Methods
Setting
Danish healthcare is mainly tax-financed and includes free-of-charge
access to services11. General practices are typically
independent, physician-owned clinics, and nearly all Danes are listed
with a specific general practice clinic. General practitioners (GPs) are
remunerated through a mix of capitation and fee-for-services based on a
national agreement between the Danish Regions and the Organisation of
GPs. In Denmark, GPs are responsible for most prescriptions and chronic
care management12.
The current study was a part of a larger quality improvement project
focusing on polypharmacy and communication inspired by the World Health
Organisations global initiative “Medication without
harm”13. The project was conducted in a close
collaboration between the Centre for Health and Care in the Municipality
of Frederikshavn, Denmark, and a large GP clinic in Frederikshavn
(hereafter GPF).
The GPF is a large clinic with a strategic focus on older patients and
patients with chronic diseases. The GPF has a close collaboration with
the municipal and regional health services. The GPF has an affiliated
population of approximately 8,900 patients, of which more than 2,300
citizens are older than 65 years. The GPF employs eight GPs, ten nurses,
ten medical students, or GP trainees, a social and health assistant, a
pharmaconomist, and a physiotherapist.
In the Municipality of Frederikshavn, the Centre for Health and Care
runs 12 care homes, of which eleven are covered by a specific GP
practice. The GPF is affiliated ”care home doctor” for four of the
care homes in the municipality.
Ethics
The project was approved by the Management in the Municipality of
Frederikshavn. According to Danish legislation, no formal permission
from the national or regional Committee on Health Research Ethics was
required for this type of study, as patients were not treated inferior
to usual care and no biological material was collected. It was conducted
as a quality improvement project and informed consent was not required
for the specific data collected. The study was conducted in accordance
with the Basic & Clinical Pharmacology & Toxicology policy for
experimental and clinical studies14. The study is in
compliance with the General Data Protection
Regulation15 and a part of North Denmark Region’s
record of processing activities (K2023-008). The study is registered in
ClinicalTrials.gov (registered January 31, 2023, awaiting
ClinicalTrials.gov ID).
Study design and
population
The study was conducted in the 2-years period from the January 2020 to
December 2021 using an uncontrolled before-and-after design. The study
included care home residents living in selected care homes, in which the
GPF was associated “care home doctors”, and community-dwelling
patients with chronic disease listed with the GPF.
The Chronic Care Model
In Denmark, chronic care consultations are provided to patients with one
or more chronic conditions. The organisation of these consultations
varies across GP clinics, depending on e.g. the size of the clinic and
the competencies in the staff group16. In connection
with this project, a new, local Chronic Care Model was drawn up for
patients with one or more chronic conditions such as diabetes, chronic
obstructive pulmonary disease, hypertension, heart failure, or atrial
fibrillation. The overall aim of the model was to obtain sufficient
depth and breadth in the chronic care consultations over a one-year
period.
The new Chronic Care Model is illustrated in figure 1.
In addition to the Chronic Care Model, a new cross-sectoral
communication model was established. This included regular contact
between the care home nurses and the GPF (weekly by telephone, e-mail,
visit, and/or online conference); support opportunity from a pharmacist
employed in Frederikshavn Municipality; and support opportunity from a
specialized geriatric department at the hospital every second week.
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Care home residents
The four care homes affiliated
with the GPF accommodate 190 residents. Of these, 128 were patients in
the GPF (the remaining residents kept their family doctor when moving
into the care home) (figure 2). In the period from March 24, 2020, to
June 16, 2021, the intervention was offered to new residents and
residents that had not yet attended a consultation focusing on
pharmacological treatment in The Chronic Care Model.
Community-dwelling patients with chronic
disease
The GPF had 1,800 community-dwelling patients with chronic diseases
listed in the period 2020-2021 (figure 2). From June 3, 2020, to
November 16, 2021, patients were invited for the consultation focusing
on pharmacological treatment in the month of their birthday and,
thereby, included randomly and consecutively throughout the study
period.
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Intervention
In this study, the focus was placed on the annual consultation focusing
on pharmacological treatment in the Chronic Care Model. This specific
consultation constituted the “intervention”. It included a structured
review of the patient’s health state, in addition to a structured
medication review with a focus on appropriate medication and
deprescribing. Medication changes were registered as deprescribing (dose
reduction or stopping/pausing of medications), new prescription, and
other medication changes (e.g., dose increase or change in dosing
interval). Additionally, issues such as treatment plans for addictive
drugs, dose dispensing, resuscitation, life-prolonging treatment, and
terminal care were discussed when relevant. A selected group of
providers (two doctors and three nurses) from GPF were responsible for
conduction of the intervention in the present study. The GPs performed
the medication reviews. In care home residents, the GPs also carried out
the related consultation. In community-dwelling patients, the nurses
were responsible for the consultations with the GPs as close support.
Data collection and
outcomes
Before and 3-4 months after the consultation focusing on pharmacological
treatment, information regarding medication changes and health-related
outcomes were collected during consultations.
Health-related outcomes were collected by a nurse or the patient’s
contact person together with the patient and, if possible, also
relatives. The primary outcome was changes from baseline to 3-4 months
follow-up in 1) self-reported health status (on a scale from 1 to 10).
Secondary outcomes were 2) general condition (rated on a 5-point Likert
Scale as “much below average”, “below average”, “average”, “above
average” and “much above average”); and 3) functional level (rated on
a 5-point Likert Scale as “independent”, “frail”, “mild
disability”, “disability” and “severe disability”). General
condition and functional level were determined by clinical evaluation.
The outcomes were developed with inspiration from Garfinkel17.
Statistical analysis
Descriptive and non-parametric data were summarized and displayed by
medians [inter quartile range (IQR)] for continuous data and as
proportions (percentages) for categorical data. Parametric data was
displayed by means and standard deviation (SD). Paired t-test was used
to compare means of self-reported health status at baseline and
follow-up. McNemars test was used when comparing paired proportions for
categorical variables. General condition and functional level were
dichotomised and analysed as proportion of patients with general
condition rated as “average or above” (defined as: “average”,
“above average” or “much above average”). The proportion of patients
with functional level rated as “without any disability” was defined as
the categories: “independent” or “frail”. Statistical analyses were
performed in STATA 17. Statistical significance was indicated by a
two-tailed p value of 0.05.