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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 Division of Endocrinology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada b BC Diabetes, Vancouver, British Columbia, Canada

a r t i c l e i n f o

Article history: Received 2 May 2016 Received in revised form 17 October 2016 Accepted 21 October 2016

Keywords: diabetes nurse case manager randomized controlled trial tertiary care setting diabetes distress psychosocial outcomes

a b s t r a c t

Objectives: To examine the effects of a 6-month nurse case manager (NCM) intervention compared to stan- dard 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 out- comes included body mass index, blood pressure, diabetes-related behaviour measures, depressive symp- toms, 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.

Mots clés : infirmière gestionnaire de cas de diabète essai clinique à répartition aléatoire cadre des soins tertiaires détresse liée au diabète critères de jugement psychosociaux

r é s u m é

Objectifs : Examiner les effets de l’intervention de 6 mois d’une infirmière gestionnaire de cas (IGC) par rapport aux effets des soins courants (SC) sur la régulation de la glycémie et la détresse liée au diabète dans le cadre canadien des soins tertiaires. Méthodes : Nous avons recruté 140 adultes atteints du diabète de type 2 qui avaient des concentrations d’hémoglobine glyquée (A1c)>8% (64 mmol/mol) de 2 établissements de soins tertiaires et les avons répartis de manière aléatoire comme suit : 1) intervention de 6 mois d’une IGC en plus des SC ou 2) SC par les endocrinologues traitants. Les évaluations ont été réalisées au début et après 6 mois. Les critères de jugement principaux étaient les concentrations de l’A1c et les scores de la détresse liée au diabète (SDD). Les critères secondaires étaient les suivants : l’indice de masse corporelle, la pression artérielle, les mesures du comportement lié au diabète, les symptômes de dépression, la motivation personnelle et la perception du soutien. Résultats : Au suivi après 6 mois, le groupe IGC montrait des réductions 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 réduction des SDD de −0,40 (réduction de 26%) par rapport au groupe SC (p=0,001; n=134). Les adultes du groupe IGC avaient une pression artérielle plus basse, mangeaient plus de fruits et de légumes, faisaient plus d’exercice, vérifiaient leurs pieds plus fréquemment, étaient plus motivés, étaient moins dépressifs et s’apercevaient d’un plus grand soutien. Il n’y avait aucun changement et aucune différence entre les groupes en ce qui concerne l’indice de masse corporelle, l’observance thérapeutique ou la fréquence 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]

Can J Diabetes 41 (2017) 297–304

Contents lists available at ScienceDirect

Canadian Journal of Diabetes j o u r n a l h o m e p a g e :

w w w. c a n a d i a n j o u r n a l o f d i a b e t e s . c o m

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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Conclusions : Comparativement aux SC, l’intervention d’une IGC était plus efficace pour améliorer la régulation de la glycémie et réduire la détresse liée au diabète. Par conséquent, il s’agit d’un complément viable aux soins courants offerts aux diabétiques dans le cadre des soins tertiaires, particulièrement chez les patients exposés à un risque élevé qui ont une régulation médiocre.

© 2017 Canadian Diabetes Association.

Introduction

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). Dia- betes and its associated complications are a significant 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 improve- ments 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 hemo- globin (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 evi- dence (4,5). In fact, a meta-analysis of 11 different quality- improvement strategies for diabetes care found that interventions involving case-management strategies led to the greatest reduc- tions in A1C levels (5). Case management encompasses the assess- ment, 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 diabe- tes case management interventions to be effective in improving gly- cemic 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 ran- domized to a nurse case manager (NCM) intervention achieved the collective treatment target for A1C levels, BP and low-density lipo- protein levels (11).

Although there is overwhelming evidence supporting NCM models in the treatment of diabetes, these studies have been con- ducted predominantly in primary care and community-based set- tings 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 dia- betes found a significant 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 dia- betes 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 first 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 ter- tiary care hospitals in Canada or referred by tertiary hospital- affiliated endocrinologists. In addition, this Canadian-based study is the first to include both a primary clinical outcome (A1C levels) and a psychosocial outcome (diabetes distress).

Methods

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 com- pleted 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 ter- tiary care centre in Vancouver, British Columbia, and brings together outpatient services at Vancouver General Hospital, including spe- cialty clinics, along with medication education, physician teach- ing clinics and research, at a single site.

Inclusion/exclusion criteria

To be eligible for the study, patients had to 1) have physician- diagnosed 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 psychiat- ric 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 affiliated with the 2 ter- tiary care hospitals. If recruited from the hospital, the invitation to participate in the study was made by a member of the treating endo- crine team (endocrinology fellow or resident). The primary endo- crinologist or the member of the team briefly 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 base- line assessments. In the case of outpatient referrals, the invita- tions came from the treating endocrinologist. These patients had been referred to the treating endocrinologist by their community- based family (primary) physician. All potential subjects who met the study entry criteria were approached by treating endocrinolo- gists to participate in the study. As such, participants were repre- sentative 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 stratified permuted block randomization scheme, with the endocrinologist being the sole stratification factor. The permuted block aspect of the randomization scheme ensured that treatment assignment remained balanced throughout the enrol- ment 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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Nurse case manager intervention

Nurse case management was conducted by a single individual, GK, a certified 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. Partici- pants 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, thereaf- ter, as each participant warranted. The purpose of follow-up contact was to monitor participants’ diabetes control, risk factors and man- agement goals and to recommend treatment additions or modifi- 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 partici-

pants 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 medi- cation, the meaning of A1C levels, the role of blood glucose moni- toring, 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 moni- toring (target driven) and were given home blood glucose moni- tors and 10 strips.

All of the NCM participants were asked what their target goals were: blood glucose, exercise, weight (and smoking cessation if rel- evant) 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 Cana- dian Diabetes Association were offered to those who appeared to benefit from such materials. Those able to read at sufficient levels of understanding were given written diabetes-related informa- tion from the Canadian Diabetes Association and BCDiabetes.ca; free literature from local big-chain pharmacies was offered; when appro- priate, 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.

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

purposeful blood glucose monitoring; glucose targets were deter- mined 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 adjust- ment, the NCM independently adjusted insulin according to the fol- lowing 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 incre- ments 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 once- daily 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 carbo- hydrate 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: outpa- tient mental health clinics, smoking cessation clinics, physio- therapy groups, nutrition counselling, social services and/or walking/ exercise/sports programs in the community.

Eye examination referrals were made to local expert optom- etrists 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 informa- tion (office 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 adjust- ments contacted the NCM daily usually in the morning, with their fasting blood sugar levels so as to gain assistance with dose adjust- ments. However, once the patients were comfortable with the algo- rithm, 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 ini- tiated by the participant unless for a further prearranged call.

With respect to diabetes-related distress and depression, dis- cussion was initiated with all treatment participants about the asso- ciation between depression and diabetes; answers to questions by subjects in the study questionnaires were pursued. The nurse encour- aged discussion about thoughts and feelings and about activities the subjects enjoyed. Inquiries were made about alcohol and sub- stance abuse and about access to counsellors or psychiatrists. Refer- rals to psychiatrists were suggested and facilitated by the treating endocrinologist, as necessary.

Standard care

Beyond the NCM’s arranging for the second and final visit at 6 months to collect study-specific data points, SC participants were

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managed entirely by the referring endocrinologist, who deter- mined treatment parameters, made changes to treatment regi- mens and scheduled follow-up appointments according to their usual patterns of practice.

Participation and assessment

Participants in both the NCM group and the SC group com- pleted baseline and 6-month assessments. A week prior to these visits, participants were instructed to have their A1C levels mea- sured 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, partici- pants had the following measured: BP, weight and height. Partici- pants 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 assess- ment, 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 emo- tional distress and functioning as they relate to living with diabe- tes. 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 <2 indicates low or no distress; a score of 2 through 2.9 indicates moderate distress; and a score of ≥3 indi- cates high distress.

Secondary outcomes included clinical, behavioural and psycho- social outcome measures.

BP was measured using an Omron Digital Blood Pressure Monitor HEM-907 (Kyoto, Japan). Two upper-arm readings were taken, and the average of the 2 was recorded. Height and weight were mea- sured using the Health o meter mechanical eye-level upright stan- dard physician’s scale with attached stadiometer (Sunbeam, Boca Raton, Florida, United States). Body mass indexes were calculated as weight in kilograms divided by height in metres squared.

Self-management behaviours were assessed using items from the Summary of Diabetes Self-Care Activities Measure, revised (17). This instrument measures self-care behaviours, including diet, exer- cise, blood-sugar testing and foot care. Participants were asked to report the number of days in the past week (range, 0 to 7 days) during which they performed specific self-care practices. Greater numbers of days indicated better self-management. Medication adherence was assessed using the 4-item Morisky scale that assesses beliefs and behaviours associated with taking medications (18). Responses were scored on a dichotomous scale: 0 = no, and 1 = yes. A total score was calculated by adding up all items; lower scores indicated better adherence.

Participant motivation was measured by the 13-item Patient Acti- vation Measure, which assesses participants’ self-reported knowl- edge, skills and confidence in managing their own health (19). Diabetes-specific social support was assessed by a 4-item scale devel- oped by Tang et al (20) that measures the amount of support and satisfaction with that support by family members, friends and the healthcare team. Depressive symptom severity was assessed using the 9-item PRIME-MD Patient Health Questionnaire (PHQ-9) (21,22).

Demographic characteristics

Demographic characteristics included age, gender, years diag- nosed with diabetes, ethnicity, marital status, education level, income and employment status.

Sample size and power

Based on the current literature, an A1C level difference of 0.5% or more was considered clinically significant. To achieve 80% power in a 1-sided 0.05-level t test, a sample size of 72 subjects per arm was considered necessary if the true difference in A1C levels between the NCM group and the SC group was 0.5%. This assumed a stan- dard deviation of the difference in A1C levels between baseline and 6 months of 1.2% and that it was common to both groups (23). Although DDS was established as an additional primary outcome at the onset of the study, it should be noted that sample size was calculated with only A1C levels in mind. Furthermore, many sec- ondary outcomes were included without changes in sample size. Recognizing the importance of well-powered studies, caution should thus be taken in interpreting the results.

Statistical analysis

Demographic characteristics of the sample are described as means and standard deviations if they are continuous and as counts and percentages if they are categorical. Baseline values for demo- graphic and clinical variables were compared between the 2 arms to identify potential confounding variables. Categorical variables were assessed by chi-square tests, with Monte Carlo-simulated p values when necessary.

Because the primary outcomes (A1C levels and diabetes dis- tress) and the secondary outcomes are continuous measures, the assessment of whether the mean differences between the 2 groups were statistically significant was conducted using the Student t test, adjusting for baseline values. No adjustment for multiple testing was made.

A modified intention-to-treat approach was used, in which data from all participants who provided baseline and follow-up out- comes were included and analyzed based on NCM-SC group assign- ments, regardless of whether each individual participant received the assigned treatment.

Results

Study sample

There were 251 patients who met the inclusion criteria, and 140 patients who consented to participate in the study (Figure 1). Six patients did not complete baseline assessment. At the 6-month follow up, 130 patients completed A1C measurements, and 120 patients completed the survey (attrition rate 7% and 14%, respec- tively). Loss to follow up was not different in the 2 groups.

Participants’ characteristics

Table 1 presents the baseline demographic characteristics of the study’s population. No significant differences were found in the NCM and SC groups in terms of gender, ethnicity, martial status, educa- tion level, employment status or household income (all p values >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 edu- cations or less, 54% were employed and 48% reported an annual income of less than $50 000.

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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 significant reductions in mean A1C levels

(from 10.45%±2.13% to 7.72%±1.43; p<0.01, and from 10.52%±2.08 to 8.46%±2.29; p<0.01, respectively). The NCM group experienced significantly larger reductions in A1C levels (−0.73%) (Figure 2, A) compared to the SC group (p=0.027; n=134).

Diabetes distress At baseline, both the NCM and the SC groups had diabetes dis-

tress in the low to moderate category. At the 6-month follow up, the NCM group had significantly lower mean DDS scores com- pared to those found at the start of the intervention (from 1.90±0.77 to 1.37±0.38; p<0.01). This implies that the DDS score was reduced from near moderate to low. The SC group showed no change in DDS scores (from 1.92±0.84 to 1.78±0.91; p=0.23). Participants in the NCM group showed an additional reduction of −0.40 (26%) in DDS scores (Figure 2B) compared to those in the SC group (p=0.001; n=134), and all had low levels of diabetes distress at the end of the study.

Secondary outcomes

Clinical outcomes In the NCM group, the average …