Implementation and Validation of the "5As Framework of Obesity Management" in Primary Care. "5AsT"

NCT01967797 | Completed

• 1 other identifier: RES 0014622
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this project is to develop, implement and evaluate the 5As Team intervention (5AsT)for healthcare practitioners to improve their weight management patient encounters and improve patient health outcomes. The 5As of Obesity Management suite of tools is a robust, evidence-based approach to weight management, however its implementation and uptake has been heterogeneous in primary care. This project was co-created by, and will be implemented with, our partners the Southside Primary Care Network (SSPCN). A needs assessment on weight management by the SSPCN revealed the need to change provider practice to increase the number of weight management visits. Despite a robust didactic training session on weight management for all providers, which includes the 5As, the uptake in practice has been highly heterogeneous. Thus, the 5AsT intervention to address the implementation of the 5As of Obesity Management in clinical practice was developed by the collaborative team. The SSPCN consists of 25 autonomous groups of multidisciplinary professionals that provide service to a defined group of patients within the SSPCN. The 5As Team consists of multidisciplinary providers (Registered Nurse/ Nurse Practitioner, dietician, mental health worker) who work collaboratively. The intervention is a learning collaborative where these 12 different 5AsTs get together to work to address facilitators and barriers to weight management in their settings over a 6 month period. Half of the teams (N=12) will remain as controls and deliver usual care. They serve as a comparison group for the 5AsTs. This mixed methods study's primary outcomes will assess the change in provider practice and the effectiveness of the intervention and implementation. To assess the impact of 5AsT on patients, we will recruit patients presenting to the central SSPCN programming, We will not intervene directly on patients; we will observe the impact of the 5AsT and SSPCN programming on their health outcomes for a minimum of 6 months, and where possible for 18 months. Data collected includes demographics, weight (BMI), waist circumference, vital signs,and Short Form-12 (SF-12,these measures are routinely measured in the SSPCN), EuroQol-5 dimensions 5 Level (EQ-5D-5L), modified patient assessment of chronic illness (PACIC), and observed adherence to routine clinical care for guideline recommended laboratory monitoring (cholesterol panel, fasting glucose, HbA1c, where appropriate).

Conditions

Overweight and Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (3)

• Number of weight management visits/ practitioner Full Time Equivalent(FTE)

  PROVIDER INTERVENTION STUDY- This is routine operational data collected by the SSPCN on all encounters conducted by all practitioners. Providers are blinded to the outcome measure.

  Data will be collected monthly and analyzed at 6, 12 and 18 Months

• Change in BMI

  PATIENT STUDY - Primary outcome measure. All patients receive SSPCN health courses. This measure compares patients from the 5AsT clinics and the control clinics to see whether they have greater weight loss, and more success in sustained weight management. This will also be assessed by the number of interactions they have for weight management over the time frame.

  3,6,12,and 18 month where possible

• Change in Self-reported health measures-SF12

  PATIENT STUDY-All patients receive central SSPCN health programming. This compares those from 5AsT Team clinics with those from control clinics to see whether they have greater self-reported health measures and more success with sustained improvement. This will also be assessed by the number of interactions they have for weight management over the time frame.

  3,6,12 months and 18 months where possible

Secondary Outcomes (2)

• Change in Self-reported health measures- EQ5D

  3,6,12 months and 18 months where possible

• Change in PACIC Score

  3 months, 6 months, 12 months, and 18 months where possible

Other Outcomes (1)

• Qualitative Description of the Implementation Process

  12 months

Study Arms (2)

5As Team Intervention

EXPERIMENTAL

The intervention group will participate in an additional 6 month intensive learning collaborative model designed around the 5As of obesity management, but which addresses areas identified as barriers (i.e. weight bias, clinical environment, clinic processes \& team based care, mental health, counseling around emotional eating, caregiver fatigue, designing appropriate patient follow-up, and additional topics identified by the professionals). A clinical Champion identified by our partner SSPCN will be available to provide 1:1 support and coaching of the practitioners \& teams as needed. The practitioners will work collaboratively to do their own needs assessment, and will identify additional resources or tools that they need to overcome the barriers to weight management in their setting. The research team will use a Practice Facilitation model to provide additional resource and support to the change process for the practitioners.

Behavioral: 5As Team Intervention

Control

NO INTERVENTION

Though the controls will have knowledge of the '5A's of Obesity Management', they will not be receiving 5As Team Intervention.

Interventions

5As Team Intervention BEHAVIORAL

The intervention group will participate in an additional 6 month intensive learning collaborative model designed around the 5As of obesity management, but which addresses areas identified as barriers (i.e. weight bias, clinical environment, clinic processes \& team based care, mental health, counseling around emotional eating, caregiver fatigue, designing appropriate patient follow-up, and additional topics identified by the professionals). A clinical Champion identified by our partner SSPCN will be available to provide 1:1 support and coaching of the practitioners \& teams as needed. The practitioners will work collaboratively to do their own needs assessment, and will identify additional resources or tools that they need to overcome the barriers to weight management in their setting. The research team will use a Practice Facilitation model to provide additional resource and support to the change process for the practitioners.

5As Team Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 18 years
• BMI ≥ 25
• Enrolling in PCN programs for overweight/ obesity or depression able and willing to give written informed consent in English

You may not qualify if:

• Children and pregnant women
• Patients whose obesity is co-managed by an obesity specialist or tertiary care center
• Patients who are unable to participate in regular clinic visits or programs due to geographic, social or physical reasons

Sponsors & Collaborators

• University of Alberta: lead
• Edmonton South Side Primary care network: collaborator
• Alberta Innovates Health Solutions: collaborator

Study Sites (1)

University Of Alberta

Edmonton, Alberta, Canada

Location

Related Publications (5)

• Campbell-Scherer DL, Asselin J, Osunlana AM, Ogunleye AA, Fielding S, Anderson R, Cave A, Johnson JA, Sharma AM. Changing provider behaviour to increase nurse visits for obesity in family practice: the 5As Team randomized controlled trial. CMAJ Open. 2019 May 30;7(2):E371-E378. doi: 10.9778/cmajo.20180165. Print 2019 Apr-Jun.

  PMID: 31147378 DERIVED

• Luig T, Asselin J, Sharma AM, Campbell-Scherer DL. Understanding Implementation of Complex Interventions in Primary Care Teams. J Am Board Fam Med. 2018 May-Jun;31(3):431-444. doi: 10.3122/jabfm.2018.03.170273.

  PMID: 29743226 DERIVED

• Asselin J, Salami E, Osunlana AM, Ogunleye AA, Cave A, Johnson JA, Sharma AM, Campbell-Scherer DL. Impact of the 5As Team study on clinical practice in primary care obesity management: a qualitative study. CMAJ Open. 2017 Apr 26;5(2):E322-E329. doi: 10.9778/cmajo.20160090.

  PMID: 28450428 DERIVED

• Ogunleye A, Osunlana A, Asselin J, Cave A, Sharma AM, Campbell-Scherer DL. The 5As team intervention: bridging the knowledge gap in obesity management among primary care practitioners. BMC Res Notes. 2015 Dec 22;8:810. doi: 10.1186/s13104-015-1685-8.

  PMID: 26695407 DERIVED

• Campbell-Scherer DL, Asselin J, Osunlana AM, Fielding S, Anderson R, Rueda-Clausen CF, Johnson JA, Ogunleye AA, Cave A, Manca D, Sharma AM. Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial. Implement Sci. 2014 Jun 19;9:78. doi: 10.1186/1748-5908-9-78.

  PMID: 24947045 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arya M Sharma, MD,PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: October 21, 2013
• Primary Completion: January 30, 2015
• Study Completion: December 22, 2016
• Last Updated: October 16, 2018

Record last verified: 2016-03

Locations

CA (1)