Condition category
Not Applicable
Date applied
23/03/2010
Date assigned
07/04/2010
Last edited
04/08/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eva Grunfeld

ORCID ID

Contact details

500 University Ave.
Suite 352
Toronto
ON M5G 1V7
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2.0

Study information

Scientific title

The use of patient- and practice-level interventions to improve chronic disease prevention in family practice: A pragmatic randomised controlled trial

Acronym

BETTER

Study hypothesis

1. In a family practice group setting, to determine if a patient-centred prevention and screening intervention by a well-trained health professional, for adults aged 40 to 65, is effective.
2. In a family practice group setting, to determine if a practice-centred intervention is effective.
3. To determine if either the patient-centred or practice-centred interventions are cost-effective.

Ethics approval

1. University of Alberta Research Ethics Board, 08/04/2010
2. Ontario Cancer Research Ethics Board, 31/05/2010, ref: #10-024

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Chronic disease prevention - specifically cancer, diabetes and cardiovascular diseases

Intervention

1. Patient-level intervention with a trained health care professional during which a plan will be developed for the patient. All recommendations and discussions will be based on the 'BETTER' prevention and screening manoeuvers that are evidence-based best practice manoeuvers.
2. Practice-Level Intervention will involve a trained Practice Facilitator who will develop a plan for the practice that will focus on how to optimise the use of existing information tools and resources.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The Summary Quality Index (SQUID), measured at 6 months
A reliable and valid composite measure to track quality of care among primary care practice patients that use an electronic medical record (EMR). The primary analysis will be a comparison between the SQUID of the intervention group and the SQUID of the control group.

Secondary outcome measures

1. Assessment of the impact of the intervention in improving the quality of care, comparison made from baseline to 6 months follow-up (intervention group only)
2. Economic evaluation to examine the cost-effectiveness of the interventions
Outcomes will be measured at 12 months.

Overall trial start date

01/07/2010

Overall trial end date

01/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Strata 1:
1.1. Adult patients of the participating Family Physicians who are between the ages of 40 and 65, inclusive
1.2. Written informed consent to participate in the trial
2. Strata 2: Adults with moderate mental illness aged 40 to 65

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1120

Participant exclusion criteria

1. Patients who are unable to give written informed consent for reasons of language, literacy or competence
2. Patients who are not able to come to the family practice office
3. Off-site patients or non-active patients (no visit in the last 3 years) of the family physician

Recruitment start date

01/07/2010

Recruitment end date

01/03/2012

Locations

Countries of recruitment

Canada

Trial participating centre

500 University Ave.,
Toronto
ON M5G 1V7
Canada

Sponsor information

Organisation

Canadian Partnership Against Cancer (Canada)

Sponsor details

1 University Ave.
#300
Toronto
M5J 2P1
Canada

Sponsor type

Charity

Website

http://www.partnershipagainstcancer.ca/

Funders

Funder type

Charity

Funder name

Canadian Partnership Against Cancer (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Heart and Stroke Foundation (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25077119

Publication citations

  1. Results

    Campbell-Scherer D, Rogers J, Manca D, Lang-Robertson K, Bell S, Salvalaggio G, Greiver M, Korownyk C, Klein D, Carroll JC, Kahan M, Meuser J, Buchman S, Barrett RM, Grunfeld E, Guideline harmonization and implementation plan for the BETTER trial: Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Family Practice., CMAJ Open, 2014, 2, 1, E1-E10, doi: 10.9778/cmajo.20130040.

Additional files

Editorial Notes