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Murfet_et_al-2014Maternalandneonatalhealthoutcomesfollowingtheimplementationofaninnovativemodelofnursepractitioner-ledcarefordiabetesinpregnancy..pdf

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ORIGINAL RESEARCH

Maternal and neonatal health outcomes following the implementation

of an innovative model of nurse practitioner-led care for diabetes in

pregnancy

Giuliana O. Murfet, Penny Allen & Tania J. Hingston

Accepted for publication 28 August 2013

Correspondence to P. Allen:

e-mail: [email protected]

Giuliana O. Murfet MSc MNurs (Nurse

Practitioner) RN CDE

Nursing Practitioner

Diabetes Centre, Tasmanian Health

Organisation – North West, Burnie,

Tasmania, Australia

Penny Allen BA (Hons) MPH PhD

Research Fellow

Rural Clinical School, University of

Tasmania, Burnie, Tasmania, Australia

Tania J. Hingston MBBS (Hons)

FRANZCOG

Consultant Obstetrician and Gynaecologist

Maternity Department, North West Private

Hospital, Burnie, Tasmania, Australia

MURFET G .O . , ALLEN P . & HINGSTON T . J . ( 2 0 1 4 ) Maternal and neonatal

health outcomes following the implementation of an innovative model of nurse

practitioner-led care for diabetes in pregnancy. Journal of Advanced Nursing 70

(5), 1150–1163. doi: 10.1111/jan.12277

Abstract Aim. To investigate maternal and neonatal outcomes following implementation

of a nurse practitioner-led model of care for diabetes in pregnancy.

Background. Diabetes in pregnancy increases the risk of adverse health outcomes

in mothers and infants. The management of diabetes in pregnancy is crucial to

reduce poor outcomes.

Design. Uncontrolled before-after intervention study.

Methods. International Classification of Diseases codes were used to identify

pregnancies suspected of being complicated by diabetes. Demographic, health,

diabetes and maternity data were extracted from hospital records. Adverse

maternal and neonatal outcomes were compared pre- (2003–2006) and

postintervention (2010–2011). Adjusted relative risks (aRR) were calculated using

the glm command in Stata.

Results. A total of 261 pregnancies were included: 112 pre-intervention and 149

managed under the nurse practitioner-led model. There were 37 women with pre-

existing diabetes (26 T1DM, 11 T2DM) and 195 with gestational diabetes.

Referrals to dieticians and diabetes educators increased, while referrals to

physicians decreased. There was no decrease in the risk of adverse maternal

outcomes for all women with DIP or women with GDM. However, there was a

24% decrease in adverse neonatal outcomes overall and a 40% decrease among

infants of women with gestational diabetes.

Conclusion. The study demonstrated that nurse practitioner-led models of care

for diabetes in pregnancy are feasible. The findings suggest that the model

reduced adverse neonatal outcomes. By improving information provision, support

and care coordination, the model is particularly valuable in rural areas, where

access to medical specialists is often restricted.

Keywords: diabetes, model of care, nurse practitioner, nurses, nursing, pregnancy

Introduction

The prevalence of diabetes in pregnancy (DIP) has escalated

in developed and developing countries over the past

10–15 years (Dabelea et al. 2005, Hunt & Schuller 2007,

Baraban et al. 2008, Bell et al. 2008). This presents a chal-

lenge to health professionals and healthcare systems as DIP

increases the risk of adverse outcomes for both the mother

and child (Farrell et al. 2002, Temple et al. 2002, Dunne

et al. 2003, Clausen et al. 2005, Macintosh et al. 2006,

Hapo Study Cooperative Research Group et al. 2008, Petic-

ca et al. 2009). Women with DIP living in rural Australia

are likely to be at greater risk of complications due to poor

levels of access to specialist care and barriers to accessing

diabetes self-management information (King & Wellard

2009). A potential solution to this problem is the imple-

mentation of nurse practitioner-led models of care for DIP

in rural regions. This study evaluated a nurse practitioner-

led DIP clinic in the sparsely populated North West of the

island state of Tasmania, Australia.

Background

DIP encompasses pregnancies in women with pre-existing

type 1 diabetes (T1DM), pre-existing type 2 diabetes

(T2DM) or gestational diabetes mellitus (GDM). During

the early stages of pregnancy, particularly in the first tri-

mester when nausea and vomiting are common, the mother

with either T1DM or T2DM may find it difficult to main-

tain blood glucose levels to target, resulting in recurrent hy-

perglycaemic or hypoglycaemic events, which are associated

with pregnancy loss (Jovanovic et al. 2005). Pre-eclampsia

is a serious maternal complication found in approximately

7–13% of women with DIP (McIntyre et al. 2004, Temple

et al. 2006, Peticca et al. 2009), compared with approxi-

mately 3% in normoglycaemic pregnancies (McIntyre et al.

2004). As a consequence of pre-eclampsia, glycaemic

changes and/or foetal complications, the pregnancy may

not reach full term. Pre-term labour accounts for around

31–38% of pregnancies complicated by diabetes (Ferrara

et al. 2012). A further concern is the approximate 2�5–6 fold increased risk of perinatal and early neonatal mortality

compared with the general population (Dunne et al. 2003,

Macintosh et al. 2006). Pregnancies that continue to near

full term may be complicated by difficulties encountered

during birth. The large, macrosomic baby born vaginally

may result in perineal lacerations requiring repair (Berard

et al. 1998). On occasion, the macrosomic infant is simply

too large for a vaginal delivery. Consequently, women with

DIP typically have high rates of caesarean delivery with a

large Canadian study reporting caesarean rates of 52%

among women with T1DM and 38% among women with

T2DM or GDM (Peticca et al. 2009).

Infants born to women with DIP are at increased risk of

growth retardation, macrosomia, birth trauma, polycytha-

emia, cardiomyopathy, thrombosis, hypoglycaemia, hypo-

magnesaemia, jaundice, feeding difficulties and long-term

metabolic abnormalities (Inkster et al. 2006, Ponzo et al.

2006, Hawdon 2011). Respiratory distress syndrome

(RDS), which affects approximately 5% of infants born to

women with T1DM, (Persson et al. 2009) poses a serious

risk to the survival of the neonate. A major concern is the

risk of congenital abnormalities, which occur in 5–10% of

infants born to women with diabetes (Farrell et al. 2002,

Evers et al. 2004, McElduff et al. 2005, Macintosh et al.

2006). Congenital anomalies are seen more frequently in

Why is this research or review needed?

• This research describes an innovative model of nurse practi- tioner-led care for the women with pregnancies complicated

by diabetes.

• Published studies of nurse-led care models for the manage- ment of diabetes in pregnancy differ from the model pre-

sented in this paper.

• Few studies have evaluated the effectiveness of nurse-led models for reducing adverse maternal and neonatal health

outcomes in pregnancies complicated by diabetes.

What are the key findings?

• The nurse practitioner-led model of care increased referrals to dieticians and diabetes educators.

• The model resulted in decreased referrals to physicians for diabetes management.

• There was a 24% reduction in the risk of adverse neonatal outcomes among all women with diabetes in pregnancy in the

postintervention period and a 40% reduction in the risk of

adverse neonatal outcomes among women with gestational

diabetes.

• The model may have played an important role in reducing adverse neonatal outcomes.

How should the findings be used to influence policy/

practice/research/education?

• The findings support the implementation of nurse practi- tioner-led care models for women with pregnancies compli-

cated by diabetes.

JAN: ORIGINAL RESEARCH Nurse practitioner-led care for diabetes in pregnancy

babies born to mothers with pre-existing T1DM (Peticca

et al. 2009) or T2DM, compared with women with GDM

(Macintosh et al. 2006).

Macrosomia is a common complication seen in babies of

women who have DIP. Although there are differing defini-

tions for macrosomia, a generally accepted definition is

birthweight >4 kg and/or >90th percentile for gestational

age (Negrato et al. 2012). Macrosomia can lead to pre-term

delivery, stillbirth and early neonatal death (Zhang et al.

2008). Furthermore, the large baby can sustain damage as

it passes through the birth canal, resulting in shoulder dys-

tocia, fractures to the clavicle and injury to the brachial

plexus and facial nerve (Berard et al. 1998).

The long-term effects of GDM in women include an

increased risk of recurrence in subsequent pregnancies,

impaired glucose tolerance and diabetes in the future

(Homko et al. 2001, Kim et al. 2007, Anderberg et al.

2011, Malinowska-Polubiec et al. 2012). Children born to

women with DIP are at increased risk of insulin resis-

tance, impaired glucose tolerance, metabolic disorders,

increased BMI, changes in fat distribution, childhood

obesity and developing diabetes in childhood or teenage

years (Weintrob et al. 1996, Crume et al. 2011, Dabelea

& Crume 2011, Yessoufou & Moutairou 2011, Sparano

et al. 2013).

Australian guidelines for the management of diabetes in

pregnancy

The management of diabetes in pregnancy is crucial to

reduce adverse maternal and peri-natal outcomes. Models

consisting of dietary and blood glucose advice and insulin

therapy have been shown to improve glycaemic control and

reduce rates of macrosomia, premature delivery, shoulder

dystocia, caesarean delivery, stillbirth and neonatal mortal-

ity (Crowther et al. 2005, Temple et al. 2006, Landon

et al. 2009).

Given the strength of this evidence, the Australasian Dia-

betes in Pregnancy Society (ADIPS) guidelines recommend

fasting blood glucose levels to be targeted at 4�0–5�5 mmol/ L and 2-hour postprandial levels at <7 mmol/L (mmol/L is

the number of glucose molecules in 1 L of blood and is the

most common measurement used in Australia, the UK and

Europe). The guidelines also recommend ingestion of high-

dose folate supplementation (5 mg daily), a review of medi-

cations, monitoring of blood glucose levels and review of

HbA1c every 4–8 weeks in women with pre-existing diabe-

tes (McElduff et al. 2005). Where glycaemic targets are not

met, a review of diet and lifestyle is explored and insulin

therapy initiated in GDMs if, after lifestyle changes, glycae-

mic readings remain over target. Women with T1DM and

T2DM should also be monitored for progression of diabetic

complications such as retinopathy and nephropathy, and

their diabetes self-management knowledge should be

reviewed, particularly in relation to sick day care, hypo-

glycaemia and dietary guidelines (McElduff et al. 2005).

The guidelines emphasize the importance of multidisciplin-

ary review every 1–4 weeks for the first 30 weeks in

women with pre-existing diabetes, then 1–2 weekly until

birth.

The nurse practitioner-led model of care for diabetes in

pregnancy

In early 2007, the Diabetes Nurse Practitioner (DNP)

undertook an audit to describe the current status of screen-

ing and care provision in the region for women with GDM

and pre-existing diabetes and the effects of maternal diabe-

tes on the foetus, neonate and mother. In 2009, the DNP

reviewed these data to improve health outcomes through

establishing a pilot Diabetes in Pregnancy Clinic (DIPC) at

one hospital site. The clinic incorporated a ‘one stop shop’

principle, where the obstetrician, midwives, a Credentialed

Diabetes Educator (whose primary discipline was a nurse)

(CDE) and a dietician were all on site, with the DNP

co-ordinating the care model.

Between February–July 2009, the DNP worked in con-

junction with key stakeholders to initiate changes to service

delivery for pregnancies complicated by diabetes throughout

North West Tasmania. These discussions informed the

development of a model of care that was efficient in both

staffing and financial resources, consumer-focused and,

whilst acknowledging limited medical specialist access in

North West Tasmania, enabling the provision of evidence-

based care. Discussions included local obstetricians, diabe-

tes educators, antenatal nurses and dieticians.

The DNP and an endocrinologist developed an evi-

denced-based screening and management protocol, which

was implemented in collaboration with maternity service

staff from the two local public hospitals and one private

hospital. Universal screening for GDM commenced in July

2009, with women screened at 26–28 weeks of pregnancy.

As per ADIPS guidelines, positive results were 1-hour

venous plasma glucose level of ≥7�8 mmol/L after a 50-g glucose load (morning, non-fasting) (Hoffman et al. 1998).

Positive diagnoses were confirmed by a positive 75-g oral

glucose tolerance test (fasting) with a venous plasma glu-

cose level at 0 hours of ≥5�5 mmol/L and/or at 2 hours of ≥8�0 mmol/L. The management protocol included algorithms, with

specific guidelines, to enable prompt initiation of insulin

therapy onsite by the obstetrician and CDE for women

G.O. Murfet et al.

with GDM. Women with pre-existing diabetes (T1DM

and T2DM) were referred to the diabetes physician on

initial consultation. Insulin was initiated on site for

women with GDM who failed to remain below the pro-

tocol blood glucose targets adopted from the American

Diabetes Association, as more recent and reflective of the

HAPO study outcomes (≤5�5 mmol/L fasting and 2-hour

postprandial levels ≤6�7 mmol/L) (McElduff et al. 2005) after commencing a programme of healthy eating and

physical activity for 2 weeks. Insulin doses were recorded

on a proforma supported by the protocol and a prescrip-

tion was provided to the woman by the obstetrician. The

prescription was filled at the hospital pharmacy on the

day and the woman would return to the DIPC for insulin

Diagnosis

Universal screening as per ADIPS guidelines: on presentation, 12–16 weeks in high risk and/or repeated at 26–28 weeks 50 g GCT, if positive an additional 75 gm OGTT NB: This has changed to OGTT only now (as per ADIPS guidelines)

Referral To dedicated 4 hour/week DIPC The woman is seen by the CDE, dietician, obstetrician and antenatal nurse Visits to clinic start from diagnosis Referral to physician only occurs once the GDM woman reaches 24 units of insulin, to eliminate other causes of hyperglycaemia, or on presentation for T1DM and T2DM

DIPC Clinic Visits

CNE has an initial 1:1 30 minute consult with the woman to instruct on GDM or review educational level in pre-existing cases, management, screening and BG monitoring Dietician has 1:1 30 minute consult for nutritional assessment and advice Each subsequent visit the woman is seen simultaneously by the dietician and CDE (nurse) in a 20 minute block

Monitoring and Surveillance

Continue within multidisciplinary DIPC team generally on a fortnightly basis and weekly from 36 weeks If the GDM woman is not able to achieve ADIPS targets they are promptly started on insulin on-site, or a continuous glucose monitoring system was used in T1DM/T2DM cases The onsite pharmacy is prepared with stock of relevant insulin pens (rapid analogue and Protaphane) which the consumer purchases and returns to the clinic After-hours on-call service by CDE (nurse) provided as a resource for women if concerned about BGLs

Follow-Up

OGTT is recommended at 6–12 weeks post delivery Follow-up care is provided by antenatal nurse and general practitioner

Audit

At completion of pregnancy an audit of screening processes, treatment and neonatal/maternal outcomes is conducted by the CDE

Working Party The model is supported across the region in both private and public settings; Diabetes in Pregnancy Working Party was developed to ensure consistency and evidence base The Working Party meets 3 times per year for 1 hour including paediatricians, CNEs, NUM, obstetrician, antenatal nurse, pathologist, dieticians NB: Obstetricians have acknowledged their satisfaction in being involved in insulin management and increasing comfort in prescribing and adjusting insulin

Figure 1 Nurse Practitioner-led model of care.

JAN: ORIGINAL RESEARCH Nurse practitioner-led care for diabetes in pregnancy

education with the CDE. The protocol incorporated a

maximum insulin dose of 24 units. Patients who reached

this threshold were referred to a physician for elimination

of other causes of hyperglycaemia; at which time the

woman was on >40 units of insulin at review.

The DNP liaised with the pharmacy departments of the

two local public hospitals to enable appropriate insulins to

be dispensed on the day of the clinic, as required. By

August 2009, the DIPC, incorporating a multidisciplinary

team [obstetrician, diabetes educator, dietician and antena-

tal nurse] and the use of a Management of Gestational Dia-

betes Protocol, was established at the public and private

hospital sites. Figure 1 outlines the DNP model of care for

pregnancies complicated by diabetes.

In women with T1DM or T2DM, a Continuous Glucose

Monitoring System (CGMS) was used to identify target

areas of hyperglycaemia, with women sent to the Diabetes

Centre for this monitoring. An after-hours DNE contact

number was provided to women for further information

and support regarding management of blood glucose levels

(BGLs). Dependant on glycaemic control, use of insulin and

obstetric reasons, women were reviewed on a 1–4 weekly

basis.

Women who screened positive for GDM were informed

of diagnosis, provided information and booked into the

next weekly DIPC. As per ADIPS guidelines at the time of

the study, screening could occur earlier, either at

12–16 weeks if the woman had a previous history of

GDM, or at presentation if the woman was symptomatic.

At the DIPC, women received an initial assessment with the

dietician and education with the CDE, including education

about home blood glucose monitoring. At future appoint-

ments, clients were seen by the dietician and CDE simulta-

neously, with review by the midwife and obstetrician as

necessary.

The study

Aim

The study aimed to investigate maternal and neonatal

health outcomes pre- and postimplementation of a nurse

practitioner-led model of care for pregnancies complicated

by diabetes in a rural locality.

Design

Uncontrolled before-after study of maternal and neonatal

outcomes following implementation of a nurse practitioner-

led model of care for DIP.

Sample/participants

The pre-intervention audit included all pregnancies in

North West Tasmania that were complicated by diabetes

between July 2003–June 2006. Between late 2006–2009,

one local hospital underwent major organizational and

funding changes. Additionally, in 2008, a trial DIP screen-

ing programme was implemented for 12 months by one of

the antenatal services with support of the Diabetes Centre

as preliminary data highlighted lack of screening and man-

agement. It was, therefore, decided to exclude these periods

from the study to reduce bias and potential contamination

of the results from the effects of the DIPC pilot. While the

nurse-led DIPC was implemented in August 2009, it took

several months for the model to become embedded in local

maternity services. It was therefore decided to delay the

postintervention audit to cover the period from January

2010–December 2011.

The inclusion criteria for the pre- and postintervention

periods were: (1) Women with pre-existing diabetes who

attended maternity services at either of the two local public

hospitals or the one local private hospital during the study

period; (2) Women diagnosed with GDM who attended

maternity services at the same hospitals during the study

period. The DNP used International Classification of Dis-

eases (ICD) codes (Table 1) to identify women with preg-

nancies suspected of being complicated by diabetes. This

was necessary as the pre-intervention audit found screening

at one hospital was extremely limited.

Data collection

Three CDEs recorded data from maternity services records

onto a data collection audit form for all pregnancies sus-

pected of being complicated by diabetes. The lead DNP

reviewed each form for completeness and cross-checked a

random sample of 20% of forms with medical records for

data accuracy. The audit form included information on

demographics, GDM-specific screening, pre-existing diabe-

tes-specific complication screening, referral to multidisci-

plinary team, monitoring of diabetes, treatments for

diabetes during pregnancy and both maternal and neonatal

health outcomes. Local experts in the field, including a dia-

betes paediatrician, diabetes nurse educator with a preg-

nancy portfolio and diabetes physician, reviewed the audit

tool for content validity prior to use. Furthermore, an

expert ‘diabetes in pregnancy’ endocrinologist (based inter-

state) validated the panel’s findings, benchmarking the form

against current best practice evidence. BMI was not avail-

able for the pre-intervention group as height and weight

G.O. Murfet et al.

were not routinely measured as part of antenatal care dur-

ing this period. HbA1c using Diabetes Control and Compli-

cations Trial (DCCT)% units were converted to

International Federation of Clinical Chemistry (IFCC)

mmol/mol units. Socio-economic status (SES) was derived

from the Australian Bureau of Statistics (ABS) Socio-Eco-

nomic Indexes for Areas (SEIFA) 2006, (Australian Bureau

of Statistics 2006) by matching postcodes to the Index of

Relative Socio-economic Advantage and Disadvantage (IR-

SAD), an area-level measure of socio-economic advantage

to disadvantage that includes data on income, education

level, unemployment, housing expenditure and assets. The

higher deciles of this measure indicate relative advantage in

an area.

Ethical considerations

Research Ethics Committee approval for the audit was

granted by the Patient Care Committee of the Quality and

Safety Executive Unit at the North West Regional Hospital,

Tasmania and from the Executive Board of the North West

Private Hospital. Patient anonymity was maintained by

assigning a unique study identifier to each pregnancy and

not recording patient identifiable data such as names and

addresses.

Data analysis

Macrosomia was defined as birthweight >90th percentile

for gestational age, while pre-term births were defined as

births up to 37 weeks gestation. Adverse maternal

outcomes included loss of consciousness, threatened abor-

tion requiring cervical sutures, hypoglycaemia, diabetic

ketoacidosis, metabolic complication, polyhydramnious,

placenta previa, pyelonephritis, emergency caesarean sec-

tion, failure to progress in labour, 2–4° tear and postpar-

tum haemorrhage. Adverse neonatal health outcomes were

defined as hypoglycaemia [BGL <2�5 mmol/L], still birth or neonatal death, RDS, congenital abnormality, pre-term

delivery, neural tube defect or birth injury. Birth injuries

included shoulder dystocia, fractures to the clavicle, injury

to the brachial plexus and/or facial nerve and Erb’s palsy.

Postpartum follow-up comprised of a follow-up OGTT at

6–12 weeks in GDMs, or in women with T1DM/T2DM, a

review of renal function and retina.

All audit forms were entered into Excel (Microsoft, Red-

mond, WA, USA), then imported into Stata 12 (StataCorp,

College Station, TX, USA) for analysis. Descriptive statistics

were run to investigate the proportions of categorical vari-

ables and the distribution of continuous variables. Pearson’s

chi-square test or Fisher’s exact tests were utilized for the

investigation of associations between categorical variables,

while independent t-tests were used to investigate differ-

ences in continuous data between the pre- and postinterven-

tion groups. Adjusted relative risks (aRR) of adverse

maternal and neonatal outcomes were calculated for the

pre-intervention vs. postintervention groups (with 95% con-

fidence intervals) using a Poisson regression model with

robust error variance, as recommend by Zou (2004). The

regression models included adjustment for maternal age,

pre-existing diabetes, socio-economic status and Asian or

indigenous ethnicity. In the GDM only group, the aRR of

Table 1 ICD codes used to identify study participants.

ICD codes

O24�0 Pre-Existing T1DM in pregnancy 024�1 Pre-Existing T2DM in pregnancy 024�2 Pre-Existing DM other specified in pregnancy 024�3 Pre-Existing DM unspecified in pregnancy 024�4 Gestational Diabetes Mellitus, diabetes arising at >24 weeks in pregnancy 024�5 Pre-existing impaired glucose regulation 024�9 Diabetes mellitus in pregnancy, unspecified onset 033�5 Maternal care for disproportion due to unusually large foetus (included if screening for GDM had not occurred & hypoglycaemia

evident)

036�6 Maternal care for excessive foetal growth (known or expected LGA) 035�0 Maternal care for (suspected) Central Nervous System malformation in foetus – anencephaly, spina bifida (included if the baby was

macrosomic and screening for GDM had not occurred

P70�0 Syndrome of infant of a mother with gestational diabetes P70�1 Syndrome of infant of diabetic mother – maternal diabetes mellitus (pre-existing) affecting foetus or new born (with

hypoglycaemic)

P70�4 Other neonatal hypoglycaemia (included if the baby was macrosomic and screening for GDM had not occurred)

JAN: ORIGINAL RESEARCH Nurse practitioner-led care for diabetes in pregnancy

Table 2 Pre- and postintervention group characteristics and outcomes.

Pre-intervention (n = 112)

n (%) or Mean (SD)

Postintervention (n = 149)

n (%) or Mean (SD) P value

Age 30�6 (5�8) 31�1 (5�4) ns Ethnic background

Australian or New Zealander (non-Indigenous) 98 (87�5) 122 (81�9) ns Aboriginal or Torres Strait Islander 6 (5�4) 12 (8�1) South East Asian 4 (3�6) 4 (2�7) British 2 (1�8) 4 (2�7) Asian 0 (–) 4 (2�7) European 0 (–) 2 (1�3) Middle Eastern 1 (0�9) 0 (–) Not stated 1 (0�9) 1 (0�7)

Indigenous or Asian ethnic background 10 (8�9) 20 (13�4) ns Index of Relative Socio-economic Advantage and Disadvantage (IRSAD) Decile (1 lowest to 10 highest)

1 6 (5�4) 9 (6�0) * 2 74 (66�1) 97 (65�1) 3 15 (13�4) 21 (14�1) 4 14 (12�5) 22 (14�8) ≥5 3 (2�7) 0 (–)

Singleton pregnancy 109 (97�3) 142 (97�3) ns BMI – 30�3 (7�7) – Diabetes type

Pre-existing T1DM 15 (13�4) 11 (7�4) * Pre-existing T2DM 5 (4�5) 6 (4�0) GDM 64 (57�1) 131 (87�9) Unknown (suspected GDM) 28 (25�0) 1 (3�4)

Treatment type

Diet/exercise 84 (75�0) 64 (43�2) <0�0001 Diet/exercise and insulin 28 (25�0) 84 (56�8)

Referral to physician for diabetes management 63 (56�3) 37 (24�8) <0�0001 Referral to diabetes educator for diabetes management 36 (32�1) 144 (96�6) <0�0001 Referral to dietician for diabetes management 18 (16�1) 137 (91�9) <0�0001 Maternal complications

Maternal hypoglycaemia 2 (1�8) 3 (2�0) ns Loss of consciousness 0 1 (0�7) ns Diabetic ketoacidosis 0 0 –

Maternal metabolic complication 6 (5�4) 2 (1�3) ns Threatened abortion requiring sutures 1 (0�9) 0 ns Pre-eclampsia 21 (18�8) 18 (12�3) ns Polyhydramnious 3 (2�7) 3 (2�0) ns Pyelonephritis 1 (0�9) 1 (0�7) ns Premature labour/placenta previa 2 (1�8) 2 (1�3) ns 2–4° tear 17 (15�2) 13 (8�7) ns Failure to progress/emergency caesarean section 7 (96�2) 1 (0�7) 0�02 Caesarean section 57 (50�9) 69 (47�3) ns Postpartum haemorrhage 4 (3�6) 3 (2�0) ns Adverse maternal outcome† 42 (37�5) 42 (28�8) ns

Neonatal outcomes

Gestational week of birth 37�9 (2�2) 37�5 (4�4) ns Pre-term delivery 28 (25�0) 24 (16�4) ns Birthweight (grams) 3681�7 (619�8) 3445�6 (584�1) 0�002 Neonatal hypoglycaemia 59 (52�7) 48 (33�1) 0�003 Neonatal respiratory distress syndrome 29 (25�9) 22 (15�2) 0�033 Neonatal macrosomia 61 (55�0) 30 (20�8) <0�0001 Birth injuries 13 (11�6) 3 (2�1) 0�002

G.O. Murfet et al.

adverse neonatal health outcomes was adjusted for mater-

nal age, socio-economic status and Asian or indigenous eth-

nicity. All tests were two-sided and differences were

accepted at P < 0�05 significance level.

Results

A total of 261 audit forms were completed by the CDEs

and data from all forms were included in the study. The

pre-intervention sample comprised 112 (43%) pregnancies,

while the postintervention sample comprised 149 (57%)

pregnancies that were managed under the new nurse practi-

tioner-led model of care.

Mean age was 31 (SD 6) years and BMI was 30 (SD 8) at

first pre-natal appointment (for the postintervention group

only as BMI was not available for the pre-intervention

group). A total of 220 (84%) women were from a Cauca-

sian background (Table 2) and 18 (7%) were from an

Aboriginal or Torres Strait Islander background. Socio-eco-

nomic status (derived from IRSAD) indicated that 99% of

women resided in areas that were among the four lowest

deciles for socio-economic deprivation in Australia.

There was no difference between the pre- and postinter-

vention groups for age, mean 31 (SD 6) vs. 31 (SD 5)

(t(259) = �0�7542, P = 0�45), singleton pregnancies (97% vs. 97%, v2(1) = 0�0, P = 0�98), the proportion of women with indigenous or Asian ethnic background (9% vs. 13%,

v2(1) = 1�3, P = 0�26) or the proportion residing in areas among the two lowest deciles for socio-economic status

(71% vs. 71%, v2(1) = 0�0, P = 0�96) (Table 2). A total of 37 (14%) women had pre-existing diabetes

and 195 (75%) were diagnosed with GDM, while no diabe-

tes diagnosis information was available for 29 (11%)

women. Women in the postintervention group were more

likely to have GDM (76% vs. 89%, v2(1) = 6�1, P = 0�014). A total of 84 women experienced one or more adverse

maternal outcomes and 158 infants experienced one or

more adverse neonatal outcomes (Table 2). The most com-

mon adverse maternal outcome was caesarean section

(n = 126, 48%), followed by pre-eclampsia (n = 39, 15%)

and 2–4° vaginal tear (n = 30, 12%). The most common

adverse neonatal outcome was hypoglycaemia requiring

treatment (n = 107, 41%), followed by macrosomia

(n = 91, 35%) and respiratory distress syndrome (n = 51,

20%). There were eight congenital abnormalities reported

in the offspring of women with T1DM: four cardiac; two

cephalic; one renal; and one neural tube defect. Two con-

genital abnormalities were recorded in the offspring of

women with T2DM: one cephalic anomaly; and one neural

tube defect. Seven congenital abnormalities were noted in

women with ‘suspect’ GDM: three renal anomalies; two

major cardiac; one chromosomal; and one minor anomaly.

Following implementation of the model of care, the pro-

portion of women referred to dieticians (16% vs. 92%,

v2(1) = 152�6, P < 0�0001) and diabetes educators increased (32% vs. 97%, v2(1) = 124�3, P < 0�0001). Among women with GDM (Table 3), the proportion using

insulin, rather than diet and exercise alone, to manage

their diabetes increased from 10% to 53% (v2(1) = 43�7, P < 0�0001), yet this was achieved despite a decrease in the proportion of women referred to physicians for diabetes

care (48% vs. 15%, v2(1) = 28�4, P < 0�0001). HbA1c level was taken on presentation and 3 monthly in

women with pre-existing diabetes. There was no significant

difference in mean HbA1c level among women with pre-

existing diabetes in the pre-intervention (70 [SD 4] mmol/

mol IFCC, 8�6% [SD 1�8] DCCT) and postintervention

Table 2 (Continued).

Pre-intervention (n = 112)

n (%) or Mean (SD)

Postintervention (n = 149)

n (%) or Mean (SD) P value

Neural tube defect 1 (0�9) 0 ns Neonatal congenital abnormality 16 (14�3) 1 (0�7) <0�0001 Stillbirth or neonatal death 4 (3�6) 2 (1�3) ns Adverse neonatal outcomes‡ 86 (76�8) 72 (49�0) <0�0001 Postpartum follow-up 30 (33�3) 61 (46�2) ns

*Unable to calculate due to 1 cell expected cell count <5. †Hypoglycaemia, loss of consciousness, diabetic ketoacidosis, metabolic complication, threatened abortion requiring cervical sutures, polyhy-

dramnious, premature labour/placenta previa, pyelonephritis, emergency caesarean section/failure to progress, 2–4° tear, postpartum haemor-

rhage. ‡Macrosomia, hypoglycaemia, still birth or neonatal death, RDS, congenital abnormality, pre-term delivery, neural tube defect, birth injury.

JAN: ORIGINAL RESEARCH Nurse practitioner-led care for diabetes in pregnancy

Table 3 Pre- and postintervention group characteristics and outcomes in GDM/suspected GDM group.

Pre-intervention (n = 92)

n (%) or Mean (SD)

Postintervention (n = 132)

n (%) or Mean (SD) P value

Age 30�7 (5�9) 31�2 (5�6) ns Ethnic background

Australian or New Zealander (non-Indigenous) 83 (90�2) 109 (82�6) * Aboriginal or Torres Strait Islander 3 (3�3) 9 (6�8) South East Asian 4 (4�3) 3 (2�3) British 0 (–) 4 (3�0) Asian 0 (–) 4 (3�0) European 0 (–) 2 (1�5) Middle Eastern 1 (1�1) 0 (–) Not stated 1 (1�1) 1 (0�8)

Indigenous or Asian ethnic background 7 (7�6) 16 (12�1) ns Singleton pregnancy 89 (96�7) 127 (96�9) ns BMI Not available 30�4 (7�9) – Treatment type

Diet/exercise 83 (90�2) 62 (47�3) <0�0001 Diet/exercise and insulin 9 (9�8) 69 (52�7)

Referral to physician for diabetes management 44 (47�8) 20 (15�2) <0�0001 Referral to diabetes educator for diabetes management 28 (30�4) 128 (97�0) <0�0001 Referral to dietician for diabetes management 12 (13�0) 121 (91�7) <0�0001 Maternal complications

Maternal hypoglycaemia 1 (1�1) 1 (0�8) ns Loss of consciousness 0 0 –

Diabetic ketoacidosis 0 0 –

Maternal metabolic complication 0 0 –

Threatened abortion requiring sutures 1 (1�1) 0 ns Pre-eclampsia 13 (14�1) 13 (9�9) ns Polyhydramnious 2 (2�2) 3 (2�3) ns Pyelonephritis 1 (1�1) 1 (0�8) – Premature labour/placenta previa 2 (2�2) 2 (1�5) ns 2–4° tear 15 (16�3) 12 (9�2) ns Failure to progress/emergency caesarean section 6 (6�5) 1 (0�8) ns Caesarean section 45 (48�9) 58 (44�3) ns Postpartum haemorrhage 3 (3�3) 3 (2�3) ns Adverse maternal outcome† 31 (33�7) 36 (27�5) ns

Neonatal outcomes

Gestational week of birth 38�3 38�3 ns Pre-term delivery 17 (18�5) 18 (13�7) ns Birthweight (grams) 3706�3 (620�7) 3411�6 (559�2) <0�0001 Neonatal hypoglycaemia 44 (47�8) 38 (29�0) 0�004 Neonatal respiratory distress syndrome 17 (18�5) 16 (12�2) ns Neonatal macrosomia 45 (48�9) 24 (18�5) <0�0001 Birth injuries 10 (10�9) 3 (2�3) 0�007 Neural tube defect 1 (0�9) 0 ns Neonatal congenital abnormality 7 (7�6) 0 (0) 0�002 Stillbirth or neonatal death 2 (2�2) 1 (0�8) ns Adverse neonatal health outcome‡ 67 (72�8) 58 (43�9) <0�0001 Postpartum follow-up 30 (33�3) 61 (46�2) ns

*Unable to calculate due to 1cell expected cell count <5 †Hypoglycaemia, loss of consciousness, diabetic ketoacidosis, metabolic complication, threatened abortion requiring cervical sutures, polyhy-

dramnious, premature labour/placenta previa, pyelonephritis, emergency caesarean section/failure to progress, 2–4° tear, postpartum haemor-

rhage ‡Macrosomia, hypoglycaemia, still birth or neonatal death, RDS, congenital abnormality, pre-term delivery, neural tube defect, birth injury

G.O. Murfet et al.

groups (68 [SD 2] mmol/mol IFCC 8�4% [SD 2�3] DCCT (t(31) = 0�32, P = 0�75). As ADIPS guidelines do not support routine HbA1c testing in women with GDM, com-

parison of HbA1c levels among this group was not per-

formed.

Gestational week of birth did not change following the

intervention, although mean birthweight decreased from

3682 g (SD 620) to 3446 g (SD 584) (t(246) = 3�1, P = 0�002). There was a reduction in neonatal hypoglycaemia (53% vs.

33%, v2(1) = 10�0, P = 0�002), neonatal respiratory distress syndrome (26% vs. 15%, v2(1) = 4�6, P = 0�033), neonatal macrosomia (55% vs. 21%, v2(1) = 31�8, P < 0�0001), birth injuries (12% vs. 2%, v2(1) = 9�8, P = 0�002) and congeni- tal abnormalities (14% vs. 1%, v2(1) = 19�2, P < 0�0001). The adjusted relative risk of adverse neonatal outcomes

postintervention compared with pre-intervention was 0�76 (95% CI 0�61–0�94).The adjusted relative risk of adverse maternal outcomes was not significant (aRR 0�75, 95% CI 0�52–1�09). In the GDM group, the adjusted relative risk of adverse neonatal outcomes was 0�60 (95% CI 0�48–0�76). The adjusted relative risk of adverse maternal outcomes was not significant (aRR 0�80, 95% CI 0�54–1�20).

Discussion

Our results indicate that a nurse practitioner-led model of

care may play an important role in improving neonatal out-

comes in rural localities. Rural localities throughout the

world are often characterized by a shortage of medical spe-

cialists, including endocrinologists. This was the case for the

region where we conducted the research, in the North West

of Tasmania, Australia. Prior to implementation of the nurse

practitioner-led DIPC model, pregnant women were not

routinely screened for GDM at all hospitals in the region.

Following implementation of the DIPC model, the risk of

adverse neonatal outcomes was reduced by 24% overall

and 40% among women with GDM. In the GDM group,

macrosomia rates decreased from 49% to 19%, while the

prevalence of congenital abnormalities reduced from 8% to

zero. Ferrara et al. (2012) similarly found women with

GDM whose pregnancies were managed by centres with

high levels of referral to diabetes nurse telephone counsel-

ling were >70% less likely to have a macrosomic infant.

Garcia-Patterson et al. (2003) reported a macrosomia rate

of 5% among women with mild GDM who received diabe-

tes nurse care. Reducing rates of macrosomia is vitally

important, not only for the short-term health of the infant

but also for reducing obesity and the risk of developing

T2DM in adulthood.

It is surprising, given the decrease in adverse neonatal

outcomes observed in the postintervention period, that

there was no statistically significant reduction in adverse

maternal outcomes. The only other study, to our knowl-

edge, to investigate maternal outcomes following implemen-

tation of a nurse-led model of care for DIP also reported no

difference in maternal outcomes such as caesarean deliveries

(Garcia-Patterson et al. 2003). Despite this, we hope that

long-term follow-up, if undertaken, may demonstrate a

reduction in the development of T2DM and other aspects

of metabolic syndrome, attributable to the lifestyle and diet

education given to women under the DIPC model.

The DIPC model was devised to ensure maximum effi-

ciency of resources available locally. A systematic consumer-

focused approach was adopted throughout the development

of the model. This resulted in a model that delivered multidis-

ciplinary care in a single consultation, rather than the client

having to attend multiple appointments at different health-

care facilities. Unlike the Spanish model described by Garcia-

Patterson et al. (2003) or the American nurse-led telephone

counselling model described by Ferrara et al. (2012), the

nurse practitioner-led DIPC model organized care that was

delivered by a multidisciplinary team of CDEs, dieticians,

obstetricians and midwives in one consultation. This ensured

consistency in the diabetes self-care language used by health-

care professionals and in glycaemic targets set for women.

A notable strength of the DIPC nurse practitioner-led

model is its use of contemporary evidence to promote high-

quality care in a rural area with lack of medical specialist

services. The model was developed according to interna-

tional research and Australian guidelines for the manage-

ment of diabetes in pregnancy. Additionally, local clinicians

and national experts in the field had input into the develop-

ment of the model. This ensured that the model was both

evidence-based and relevant to the local healthcare context.

The clear systematic integrated care pathway should support

the continued provision of evidence-based care regardless of

health professional turnover, as is common in rural regions.

One potential criticism of the DIPC model is the delayed

implementation of the new consensus thresholds for classifi-

cation of GDM (International Association of Diabetes Preg-

nancy Study Groups Consensus Panel 2010). However,

consensus was not yet achieved at the time that the model

was implemented. It is currently unknown what impact the

thresholds for the diagnosis of GDM (fasting venous

plasma glucose level of ≥5�1 mmol/L, or, after a 75 g preg- nancy glucose tolerance test, 1 hour venous plasma glucose

≥10 mmol/L or ≥8�5 after 2 hours) currently awaiting ADIPS-endorsement, (Nankervis et al. 2013) would have

on resourcing of the model. Additionally, implementation

JAN: ORIGINAL RESEARCH Nurse practitioner-led care for diabetes in pregnancy

of the new diagnostic thresholds may potentially flood the

DIPC with obese women who have minor elevations in

BGLs without improving maternal and neonatal outcomes

(Moynihan 2012).

Under the DIPC model of care, women are monitored by

CDEs rather than by general practitioners and endocrinolo-

gists. Whilst a cost analysis was beyond the remit of this

study, we propose that the monitoring, information, sup-

port and care coordination provided through the model

may have improved BGLs and therefore prevented adverse

outcomes that require expensive specialist care. As high-

lighted by ACHOIS, (Crowther et al. 2005) if the DIPC

model did contribute towards the reduction in perinatal

complications, the economic benefits gained may outweigh

the costs of the model.

Strengths of the research include the use of ICD criteria

to identify all pregnancies potentially complicated by diabe-

tes across the whole region of north-west Tasmania in the

pre- and postintervention period. ICD codes were used to

search the records of all three regional antenatal clinics,

whether these were private or public hospital clinics. This

avoided the introduction of bias arising from the selection

of a single clinic or a private or public facility only, as the

socio-economic profiles of patients differ according to

whether they are publicly funded.

The extraction of pregnancy and neonatal outcome data

directly from medical notes, by trained CDEs, rather than

requesting this information from nurses, clinicians or moth-

ers avoided the introduction of recall bias. However, the use

of three CDEs to extract data from medical notes onto audit

forms may have introduced misclassification bias due to

slightly different interpretations of clinical notes. Addition-

ally, using CDEs who delivered the model to extract mater-

nal and neonatal data may have led to positive outcome

bias. However, we attempted to minimize this bias by pro-

viding the nurses with training and instructing them to fol-

low the study protocol. The lead nurse practitioner was also

available to answer the nurses’ questions throughout this

process.

Limitations

Limitations of this study include BMI not being available

for the pre-intervention group. This was due to height and

weight not being measured in antenatal appointments dur-

ing the pre-intervention period and the absence of diabetes

in pregnancy screening. As such, we could not adjust for

BMI in any of our models.

Unfortunately, we were unable to adjust for HbA1c level,

which is an important potential confounder of the study

findings. We could not adjust for HbA1c level in our multi-

variate regression models as the number of women with pre-

existing diabetes was too small. We intend to conduct a pro-

spective controlled trial of the model in the near future. In

the proposed study, all women with T1DM and T2DM, will

have regular HbA1c tests. This will ensure that we can

include HbA1c level in future statistical models.

The absence of a control group and absence of data col-

lected over time are shortcomings that limit the capacity to

attribute changes in neonatal outcomes to the intervention

alone. Unfortunately, due to staffing pressures and a short-

age of resources, it was not possible to collect data over

several time points. We were unable to include a control

group as the DIPC was delivered to all pregnant women

with DIP living in the region and difficulties accessing

maternity data from another regional health service. Other

factors, such as improvements in maternity services, special-

ist care and neonatal care may have played a role in

improved neonatal outcomes. As such, the results of this

research may be interpreted as evidence for the feasibility

of the model rather than its effectiveness per se. We hope

that these limitations and the potential for bias in a retro-

spective study will be overcome in our future controlled

trial of nurse practitioner-led management for DIP.

Conclusion

This research demonstrates that a diabetes nurse practi-

tioner-led model of care for pregnancies complicated by

diabetes may lead to a reduction in adverse neonatal out-

comes in a rural setting. The diabetes nurse practitioner

implemented a model of care provided by a multidisciplin-

ary team that included dieticians, Credentialed Diabetes

Educators, obstetricians and midwives. The findings suggest

that the model may have improved neonatal outcomes

without increasing referrals to physicians. This model of

care for diabetes in pregnancy is particularly valuable in

rural areas, where access to medical specialists is often

restricted.

Acknowledgements

We thank all of the women who received care throughout

their pregnancies from the staff of the Diabetes in Pregnancy

Clinic. This research would not have been possible without

them. Our sincere gratitude is also extended to the following

staff who contributed to data collection and the success of

the model of care: Ruth Young, Maria Smith, Alana Jarvis,

Nicole Samra, Dr Joanne Campbell, Dr Kim Dobromilsky,

Meg Arvier, Lyn Johnson.

G.O. Murfet et al.

Funding

This research received no specific grant from any funding

agency in the public, commercial, or not-for-profit sectors.

Conflict of interest

Giuliana Murfet is a Director of the Board of the Austra-

lian Diabetes Educators Association. Penny Allen and Tania

Hingston have no conflicts of interest to declare.

Author contributions

All authors have agreed on the final version and meet at

least one of the following criteria [recommended by the

ICMJE (http://www.icmje.org/ethical_1author.html)]:

• substantial contributions to conception and design, acquisition of data, or analysis and interpretation of

data;

• drafting the article or revising it critically for important intellectual content.

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