Accreditation Clinical Trial
Official title:
Unannounced or Announced Periodic Hospital Surveys: A Study Protocol for a Nationwide Cluster-randomised, Controlled Trial
Introduction: Accreditation programmes for healthcare systems have been implemented in more
than 70 countries to stimulate high-quality organisational performance. Several Danish
healthcare institutions are covered by the Danish Healthcare Quality Programme (DDKM) and
all Danish public hospitals have been accredited according to the DDKM since 2010.
The dates of each survey are currently being announced 8-10 months beforehand. Announcing
surveys has been criticised for creating an "arranged reality". It has therefore been
suggested that a national intervention be conducted to evaluate the effect of unannounced
hospital surveys.
Methods and analysis: All public somatic and psychiatric hospitals in Denmark (n=30) were
invited to participate in the trial. Twenty-three hospitals (77%) (3 university hospitals, 5
psychiatric hospitals, and 15 general hospitals) agreed to participate and to be randomised
to one of the trial clusters. Eleven hospitals will receive announced surveys (control
group) and 12 hospitals will receive unannounced surveys (intervention group).We hypothesise
that hospitals receiving unannounced surveys will be rated as less successful than hospitals
receiving announced surveys, defined as meeting less compliance with accreditation standards
and performance indicators. Nine experienced surveyors employed and educated by The Danish
Institute for Quality and Accreditation in Health Care (IKAS) will be responsible for
conducting the surveys according to an abbreviated version of the current Danish periodic
survey. The outcome is compliance with indicators reflecting organisational performance.
Compliance will be analysed using logistic or linear regression analysis with random
effects, contingency tables, and Pearson's chi-squared test or Fishers exact test, whichever
is most appropriate.
Ethics and Dissemination: This trial is pending ethics approval from Research Ethichs Comite
for North Denmark Region. The findings from this randomised controlled trial will be
disseminated through peer-reviewed journals, national and international conferences and will
be utilised as health care political decision making for the future national accreditation
programme. In addition, the results will facilitate to validate the effect of unannounced
hospital surveys; given the issues of currently meeting an "arranged reality" during
hospital surveys, this seems extremely desirable.
Accreditation by external audit to validate that healthcare organisations' operations and
practices satisfy agreed high-quality service criteria are being conducted in more than 70
countries (1,2). In 2003, the Danish government and The Danish Regions (responsible for all
public hospitals) decided to implement a nationwide model of quality in healthcare which
involves formal accreditation of all Danish public hospitals. In 2007, a national Institute
for Quality and Accreditation in Healthcare (IKAS) was formed to develop The Danish
Healthcare Quality Programme (DDKM); and since 2010, all public hospitals have been
accredited based on announced on-site surveys which are conducted every third year
(including a periodic midterm survey). Other types of healthcare institutions are now also
included in the program and accredited on a regular basis (e.g. private hospitals covered by
the extended free hospital choice, pharmacies, and nursing homes), and a plan for
accreditation in general practices is currently (2014) being negotiated (3-5).
The DDKM is based on announced surveys and the procedure of pre-announcing the dates for all
surveys has been criticised for creating an "arranged reality" and for not reflecting the
daily work with quality of care. This criticism is not unique to the Danish setting, but has
been raised in a number of countries that operate accreditation systems based upon announced
surveys (6,7). Another possible negative effect of announcing the surveys is the
considerable amount of time and human resources that are used to prepare for the announced
survey which implies that less time is available for patient care in the period of
preparations (6). It has been proposed that unannounced accreditation surveys may be
instrumental in alleviating these problems. An unannounced survey is an external visit paid
to an organisation without prior notice of when the visit will take place (2).
Unannounced surveys have been used for several years by The Joint Commission in the United
States and the Aged Care Standards and Accreditation Agency in Australia, but to our
knowledge no peer-reviewed literature has been published on the experiences of changing the
procedure from announced to unannounced surveys (2,7,8). Only one project, launched by The
Centre for Clinical Governance Research (CCGR) in Australia in 2012, encompasses an
empirical test of short-notice surveys in two accreditation programmes. This study was
conducted in a paired design where short-notice surveys are compared with the most recent
and most advanced notification survey. The study found that use of the short-notice survey
approach to the rating of organisational performance was less successful than the advanced
notification survey (5% significance level, P=0.044) (9).
The present trial is designed by IKAS and the Danish Center for Healthcare Improvements
(DCHI) to inform a decision whether or not to implement unannounced accreditation surveys in
the 3rd version of the DDKM in 2016. In September 2013, the IKAS Board of Directors decided
to approve and finance the project, and it is expected that the results from the present
trial will be available for the Board's decision in 2015.
To provide the best possible basis for political decision-making, the present study is
designed as a nationwide cluster-randomised, controlled trial including general hospitals,
university hospitals, and psychiatric hospitals from all five regions in Denmark. The
objective of this trial is to evaluate the effect of unannounced hospital surveys based on
findings of a survey embracing an abbreviated set of the national accreditation standards
and performance indicators from the DDKM version 2. We hypothesise that unannounced surveys
produce less successful measures of organisational performance than announced surveys. This
study defines less successful as less compliance with the included standards and performance
indicators.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research