Potentially Inappropriate Prescribing (PIP)PIP in LTCNCT02523482
Potentially Inappropriate Prescribing (PIP) in Long-Term Care (LTC) Patients
An observational study of Potentially Inappropriate Prescribing (PIP), run by Bruyère Health Research Institute. at 6 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 66 years and olderHealthy volunteers can take part
- Conditions the study is for
- Potentially Inappropriate Prescribing (PIP)
- How many people
- 275 participants
- Where
- 6 sitesCanada
- Study dates
- Jun 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: All consenting residents, of both genders, newly admitted to LTC or convalescent or respite care at the participating care facilities.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Recruiting
Residence St. Louis
Ottawa, Ontario, K1C 3B1
Melissa Donskov
Lise Bjerre, MD, PhD
- Recruiting
Centre d'accueil Champlain
Ottawa, Ontario, K1L 5C6
France Galipeau
Lise Bjerre, MD, PhD
- Recruiting
Residence Elisabeth Bruyere
Ottawa, Ontario, K1N 5C8
Melissa Donskov
Lise Bjerre, MD, PhD
- Recruiting
Garry J Armstrong
Ottawa, Ontario, K1N 5M2
Kerri-Ann Ede
Lise Bjerre, MD, PhD
- Recruiting
Carleton Lodge
Ottawa, Ontario, K2C 3H1
Judy Miller
Lise Bjerre, MD, PhD
- Recruiting
Peter D Clark
Ottawa, Ontario, K2G 6P8
Karen Currie
Lise Bjerre, MD, PhD
About this study
Official title: 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.
Read the 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):
- 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.
- 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).
- Keywords
- Prescriptions, Epidemiology, STOPP/START Criteria, Beers Criteria
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of STOPP/START and Beers criteria by comparing their use in health administrative data and clinical data
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").
Measured: 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
To compare the detection rates of the full STOPP/START and full Beers criteria with one another when applied to clinical data.
Measured: Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC
Secondary outcomes (3)
Assessing STOPP/START and Beers criteria subset Performance in health administrative data versus full criteria used in clinical data
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.
Measured: 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
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.
Measured: 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
To compare the performance of the subset of STOPP/START and Beers criteria applicable to HAD with one another when applied to HAD.
Measured: Participants will be observed retrospectively from Admission to Long Term Care facility to one year prior to admission to LTC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJun 2014
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Potentially Inappropriate Prescribing (PIP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Collaborators
- Bruyere Centre for Learning, Research and Innovation in Long-Term Care (CLRI), Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, Lise Bjerre, Bruyère Health Research Institute.
- Investigators
- Lise Bjerre, MD, PhD, Principal investigator, Clinician Investigator, Bruyere Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523482
- Sponsor's protocol ID
- CLRI - PIP in LTC
- Acronym
- PIP in LTC
- Status last verified
- Aug 2015
- First submitted
- 7 Aug 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bjerre LM, Halil R, Catley C, Farrell B, Hogel M, Black CD, Williams M, Ryan C, Manuel DG. Potentially inappropriate prescribing (PIP) in long-term care (LTC) patients: validation of the 2014 STOPP-START and 2012 Beers criteria in a LTC population--a protocol for a cross-sectional comparison of clinical and health administrative data. BMJ Open. 2015 Oct 9;5(10):e009715. doi: 10.1136/bmjopen-2015-009715.
PubMed 26453592
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potentially Inappropriate Prescribing (PIP) in Long-Term Care (LTC) Patients: Validation of the 2014 STOPP-START and 2012 Beers Criteria in a LTC Population
- ClinicalTrials.gov ID
- NCT02523482
- Acronym / sponsor ID
- PIP in LTC / CLRI - PIP in LTC
- Keywords
- Prescriptions, Epidemiology, STOPP/START Criteria, Beers Criteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Collaborators
- Bruyere Centre for Learning, Research and Innovation in Long-Term Care (CLRI), Ontario Ministry of Health and Long Term Care
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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):
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- All consenting residents, of both genders, newly admitted to LTC or convalescent or respite care at the participating care facilities.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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").
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.
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- Derived from this study: PubMed 26453592Bjerre LM, Halil R, Catley C, Farrell B, Hogel M, Black CD, Williams M, Ryan C, Manuel DG. Potentially inappropriate prescribing (PIP) in long-term care (LTC) patients: validation of the 2014 STOPP-START and 2012 Beers criteria in a LTC population--a protocol for a cross-sectional comparison of clinical and health administrative data. BMJ Open. 2015 Oct 9;5(10):e009715. doi: 10.1136/bmjopen-2015-009715.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Bjerre, MD, PhD principal investigator
Clinician Investigator, Bruyere Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Potentially Inappropriate Prescribing (PIP), run by Bruyère Health Research Institute. at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise M Bjerre, MD, PhD (613-562-6262 ext. 2942, lbjerre@bruyere.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02523482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.