Potentially Inappropriate Prescribing (PIP) in Long-Term Care (LTC) Patients (PIP in LTC)

August 12, 2015 updated by: Lise Bjerre, Bruyere Research Institute

Potentially Inappropriate Prescribing (PIP) in Long-Term Care (LTC) Patients: Validation of the 2014 STOPP-START and 2012 Beers Criteria in a LTC Population

The study objectives are: to validate the subsets of Screening Tool of Older People's Prescriptions (STOPP) and Screening Tool to Alert Right Treatment (START), or STOPP/START criteria, and Beers criteria applicable to HAD by comparing their performance when applied to clinical and HAD for the same patients, and, using clinical data, to compare the performance of the full STOPP/START and full Beers criteria with each other.

Study Overview

Status

Unknown

Conditions

Detailed Description

Potentially inappropriate prescribing (PIP) is frequent, particularly in Long-Term Care (LTC) patients. Tools such as STOPP/START and Beers criteria were developed to identify PIP in clinical settings. Due to lack of clinical data in such databases, only a subset of these criteria are applicable to routinely collected health administrative data (HAD). This subset was shown to identify PIP in HAD with a frequency comparable to clinical studies using the full STOPP-START criteria. Nonetheless, the performance of subsets of STOPP/START and Beers criteria in HAD compared to clinical data from the same patients is unknown; furthermore, the performance of the updated 2014 STOPP-START and 2012 Beers criteria compared with one another is also unknown.

The overall aim of this study is to validate medication appropriateness criteria applicable to HAD by comparing their performance when applied to clinical data. The present study has two main and three secondary objectives (see Figure 1 for details):

A. Main objectives:

Objective 1: To validate subsets of the STOPP/START and Beers criteria defined by their applicability to HAD, by comparing their performance in detecting PIP when applied to HAD with that of the full set of criteria applied to clinical data for the same residents (with the clinical data providing the "gold standard").

Objective 2: To compare the detection rates of the full STOPP/START and full Beers criteria with one another when applied to clinical data.

B. Secondary objectives:

Objective 3: To assess the number and proportion of unidentified PIP when using the subset of STOPP/START and Beers criteria with HAD when compared with the full set of criteria, when applied to clinical data.

Objective 4: To compare the performance of the subset of the STOPP/START and Beers criteria applied to the HAD in detecting PIP when compared to clinical data for the same residents.

Objective 5: To compare the performance of the subset of STOPP/START and Beers criteria applicable to HAD with one another when applied to HAD.

To achieve these objectives, the investigators will conduct a cross-sectional study of linked HAD and clinical data. Eligible patients will be 66 years and over and recently admitted to one of six LTC facilities in Ottawa, Ontario, beginning June 1st, 2014. The target sample size is 275, but recruitment may stop if interim analyses demonstrate statistical significance can be achieved with fewer patients. Medication, diagnostic and clinical data will be collected after admission by a pharmacist not otherwise involved in the patient's care. The main outcome measure is the proportion of PIP missed by the subset of STOPP/START criteria applied to HAD when compared to clinical data (the gold standard).

Study Type

Observational

Enrollment (Anticipated)

275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1C 3B1
        • Recruiting
        • Residence St. Louis
        • Contact:
          • Melissa Donskov
        • Principal Investigator:
          • Lise Bjerre, MD, PhD
      • Ottawa, Ontario, Canada, K1L 5C6
        • Recruiting
        • Centre d'accueil Champlain
        • Principal Investigator:
          • Lise Bjerre, MD, PhD
        • Contact:
          • France Galipeau
      • Ottawa, Ontario, Canada, K1N 5C8
        • Recruiting
        • Residence Elisabeth Bruyere
        • Contact:
          • Melissa Donskov
        • Principal Investigator:
          • Lise Bjerre, MD, PhD
      • Ottawa, Ontario, Canada, K1N 5M2
        • Recruiting
        • Garry J Armstrong
        • Principal Investigator:
          • Lise Bjerre, MD, PhD
        • Contact:
          • Kerri-Ann Ede
      • Ottawa, Ontario, Canada, K2C 3H1
        • Recruiting
        • Carleton Lodge
        • Principal Investigator:
          • Lise Bjerre, MD, PhD
        • Contact:
          • Judy Miller
      • Ottawa, Ontario, Canada, K2G 6P8
        • Recruiting
        • Peter D Clark
        • Principal Investigator:
          • Lise Bjerre, MD, PhD
        • Contact:
          • Karen Currie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consenting residents, of both genders, newly admitted to LTC or convalescent or respite care at the participating care facilities.

Description

Inclusion Criteria:

  • OHIP-eligible resident aged 66 and over at the time of admission to long-term care in Ottawa
  • Newly admitted to LTC or convalescent care at the participating care facilities
  • Consent to participate

Exclusion Criteria:

  • Residents will be excluded if they decline to participate in the study.
  • Residents will be excluded if they do not have a valid Ontario Health Insurance Plan (OHIP) number.
  • Residents residing in Ontario whose health care is covered through other plans, and are therefore not captured through ICES data, such as First Nations people living on reserve, members of the Armed Forces, and refugee claimants, will also be excluded.
  • A resident will also be excluded if he or she has no prescribed medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of STOPP/START and Beers criteria by comparing their use in health administrative data and clinical data
Time Frame: Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC
To validate subsets of the STOPP/START and Beers criteria defined by their applicability to HAD, by comparing their performance in detecting PIP when applied to HAD with that of the full set of criteria applied to clinical data for the same residents (with the clinical data providing the "gold standard").
Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC
Comparison of STOPP/START and Beers criteria
Time Frame: Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC
To compare the detection rates of the full STOPP/START and full Beers criteria with one another when applied to clinical data.
Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing STOPP/START and Beers criteria subset Performance in health administrative data versus full criteria used in clinical data
Time Frame: Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC
To assess the proportion of unidentified PIP when using the subset of STOPP/START and Beers criteria with health administrative data when compared with the full set of criteria applied to clinical data.
Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC
Assessing STOPP/START and Beers subset criteria performance in health administrative data when compared to clinical data for same resident
Time Frame: Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC
To compare the performance of the subset of the STOPP/START and Beers criteria applied to the HAD in detecting PIP when compared to clinical data for the same residents.
Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC
Comparison of performance of subset of STOPP/START with Beers criteria in health administrative data
Time Frame: Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC
To compare the performance of the subset of STOPP/START and Beers criteria applicable to HAD with one another when applied to HAD.
Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bruyere Research Institute

Collaborators

Ontario Ministry of Health and Long Term Care
Bruyere Centre for Learning, Research and Innovation in Long-Term Care (CLRI)

Investigators

  • Principal Investigator: Lise Bjerre, MD, PhD, Clinician Investigator, Bruyere Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CLRI - PIP in LTC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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