).
  • Institutionalized patients
  • Patients in the Home Care Program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sector Sanitario Tramuntana

Inca, Balearic Islands, 07300, Spain

Location

Related Publications (3)

  • Simo Minana J. [Use of prescription drugs in Spain and Europe]. Aten Primaria. 2012 Jun;44(6):335-47. doi: 10.1016/j.aprim.2011.06.009. Epub 2011 Oct 22. Spanish.

    PMID: 22018798BACKGROUND

  • Hill-Taylor B, Sketris I, Hayden J, Byrne S, O'Sullivan D, Christie R. Application of the STOPP/START criteria: a systematic review of the prevalence of potentially inappropriate prescribing in older adults, and evidence of clinical, humanistic and economic impact. J Clin Pharm Ther. 2013 Oct;38(5):360-72. doi: 10.1111/jcpt.12059. Epub 2013 Apr 2.

    PMID: 23550814BACKGROUND

  • Gallagher P, Ryan C, Byrne S, Kennedy J, O'Mahony D. STOPP (Screening Tool of Older Person's Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment). Consensus validation. Int J Clin Pharmacol Ther. 2008 Feb;46(2):72-83. doi: 10.5414/cpp46072.

    PMID: 18218287BACKGROUND

Related Links

Study Officials

  • Jesús Martínez, Pharm D

    Hospital Comarcal de Inca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharm D

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 25, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

July 27, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)