Telemonitoring for High-risk Pregnancies in an International Context (PregnaDigit EU): a Hybrid Type 2 Study
Conditions: Telemedicine, Digital Health, Pregnancy Complications
Sponsor: UMC Utrecht

Versie 2, 14-04-2024 
 
RESEARCH PROTOCOL (nWMO) 
Version 14-04-2025 
 
PROTOCOL TITLE Development of an international remote digital care system for accessible, 
inclusive and sustainable pregnancy care 
Short title (max 43 characters) 
PregnaDigit EU/PREGmatic 
Version 
2 
Date 
14-04-2025 
Department 
Woman and baby 
Coordinating 
investigator/project leader 
M.N. Bekker  
Division of Woman and Baby 
Lundlaan 6, 3584 EA Utrecht, The Netherlands 
Tel +31 88 75 56426   
m.n.bekker-3@umcutrecht.nl 
Principal investigator (in Dutch: 
hoofdonderzoeker/ uitvoerder) 
 
University Medical Center Utrecht 
 
 
 
 
M.N. Bekker  
Division of Woman and Baby 
Lundlaan 6, 3584 EA Utrecht, The Netherlands 
Tel +31 88 75 56426   
m.n.bekker-3@umcutrecht.nl 
 
 
Other investigator(s) 
University Medical Center Utrecht 
 
 
 
 
Erasmus Medical Center Utrecht  
 
 
 
 
M. Depmann 
Division of Woman and Baby 
Lundlaan 6, 3584 EA Utrecht, The Netherlands 
Tel +31 88 75 56426   
m.depmann-3@umcutrecht.nl 
 
A. Franx 
Division of Obstetrics and Fetal Medicine 
Room SP-4469 

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Erasmus University Rotterdam 
 
 
 
 
 
 
 
 
 
Catalan health institute: Vall 
d’Hebron University Hospital & Vall 
d’Hebron Research Institute 
(VHIR)  
 
 
 
Region Stockholm: Karolinska  
Institutet 
 
 
 
 
 
Aarhus University Hospital 
PO Box 2060, 3000 CB Rotterdam, The Netherlands 
Tel +31 615040266  
a.franx@erasmusmc.nl 
 
 
C.T.B. Ahaus 
Erasmus School of Health Policy & Management 
ahaus@eshpm.eur.nl 
 
P.J. Porte 
Erasmus School of Health Policy & Management 
porte@eshpm.eur.nl 
 
 
Nerea Maiz Elizaran 
Paseo de la Vall d'Hebron, 125, 08035, Barcelona 
Tel: +34 93 489 30 85 
nerea.maiz@vallhebron.cat  
 
 
O. Stephansson 
Karolinska Vägen, 171 64, Solna 
Tel: +46 70 283 98 27 
olof.stephansson@ki.se  
 
L. Henning Pedersen 
Aarhus University, 8000 Aarhus 
Tel: +45 8715 0000 
lhp@clin.au.dk   
Sponsor (in Dutch: 
verrichter/opdrachtgever) 
UMC Utrecht 
 
 
Subsidising party <if applicable> EIT Health, ZonMw  
 
 

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1.  INTRODUCTION AND RATIONALE 
The incidence of medical pregnancy care is rising in the Netherlands. Between 1999-2012, 
34% of women gave birth in primary care [1], while only 24% of women did so in 2020 [2]. 
This rising need for medical care coincides with growing shortages in obstetric healthcare 
professionals (OHPs) and growing costs. Increasing demand and decreasing supply may 
result in substandard care, affecting pregnant women in vulnerable circumstances the most. 
Thus, there is an urgent need to innovate current medical pregnancy care and move care 
from hospital to home when possible. MedTech innovations for remote digital pregnancy care 
(RDPC) are available.  
In recent years, the MedTech industry developed various blood pressure measuring devices 
to monitor maternal blood pressure (MBP) from home, as well as cardiotocography (CTG) 
devices capable of monitoring fetal heart rate (FHR) from home thus enabling remote digital 
pregnancy care (RDPC). These developments include the development of data platforms 
connecting remote devices to the Electronic Medical Record (EMR).  
 
In the past decade we have performed pioneering research of RDPC point solutions for the 
monitoring of pregnancy complications. In the randomised HoTel trial (PI Mireille Bekker, 
UMC Utrecht METC nr. 16-516), home-monitoring of fetal heart rate, maternal symptoms, 
and blood pressure was feasible and as safe as in-hospital admission in complicated 
pregnancies, with lower costs and better end-user experience [4]. 
RDPC is ready for the next level, but its wide-scale use is hampered by lack of knowledge on 
the impact on health equity, reimbursement and cost-effectiveness, and lack of key enabling 
methodologies including digital care paths, change models, and a FAIR data infrastructure to 
embed RDPC in care paths, the electronic medical record (EMR) and payment models. 
Although ‘point solutions’ are available, both the MedTech and healthcare sectors need 
innovative ‘system solutions’ to overcome these knowledge and methodology gaps together 
and work towards large-scale application of RDPC. 
PregnaDigit/PREGmatic will expand on this state-of-the-art by developing and evaluating a 
‘system solution’ that addresses all forementioned knowledge and methodology gaps 
hampering RDPC upscaling. By industrial and experimental research we will design care 
paths and solutions for health inequities, costing and a FAIR data infrastructure with 
prediction models. The project will deliver knowledge, insights, recommendations, business 
models and roadmaps for market entrance. PregnaDigit/PREGmatic will thus facilitate 
nationwide and international adoption of RDPC as the new standard of care. 

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PregnaDigit/PREGmatic’s system solution aims to keep pregnancy care accessible for all 
women, regardless of their socioeconomic status, and relieve pressure on the health system 
while reducing costs. We aim to enable the hybrid transformation and care replacement of a 
substantial part of current pregnancy care to RDPC by 2030. 
2. OBJECTIVES 
Primary Objective: to facilitate nationwide and international adoption of RDPC as the new 
standard of care. 
Secondary Objective(s): our objectives are described in the following work packages (WP): 
WP 
Objective(s) 
1 Management and 
strategy 
Overall PregnaDigit EU/PREGmatic Management & Strategy. 
2 Change & Care models Implement and evaluate care models incorporating RDPC for 
high-risk pregnancies in four academic hospitals. 
3 Cost & 
Reimbursements 
Measure differences in costs between current care and new care 
with incorporated RDPC. Design alternative payment models for 
RDPC. 
4 Medtech and 
Technology 
Evaluate end-user experiences regarding CTG devices and their 
patient- and clinician dashboarding and platform solutions.  
 
Determine usability and scalability for a wider range of  
pregnancy complications and digital connection to end-users 
5 Data support 
Set up FAIR data structure which will make data supported 
decision making and benchmarking available to prove our Value 
Case of RDPC. 
3. STUDY DESIGN 
A prospective cohort study with a retrospective control group will be conducted. The duration 
of the intended first part of the study is 12 months. This study will be conducted in the UMC 
Utrecht, Karolinksa University hospital and Vall d’Hebron hospital.  The duration of the 
second part of the study is 36 months. This study, a continuum of part 1, will be conducted in 

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the UMC Utrecht, the Erasmus Medical Center, Karolinska University hospital and Aarhus 
University hospital.  
 
4. STUDY POPULATION 
4.1 Population 
Pregnant women with manifest complications, such as hypertensive disorders of pregnancy, 
fetal growth restriction, premature rupture of membranes, decreased fetal movements, and a 
perinatal death in a previous pregnancy. According to consensus guidelines, these women 
require hospital admission for fetal and maternal monitoring. In PregnaDigit/PREGmatic 
however these women will be monitored at home by RDPC in a new care model using CTG 
& MBP devices, and online platforms. These women comprise an estimated 10% of the 
pregnant population. In the Netherlands, patients requiring CTG home monitoring who are 
enrolled from the Erasmus Medical Center or University Medical Center Utrecht will be 
included in both the PregnaDigit EU study and the PregnaDigit NL study (OBS_24U-1334) 
during the duration of the EU study. 
4.2 Inclusion criteria 
- 
Gestational age ≥26 weeks 
- 
Age ≥18 years 
- 
Singleton pregnancy 
- 
The presence of one (or more) of the following complications according to local 
protocol requiring CTG monitoring: 
o Pre-eclampsia* 
o Preterm rupture of membranes 
o Fetal growth restriction** 
o Recurrent reduced fetal movements 
o Fetal anomaly requiring CTG monitoring 
o Intra-uterine fetal death in a previous pregnancy 
o Other reasons requiring CTG monitoring 
- 
Ability to understand Dutch, English, Spanish, Swedish or Danish 
- 
Ability to provide written informed consent 
- 
Ability to understand study instructions  
 
*Preeclampsia is gestational hypertension accompanied by ≥1 of the following new-onset 
conditions at or after 20 weeks’ gestation: 

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- 
Proteinuria 
- 
Other maternal organ dysfunction, including: 
o Acute kidney injury (creatinine ≥90umol/L; 1 mg/dL) 
o Liver involvement (elevated transaminases, eg, alanine aminotransferase 
or aspartate aminotransferase >40 IU/L) with or without right upper 
quadrant or epigastric abdominal pain 
o Neurological complications (examples include eclampsia, altered mental 
status, blindness, stroke, clonus, severe headaches, and persistent visual 
scotomata) 
o Hematological complications (thrombocytopenia–platelet count 
<150 000/μL, disseminated intravascular coagulation, hemolysis) 
o Uteroplacental dysfunction (such as fetal growth restriction, abnormal 
umbilical artery Doppler wave form analysis, or stillbirth) 
 
** For example, FGR is defined as: 
- 
Fetal abdominal circumference (FAC) or estimated fetal weight (EFW) <10th 
percentile and abnormal Doppler sonography assessment defined as pulsatility index 
of umbilical artery >p95 and/or absence or reversed enddiastolic flow velocity flow of 
umbilical artery 
- 
FAC or EFW <p3 with or without abnormal umbilical artery Doppler flow  
 
4.3 Exclusion criteria 
- 
Pregnancy complications requiring IV therapeutics  
- 
Pregnancy complications with requiring an (expected) obstetric intervention within 
48 hours 
- 
Current blood pressure ≥160 mmHg systolic or ≥110 mmHg diastolic 
- 
Active antepartum haemorrhage 
- 
CTG with abnormalities indicating fetal distress or hypoxia 
- 
Place of residence >30 minutes distance from a hospital 
- 
Implanted medical device (e.g. pacemaker) 
 
4.4 Sample size calculation 
Since our main objective is to facilitate nationwide and international adoption of RDPC as the 
new standard of care, a sample size calculation is not indicated. Based however on our 

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experience in the HoTeL study (METC nr. 20-442) [3], we expect to include a total of 400 
patients internationally. 
 
5. INVESTIGATIONAL PRODUCT / MEDICAL DEVICE 
Remote CTG monitoring will be performed by ICT HCTS and Nemo, both CE certified CTG 
devices. In this study, the devices are not an investigational product. 
 
6. METHODS 
6.1.1 
main study parameter 
Implementation 
The implementation process of home monitoring will be analyzed according to the taxonomy 
of Proctor et al [8].  
 
Proctor defined 8 implementation outcomes: acceptability, adoption, appropriateness, 
feasibility, fidelity, costs, penetration and sustainability (appendix table 1). These outcomes 
form the main study parameters for assessment of the implementation of home monitoring in 
PregnaDigit/PREGmatic:  
 
- 
Acceptability: the perception among patients and obstetric healthcare professionals 
that home monitoring is agreeable, palatable, or satisfactory 
- 
Adoption: the initial decision to implement home monitoring  
- 
Appropriateness: the perceived fit, relevance, or compatibility of home monitoring for 
all 
o stakeholders 
o achievement of specific benefits: enhancing patient autonomy, improved 
quality of life due to reduced hospital visits, increased patient independence 
and self-esteem, increased patient satisfaction and compliance 
- 
Feasibility: the extent to which home monitoring can be successfully used or carried 
out within the hospital 
- 
Fidelity: the degree to which home monitoring was implemented as it was described 
in the original protocol 
- 
Costs: financial impact of the implementation of home monitoring. May include costs 
of treatment delivery, cost of the implementation strategy, and cost of using the 
service setting 
- 
Penetration: the integration of home monitoring in a hospital 

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- 
Sustainability: the extent to which the use of home monitoring is maintained within a 
hospital 
 
Clinical effectiveness 
In order to assess clinical effectiveness we will measure a composite outcome of perinatal 
mortality and maternal and neonatal morbidity.  
 
The composite of perinatal outcome is defined as:  
- 
perinatal mortality (maternal or fetal/neonatal),  
- 
a 5-minute Apgar score below 7 and/or an arterial cord blood pH below 7,05,  
- 
maternal morbidity (one or more of the following:  
o pre-eclampsia (defined according to section 4.3), eclampsia (new-onset, 
generalized, tonic clonic seizures or coma in woman with preeclampsia), 
HELLP syndrome (hemolysis, elevated liver enzymes, low platelet count 
probably representing a severe form of preeclampsia), venous 
thromboembolic events (deep vein thrombosis and/or pulmonary embolism) 
- 
NICU admission of the new-born and during-labor caesarean section 
6.1.2 
Secondary study parameters 
Management & Strategy 
Aim 
Overall PregnaDigit EU Management & Strategy 
Description & tasks 
The Central Management Team (CMT) consists of EUR and the 
UMCU. The CMT will ensure that the overall PregnaDigit 
EU/PREGmatic objectives are met and thus leads ongoing co-
creation, planning, strategy, communication, and training. The CMT 
meets weekly. The academic hospitals, MedTech & technology 
partners will ensure local adoption of the new care models, IT 
connections with the new devices, possibly within the existing 
EMRs, and data sharing for both the benchmarking on outcomes, 
clinical time, processes and experiences. After the initial local set-
up phase, they will meet monthly. The PregnaDigit EU/PREGmatic 
Consortium includes all PregnaPartners. Every 6 months an 
internal update and evaluation meeting on planning and strategy for 
all work packages and patient representative organizations will be 
held towards the final delivery of the manual and roadmap. 
 

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Change & care models 
Aim 
Implement and evaluate care models incorporating RDPC for high-risk 
pregnancies four academic hospitals.  
 
Develop a the RDPC system solution and focus on hybrid care path 
implementation and usage of these care models taking change behaviour 
and views of all end-users into account. 
Description 
Task 2.1 [New care models for RDPC]  
 
2.1.1. Implement care models in a multidisciplinary setting with participating 
obstetric care professionals and end-users, facilitating and embedding 
RDPC for high-risk pregnancies replacing the in-hospital care monitoring. 
 
Population and intervention: 
Pregnant women with manifest complications, such as hypertensive 
disorders of pregnancy, fetal growth restriction, premature rupture of 
membranes, decreased fetal movements, and a perinatal death in a 
previous pregnancy. According to consensus guidelines, these women 
require hospital admission for fetal and maternal monitoring. In PregnaDigit 
EUPREGmatic these women will be monitored at home by RDPC in a new 
care model. 
 
2.1.2 Draw up Metro maps of the care as usual and the new care pathways 
to clarify the difference in care activities and costs.  
  
2.1.3 Measurement of clinical outcomes and user experiences with trained 
end-users. We will measure maternal and neonatal mortality and morbidity, 
and patient-reported health (ICHOM) and quality of life status, next to 
experience measures for both patients and clinicians. We will also measure 
process indicators such as inpatient admission days, days of telemonitoring, 
and amount of clinician contact. 
 
Task 2.2 [Develop a RDPC transformation manual]  
 

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2.2 Develop a system manual that enables European upscaling of RDPC. 
We will perform a stakeholder analysis with all stakeholders (including 
professionals, end-users, payors) according to the taxonomy of Proctor et 
al. using semi-structured interviews and questionnaires (based on NOMAD 
and MIDI validated questionnaires). 
Deliverables D2.1.1 RDPC care models available 
D2.1.2 Metro maps of care models 
D2.1.3 Insights in clinical outcomes and user experiences of RDPC 
D2.2 Launch of RDPC transformation manual 
 
Costs & reimbursements 
Aim 
To measure the actual differences in cost between the current care and the 
new care with incorporated RDPC. 
 
To design an alternative payment model for the systemic and integrated use 
of home monitoring tools in healthcare. 
Description 3.1 Measuring cost of care as usual and new care (09-2024 - 12-2025) 
Measure costs of care-as-usual and new RDPC using Metro maps developed 
in WP2.  
 
3.2 Budget impact analysis (01-2025 - 09-2025) Evaluate where can we see 
savings and whether they extrapolate to new reimbursement possibilities.  
 
3.3 Alternative payment models (09-2025 – 12-2025) Together with payors, 
propose new payment models fitting the systemic change (for example, by 
using shared savings) and conduct a retrospective analysis of changes in 
reimbursement and costs. 
Milestones 
3.1.1 Costs of care-as-usual [12-2024] 
M3.1.2. Costs of new care RDPC [12-2025] 
M3.2 Budget impact analysis [09-2025] 
M3.3 Payment models fitting the new care [12-2025]  
 
MedTech & Technology 

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Aim 
Evaluate end-user experiences regarding CTG devices and their 
patient- and clinician dashboarding and platform solutions.  
  
Determine usability and scalability for a wider range of  
pregnancy complications and digital connection to end-users. 
Description & tasks 4.1 Evaluation of instalment and usage experiences (09-2024- 10- 
2025).We will assess the experiences of pregnant women and health  
care professionals through interviews and questionnaires identifying  
barriers and successes during IT connectivity and usage. 
 
4.2 Development of a user-guideline for implementing new  
medical devices in a remote care setting. (10-2025 - 12-2025). We 
will develop a user-guideline and requirement/specification  
documentation for using such CTG medical devices in hospital care. 
Milestones 
M4.1 User experiences of pregnant women and health care  
Professionals [10-2025] 
M4.2 Requirements and specifications [12-2025] 
 
Data Support 
Aim 
Set up FAIR data structure which will make data supported decision 
making and benchmarking available to prove our Value Case of 
RDPC. 
Description & tasks Preparation of the total measurement set including coding and 
data collection (case report forms and data infrastructure) ready  
upon start of patient inclusion in January 2025. Ready for data- 
extractions and analysis on a 6-monthly base. 
 
6.2 Other study parameters  
Find the parameters needed to complete the above mentioned deliverables in the attached 
excel sheet “Core_dataset_PregnaDigitEU_05112024”.  
 
6.3 Study procedures 
When one of the prespecified indications for fetal monitoring (see 4.2) occurs, this will be 
executed via telemonitoring. Patients are instructed to send a CTG once daily using one of 
the available devices. The CTG will be sent to the hospital via a platform, either stand-alone, 
or integrated in the electronic medical record depending on the device used. The CTG will be 

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assessed by obstetric health care personnel (e.g. midwife, gynaecologist, resident) the same 
day. Maternal parameters, such as temperature or blood pressure are measured daily by the 
patient if indicated. 
If it is necessary for the participant for either maternal or fetal indication to be admitted to the 
hospital ward or labor ward, all data of interest during the admittance will be collected. If it is 
possible for this same patient to be discharged again, she will go home with telemonitoring 
and we will still follow this patient during prenatal care and delivery. 
Both patients and obstetric healthcare providers will be invited to complete an online 
questionnaire, distributed via Castor EDC, to gather data on their experiences with CTG 
home monitoring. These questionnaires are designed to facilitate an analysis of the primary 
outcomes, specifically focusing on implementation outcomes. 
6.4 Withdrawal if individual subjects 
Subjects can leave the study at any time for any reason if they wish to do so without any 
consequences. The investigator can decide to withdraw a subject from the study for urgent 
medical reasons. 
6.5 Replacement if individual subject after withdrawal 
NA 
6.6 Follow-up of subjects withdrawn from treatment 
Subject having withdrawn from the study will be offered care as usual. 
 
7. 7. STATISTICAL ANALYSIS 
For the primary analysis of implementation, the scores of the implementation questionnaire 
filled out by one time by patients and by the obstetric healthcare providers at baseline and 
halfway the study will be compared. The paired  t-test will be used if the outcome is normally 
distributed and a non-parametric Wilcoxon signed-rank  if skewed. These outcomes will be 
presented as means with standard deviation, geometric means with 95% CI, or as median 
with interquartile range, whichever appropriate. To evaluate determinants for success and 
failure of implementation, our primary outcome will be further analyzed for contributing 
factors using a regression model. 
 
The secondary outcome is the clinical effectiveness. The composite (dichotomous) endpoint 
of perinatal mortality, a 5-minute Apgar score below 7 and/or an arterial pH below 7,05, 
maternal morbidity (such as eclampsia, HELLP syndrome, thromboembolic events), NICU 
admission of the newborn, will be analyzed with logistic regression analysis with correction of 
predefined confounders as parity and diagnosis of pregnancy complication. 
 

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8. ETHICAL CONSIDERATIONS 
8.1 Regulation statement 
The study will be conducted in the Netherlands according to ‘gedragscode 
gezondheidsonderzoek’ and in all (inter)national sites in accordance with the EU GDPR 
(General Data Protection Regulation) and other (local) guidelines, (local) regulations and 
(local) Acts (e.g. in the Netherlands the WGBO (Wet geneeskundige 
behandelingsovereenkomst). 
8.2 Recruitment and consent 
Pregnant women included in the Pregnadigit EU/PREGmatic study from the Netherlands, 
both in the retrospective and prospective cohorts, specifically from the Erasmus Medical 
Center and the University Medical Center Utrecht, are recruited and asked to provide 
informed consent in accordance with the study protocol patient information leaflet and 
informed consent form from the Pregnadigit NL protocol (OBS_24U-1334). Pregnant women 
recruited from European partner hospitals will be asked to provide informed consent 
following the local guidelines and regulations. 
9. ADMINISTRATIVE ASPECTS  
9.1 Handling and storage of data and documents 
Data will be collected in a web-based registry (Castor EDC).  This is a ‘good clinical practice’ 
classified online data management system. Data collection and entry will be done by the 
local research team. Data will be managed according to the datamanagementplan (ID 
159476). The datamanagementplan is set up in agreement with the datamanager of the 
division of Woman and Baby. Participants will be given a computer generated numeric code. 
The code consist of a centre number plus a random number. The key to decode study 
subjects will only be available to the local coordinating investigator. Persons who have 
access to the data include: local research staff and local monitoring & quality assurance 
personnel. The data will be kept for 10 years. The handling of personal data complies with 
the European General Data Protection Regulation (in Dutch: Algemene verordening 
gegevensbescherming, AVG). Only coded (pseudonymised) data—without names or directly 
identifying information—will be shared. In cases where it is necessary to share data with 
external institutions, secure transfer methods will be used. For example, data may be 
transmitted using secure platforms such as Zivver to ensure confidentiality during 
transmission. If the data are to be used for secondary scientific research, an assessment will 
take place to evaluate whether such use is permissible. This review will be conducted 
according to applicable institutional policies and may involve a data extraction committee, the 
head of department, or a designated data steward. The conditions for approval and the 

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outcome of the review will be documented in accordance with institutional governance 
procedures. 
 
9.2 Amendments 
Amendments are changes made to the research after local approval has been received (e.g. 
in Utrecht, the Netherlands, the Confirmation Quality Check). Any change that may cause the 
investigation to fall within the scope of the WMO is submitted to the ethical committee after a 
quality check by the research quality coordinator of the division.  Other changes must 
undergo further review by the research quality coordinator of the division. Internationally, 
amendments are tested according to local rules.  
9.3 End of study 
The investigator will report the end of study date, and later, the final report date, in Vidatum. 
The end of the study is defined as the last study procedure of the last participant.  
 
10. REFERENCES 
 
1. https://assets.perined.nl/docs/6f9eb6f1-f40c-4fb6-92b7-55787f230704.pdf 
2. https://assets.perined.nl/docs/3d6a2b46-aa8a-417e-a55e-de0184fe2078.pdf 
3. Bekker MN, Koster MPH, Keusters WR, et al. Home telemonitoring versus hospital 
care in complicated pregnancies in the Netherlands: a randomised, controlled non-
inferiority trial (HoTeL). Lancet Digit Health. 2023 Mar;5(3):e116-e124. doi: 
10.1016/S2589-7500(22)00231-X. PMID: 36828605. 
4. Proctor, E., Silmere, H., Raghavan, R., Hovmand, P., Aarons, G., Bunger, A., & 
Hensley, M. (2011). Outcomes for implementation research: conceptual distinctions, 
measurement challenges, and research agenda. Adm Policy Ment Health (2011) 
38:65–76 
 
 
 

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11. APPENDIX 
 
Table 1; Taxonomy of implementation outcomes by Proctor et al [4] 
Outcome 
Definition 
Acceptability 
the perception among implementation 
stakeholders that a given treatment, service, 
practice, or innovation is agreeable, palatable, 
or satisfactory 
 
Adoption 
the intention, initial decision, or action to try or 
employ an innovation or evidence-based 
practice 
Appropriateness 
the perceived fit, relevance, or compatibility of 
the innovation or evidence based practice for a 
given practice setting, provider, or consumer; 
and/or perceived fit of the innovation to 
address a particular issue or problem 
Feasibility 
the extent to which a new treatment, or an 
innovation, can be successfully used or carried 
out within a given agency or setting 
Fidelity 
the degree to which an intervention was 
implemented as it was prescribed in the 
original protocol or as it was intended by the 
program developers 
Costs 
the cost impact of an implementation effort 
Penetration 
the integration of a practice within a service 
setting and its subsystems 
Sustainability 
the extent to which a newly implemented 
treatment is maintained or institutionalized 
within a service setting’s ongoing, stable 
operations 

 
 
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