Implementation of a nurse-led self-management support programme among patients with diabetes in primary care: inquiry into efficiency

The increased risk for mental health problems in a chronic patient is at least
twice as high as in the general population. The mutual relation between
psychological problems and disease management leads to a downward spiral,
disempowering the people involved and negatively influencing the course of the
chronic disease. The consequences can be translated in terms of decreased
individual well-being as well as increased social cost.

Given the increasing number of chronic patients, the need for a significant
transformation of health care is recognized. Current health policy stresses the
importance of a pro-active approach that supports patients in day-to-day
management of their chronic condition. However, treatment is yet mainly
focused on the biomedical or clinical aspects of the chronic disease itself
rather than on its psychosocial consequences. Psychosocial problems often
remain unrecognized and are under-treated in current health care. If
co-occurring mild or moderate mental problems are detected, they have
increasingly been prescribed antidepressants and benzodiazepines. It does not
support patients to handle impaired abilities in daily life by learning how to
self-manage them.

Integrating diagnostics and psychological counselling in routine care is
essential to actively prevent a downward spiral in chronic patients. We will
evaluate the integration of an (cost) effective nurse-led intervention into the
regular encounters between patients with diabetes mellitus type 2 and practice
nurses. The intervention will be supplemented by a feasible (stepped) screening
method to examine patients* need for self-management support. It primarily aims
to improve daily functioning of patients. The practice nurse facilitates that
patients explore possible solutions for their problems themselves, so the
individual context of patients will be taken into account.

Our pragmatic trial aims to integrate a cost-effective innovative care
intervention in regular primary care. The intervention needs to be adapted for
practice nurses to detect mental health problems in physical chronic patients
and to provide, according to one*s needs, support in self-management, during
regular consultations. Integrating this pro-active approach in routine care has
to enable a shift towards integral chronic care, with simultaneous attention to
both somatic and psycho-social aspects of a chronic physical disease. This
approach intends to improve daily functioning of chronic patients.
The primary objective of this study is to evaluate the implementation of SMS
provided by practice nurses during regular diabetes check-ups. The following
questions will be addressed:
1. What is the effect of implementation of SMS in regular primary care on
perceived problems in daily functioning (primary outcome) and on the secondary
outcome parameters participation and autonomy, control over the disease,
self-efficacy, quality of life, and appreciation of care of diabetes type II
patients? (effect evaluation)
2. In what extent is it, from a societal perspective, cost-effective to deliver
SMS in the primary care setting? (economic evaluation)
3. What are barriers hampering the integration of SMS in regular care at the
level of the practice organization, practice nurses, general practitioners and
the patients involved? (process evaluation)

After successful implementation, care for mental health problems can easily be
permanently integrated in the regular payment system, not only for diabetes but
also in the future for COPD and CVD.

The design involves a pragmatic, 2-armed randomized trial with an intervention
arm of 23 practice nurses applying SMS added to usual care, and a control arm
of 23 practice nurses providing care as usual. A cluster randomisation on POH
level is necessary as the POH is a unit of analysis. Usual care consists of
3-monthly check-ups conforming to diabetes guidelines. SMS will be integrated
in the regular encounters between diabetes type 2 patients and practice nurses
in general practice. Practice nurses in the intervention arm will be trained to
carry out SMS. Practice nurses in the control arm receive training after T12.
Follow-up measurements will be carried out by patient questionnaires at
baseline, and 3 and 12 months after inclusion. Cost measurements will be
carried out by means of random cohort measurement (3 subgroups retrospectively
measure 3 random months a year). Process evaluation will focus on actual
performance and possible barriers/facilitators for the implementation of SMS.
Both quantitative and qualitative information will be collected among practice
nurses, patients and GP*s.

To maintain the desirable contrast between intervention and control group, and
to guarantee comparability between both groups, practice nurses will not be
involved in the detection of patients with mental problems. Recruitment of
patients will be carried out equally for both groups by the researcher.
Patients who visit their practice nurse for a diabetes check-up within the next
two months will be sent the Distress Screener (DS, 3 items), and the Daily
Functioning Thermometer (DFT), a VAS-scale indicating problems with daily
functioning. Patients give informed consent to use the scores for recruitment
of eligible patients. For each practice nurse, 10 consecutive patient with
moderate or severe mental problems (DS > 3 and/or DFT < 6) will be asked to
participate in the study and give informed consent for participation.

After training, a practice nurse is supposed to be competent regarding the
following elements:

1. Each patient who visits a practice nurse will be examined for problems with
daily functioning following the limitations of their diabetes. If applicable
the Distress Screener (DS) and Daily Functioning Thermometer (DFT) will be
administered and, if indicated (with DS > 3 and/or DFT < 6), patients complete
the 4DSQ, a self-report questionnaire that distinguishes between patients with
mild, moderate or severe mental health problems. Patients with severe problems
will be referred to the GP.
2. Providing patients having moderate problems of functioning with Problem
Solving Support, unless their problems are too emotional. Problem Solving
Support consists of 7 stages that efficiently address psychosocial problems:
(a) defining the problem, (b) setting achievable goals, (c) generating
alternative solutions, (d) evaluating pro*s and cons, (e) choosing solutions,
(f) implementing the preferred solution and (g) evaluating the outcome.
3. Use of reattribution in patients with strong emotional involvement. Practice
nurses will take the problems of daily functioning as a starting point and will
aim at reattribution of negative cognitions, by stimulating positive
behaviours.
An essential characteristic of SMS, as the practice nurse will be trained for,
is to tailor it to the specific needs and context of a patient. Problems and
solutions are mainly defined by patients themselves. The practice nurse only
facilitates decision making about action plans by the patient him/herself.





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Experiences with SMS in the previous study DELTA show that the perceived burden
is very low. Chronically ill elderly patients were satisfied and would
recommend the intervention to other patients with a chronic condition. More
than 90% of the participating patients suggested implementation of the
intervention in regular care.

In our pragmatic trial, the effect of this innovative care intervention
integrated in regular care will be evaluated. SMS will be integrated in the
daily work of POH's in the intervention group. It takes place during regularly
diabetes check-ups. If necessary, the (three-quarterly) consultation will be
advanced.Practice nurses in the control arm will be trained in SMS after
follow-up.

Patients will be recruited for the two trial arms using two short
self-administered questionnaires (DS and DFT). Patients in the control group do
not complete the 4DSQ at T0, to prevent patients' awareness of mental health
problems without providing self-management support from trained practice
nurses. However, we do not keep patients from psychosocial care.
Follow-up measurements will be carried out after the inclusion visit, and 3 and
12 months after inclusion. Data will be collected using self-administered
questionnaires. With regard to the process evaluation, some patients will be
invited for a semi-structurered interview (after T12) . Besides, communication
between POH and patient during the diabetes check up will be audio recorded
after patients' informed consent.