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Research in Social and

Administrative Pharmacy j (2015) j–j

Commentary
Model for the evaluation of implementation programs
and professional pharmacy services
Joanna C. Moullin, B.Pharm.a,*, Daniel Sabater-Hernández, Ph.D.a,b,
Shalom I. Benrimoj, Ph.D.a
a
Graduate School of Health, University of Technology Sydney, Level 4, Building 7, 67 Thomas St Ultimo, P.O. Box 123
Broadway, 2007 NSW, Australia
b
Academic Centre in Pharmaceutical Care, Pharmaceutical Care Research Group, Faculty of Pharmacy, University of
Granada, Campus Universitario de Cartuja s/n, C.P. 18071, Granada, Spain

Summary
Pharmacy practice and pharmaceutical care research of professional services has largely focused on patient
outcomes and cost-effectiveness. Research studies have been, for the most part, conducted in controlled
conditions prior to full scale implementation. There appears to be a dearth of process and evaluation of
implementation reported. Conducting implementation research or adding implementation measures to an
impact study, adds external validity to service and patient outcomes. Evaluations are required for all
aspects of implementation including indicators of movement through the implementation stages (formative
and summative implementation process evaluation), measures of influencing factors (barriers and
facilitators) and change in factors over time (implementation impact), assessment of strategies and/or
the implementation program, and overall measures to generate a level of implementation (implementation
outcomes). The level of implementation of a professional pharmacy service can be estimated from the level
of service delivery (reach and fidelity) and level as a service provider (integration and strength of support in
the service environment). The model may be used for evaluating professional pharmacy services and for
evaluating implementation programs.
Ó 2015 Elsevier Inc. All rights reserved.

Keywords: Program evaluation [MeSH]; Health services administration [MeSH]; Health plan implementation [MeSH];
Pharmaceutical services [MeSH]

Background in implementable, cost-effective, evidence-based,


patient-centred professional pharmacy services.
Governments and health care practitioners
As an example in Australia there is an increasing
share common goals to improve patients’ clinical
pool of funds available for professional services in
outcomes, quality of life and the rationale use of
community pharmacy.1 Since 1990 the profes-
medicines. In light of this, community pharmacy
sional body representing pharmacy owners (Phar-
stakeholders have become increasingly interested
macy Guild of Australia) has negotiated five year

Conflicts of interest: none.


* Corresponding author. Tel.: þ61 426 266 156 (mobile), þ34 674 415 730 (mobile).
E-mail address: jcmoullin@gmail.com (J.C. Moullin).

1551-7411/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.sapharm.2015.08.003
2 Moullin et al. / Research in Social and Administrative Pharmacy j (2015) 1–8

Community Pharmacy Agreements with the were originally designed and intended.12 Phar-
Commonwealth Government for remuneration.2 macy practice is similarly struggling with imple-
The sixth agreement has recently been signed. mentation. The use of implementation theory,
There is a significant change in the funding ar- knowledge and tools may offer some much needed
rangements for community pharmacies, removing guidance.
the mark-up on products and doubling the fund- The core concepts of implementation are (1) a
ing available for professional pharmacy services.1 process to implement (2) an innovation (profes-
This movement to introduce and integrate services sional pharmacy service), which is influenced
into the practice of community pharmacy is across (3) contextual domains by (4) factors, (5)
echoed around the World.3–7 strategies and (6) evaluations.13 A Framework for
the Implementation of Services in Pharmacy
(FISpH) has been developed using the core con-
Implementation gap
cepts and contextualized to the community phar-
The implementation of new innovations, such macy setting.14 Meta-frameworks, models or
as professional pharmacy services, is a complex theories are necessary to operationalize each
process. No single strategy appears to be sufficient concept. To generate the foundation for the
to drive successful implementation.8–10 High qual- FISpH, a qualitative study investigated the pro-
ity service provision cannot be assumed to occur. cess and influences of implementation in Austra-
Internationally, across multiple disciplines there is lian community pharmacies.14 Analysis of the
a realization of translational gaps and the need to interview data produced a six stage implementa-
study and improve implementation. “Science to tion process from development or discovery to
service,” “research to reality,” “evidence to prac- sustainability (Fig. 1), as well as distinguishing a
tice,” “know-do,” are terms used to indicate range of implementation steps pharmacies
gaps in the take-up and application of innova- completed as they moved through the stages.
tions.11 More recently there has been discussion Contextual domains or the ecological levels of im-
of an “implementation gap” and a “quality plementation influences and determinants of pa-
chasm” referring to services not being sustained tient behavior, include individuals (pharmacy
over time and/or not being delivered as they staff, external help), organization/pharmacy(s),

Fig. 1. Framework for the Implementation of Services in Pharmacy (FISpH).14


Moullin et al. / Research in Social and Administrative Pharmacy j (2015) 1–8 3

local setting (e.g. patients, community and health An audit of the effectiveness of the development,
care professionals) and system. Across these do- administration and outcomes of the fifth agree-
mains overarching influences were revealed and ment in Australia reported that there was a lack
preliminary lists of implementation factors of evaluation and internal auditing by the profes-
(barriers and facilitators e.g. readiness for change, sion, which subsequently did not allow the gov-
perception, competence, appropriateness, relative- ernment to assess value for money or
advantage etc.) and strategies (e.g. training, performance of the agreement.15 Consequently a
changing roles and responsibilities) utilized by requirement in the preceding sixth agreement
pharmacy were investigated. The remaining (2015–2020) is for improved accountability and
concept of the framework, evaluations, appeared evaluation.1 This push for evaluation is also being
widely lacking.14 As such, a theoretical based, seen in academia with a move to include impact
yet practical model for the evaluation of imple- data in research proposals and reports.17
mentation programs and professional pharmacy
services is required.
Implementation measures
Along with service and patient outcomes it is
Current focus of evaluation
vital that pharmacy researchers begin to evaluate
Along with the poor evaluation conducted implementation. Evaluations are required for all
internally by community pharmacies in aspects of implementation including indicators of
Australia,14 there appears to be limited evaluation movement through the implementation stages
of implementation of services and programs con- (formative and summative implementation pro-
ducted by professional organizations and re- cess evaluation), measures of influencing factors
searchers.15,16 To satisfy policymakers, funders and change in factors over time (implementation
and subsequently practitioners with viable remu- impact), assessment of strategies and/or imple-
neration packages, pharmacy practice research mentation program and overall measures to
and service evaluations have been predominantly generate a level of implementation (implementa-
focused on patient outcomes and cost- tion outcomes).
effectiveness. Research studies have been largely Implementation research, involves investi-
conducted in controlled conditions, prior to im- gating an implementation program or implemen-
plementation and there appears to be a dearth tation strategy/intervention and its effects on
of process or implementation indicators implementation indicators and level of implemen-
reported.16 tation success, while service research involves
A systematic review on intervention research in investigating the effects of a service or clinical
pharmacy practice reported a lack of pharmacist intervention on patient’s health, quality of life and
behavior indicators, such as fidelity measures.16 other service outcomes. Therefore measures of
Fidelity is an implementation outcome that mea- implementation serve as indicators of implemen-
sures the degree to which a service is implemented tation processes, impact and outcomes (imple-
and delivered as it was designed. As such it in- mentation success) as well as intermediate
cludes evaluating the behavior of the pharmacist, outcomes in relation to service process, impact
as the service provider. Of the 50 studies that eval- and outcomes.18 As such implementation indica-
uated the impact of professional pharmacy ser- tors may be used as process, impact and outcome
vices, only 21 reported on pharmacists’ behavior. measures of an implementation program or as in-
Of these 21, only four studies measured both pa- termediate process indicators in relation to the
tient outcomes and pharmacists’ behavior. It service, social and clinical outcomes.
was further noted that many of the studies, despite Frameworks and models have been developed
claiming to report on behavior, used measures of that include implementation evaluations,
adoption, that is number of pharmacists or phar- including those by Glasgow et al.,19 Proctor
macies registered to deliver a program, rather et al.,18 Green et al.,20 Lehman et al.,21 and Steck-
than measures such as fidelity, or other quality ler et al.22 In addition to measuring implementa-
or performance measures.16 tion indicators, literature reviews on
Poor monitoring by pharmacists and a lack of implementation tools have been conducted,23
evaluation of implementation in pharmacy prac- tools developed for particular implementation
tice has been discussed as an issue in Australia, concepts (e.g. Stages of Implementation Comple-
including among government policymakers.15,16 tion,24 formative evaluation of normalization25)
4 Moullin et al. / Research in Social and Administrative Pharmacy j (2015) 1–8

and models of particular outcomes (e.g. imple- is widely accepted,20,31 and therefore the focus will
mentation fidelity26). In recent years the field of be on describing the implementation evaluation
Implementation Science has focused heavily on section. Implementation evaluation may be used
the development and testing of implementation to assess implementation programs and in service
tools and measures and large databases have evaluations. The arrows indicate the flow of affect,
been developed as repositories.27,28 Many tools while the curved arrows hypothesized relation-
and measures remain discipline specific, however ships between the implementation and service
provide guidance for pharmacy. evaluations. These relationships may be used to
develop prescriptive models and theories for hy-
pothesis testing.
Implementation process evaluation consists of
Model for the evaluation of implementation
indicators of progress, such as stage attainment
programs and professional pharmacy services
(the implementation stage in which pharmacies
Conducting implementation research or add- are situated), and the movement and rate of
ing implementation measures to an impact study movement through these stages. Assessing the
as a hybrid design, or to a service or implementa- progress through the stages involves determining:
tion program assessment, will add external val- is a pharmacy aware of the service, indicating they
idity to the service and patient outcomes.11,29 are in exploration stage (exploration indicator:
Based on the FISpH14 and implementation sci- awareness); have they decided to adopt the ser-
ence literature18,19,21,22,26,30 a model for the evalu- vice, indicating they are in preparation stage
ation of implementation programs and (preparation indicator: adoption); are delivering
professional pharmacy services is proposed the service to a limited extent, indicating they are
(Fig. 2). To conduct implementation research testing (testing indicator: limited provision); are
and evaluations, tools for the implementation in- delivering the service to full capacity, indicating
dicators in pharmacy will need to be developed that they are in operation (operation indicator:
and tested. full provision); or are continuing to provide the
The implementation evaluation model involves service, maintaining the capacity and support for
both indicators for implementation process, its provision and benefits over an extended period
impact, and outcome and service process, impact of time after any external support has ceased,
and outcome. The service evaluation component indicating they are in sustainability (sustainability

Fig. 2. Model for the evaluation of implementation programs and professional pharmacy services.
Moullin et al. / Research in Social and Administrative Pharmacy j (2015) 1–8 5

indicators: continued delivery, capacity and ben- value the staff place in its provision. Support and
efits)? (See explanation below). In addition to perception may be evaluated at an individual,
stages, steps or activities conducted as part of the pharmacy, local, and system level (staff, pharma-
implementation process, may be designed into a cists, owner, patient, community, other health
measurement tool to assess the movement and care professionals, politicians etc.).
rate of movement through the stages. A level of service implementation may be
The evaluation of implementation impact in- estimated from the level of service delivery (reach
volves assessing the influences affecting implemen- and fidelity) and level as a service provider
tation. The FISpH framework states that there are (integration and strength of support in the service
factors, strategies and evaluations involved in and environment). This overall outcome can be looked
affecting the implementation of pharmacy ser- at from various ecological perspectives. For
vices. All influences act as indicators of the impact example, one could measure the outcome for an
of the implementation effort on the attainment of individual staff member (micro level), the phar-
implementation and service and patient outcomes. macy as a whole or for a group of pharmacies
Factors include features of the service and char- (meso level). Alternatively measures can be aggre-
acteristics and determinants of behavior, of phar- gated to look at a service’s implementation out-
macy staff, the pharmacy(s), local setting, and comes nationally (macro or system level).
system. Strategies are targeted efforts (method,
technique or activity) designed to enhance moving Final stage attainment – sustainability
of an innovation into use and integrating into
Sustainability is the final phase of the imple-
routine practice.29,32 Evaluations include all indi-
mentation process in the FISpH (Fig. 1). As such,
cators in the model. Tools to assess implementa-
the level of implementation, as calculated through
tion influences may be used in a formative
measurement of implementation outcomes, is
capacity to aid successful implementation.33 The
related to reaching and maintaining sustainability
formative use of evaluations may be assessed as
of service provision. The measurement of sustain-
part of implementation impact.
ability is based on three ideas;
Implementation outcomes are depicted as the
level of provision and the level as provider 1. The definition of sustainability is conceptual-
(Fig. 2). The level of service provision is ‘how ized as consisting of three constructs: routini-
much and how well’ the service is being delivered. zation, (repetitive, recognizable pattern of the
This is determined by two primary measures: new service) institutionalization (supporting
Reach, which is the number of services performed conditions), and maintenance of benefits.35–37
(or patients participating) as a proportion of the These three constructs are depicted in the im-
potential population for the service and the repre- plementation part of the evaluation model
sentativeness of this group19; and fidelity, which (Fig. 2). Routinization consists of the integra-
refers to the degree to which the service is per- tion or delivery of the new service, institution-
formed as it was originally designed.34 Fidelity in- alization as the individual, organizational and
cludes adherence to the components of the service, system context,38–41 including support and ca-
the dose (for example are all follow-up sessions pacity for continued delivery and mainte-
completed), the quality, patient responsiveness, nance of benefits as service and patient
program differentiation or how much it differs outcomes. Benefits incorporate economic,
from other existing services, and how it was clinical and humanistic outcomes and mea-
adapted.34 sures such as quality of life, satisfaction, effi-
The level as a service provider is related to ciency etc. In addition to economic
support in the service environment and the level of outcomes for the health care system and orga-
integration. Service integration includes routini- nizations, pharmacies are also interested in
zation, which is the degree to which the new other potential business benefits such as
service has become part of the pharmacy’s prin- differentiating their pharmacy from the mar-
ciples and everyday practice, and institutionaliza- ket, improved customer loyalty and profes-
tion measures the pharmacy’s ability to support sional satisfaction.
and enable ongoing service delivery and improve- 2. Implementation of professional services in
ment. Support includes measures of context (such pharmacy involves the process of implement-
as culture, climate, and capacity) to measure the ing a service, as well as changing the business
pharmacy’s ability to maintain the service and the model and professional practice to an
6 Moullin et al. / Research in Social and Administrative Pharmacy j (2015) 1–8

environment to one that is supported and implementation evaluations are conducted


conducive to service delivery. Therefore look- concurrently.
ing at only the level of service provision does A second application of the model is to assist
not account for the change in nature or in the in the design of implementation research ques-
future maintenance of the service environ- tions. As an example of an implementation
ment. There has been increased appreciation research study, assessing an implementation strat-
for the importance of context and the need egy or program, the dependent variable may be
for qualitative and quantitative measures to the degree of integration of the service (routini-
help understand and predict implementation zation and institutionalization), and independent
outcomes.42 variables reach (number of patients receiving the
3. Local setting and system factors are impera- service and their representatives of the target
tive when considering the attainment of population) and fidelity (delivery of the service
complete sustainability and measuring imple- as it was designed). Additionally, process indica-
mentation from a systems perspective. Com- tors (such as number of pharmacies moving
plete sustainability cannot be achieved through the stages or change in influences) may
without stakeholder buy-in, political support be added, and these measures may be used
and funding.39,43 formatively to try and increase the implementa-
tion. An alternative is a hybrid design evaluating
both the implementation and effectiveness of a
service. Adjustments to the Consolidated Stan-
Implications for practice and research
dards of Reporting Trials (CONSORT) statement
The model provides a structure for choosing have been made to enhance external validity.44,45
measures and outcomes for implementation pro- It has been suggested this should be further
grams, implementation studies or service research. extended to include implementation measures.46
The implementation indicators should be The model for the evaluation of implementation
measured at various stages of the implementation and professional pharmacy services would suggest
process to evaluate the process, impact and out- inclusion of implementation and sustainability
comes. During the first stage, exploration, the measures as outcomes.
service is being appraised by the pharmacy, and
therefore indicators of implementation influences
may be measured to aid the adoption decision, to Conclusion
assist in the tailoring of implementation strategies
A model for the evaluation of implementation
and in agreeing on implementation objectives
and professional pharmacy services is proposed.
for future formative evaluations of influences.
The model recommends the inclusion of imple-
Subsequently evaluation may include measuring
mentation indicators (process, impact and
the movement from exploration to preparation
outcome) along with service evaluations. To
and to later stages. Process indicators at an
confidently attribute patient outcomes to the ser-
individual or pharmacy level may include the
vice being evaluated it is imperative that imple-
rate of movement and number of activities of an
mentation measures are also evaluated.
implementation program completed during a
Furthermore, doing so allows program and ser-
stage, while at a systems level the rate and number
vice evaluators to assess the true level of service
of pharmacies may be evaluated. During the implementation and quality of service delivery.
following stages changes in the implementation
The model may also be used to guide formative
influences may be used to evaluate the implemen-
evaluation to enhance implementation success and
tation program’s impact. Once service delivery
to conduct implementation research.
begins the level of provision may be assessed.
This may be used as an implementation outcome
evaluation and as a service process evaluation. References
Finally the integration of the service into routine
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