CW Reliability and Validity Discussion

Can J Diabetes 41 (2017) 297?304
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Original Research
Diabetes Nurse Case Management in a Canadian Tertiary Care Setting:
Results of a Randomized Controlled Trial
Danni Li MD a, Tom Elliott MBBS a,b, Gerri Klein RN, CDE a,b, Ehud Ur MBBS a, Tricia S. Tang PhD a,*
a
b
Division of Endocrinology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
BC Diabetes, Vancouver, British Columbia, Canada
a r t i c l e i n f o
a b s t r a c t
Article history:
Received 2 May 2016
Received in revised form
17 October 2016
Accepted 21 October 2016
Objectives: To examine the effects of a 6-month nurse case manager (NCM) intervention compared to standard care (SC) on glycemic control and diabetes distress in a Canadian tertiary-care setting.
Methods: We recruited 140 adults with type 2 diabetes and glycated hemoglobin (A1C) levels >8%
(64 mmol/mol) from 2 tertiary care facilities and randomized them to: 1) a 6-month NCM intervention
in addition to SC or 2) SC by the primary endocrinologists. Assessments were conducted at baseline and
at 6 months. Primary outcomes included A1C levels and diabetes distress scores (DDS). Secondary outcomes included body mass index, blood pressure, diabetes-related behaviour measures, depressive symptoms, self-motivation and perception of support.
Results: At the 6-month follow up, the NCM group experienced larger reductions in A1C levels of -0.73%
compared to the SC group (p=0.027; n=134). The NCM group also showed an additional reduction of -0.40
(26% reduction) in DDS compared to those in the SC group (p=0.001; n=134). The NCM group had lower
blood pressure, ate more fruit and vegetables, exercised more, checked their feet more frequently, were
more motivated, were less depressed and perceived more support. There were no changes and no group
differences in terms of body mass index, medication compliance or frequency of testing.
Conclusions: Compared to SC, NCM intervention was more effective in improving glycemic control and
reducing diabetes distress. It is, therefore, a viable adjunct to standard diabetes care in the tertiary care
setting, particularly for patients at high risk and with poor control.
? 2017 Canadian Diabetes Association.
Keywords:
diabetes nurse case manager
randomized controlled trial
tertiary care setting
diabetes distress
psychosocial outcomes
r ? s u m ?
Mots cl?s :
in?rmi?re gestionnaire de cas de diab?te
essai clinique ? r?partition al?atoire
cadre des soins tertiaires
d?tresse li?e au diab?te
crit?res de jugement psychosociaux
Objectifs : Examiner les effets de l?intervention de 6 mois d?une in?rmi?re gestionnaire de cas (IGC) par
rapport aux effets des soins courants (SC) sur la r?gulation de la glyc?mie et la d?tresse li?e au diab?te
dans le cadre canadien des soins tertiaires.
M?thodes : Nous avons recrut? 140 adultes atteints du diab?te de type 2 qui avaient des concentrations
d?h?moglobine glyqu?e (A1c)>8% (64 mmol/mol) de 2 ?tablissements de soins tertiaires et les avons r?partis
de mani?re al?atoire comme suit : 1) intervention de 6 mois d?une IGC en plus des SC ou 2) SC par les
endocrinologues traitants. Les ?valuations ont ?t? r?alis?es au d?but et apr?s 6 mois. Les crit?res de jugement
principaux ?taient les concentrations de l?A1c et les scores de la d?tresse li?e au diab?te (SDD). Les crit?res
secondaires ?taient les suivants : l?indice de masse corporelle, la pression art?rielle, les mesures du
comportement li? au diab?te, les sympt?mes de d?pression, la motivation personnelle et la perception
du soutien.
R?sultats : Au suivi apr?s 6 mois, le groupe IGC montrait des r?ductions plus grandes des concentrations
de l?A1c de -0,73% que celles du groupe SC (p=0,027; n=134). En plus, le groupe IGC montrait une r?duction
des SDD de -0,40 (r?duction de 26%) par rapport au groupe SC (p=0,001; n=134). Les adultes du groupe
IGC avaient une pression art?rielle plus basse, mangeaient plus de fruits et de l?gumes, faisaient plus
d?exercice, v?ri?aient leurs pieds plus fr?quemment, ?taient plus motiv?s, ?taient moins d?pressifs et
s?apercevaient d?un plus grand soutien. Il n?y avait aucun changement et aucune diff?rence entre les groupes
en ce qui concerne l?indice de masse corporelle, l?observance th?rapeutique ou la fr?quence des analyses.
* Address for correspondence: Tricia S. Tang, PhD, University of British Columbia, 2775 Laurel Street, Suite 10211, Vancouver, British Columbia, Canada V5Z 1M9.
E-mail address: [email protected]
1499-2671 ? 2017 Canadian Diabetes Association.
The Canadian Diabetes Association is the registered owner of the name Diabetes Canada.
http://dx.doi.org/10.1016/j.jcjd.2016.10.012
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D. Li et al. / Can J Diabetes 41 (2017) 297?304
Conclusions : Comparativement aux SC, l?intervention d?une IGC ?tait plus e?cace pour am?liorer la r?gulation
de la glyc?mie et r?duire la d?tresse li?e au diab?te. Par cons?quent, il s?agit d?un compl?ment viable aux
soins courants offerts aux diab?tiques dans le cadre des soins tertiaires, particuli?rement chez les patients
expos?s ? un risque ?lev? qui ont une r?gulation m?diocre.
? 2017 Canadian Diabetes Association.
Introduction
Methods
The prevalence of diabetes is rising worldwide, primarily because
of an aging and increasingly obese population. In 2010, 2.7 million
(7.6%) people in Canada were diagnosed with diabetes, and this
number is projected to reach 4.2 million (10.8%) by 2020 (1). Diabetes and its associated complications are a signi?cant burden on
the Canadian economy, costing $11.7 billion in 2010 and expected
to rise to $16 billion by 2020 (1).
Despite compelling evidence that tight glucose control can
prevent or delay complications (2), outcomes are poor, and improvements are needed. For instance, among 3002 Canadian patients in
a primary care setting, Braga et al (3) found that 30%, 39% and 53%
achieved treatment targets for blood pressure (BP), glycated hemoglobin (A1C) and cholesterol, respectively. Moreover, only 7%
achieved all 3 goals. Clearly, greater efforts are needed to help
patients improve diabetes-related health outcomes in Canada.
Among the various models investigated to improve diabetes care
delivery, case management has produced the most favourable evidence (4,5). In fact, a meta-analysis of 11 different qualityimprovement strategies for diabetes care found that interventions
involving case-management strategies led to the greatest reductions in A1C levels (5). Case management encompasses the assessment, implementation, coordination and monitoring of options and
services required to meet individual health needs (6). It can include
patients? education, coaching, treatment adjustment, monitoring and
care coordination (7).
Several systematic and integrative reviews have shown diabetes case management interventions to be effective in improving glycemic control (6?10) by up to 0.89% (6). In addition, a study of 556
patients receiving care in a Veteran Affairs healthcare system found
that, compared to controls, a greater proportion of patients randomized to a nurse case manager (NCM) intervention achieved the
collective treatment target for A1C levels, BP and low-density lipoprotein levels (11).
Although there is overwhelming evidence supporting NCM
models in the treatment of diabetes, these studies have been conducted predominantly in primary care and community-based settings in the United States and Europe (6). In fact, of the 29 case
management studies in the meta-analysis of Welch et al (6), only
1 study was conducted with patients attending a tertiary care clinic
in Canada. That randomized controlled trial of 46 patients with diabetes found a signi?cant reduction in A1C levels associated with a
telephone-based nursing intervention compared to standard care
conditions (12). However, the study recruited patients with both
type 1 and type 2 diabetes requiring insulin, and it focused on insulin
titration to the exclusion of other core self-management issues, such
as healthful eating, physical activity and psychosocial well-being.
To our knowledge, no studies of NCM-assisted patients with diabetes have been conducted in a Canadian tertiary care setting that
focus on comprehensive care of patients with type 2 diabetes only
who are being treated with oral agents and/or insulin.
The current study is the ?rst randomized controlled trial (RCT)
to evaluate the impact of NCM intervention for patients with poorly
controlled type 2 diabetes who were recently discharged from 2 tertiary care hospitals in Canada or referred by tertiary hospitala?liated endocrinologists. In addition, this Canadian-based study
is the ?rst to include both a primary clinical outcome (A1C levels)
and a psychosocial outcome (diabetes distress).
Study design, setting and population
This study was approved by the University of British Columbia
and Providence Health Clinical Research Ethics Boards. It is an RCT
of a 6-month NCM intervention compared to standard care (SC). The
study was initiated in September 2012, enrollment was completed in July 2014, and follow up was completed in January 2015.
The protocol is viewable at https://clinicaltrials.gov/ct2/show/
NCT01659294.
The study was conducted at BCDiabetes.ca, based in the Gordon
and Leslie Diamond Health Care Centre. The centre is the main tertiary care centre in Vancouver, British Columbia, and brings together
outpatient services at Vancouver General Hospital, including specialty clinics, along with medication education, physician teaching clinics and research, at a single site.
Inclusion/exclusion criteria
To be eligible for the study, patients had to 1) have physiciandiagnosed type 2 diabetes; 2) be =18 years of age; (3) have A1C levels
=8% and 4) to be able to read and write English. Patients were
excluded if they had previously worked with an NCM or had any
serious health conditions (e.g. terminal cancer), serious psychiatric illness or self-reported excessive alcohol or illicit drug use that
would impede meaningful participation in the study.
Recruitment
Study participants were recruited using 2 streams: 1) patients
who had been recently discharged from 2 tertiary care hospitals in
Vancouver (Vancouver General Hospital or St. Paul?s Hospital) and
2) patients referred by endocrinologists a?liated with the 2 tertiary care hospitals. If recruited from the hospital, the invitation to
participate in the study was made by a member of the treating endocrine team (endocrinology fellow or resident). The primary endocrinologist or the member of the team brie?y described the study
and its eligibility criteria. The NCM contacted interested patients
and scheduled initial visits during which she described the study
in greater detail, obtained informed consent and conducted baseline assessments. In the case of outpatient referrals, the invitations came from the treating endocrinologist. These patients had
been referred to the treating endocrinologist by their communitybased family (primary) physician. All potential subjects who met
the study entry criteria were approached by treating endocrinologists to participate in the study. As such, participants were representative of new diabetes referrals (with A1C levels >8.0) seen by
the referring endocrinologists.
Randomization process
Each participant was randomly assigned to the intervention or
control group by using a strati?ed permuted block randomization
scheme, with the endocrinologist being the sole strati?cation factor.
The permuted block aspect of the randomization scheme ensured
that treatment assignment remained balanced throughout the enrolment period. Randomized assignments were completed in advance
and kept in individual, sealed, sequentially labelled envelopes that
were opened at the time of the randomization of each participant.
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D. Li et al. / Can J Diabetes 41 (2017) 297?304
Nurse case manager intervention
Nurse case management was conducted by a single individual,
GK, a certi?ed diabetes educator with a master?s degree in nursing
and 37 years of nursing experience. The nurse received informal
in-house diabetes training by working with 1 of the endocrinologists.
The general principle (although not the exact framework) used
by the NCM was the Empowerment and Self-Management model
developed by Funnell and Anderson (13).
NCM intervention was an adjunct to standard care. Participants in the NCM group received a 60-minute initial consultation
with the NCM, followed by contact via telephone or e-mail or in
person at a minimum of every other week initially and, thereafter, as each participant warranted. The purpose of follow-up contact
was to monitor participants? diabetes control, risk factors and management goals and to recommend treatment additions or modi?cations where desirable. There were 3 core components of the NCM
intervention: 1) diabetes self-management education and support;
2) monitoring and algorithm-driven treatment adjustment; and 3)
care coordination with other health professionals.
Diabetes education
A brief education-needs assessment was made. All participants were asked to talk about their conditions and to say what they
felt had contributed to their diagnoses and what had helped them
to handle their diabetes and what had not. Participants were asked
to read information that was given and then to explain what they
had read in their own words.
During the initial consultation prior to randomization, the NCM
delivered diabetes education and provided supplementary written
literature to patients.
Broad topics included the process of diabetes, health behaviour
changes, healthful eating, physical activity and the role of medication, the meaning of A1C levels, the role of blood glucose monitoring, short- and long-term complications, stress and coping.
Whenever participants were prescribed sulfonylureas and/or insulin,
they were educated in the concept of purposeful blood glucose monitoring (target driven) and were given home blood glucose monitors and 10 strips.
All of the NCM participants were asked what their target goals
were: blood glucose, exercise, weight (and smoking cessation if relevant) and where they felt comfortable. Informal contracts between
participants and educators were discussed and implemented, either
in writing in the nursing notes or verbally, laying out a plan of what
the participants and nurses were to do.
Participants were given diabetes-related information in their
mother tongue where possible. Literacy was evaluated at consent,
when the participants were asked to read the consent form and
restate them in their own words. Some could not read English at
the level required for understanding and, therefore, were not given
written diabetes information. Picture-based materials from the Canadian Diabetes Association were offered to those who appeared to
bene?t from such materials. Those able to read at su?cient levels
of understanding were given written diabetes-related information from the Canadian Diabetes Association and BCDiabetes.ca; free
literature from local big-chain pharmacies was offered; when appropriate, participants were given the book Understand Your Diabetes
(14).
Discussions where initiated about what was good information
and what was not so good. Other Internet sources were accessed
and discussed as ways of discovering what to believe and what not
to listen to.
299
purposeful blood glucose monitoring; glucose targets were determined by the referring endocrinologist. Participants were instructed
by the NCM to communicate their blood glucose monitoring results
by e-mail or phone. The NCM offered feedback and intervention
when they were considered appropriate. Blood pressure readings
and targets were discussed with participants; when medication
adjustments were considered desirable, the NCM communicated
directly with the endocrinologist. With respect to insulin adjustment, the NCM independently adjusted insulin according to the following algorithms: 1) for once-daily basal insulin adjustment, target
fasting glucose levels were 5 mmol/L to 7 mmol/L. Patients were
encouraged to make daily adjustments in dose (default increments of 2 U for above-target and decrements of 4 U for below target,
no change for to-target values); 2) for twice-daily basal insulin,
fasting glucose targets were used to adjust evening insulin doses,
and evening blood glucose targets were used to adjust morning
insulin doses (same adjustment parameters as those for oncedaily basal insulin); 3) for prandial rapid insulin, participants were
asked to test before and 2 hours after meals; the before-meal targets
were 5 mmol/L to 7 mmol/L, and the 2-hour post meal targets were
5 mmol/L to 10 mmol/L. The NCM reviewed the concept of carbohydrate counting and iterated the carbohydrate-to-insulin ratio.
Linkage to allied healthcare services
The NCM determined the need for adjunct interventions. When
indicated, and after consultation with endocrinologist and/or family
physicians, participants were referred to the following: outpatient mental health clinics, smoking cessation clinics, physiotherapy groups, nutrition counselling, social services and/or walking/
exercise/sports programs in the community.
Eye examination referrals were made to local expert optometrists for all participants who had not had a retinal check in the
past year. Podiatric referrals were made when clinically indicated.
Specialist medical referrals for comorbid conditions were made as
necessary during the study by the treating endocrinologist.
With respect to communication between the participants and
the NCM, all participants were given the nurse?s contact information (o?ce phone, e-mail and, if on insulin, cell phone number).
The frequencies and dates and times of education and support were
agreed upon by the patients and the NCM. Patients who requested
more support accessed the NCM more often. The NCM would
follow up by phone or e-mail with patients new to insulin and set
up a contact schedule dependent upon patient preference and
reported blood sugar levels. Patients undergoing dose adjustments contacted the NCM daily usually in the morning, with their
fasting blood sugar levels so as to gain assistance with dose adjustments. However, once the patients were comfortable with the algorithm, they managed their own dose adjustments independently
and contacted the NCM only for scheduled appointments. If the NCM
participant did not call at the expected time, the nurse called the
participant. After a third call by the nurse, all further calls were initiated by the participant unless for a further prearranged call.
With respect to diabetes-related distress and depression, discussion was initiated with all treatment participants about the association between depression and diabetes; answers to questions by
subjects in the study questionnaires were pursued. The nurse encouraged discussion about thoughts and feelings and about activities
the subjects enjoyed. Inquiries were made about alcohol and substance abuse and about access to counsellors or psychiatrists. Referrals to psychiatrists were suggested and facilitated by the treating
endocrinologist, as necessary.
Standard care
Monitoring and algorithm-driven treatment adjustment
Participants randomized to the NCM cohort were reviewed by
the NCM at intervals determined and driven by the results of
Beyond the NCM?s arranging for the second and ?nal visit at
6 months to collect study-speci?c data points, SC participants were
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300
D. Li et al. / Can J Diabetes 41 (2017) 297?304
managed entirely by the referring endocrinologist, who determined treatment parameters, made changes to treatment regimens and scheduled follow-up appointments according to their usual
patterns of practice.
Demographic characteristics
Demographic characteristics included age, gender, years diagnosed with diabetes, ethnicity, marital status, education level, income
and employment status.
Participation and assessment
Sample size and power
Participants in both the NCM group and the SC group completed baseline and 6-month assessments. A week prior to these
visits, participants were instructed to have their A1C levels measured at a self-selected laboratory. If no blood had been drawn prior
to the visit, blood was drawn on the day of the visit with the NCM,
and point-of-care A1C levels were measured at the time of the visit
so as to direct clinical decision making. At the NCM visit, participants had the following measured: BP, weight and height. Participants also completed a 20-minute self-report survey. Upon
completion, participants received a stipend of $20 for their time and
effort.
Outcomes and measurements
Primary outcomes included A1C levels and diabetes distress. The
A1C levels were measured at a participant-selected laboratory that
used standard high-performance liquid chromatography methods
on a machine calibrated to the national standard (mean 5.0%, top
of normal range = 6.0%). For participants who did not obtain blood
work at a laboratory prior to baseline and the 6-month assessment, the NCM performed point-of-care testing using the Bayer
DCA2000+ Analyzer (Bayer, Keverkusen, Germany) (15). Diabetes
distress was assessed using the 17-item Diabetes Distress Scale (DDS)
developed by Polonsky and colleagues (16). The DDS measures emotional distress and functioning as they relate to living with diabetes. Responses are scored on a 6-point Likert scale (1 = no problem
to 6 = serious problem). A total score is derived by taking the mean
of all items. A score of 0.08). Although various ethnic groups were involved in the study,
about half were Caucasian. The mean age of the participants was
57 years, and the mean number of years of living with diabetes was
11; 54% were married, 58% were male, 31% had high school educations or less, 54% were employed and 48% reported an annual
income of less than $50 000.
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D. Li et al. / Can J Diabetes 41 (2017) 297?304
301
Figure 1. Study ?owchart. A1C, HbA1c; GP, general practitioner; NCM, nurse case management; SC, standard care.
Table 1
Demographic information concerning the modi?ed intent-to-treat population
All
N=134
SC
n=64
NCM
n=70
Age
Years with
diabetes
Gender
Mean (SD)
57.43 (11.01) 58.23 (10.87) 56.69 (11.16)
Mean
10.84
11.84
9.91
(SD)
(8.24)
(8.10)
(8.33)
Male
78 (58%)
37 (58%)
41 (59%)
Female
56 (42%)
27 (42%)
29 (41%)
Ethnicity
Arabic
3 (2%)
2 (3%)
1 (1%)
Black
4 (3%)
2 (3%)
2 (3%)
Chinese
19 (14%)
5 (8%)
14 (20%)
First Nations
5 (4%)
4 (6%)
1 (1%)
South Asian
15 (11%)
9 (14%)
6 (9%)
White
65 (49%)
29 (45%)
36 (51%)
Other
23 (17%)
13 (20%)
10 (14%)
Marital
Never married
27 (20%)
11 (17%)
16 (23%)
Married
72 (54%)
33 (52%)
39 (57%)
status
Living with partner
3 (2%)
3 (5%)
0 (0%)
Separated/divorced
20 (15%)
12 (19%)
8 (12%)
Widowed
11 (8%)
5 (8%)
6 (9%)
n missing
1 (1%)
0
1 (1%)
Education
Less than high school
12 (9%)
9 (14%)
3 (4%)
High school
29 (22%)
11 (17%)
18 (26%)
College/technical
32 (24%)
15 (24%)
17 (24%)
University
41 (31%)
22 (35%)
19 (27%)
Graduate degrees
19 (14%)
6 (10%)
13 (19%)
n missing
1 (1%)
1 (1%)
0
Income
$20,000
30 (22%)
20 (31%)
10 (14%)
$20,000?$29,000
14 (10%)
6 (9%)
8 (11%)
$30,000?$39,000
17 (13%)
7 (11%)
10 (14%)
$40,000?$49,000
16 (12%)
10 (16%)
6 (9%)
$50,000?$59,000
9 (7%)
5 (8%)
4 (6%)
$60,000?$69,000
11 (8%)
5 (8%)
6 (9%)
$70,000
37 (28%)
11 (17%)
26 (37%)
Employment Full time
60 (45%)
26 (41%)
34 (49%)
Part time
12 (9%)
6 (9%)
6 (9%)
Unemployed
9 (7%)
5 (8%)
4 (6%)
Homemaker
4 (3%)
2 (3%)
2 (3%)
In school
1 (1%)
0 (0%)
1 (1%)
Retired
35 (26%)
17 (27%)
18 (26%)
Other
13 (10%)
8 (12%)
5 (7%)
NCM, nurse case management; SC, standard care.
Note: No signi?cant differences between randomized groups; all p values >0.05.
Primary outcomes
Glycemic control
At baseline, glycemic control was inadequate for both the NCM
and the SC groups (Figure 2, Table 2). At the 6-month follow up,
both groups had achieved signi?cant reductions in mean A1C levels
Figure 2. Changes in A1C levels and DDS scores in 6 months in the NCM and SC groups.
Sample means with 95% CIs for each treatment group at baseline and after 6 months
are shown. A1C, HbA1c; DDS, diabetes distress score; NCM, nurse case management; SC, standard care.
(from 10.45%?2.13% to 7.72%?1.43; p
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