Randomized Controlled Study to Incentivize Doctors for Appropriate Use of Medical Care in NL

September 7, 2022 updated by: Hai Van Nguyen, Memorial University of Newfoundland

When Less is More: A Real World Randomized Controlled Study to Incentivize Doctors for Appropriate Use of Medical Care in NL

Choosing Wisely Canada is a campaign for promoting appropriate use of medical services to reduce unnecessary prescribing and unnecessary diagnostic tests. Its success depends on physicians' uptake of the campaign's recommendations on appropriate use of health care. This study will conduct a cluster-randomized controlled trial to evaluate the effects of two low-cost incentives for physicians to promote their uptake of Choosing Wisely recommendations in Newfoundland and Labrador (NL). The first incentive involves placing a motivational poster in a physician's examination room. These posters will contain motivational messages about the important roles that doctors and patients can play in reducing unnecessary care. The second incentive involves sending thank-you letters to physicians to recognize their contribution in reducing unnecessary care, and thus, 'nudge' them into following recommendations. The study will evaluate the effects of the incentives on physicians' prescribing of antibiotics and serum ferritin tests. Potential cost savings of implementing the two incentives will also be estimated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will employ a prospective, cluster randomized controlled trial design and will involve fee-for-service family physicians in NL. Randomization will be performed at the clinic level and stratified by clinic size. Clinics will be randomized into one of four groups: i) the control group will not receive any incentive; ii) the poster group will receive posters only; iii) the letter group will receive thank-you letters only; and iv) the double incentive group will receive both posters and thank-you letters. The number of clinics in each group will be equal.

The study will test two interventions. First, it will examine the impact of placing a poster in a physician's examination room containing motivational messages about the important roles that doctors and patients can play in reducing unnecessary care. The second incentive will involve sending thank-you letters to physicians aiming to encourage them to following Choosing Wisely's recommendations by recognizing their contribution in reducing unnecessary care. The study will focus on physicians' prescribing of antibiotics and serum ferritin tests. The posters will be designed to contain inspirational messages and pictures that highlight the important and unique roles that physicians and patients play in reducing unnecessary care and health care costs. These will be displayed in physicians' examination rooms so that they are salient to doctors and patients. The thank-you letters will contain two types of information: the changes in the rates of antibiotics and serum ferritin tests ordered since Choosing Wisely NL's introduction and a thank you message from the NL Medical Association (NLMA). These will be sent to doctors quarterly (to reinforce the message) with the changes in the rates of antibiotics and serum ferritin tests ordered being updated.

These incentives will be delivered over a 12-month period. The researchers will measure changes in the study outcomes at the end of this 12-month intervention period. Further, to examine if the effects of the intervention are sustained, these changes will be evaluated again 6 months after the withdrawal of incentives. The two incentives will be delivered via NLMA to its member family physicians. As such, physicians will be blinded to this study (i.e., they would not know that these posters and letters are part of a study). The study will focus on fee-for-service physicians in NL as data on the number of patients are only available for these physicians.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • School of Pharmacy, Memorial University of Newfoundland

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All Fee-For-Service family physicians registered with the NL Medical Association

Exclusion Criteria:

  • Salary based family physicians

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

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Poster Only
This arm will only receive motivational posters.
Behavioral: Poster
Posters contain inspirational messages and pictures highlighting the important and unique roles that patients and physicians can play in reducing unnecessary care and health care costs. These posters will be placed in physician offices.
EXPERIMENTAL: Thank-you Letter Only
This arm will only receive thank-you letters.
Behavioral: Thank-you Letter
Physicians will be sent thank-you letters containing changes in the rates of antibiotics and serum ferritin tests ordered since introduction of Choosing Wisely NL and a thank-you message from the NL Medical Association.
EXPERIMENTAL: Double Incentive
This arm will receive both motivational posters and thank-you letters.
Behavioral: Poster
Posters contain inspirational messages and pictures highlighting the important and unique roles that patients and physicians can play in reducing unnecessary care and health care costs. These posters will be placed in physician offices.
Behavioral: Thank-you Letter
Physicians will be sent thank-you letters containing changes in the rates of antibiotics and serum ferritin tests ordered since introduction of Choosing Wisely NL and a thank-you message from the NL Medical Association.
NO_INTERVENTION: Control
This arm will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of antibiotic prescriptions
Time Frame: 12 months
Rate of antibiotic prescriptions will be calculated as the number of antibiotic prescriptions per patient.
12 months
Rate of ordering of serum ferritin tests
Time Frame: 12 months
Rate of serum ferritin tests ordered will be calculated as the number of serum ferritin tests ordered per patient.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost savings from implementing the incentives
Time Frame: 12 months

Cost savings for 'Poster Only' arm: To estimate cost savings for this arm, reductions in prescription of antibiotics and serum ferritin tests in this arm (relative to control arm) estimated by the RCT will be converted into monetary values using pricing data from the literature.

Cost savings for 'Thank-you Letter Only' arm: To estimate cost savings for this arm, reductions in prescription of antibiotics and serum ferritin tests in this arm (relative to control arm) estimated by the RCT will be converted into monetary values using pricing data from the literature.

Cost savings for 'Double Incentive' arm: To estimate cost savings for this arm, reductions in prescription of antibiotics and serum ferritin tests in this arm (relative to control arm) estimated by the RCT will be converted into monetary values using pricing data from the literature.

Total cost savings will then be compared with total cost of implementing the associated incentive to estimate total net cost savings.
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial University of Newfoundland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hai Nguyen, PhD, Memorial University of Newfoundland

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 (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017.282

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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