Building on Existing Tools to Improve Chronic Disease Prevention in Family Practice: The Better Project

ISRCTN	ISRCTN07170460
DOI	https://doi.org/10.1186/ISRCTN07170460
Protocol serial number	2.0
Sponsor	Canadian Partnership Against Cancer (Canada)
Funders	Canadian Partnership Against Cancer (Canada), Heart and Stroke Foundation of Canada

Submission date: 23/03/2010
Registration date: 07/04/2010
Last edited: 25/01/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Eva Grunfeld
Scientific

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

Study information

Primary study design	Interventional
Study design	Pragmatic randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The use of patient- and practice-level interventions to improve chronic disease prevention in family practice: A pragmatic randomised controlled trial
Study acronym	BETTER
Study objectives	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(s)	1. University of Alberta Research Ethics Board, 08/04/2010 2. Ontario Cancer Research Ethics Board, 31/05/2010, ref: #10-024
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1120
Key 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
Key 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
Date of first enrolment	01/07/2010
Date of final enrolment	01/03/2012

Locations

Countries of recruitment

Canada

Study participating centre

500 University Ave.

Toronto
ON M5G 1V7
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/01/2014		Yes	No
Results article	results	01/01/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/01/2017: Publication reference added.