NCT02130895

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

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

May 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

May 1, 2014

Last Update Submit

December 1, 2015

Conditions

Keywords

prescribingSTOPP Criteriapotentially inappropriate prescribingclinical decision supportElectronic Medical Recordsprimary care

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 8 weeks, 16 weeks

Secondary Outcomes (2)

  • Change in rates of Potentially Inappropriate Prescribing for Individual STOPP Criteria

    16 weeks

  • Qualitative User Assessment of Decision Support

    Point in Time after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

STOPP Criteria Decision Support Content Intervention arm will receive CDS suggestions based on the STOPP criteria.

Other: STOPP Criteria Decision Support Content

Control

NO INTERVENTION

Control arm will provide care as usual during the intervention period.

Interventions

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Physician Offices

Multiple Expected, British Columbia, Canada

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 6, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations