BETTER prevention and screening: Personalized clinical visits for adults
| ISRCTN | ISRCTN21333761 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21333761 |
| Secondary identifying numbers | 201500833 |
- Submission date
- 31/08/2016
- Registration date
- 19/12/2016
- Last edited
- 31/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Family doctors often lack the resources, tools, and time to address cancer and long-term (chronic) disease prevention and screening. Most guidelines and resources focus on specific diseases, organ systems and/ or lifestyle risks, however patients are usually at risk of developing multiple conditions. Patients often lack awareness of how lifestyle contributes to the development of cancers and chronic diseases. In addition, cancer survivors and patients living in poverty achieve fewer prevention and screening goals. In a previous study, a program (BETTER) which involved an approach that proactively targeted patients to attend individual chronic disease prevention and screening program through a visit with a Prevention Practitioner improved patient care by 37%. This study is looking at an adapted version of this program, which is tailored for general health patients and cancer survivors and takes poverty into consideration (BETTER WISE). The aim of this study is to investigate the effectiveness of the BETTER WISE program in terms of cancer surveillance and general prevention and screening outcomes.
Who can participate?
Men and women aged 40-65, including general health patients and cancer survivors (breast, colorectal, or prostate cancer), who attend participating health practices.
What does the study involve?
Family doctors are randomly allocated to one of two groups. For those in the first groups, patients are booked in for a 60 minute personalized prevention visit with the Prevention Practitioner (an allied health professional within the practice). Before the visit, participants complete the BETTER WISE health survey to capture their previous screening and prevention history. At the visit, the Prevention Practitioner educates the participant on their health status and how to improve their health. Through a process of shared decision making the Prevention Practitioner identifies the patient's health goals and tailors a prevention program to that patient. The patients then complete a follow up version of the BETTER WISE health survey and attend follow up visits with the Prevention Practitioner at 6, 12, 18 and 24 months after the initial visit. Those in the second group continue as normal but are asked to complete the surveys at the same times as those in the first group.
What are the possible benefits and risks of participating?
Patients can benefit through improving their health through improved cancer and chronic disease prevention and screening. Participating practices will develop skills and resources for cancer surveillance, and cancer and chronic disease prevention and screening. Benefits to physicians may include the ability to bill for prevention and screening activities in settings that allow billing for these activities. There are no known risks involved with participating.
Where is the study run from?
Eight primary care practices in Alberta, four in Ontario and four in Newfoundland and Labrador (Canada)
When is the study starting and how long is it expected to run for?
March 2016 to July 2022
Who is funding the study?
Alberta Innovates (Canada)
Who is the main contact?
1. Dr Donna Manca (scientific)
dpmanca@ualberta.ca
2. Ms Carolina Aguilar (public)
carolina.aguilar@ualberta.ca
Contact information
Scientific
Department of Family Medicine Research Program
University of Alberta
8303 - 112 Street NW
610 University Terrace
Edmonton
T6G 2T4
Canada
 ORCID ID |
0000-0001-6073-7715 |
|---|---|
| Phone | +1 780 492 8102 |
| dpmanca@ualberta.ca |
Public
Department of Family Medicine
University of Alberta
6-10 University Terrace
Edmonton
T6G 2T4
Canada
| Phone | +1 780 248 2021 |
|---|---|
| carolina.aguilar@ualberta.ca |
Study information
| Study design | Pragmatic two-arm multi-centre cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Building on Existing Tools To improvE cancer and chronic disease pRevention and screening in primary care for Wellness of cancer survIvorS and patiEnts: The BETTER WISE Project |
| Study acronym | BETTER WISE |
| Study objectives | The aim of this study is to determine if patients aged 40-65, including general health patients and cancer survivors (breast, colorectal, and/or prostate), randomized to receive an individualized prevention visit with a Prevention Practitioner have improved cancer surveillance and general prevention and screening outcomes determined by a composite index as compared to standard care in a wait-list control group twelve months after the initial prevention visit. |
| Ethics approval(s) | University of Alberta HREB, 09/11/2016, ref: Pro00067811 |
| Health condition(s) or problem(s) studied | Cancer and chronic disease |
| Intervention | Current interventions (as of 18/12/2017): Participating primary care physicians will be randomized to have their patients in the intervention group or to a wait-list control group. The physician is defined as the “cluster” to minimize the risk of contamination in that all patients in that physician cluster will either receive the intervention or wait-list control, according to the arm to which their physician is randomly assigned. Intervention group: Patients will be scheduled for a personalized prevention visit with the Prevention Practitioner. Before the visit, patients will be asked to complete the BETTER WISE health survey. The BETTER WISE health survey will capture the patients’ detailed prevention and screening history. The intervention, a 60-minute visit with the Prevention Practitioner, will take place at the physician’s office. Before the initial prevention visit, the Prevention Practitioner will assess the patient’s medical history using the patient’s answers to the health survey as well as the patient’s medical chart (electronic or paper) to determine which prevention and screening actions the patient is eligible to receive and to prepare to discuss their risk for chronic diseases such as cancer, diabetes, and heart disease. During the prevention visit, the Prevention Practitioner and the patient will, through a process of shared decision-making and Brief Action Planning, develop a personalized Prevention Prescription for the patient. All recommendations and discussions will be based on the evidence-based BETTER WISE prevention and screening actions developed by the Clinical Working Group in Phase 1 of the project. The Prevention Prescription will be written on a standardized BETTER WISE form and may include plans for screening (e.g., mammogram, blood tests) and referrals to programs (e.g., smoking cessation). A copy will be given to the patient and copies will be placed in the patient’s medical record and in the BETTER WISE patient source documentation. The patient will complete a follow-up version of the BETTER WISE health survey and Prevention Practitioner follow-up visits at 6, 12, 18 and 24 months after the initial visit. This will allow us to evaluate the impact of the intervention over a period of one year and to follow the intervention group to assess maintenance over a two-year period. Control group: Patients will be asked to complete both the consent form and BETTER WISE health survey at baseline. Wait-list control patients will be asked to complete the BETTER WISE health survey (follow-up version) at 12 months following baseline data collection. Additional screening and prevention data will also be obtained for wait-list control patients from the patient’s medical chart (electronic or paper) at each data collection point (i.e., baseline and 12-months). A prevention appointment with the Prevention Practitioner will be made for these patients after the end of the intervention period of the study (i.e., once patients in the intervention arm complete their 12-month follow-up). Previous Interventions: Participating primary care physicians will be randomized to have their patients in the intervention group or to a wait-list control group. The physician is defined as the “cluster” to minimize the risk of contamination in that all patients in that physician cluster will either receive the intervention or wait-list control, according to the arm to which their physician is randomly assigned. Intervention group: Patients will be scheduled for a personalized prevention visit with the Prevention Practitioner. Before the visit, patients will be asked to complete the BETTER WISE health survey. The BETTER WISE health survey will capture the patients’ detailed prevention and screening history. The intervention, a 60-minute visit with the Prevention Practitioner, will take place at the physician’s office. Before the initial prevention visit, the Prevention Practitioner will assess the patient’s medical history using the patient’s answers to the health survey as well as the patient’s medical chart (electronic or paper) to determine which prevention and screening actions the patient is eligible to receive and to prepare to discuss their risk for chronic diseases such as cancer, diabetes, and heart disease. During the prevention visit, the Prevention Practitioner and the patient will, through a process of shared decision-making and Brief Action Planning, develop a personalized Prevention Prescription for the patient. All recommendations and discussions will be based on the evidence-based BETTER WISE prevention and screening actions developed by the Clinical Working Group in Phase 1 of the project. The Prevention Prescription will be written on a standardized BETTER WISE form and may include plans for screening (e.g., mammogram, blood tests) and referrals to programs (e.g., smoking cessation). A copy will be given to the patient and copies will be placed in the patient’s medical record and in the BETTER WISE patient source documentation. The patient will complete a follow-up version of the BETTER WISE health survey and Prevention Practitioner follow-up visits at 6, 12, 18 and 24 months after the initial visit. This will allow us to evaluate the impact of the intervention over a period of one year and to follow the intervention group to assess maintenance over a two-year period. Control group: Patients will be asked to complete both the consent form and BETTER WISE health survey at baseline. Wait-list control patients will be asked to complete the BETTER WISE health survey (follow-up version) at 6-month intervals over a period of 12 months following baseline data collection. Additional screening and prevention data will also be obtained for wait-list control patients from the patient’s medical chart (electronic or paper) at each data collection point (i.e., baseline, 6, and 12-months). A prevention appointment with the Prevention Practitioner will be made for these patients after the end of the intervention period of the study (i.e., once patients in the intervention arm complete their 12-month follow-up). |
| Intervention type | Other |
| Primary outcome measure | Proportion of cancer and chronic disease prevention and screening (CCDPS) actions for which the patient was eligible at baseline that are met (according to pre-defined targets) at 12-month follow-up. |
| Secondary outcome measures | 1. Proportion of patients meeting the evidence-based targets will be measured by tracking specific cancer and chronic disease prevention and screening actions (e.g. mammograms completed, alcohol consumption reduced, screening for poverty) longitudinally at 6, 12, 18 and 24 months 2. Number of targeted cancer and chronic disease prevention and screening actions that patients randomized to the intervention group were deemed eligible to improve at baseline that are met (according to pre-defined targets) at 24-month follow-up |
| Overall study start date | 31/03/2016 |
| Completion date | 28/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 1,280 |
| Total final enrolment | 115 |
| Key inclusion criteria | 1. 40-65 years of age 2. Men and women 3. Able to give written informed consent 4. Cancer survivors who are low risk breast and/or colorectal and/or prostate cancer survivors 5. Patients without a personal history of breast, colorectal or prostate cancer 6. Patients on whom the researchers can obtain access to their medical records for the previous three years 7. Patients who are able to attend in-person preventions visits at their primary care site 8. Patients who are not receiving active treatment (i.e., systemic and/or radiation therapy) for cancer |
| Key exclusion criteria | 1. Unable to give written informed consent for reasons of language, literacy, or competence 2. Unable to access their medical history for the previous three years 3. Receiving active treatment for cancer (i.e., systemic and/or radiation therapy) *Prophylactic or hormone treatments (e.g., aromatase inhibitors) are not exclusion criteria. Physicians may request that a particular patient not be invited and the rationale for exclusion will be captured (e.g. patient too frail) |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 31/08/2019 |
Locations
Countries of recruitment
- Canada
Study participating centres
8303 - 112 Street NW
610 University Terrace
Edmonton
T6G 2T4
Canada
4th Floor Janeway Hostel
Health Sciences Centre
300 Prince Philip Drive
St. John's Newfoundland
A1B 3V6
Canada
Toronto
M5G 1V7
Canada
Sponsor information
University/education
University of Alberta
Department Name
Building Room and Number
Attention: Contact Person
116 St. and 85 Ave.
Edmonton
T6G 2R3
Canada
| Website | https://www.ualberta.ca/ |
|---|---|
"ROR" |
https://ror.org/0160cpw27 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analyzed during the BETTER WISE study will not be made publicly available due to planned analyses and publications, but are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/12/2018 | 12/03/2021 | Yes | No |
| Interim results article | qualitative findings | 23/01/2023 | 24/01/2023 | Yes | No |
| Results article | results | 30/06/2023 | 03/07/2023 | Yes | No |
| Results article | 28/09/2023 | 29/09/2023 | Yes | No | |
| Results article | Qualitative results | 16/03/2023 | 31/01/2025 | Yes | No |
| Results article | Qualitative results | 19/07/2021 | 31/01/2025 | Yes | No |
| Results article | Secondary analysis | 15/04/2024 | 31/01/2025 | Yes | No |
Editorial Notes
31/01/2025: Publication reference added.
29/09/2023: Publication reference added.
03/07/2023: The following changes have been made:
1. Publication reference added.
2. The total final enrolment was changed from 1005 to 115.
12/06/2023: The intention to publish date has been changed from 31/12/2022 to 31/12/2023.
24/01/2023: Publication reference added.
10/08/2022: The overall trial end date has been changed from 31/07/2021 to 28/07/2022 and the plain English summary updated accordingly.
14/06/2022: The intention to publish date was changed from 30/06/2022 to 31/12/2022.
08/06/2021: The overall end date was changed from 30/06/2021 to 31/07/2021.
12/03/2021: The following changes have been made:
1. The overall trial end date has been changed from 30/03/2021 to 30/06/2021 and the plain English summary has been updated accordingly.
2. The intention to publish date has been changed from 30/03/2022 to 30/06/2022.
3. Publication reference added.
17/09/2019: The total final enrolment was added.
25/02/2019: The recruitment end date has been changed from 28/02/2019 to 31/08/2019.
21/11/2018: The recruitment end date was changed from 01/10/2018 to 28/02/2019.
31/05/2018: Internal review
18/12/2017: Recruitment start date was changed from 01/08/2017 to 01/01/2018 and Interventions were updated.
04/09/2017: Ethics approval has been updated.
Related to the BETTER project: http://www.isrctn.com/ISRCTN07170460
