Titre officiel
BETTER Women: Community-Based, Primary Care-Linked Peer Health Coaching to Achieve Evidence-Based Preventive Care Goals - A Pragmatic, Wait-List Controlled Effectiveness-Implementation Trial
Sommaire:
Le programme BETTER (Building on Existing
Tools To improvE cancer and chronic disease pRevention and screening in primary
care) permet aux patients bénéficiant de soins primaires de rencontrer, à l’occasion
d’une visite dédiée, un spécialiste de la prévention pour aborder les questions
de la prévention des maladies chroniques et du dépistage du cancer. Un
spécialiste de la prévention est un professionnel de la santé travaillant dans
le secteur des soins primaires et ayant reçu une formation supplémentaire pour
aborder les questions de la prévention et du dépistage des maladies chroniques,
et définir des objectifs relatifs à la santé des patients dans le cadre d’une
prise de décisions communes. Des études antérieures ont montré que cette
approche augmente le nombre de mesures de prévention et de dépistage prises par
les participants au programme. Cependant, il est difficile d’inscrire dans la
durée les changements de comportement en matière de santé sans un soutien
permanent. Il est également prouvé qu’un encadrement assuré par les pairs peut
améliorer les résultats en matière de santé dans un contexte communautaire. À
ce titre, le programme BETTER Women étend le programme BETTER en se concentrant
sur les femmes âgées de 45 à 60 ans. Il leur apporte en outre un soutien
limité dans le temps visant à favoriser les changements de comportement en
matière de santé par le biais d’un encadrement assuré par les pairs. Les pairs
assurant un encadrement dans le domaine de la santé sont des bénévoles, formés
aux techniques de soutien favorisant les changements de comportement en matière
de santé. Ils aident les femmes à atteindre leurs objectifs de santé sur une
période de six (6) mois. Dans cette étude, les chercheurs essaieront de
déterminer si les patientes qui participent au programme BETTER Women (l’extension
de l’encadrement sanitaire par les pairs) sont plus susceptibles de prendre un
plus grand nombre de mesures de prévention et de dépistage après un an, par
rapport aux femmes qui participent au programme BETTER, mais qui ne bénéficient
de l’encadrement par les pairs qu’un an plus tard. Les chercheurs examineront
également la mise en œuvre du programme afin de déterminer les facteurs
influant sur les divers aspects de la réussite et de la durabilité du
programme.
Description de l'essai
Primary Outcome:
- Increased targeted behaviours from baseline
Secondary Outcome:
- Goal achievement
- Breast cancer screening status
- Cervical cancer screening status
- Colorectal cancer screening status
- Diet status
- Improvement in diet
- Diet management
- Physical activity status
- Improvement in physical activity
- Physical activity management
- Smoking status
- Improvement in smoking
- Smoking management
- Alcohol use status
- Improvement in alcohol use
- Alcohol use management
- Up-to-date measurement of glycated haemoglobin (HbA1c)
- HbA1c control
- HbA1c
- Glycemic management
- Up-to-date measurement of blood pressure (BP)
- BP control
- Systolic BP
- Diastolic BP
- Hypertension management
- Up-to-date assessment of low-density lipoprotein (LDL) cholesterol
- LDL control
- LDL
- LDL cholesterol management
- Up-to-date assessment for obesity
- BMI control
- Management of obesity
While the BETTER program has been shown to successfully increase the number of preventive
care and screening actions completed by patient participants after six months, it is known
that it is difficult to maintain new health behaviours in the long-term. Unfortunately, it is
not feasible to fund health professionals to offer repeated follow-up visits over the time
needed to turn initial behaviour changes into long-term habits. Therefore, the investigators
are building upon the existing BETTER program by adding a peer health coaching extension that
will provide time-limited coaching for patients who want support as they work towards
achieving preventive health goals. This approach takes advantage of growing awareness of the
role of lay health coaches in improving and extending the quality and value of primary care.
This is a three-site, pragmatic, wait-list-controlled, randomized, Type 1 hybrid
effectiveness-implementation trial with blinded outcome collection after 12 months. One site
will be an urban, academic, hospital-based clinic; the second will be a clinic serving a
greater proportion of patients from rural areas; and the third site will be a suburban clinic
with a large South Asian population. Following receipt of the BETTER program (a single visit
with a prevention practitioner), investigators will invite women who are 40-65 years old to
receive behaviour change support for six months from a peer health coach (PHC). PHCs will do
a 24-hr training course, which includes special techniques to support health behaviour
change, before they are matched to a patient. At the suburban site, only South Asian PHCs
will be recruited and this work is being guided by a South Asian Community Advisory Council
made up of members of various community organizations in that region. Patients who enroll in
BETTER Women will be randomized to receive peer health coaching either immediately
(intervention group) or after a 12-month delay (wait-list control group).
Effectiveness of the program will be assessed by evaluating for each patient, how many of a
set of target chronic disease prevention and screening actions were completed at one year, in
comparison to baseline. Investigators will also assess whether patients achieved the health
goals that they set with their prevention practitioners, physiological markers of health, as
well as habits and behaviours related to diet, physical activity, smoking and alcohol use.
These outcomes will be collected via electronic surveys administered at baseline, 3-, 6-, and
12-months post enrollment as well as through extraction of data from the patients' electronic
medical records and BETTER program documents. These outcomes will be compared between the two
groups of patients in the study.
An embedded process evaluation will be conducted during the trial to examine the
implementation of the program. The process evaluation will include collection of program
data, electronic surveys administered to patients as well as qualitative interviews with
intervention group patients, peer health coaches and prevention practitioners. Investigators
will examine how acceptable the program was to patients; whether and why any adaptations were
made; how well the program was utilized; how well the PHCs delivered the intervention (e.g.,
what behaviour change techniques were used); how engaged patients and PHCs were with the
program; and mechanism(s) of action. Ultimately, investigators expect to gain an
understanding of the program's sustainability, acceptability, cost-effectiveness, and factors
that might impact future attempts at spread and scale.
Investigators expect to see that women in the intervention group (i.e., those who had a PHC)
will complete more preventive and screening actions after one year. Investigators also expect
to see that women in the intervention group will make more progress on achieving health goals
and making lifestyle changes which reduce the risk of chronic diseases and cancers, that the
intervention will increase women's access to resources in their primary care clinics and
community, as well as improve the women's ability to maintain healthy behaviours.
Voir cet essai sur ClinicalTrials.gov
