PrescribingSTOPP-RCTNCT02130895
Testing CDS in OSCAR EMR Using STOPP Criteria
A study testing STOPP Criteria Decision Support Content in people with Prescribing, run by University of British Columbia at 1 site in Canada.
Trial summary
This mixed methods study seeks to assess and understand the impact of using an advanced CDS tool to present the STOPP criteria to support prescribers at the point of decision-making. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Prescribing
- What is being tested?
- STOPP Criteria Decision Support Content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Oct 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Have been using the OSCAR EMR v 12.x for >12 months (to provide enough time for medications to be consistently documented in the EMR).
- Have OSCAR EMR installed locally in the practice.
- Agree to be or are already a part of the University of British Columbia's Department of Family Practice's (UBC DFP) research network.
- Ensure their OSCAR Service Provider (OSP) agrees to support the research network hardware/software installation.
- Have not used the STOPP criteria in OSCAR prior to the study.
Who cannot join
- Non-prescribers.
- Those who do not provide longitudinal care (e.g. walk-in clinics).
- Specialists or midwives.
- Those who do not have regular patients over age 64 (e.g. maternity clinics).
- Those who do not use OSCAR 12.1 or those that do not document prescriptions in their EMR prescription module.
- Those who have ALREADY used the STOPP rules in OSCAR prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mixed-method Study to Explore, Assess, and Explain the Translation of a Complex Set of Evidence-based Rules Into Practice Through Electronic Medical Record Based Decision Support: How Can STOPP Effectively be Deployed in Primary Care?
This mixed methods study seeks to assess and understand the impact of using an advanced CDS tool to present the STOPP criteria to support prescribers at the point of decision-making. We ask the overarching question:
How can clinical decision support tools effectively translate a complex set of evidence-based rules into primary care clinical practice?
Read more
The work is divided into 2 phases.
PHASE 1: Randomized control trial. We will measure change in potentially inappropriate prescribing by primary care prescribers (e.g. family doctors) who are using the Clinical Decision Support (CDS) tool in their Electronic Medical Record (EMR), as compared to those who are not. Potentially Inappropriate Prescribing is defined by the STOPP criteria, the same criteria that will be used in the clinical decision support tool in the EMR. We will use the OSCAR EMR for this study. EMR based queries will be developed to assess the number of potentially inappropriate prescriptions are current in each of 12 physician practices at baseline and at 16 weeks.
PHASE 2: We will then complete a qualitative follow up with participants to aid in understanding how primary care prescribers perceived the CDS. This will help explain Phase 1 findings and provide additional information to enhance future decision support tools.
Read the detailed description
The STOPP (Screening Tool of Older People's potentially inappropriate Prescriptions) criteria are a previously clinically validated set of suggested medications to avoid in patients aged 65+ with certain characteristics (e.g. benzodiazepines should be avoided in those with a fall history). These have previously been translated into point of care reminders that can be used with the OSCAR Electronic Medical Record (EMR) so that physicians are notified of potentially inappropriate prescriptions when a patient's chart is opened. This two phase explanatory study will examine if those STOPP based point of care prescribing alerts as presented to physicians in the OSCAR EMR can change potentially inappropriate prescribing patterns in primary care physicians.
PHASE 1:
A cluster randomized control trial in private primary care physician offices. The intervention is at the level of the physician and consists of activating the set of STOPP based alerts for the physician so that they see them during their workflow. These alerts will be triggered and displayed to physicians at the point of care. The alerts will suggest the physician consider Potentially Inappropriate Prescriptions (PIPs), as defined by STOPP. The control group will not have the alerts presented. (STOPP criteria are described in the full proposal, attached).
The primary outcome measure is a composite indicator:
- Δ in Number of PIPs in patients >64yo with a visit during the intervention
Number of patients >64yo with a visit during the intervention
Phase 1 Data Analysis: The outcomes will be measured using the University of British Columbia (UBC) Department of Family Practice's research network infrastructure. The network has been designed and successfully tested in a previous study (UBC ETHICS H13-02531). This network connects to OSCAR EMRs and, with permission from the physician, is able to answer practice level questions WITHOUT collecting patient level data. The practice level queries for potentially inappropriate prescriptions will be distributed to the practices through the network and only the aggregate answers (not patient level data) will be returned for analysis. For example, one of the STOPP recommendations is to not use a non-cardioselective beta blocker in patients with Chronic Obstructive Pulmonary Disease (COPD). The research network would be able to query the physician practices before and after the intervention and receive counts back on the number of patients with Chronic Obstructive Pulmonary Disease (COPD) who are also on a non-cardioselective beta-blocker.
PHASE 2:
Will seek to qualitatively explain the findings from phase 1 with the physician participants.
This will consist of one to two, two-hour, semi-structured discussion group(s) with family physicians from the intervention group. The discussion group will seek to understand specific issues with the Phase 1 tool. The discussion group will move through the following steps: (a) consent; (b) participants provide overall impressions of the tool; (c) review preliminary results from Phase 1; (d) specific feedback on how to improve the tool. The focus group will be audio recorded and qualitatively analyzed through the lens of pragmatic content analysis to better understand perceptions of the Clinical Decision Support (CDS) tool and its integration into workflow. There may be 2 discussion groups to allow for broader participation if scheduling is an issue and it may be a remote discussion group, depending on location of physician participants.
- Conditions
- Prescribing
- Being tested
- STOPP Criteria Decision Support Content
- Keywords
- prescribing, STOPP Criteria, potentially inappropriate prescribing, clinical decision support, Electronic Medical Records, primary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOPP Criteria Decision Support ContentOther
55 previously developed clinical decision support suggestions based on the STOPP criteria will be activated in the physician EMR. Each suggestion provides a patient specific rule that, if triggered will display its title in an existing "Clinical Decision Alerts" box on the bottom right hand column in the patient's EMR chart. For example, in a patient with diabetes and on a beta blocker then the suggestion "Consider: avoiding b-blockers in elderly diabetics with >=1 hypoglycaemic episodes / month" will be presented to the physician in the side bar (not a popup). The physician then can decide to review, consider, or ignore the recommendation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | STOPP Criteria Decision Support Content Intervention arm will receive CDS suggestions based on the STOPP criteria. Receives: Other: STOPP Criteria Decision Support Content |
| Control | No intervention | Control arm will provide care as usual during the intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate of potentially inappropriate prescribing
Reports will be run on EMR data to provide summary statistics to count rates for potentially inappropriate prescriptions. The reports will be generated using a series of queries that are consistent with the rules that trigger the CDS alerts. Change will be determined between baseline and 8 weeks and baseline and 16 weeks.
Measured: Baseline, 8 weeks, 16 weeks
Secondary outcomes (2)
Change in rates of Potentially Inappropriate Prescribing for Individual STOPP Criteria
The primary outcome is a composite indicator consisting of measuring each of the rates of potentially inappropriate prescriptions documented in the EMR for each of the STOPP criteria that are implemented in the intervention. This set of secondary outcomes will look at each STOPP criteria in the study individually to see if there are sub-sets of criteria that were more or less likely to change.
Measured: 16 weeks
Qualitative User Assessment of Decision Support
Findings based on qualitative discussion group from the physicians in the intervention arm. This will include recommendations on how to improve the user experience of the decision support system and the specific recommendations.
Measured: Point in Time after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
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 PrescribingStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Morgan Price, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130895
- Sponsor's protocol ID
- H14-00797
- Acronym
- STOPP-RCT
- Status last verified
- Dec 2015
- First submitted
- 1 May 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Price M, Davies I, Rusk R, Lesperance M, Weber J. Applying STOPP Guidelines in Primary Care Through Electronic Medical Record Decision Support: Randomized Control Trial Highlighting the Importance of Data Quality. JMIR Med Inform. 2017 Jun 15;5(2):e15. doi: 10.2196/medinform.6226.
PubMed 28619704
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-method Study to Explore, Assess, and Explain the Translation of a Complex Set of Evidence-based Rules Into Practice Through Electronic Medical Record Based Decision Support: How Can STOPP Effectively be Deployed in Primary Care?
- ClinicalTrials.gov ID
- NCT02130895
- Acronym / sponsor ID
- STOPP-RCT / H14-00797
- Conditions
- Prescribing
- Keywords
- prescribing, STOPP Criteria, potentially inappropriate prescribing, clinical decision support, Electronic Medical Records, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 May 2014 (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.
This mixed methods study seeks to assess and understand the impact of using an advanced CDS tool to present the STOPP criteria to support prescribers at the point of decision-making. We ask the overarching question:
How can clinical decision support tools effectively translate a complex set of evidence-based rules into primary care clinical practice?
The work is divided into 2 phases.
PHASE 1: Randomized control trial. We will measure change in potentially inappropriate prescribing by primary care prescribers (e.g. family doctors) who are using the Clinical Decision Support (CDS) tool in their Electronic Medical Record (EMR), as compared to those who are not. Potentially Inappropriate Prescribing is defined by the STOPP criteria, the same criteria that will be used in the clinical decision support tool in the EMR. We will use the OSCAR EMR for this study. EMR based queries will be developed to assess the number of potentially inappropriate prescriptions are current in each of 12 physician practices at baseline and at 16 weeks.
PHASE 2: We will then complete a qualitative follow up with participants to aid in understanding how primary care prescribers perceived the CDS. This will help explain Phase 1 findings and provide additional information to enhance future decision support tools.
Detailed description
The STOPP (Screening Tool of Older People's potentially inappropriate Prescriptions) criteria are a previously clinically validated set of suggested medications to avoid in patients aged 65+ with certain characteristics (e.g. benzodiazepines should be avoided in those with a fall history). These have previously been translated into point of care reminders that can be used with the OSCAR Electronic Medical Record (EMR) so that physicians are notified of potentially inappropriate prescriptions when a patient's chart is opened. This two phase explanatory study will examine if those STOPP based point of care prescribing alerts as presented to physicians in the OSCAR EMR can change potentially inappropriate prescribing patterns in primary care physicians.
PHASE 1:
A cluster randomized control trial in private primary care physician offices. The intervention is at the level of the physician and consists of activating the set of STOPP based alerts for the physician so that they see them during their workflow. These alerts will be triggered and displayed to physicians at the point of care. The alerts will suggest the physician consider Potentially Inappropriate Prescriptions (PIPs), as defined by STOPP. The control group will not have the alerts presented. (STOPP criteria are described in the full proposal, attached).
The primary outcome measure is a composite indicator:
- Δ in Number of PIPs in patients >64yo with a visit during the intervention
Number of patients >64yo with a visit during the intervention
Phase 1 Data Analysis: The outcomes will be measured using the University of British Columbia (UBC) Department of Family Practice's research network infrastructure. The network has been designed and successfully tested in a previous study (UBC ETHICS H13-02531). This network connects to OSCAR EMRs and, with permission from the physician, is able to answer practice level questions WITHOUT collecting patient level data. The practice level queries for potentially inappropriate prescriptions will be distributed to the practices through the network and only the aggregate answers (not patient level data) will be returned for analysis. For example, one of the STOPP recommendations is to not use a non-cardioselective beta blocker in patients with Chronic Obstructive Pulmonary Disease (COPD). The research network would be able to query the physician practices before and after the intervention and receive counts back on the number of patients with Chronic Obstructive Pulmonary Disease (COPD) who are also on a non-cardioselective beta-blocker.
PHASE 2:
Will seek to qualitatively explain the findings from phase 1 with the physician participants.
This will consist of one to two, two-hour, semi-structured discussion group(s) with family physicians from the intervention group. The discussion group will seek to understand specific issues with the Phase 1 tool. The discussion group will move through the following steps: (a) consent; (b) participants provide overall impressions of the tool; (c) review preliminary results from Phase 1; (d) specific feedback on how to improve the tool. The focus group will be audio recorded and qualitatively analyzed through the lens of pragmatic content analysis to better understand perceptions of the Clinical Decision Support (CDS) tool and its integration into workflow. There may be 2 discussion groups to allow for broader participation if scheduling is an issue and it may be a remote discussion group, depending on location of physician participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: STOPP Criteria Decision Support ContentSTOPP Criteria Decision Support Content Intervention arm will receive CDS suggestions based on the STOPP criteria. |
| Control | No intervention | –Control arm will provide care as usual during the intervention period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Have been using the OSCAR EMR v 12.x for >12 months (to provide enough time for medications to be consistently documented in the EMR).
- Have OSCAR EMR installed locally in the practice.
- Agree to be or are already a part of the University of British Columbia's Department of Family Practice's (UBC DFP) research network.
- Ensure their OSCAR Service Provider (OSP) agrees to support the research network hardware/software installation.
- Have not used the STOPP criteria in OSCAR prior to the study.
Key exclusion criteria (6 listed)
- Non-prescribers.
- Those who do not provide longitudinal care (e.g. walk-in clinics).
- Specialists or midwives.
- Those who do not have regular patients over age 64 (e.g. maternity clinics).
- Those who do not use OSCAR 12.1 or those that do not document prescriptions in their EMR prescription module.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STOPP Criteria Decision Support Content55 previously developed clinical decision support suggestions based on the STOPP criteria will be activated in the physician EMR. Each suggestion provides a patient specific rule that, if triggered will display its title in an existing "Clinical Decision Alerts" box on the bottom right hand column in the patient's EMR chart. For example, in a patient with diabetes and on a beta blocker then the suggestion "Consider: avoiding b-blockers in elderly diabetics with >=1 hypoglycaemic episodes / month" will be presented to the physician in the side bar (not a popup). The physician then can decide to review, consider, or ignore the recommendation. | Other | Intervention |
Primary outcome
Change in rate of potentially inappropriate prescribing
Time frame: Baseline, 8 weeks, 16 weeks
Reports will be run on EMR data to provide summary statistics to count rates for potentially inappropriate prescriptions. The reports will be generated using a series of queries that are consistent with the rules that trigger the CDS alerts. Change will be determined between baseline and 8 weeks and baseline and 16 weeks.
2 secondary outcomes
Change in rates of Potentially Inappropriate Prescribing for Individual STOPP Criteria
Time frame: 16 weeks
Qualitative User Assessment of Decision Support
Time frame: Point in Time after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Derived from this study: PubMed 28619704Price M, Davies I, Rusk R, Lesperance M, Weber J. Applying STOPP Guidelines in Primary Care Through Electronic Medical Record Decision Support: Randomized Control Trial Highlighting the Importance of Data Quality. JMIR Med Inform. 2017 Jun 15;5(2):e15. doi: 10.2196/medinform.6226.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOPP Criteria Decision Support Content in people with Prescribing, run by University of British Columbia at 1 site 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate of potentially inappropriate prescribing (time frame: Baseline, 8 weeks, 16 weeks). 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 NCT02130895, 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 3 Dec 2015.