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The effectiveness and cost-effectiveness of an integrated osteoporosis care programme for postmenopausal women in Flanders: study protocol of a quasi-experimental controlled design

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Abstract

Summary

Osteoporosis causes high individual and societal burden, due to limited attention to fracture prevention. Integrated care for chronic conditions has shown to facilitate management of these conditions, improving clinical outcomes alongside quality of life and cost-effectiveness. This manuscript describes an integrated osteoporosis care programme that will be implemented in primary care.

Objective

To provide a comprehensive description of a quasi-experimental study design in which a newly developed integrated osteoporosis care (IOC) programme for the management of postmenopausal osteoporosis (PO) in primary care (PC) is implemented and will be compared with care as usual (CAU).

Methods

A literature research was performed and expert meetings have been taking place, which has led to the development of a complex PC intervention based on framework for integrated people-centred health services (IPCHS).

Results

This manuscript describes the developmental process of the preclinical phase of a quasi-experimental real-world design and the interventions as a result of this process that will be implemented during the clinical phase, along with the evaluation that will take place alongside the clinical phase: An integrative approach for the management of PO in primary care was developed and will be implemented in greater region of Ghent (GRG), Belgium. The approach consists of a complex intervention targeting patients and PC stakeholders in osteoporosis care (e.g. general practitioners (GPs), physiotherapists, nurses, pharmacists). A comparison will be made with CAU using medication possession ratios (MPR) of included patients as primary outcome. These data will be obtained from the national health database. Secondary outcomes are physician outcomes, patient-reported outcome measures (PROMs), and patient-reported experience measures (PREMs). A cost-effectiveness evaluation will be performed if the programme appears to be effective in terms of MPR.

Trial Registration

ClinicalTrials.gov: NCT03970902

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Data availability

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Notes

  1. BMD is the medical term referring to the mineral content of bone as a measure of bone strength. It has been assigned the golden standard for diagnosis of osteoporosis by the World Health Organization (WHO) and is used for treatment decisions and monitoring.

  2. AGREE II is the second version of the AGREE tool, an international tool to assess the quality and reporting of practice guidelines. A Dutch validated and reliable version is available.

  3. APB is the national professional federation of pharmacists in Belgium

  4. KOVAG is the regional professional federation of pharmacists in East-Flanders, Belgium.

  5. The IMA manages databases containing all data on reimbursed healthcare consumption by all Belgian healthcare insurance companies. As health insurance is a legal obligation for all persons living and/or working in Belgium, this database covers all residents and employees in Belgian companies’ healthcare consumption conform the General Data Protection Regulation (GDPR) law.

  6. The MPR is the sum of day’s supply for all fills of a given drug in a particular time period, divided by the number of days in the time period.

Abbreviations

ADL:

activities of daily living

APB:

Algemene Farmaceutische Bond (Federal General Association of Pharmacists)

BMD:

bone mineral density

CEA:

cost-effectiveness analysis

CAU:

care as usual

DXA:

dual X-ray absorptiometry

EMR:

electronic medical record

FLS:

fracture liaison service

FRR:

fracture risk reduction

GDP:

gross domestic product

GDPR:

General Data Protection Regulation

GP:

general practitioner

GRG:

greater region of Ghent

HRQoL:

health-related quality of life

IC:

integrated care

ICC :

intraclass correlation coefficient

ICER:

incremental cost-effectiveness ratio

IF:

implementation fidelity

IMA:

InterMutualistisch Agentschap (InterMutualistic Agency)

IOC:

integrated osteoporosis care

IPCHS:

integrated people-centred health services

KOVAG:

Koninklijk Oost-Vlaams Apothekersgild (East-Flanders’ Association of Pharmacists)

MPR:

medication possession ratio

PC:

primary care

PIB:

patient information brochure

PO:

postmenopausal osteoporosis

PREM:

patient-reported experience measure

PROM:

patient-reported outcome measure

QALY:

quality-adjusted life year

RCT :

randomised controlled trial

RMIC:

Rainbow Model of Integrated Care

SD:

standard deviation

SSC:

Scientific Steering Committee

WHO:

World Health Organization

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Funding

This work was made possible through a value-based partnership between Ghent University and Amgen. This partnership has no impact on the design, conduct, analysis, or publication decisions of this project.

Author information

Authors and Affiliations

  1. Department of Public Health and Primary Care, Ghent University, Ghent, Belgium

    Caroline Verdonck, Lieven Annemans & Liesbeth Borgermans

  2. Department of Endocrinology and Rheumatology, Unit Osteoporosis and Metabolic Bone Disease, Ghent University Hospital, Ghent, Belgium

    Stefan Goemaere & Bruno Lapauw

  3. Department of Internal Medicine and Pediatrics, University Hospital Ghent, Ghent, Belgium

    Bruno Lapauw

  4. Academic Centre for General practice, Department of Public Health and Primary Care, KU Leuven – University of Leuven, Leuven, Belgium

    Geert Goderis

  5. Beringen, Belgium

    Elie Balligand & Marie-Paule Doom

  6. University Centre Geriatrics, University Hospital Antwerp, Antwerp, Belgium

    Stany Perkisas

  7. Department ELIZA, University of Antwerp, Antwerp, Belgium

    Stany Perkisas

Authors
  1. Caroline Verdonck
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  2. Lieven Annemans
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  9. Liesbeth Borgermans
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Contributions

Principal Investigator: LB. Development of the protocol: LB, LA, SG, BL, GG, and CV. Contributions to the development of the treatment guideline: LA, EB, GG, SG, BL, SP, LB and CV. Contributions to the development of the bone friendly diet: MPD and CV. All authors have revised the draft critically and have approved the final text.

Corresponding author

Correspondence to Caroline Verdonck.

Ethics declarations

Ethics approval and consent to participate

The study protocol has been approved by the Ethics Committee of the University Hospital of Ghent (No. 2019/0578) prior to inclusion of general practitioners (GPs). Written informed consent will be obtained from all patients and GPs after receiving a full explanation of the study both orally and by an information letter.

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Not applicable

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None.

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Verdonck, C., Annemans, L., Goemaere, S. et al. The effectiveness and cost-effectiveness of an integrated osteoporosis care programme for postmenopausal women in Flanders: study protocol of a quasi-experimental controlled design. Arch Osteoporos 15, 107 (2020). https://doi.org/10.1007/s11657-020-00776-7

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