Design, setting, participants

DelpHi-MV is a population-based cluster-randomized controlled intervention trial in the primary care setting; details (including sample size calculation) are described in the study protocol (Thyrian et al., Reference Thyrian2012). Enrolment into the study started in January 2012; the estimated primary completion date (first follow-up) is January 2015. Eligible patients (older than 70 years, living at home) of participating GP-practices are screened for cognitive impairment with the DemTect (Calabrese and Kessler, Reference Calabrese and Kessler2000). Patients who meet the inclusion criteria (DemTect <9) are informed by their GP about the study and are asked to participate and to sign a written consent. If the patient can name a caregiver, he or she is asked to participate as well. In case the patient is not able to give informed consent, his or her legal representative is asked to sign (as approved by the Ethical Committee of the Chamber of Physicians of Mecklenburg-Western Pomerania, registry number BB 20/11).

Participants and their caregivers are cluster-randomized into an intervention and a control group. Participating GP-practices in Mecklenburg-Western Pomerania represent the clusters for randomization (1:1 allocation ratio). Baseline and annual follow-up assessments are conducted identically in both groups. Whereas the control group receives “care as usual,” the intervention group receives the “DelpHi-Intervention” (see Figure 1 for an outline of the DelpHi-Intervention). The intervention is initiated and coordinated by Dementia Care Managers (DCMs), qualified nurses who received a dementia-specific training (Dreier et al., Reference Dreier, Thyrian and Hoffmann2011).

Figure 1. Outline of DelpHi-Intervention.

Baseline assessment

Patients who were included into the study are contacted by their designated DCM to arrange two to three personal visits at their homes to carry out a comprehensive standardized baseline assessment. The DCM collects standardized data regarding each patient's specific social, medical, psychological, pharmaceutical, and nursing situation to identify in detail the individual needs and resources of the PwD and his or her caregiver (for details see Table 1).

Table 1. Instruments used at baseline and in-depth assessment

¹Primary outcome measure.

²Secondary outcome measure.

³Trigger for intervention task.

Note: C, caregiver; DCM, Dementia Care Manager; PwD, person with dementia; C/DCM→ PwD, assessment of PwD by C or DCM; SDQ, self-developed questionnaire.

The baseline assessment includes a home medication review (HMR; Fiß et al., Reference Fiß, Thyrian and Hoffmann2013; submitted). The DCM records all drugs used by the PwD, including non-prescription medicines. In addition the DCM collects data about storage, usage (dosage, time to meal), adherence, adverse drug events, and other drug-related problems. For the intervention group this information is summarized and passed on to the regular pharmacy of the PwD, provided the PwD consented in forwarding this data and the specified pharmacy participates in the DelpHi-MV study as well. The pharmacist is trained to conduct the standardized DelpHi-medication review concerning drug-related problems such as double prescriptions, side effects, interactions, or potentially inappropriate medications that carry an increased risk of adverse drug events in elderly patients according to the German PRISCUS-list (Holt et al., Reference Holt, Schmiedl and Thürann2010). The resulting medication review including specific pharmaceutical advices is faxed to the study center. The DCM includes the medication review and the pharmacist's advice in her GP-information letter (see below). In case the regular pharmacy of a PwD is not participating, the DelpHi-MV study pharmacist conducts the medication review instead.

Intervention: the “DelpHi-Standard”

After baseline assessment the intervention group receives the DelpHi-Intervention according to the “DelpHi-Standard” for one year. The DelpHi-Standard was designed to optimize care for the PwDs and their caregivers according to the World Health Organization (1986) definition of health: “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” To meet this requirement, the intervention has to be complex, multi-professional, multimodal, and adjusted to individual needs and resources of the individual PwD and his or her caregiver as well as to local conditions.

The development of the DelpHi-Intervention is based on German guidelines for evidence-based diagnostic and treatment of dementia (DEGAM, 2008; DGPPN and DGN, 2009), a review of current literature (e.g. Vollmar et al., Reference Vollmar, Koch, Löscher and Butzlaff2007; Förstl, Reference Förstl2009), meetings and symposia with experts in the field, and the scientific advisory board of DelpHi-MV. To describe the “DelpHi-Standard,” three key areas – the “pillars of intervention” – where defined: (1) management of treatment and care, (2) medication management, and (3) caregiver support and education. Associated with these pillars are eight different action fields, where each action field includes several foci. Every focus comprises specific intervention modules that constitute the actual basis for the work of the DCM (see Figure 2).

Figure 2. Optimum Care as “DelpHi-Standard”: pillars, action fields, foci, and intervention modules (red marked area see Figure 3).

Each intervention module consists of defined algorithms that contain the trigger condition(s) derived from standardized baseline and/or in-depth assessment (see Table 1) that activate(s) a specific intervention task and at least one criterion for successful completion of that task (see Figure 3).

Figure 3. Example of an intervention module.

The DelpHi-Intervention comprises 95 of such predefined intervention modules. Feasibility, adequacy, and acceptance of intervention modules were tested and revised during the pilot phase of the study (n = 6 GPs, n = 21 probands of intervention group). Since the study takes place in the setting of routine care new developments in treatment guidelines will be incorporated into the intervention, otherwise the intervention will not be modified while it is being tested.

The comprehensive list of intervention modules helps to ensure that (1) all PwDs and their caregivers receive tailored interventions according to their individual needs and resources, and (2) the DCM would not overlook any necessary aspects of DelpHi-Intervention despite its broad spectrum and complexity.

There are following different types of intervention modules, examples of which are shown in Table 2:

Table 2. Examples for different types of intervention modules

Note: GDS, Geriatric Depression Scale; M.I.N.I., Mini International Neuropsychiatric Interview; NPI, Neuropsychiatric Inventory; CareNapD, Care Needs Assessment Pack for Dementia; ICD-10, International Classification of Disease 10; BIZA-D, Berliner Inventar zur Angehörigenbelastung Demenz; DCM, Dementia Care Manager; DCM → GP, recommendation of intervention task to general practioner; (→ DCM), delegation of intervention task to DCM by GP possible.

1. (1) In-depth assessment: standard assessment indicated a specific problem; the DCM needs to do further in-depth assessment to plan further intervention

2. (2) Case conference: assessment indicated a problem that needs to be discussed in an interdisciplinary case conference to decide whether a specific intervention task is indicated and should be recommended to the GP

3. (3) Evaluation of the situation by DCM: some situations are too complex to address with predefined algorithms; the DCM has to assess the individual situation and decide whether specific intervention tasks are indicated

4. (4) Recommendation to GP: assessment indicated a specific problem that needs to be addressed by GP and/or specialist

5. (5) Recommendation to GP, delegation of intervention task to DCM possible: assessment indicated a specific problem; the DCM recommends a certain intervention task to the GP who can then delegate this task to the DCM

6. (6) Intervention task for DCM: assessment indicated an intervention task that the DCM conducts on her own without involving the GP

7. (7) Emergency measure: in case of emergency the DCM initiates and/or conducts predetermined emergency measures

Even though, in principle, the list of predefined intervention modules forms the basis of DelpHi-Intervention, the DCM is not restricted to it. On the one hand the DCM can take additional measures if necessary – as long as these self-assigned tasks comply with principal requirements of the DelpHi-Intervention such as (1) not to double already established services but rather integrating the PwD into these or (2) not to violate patient autonomy. On the other hand it is not mandatory to conduct automatically generated intervention tasks if they do not seem appropriate from a clinical and/or nursing perspective. Non-conduction of such tasks needs to be reported and discussed in a case conference (see below). Reasons for adding as well as removing intervention tasks are documented.

Full documentation of both initiation and completion (including reasons for non-completion, if applicable) of all triggered as well as self-assigned intervention tasks is a vital part of the DelpHi-study.

A computer-assisted Intervention-Management-System (IMS) was developed to facilitate the planning and documentation of the DelpHi-Intervention. Rules for all predefined intervention modules were programmed. For data collection, the DCM uses a hand-held tablet computer with touch-screen functionality. All information entered by the DCM into the central DelpHi-information system is processed immediately (Meyer et al., Reference Meyer, Fredrich, Piegsa, Habes, van den Berg and Hoffmann2012). Whenever a predefined trigger condition is activated, the corresponding intervention task is automatically selected and assigned, including tasks for in-depth assessments and case conferences.

The DCM conducts all in-depth assessments indicated by the IMS (e.g. mobility tests, pain assessment, neuropsychiatric assessment) usually in her third home visit with the PwD. Based on these data, the IMS generates an individual preliminary list for the respective subject with suggestions for specific intervention tasks. This list is discussed and finalized in a weekly interdisciplinary case conference. Participants of this conference are the DCM, a nursing scientist, a neurologist/psychiatrist, a psychologist, and a pharmacist. The case conference is an important part of the study to check adherence to the study protocol as well as to assess the adequateness of the predefined intervention modules. Hence the case conference provides crucial information for later evaluation of the DelpHi-Intervention.

After the case conference the main results of the baseline and in-depth assessment as well as the finalized list of intervention tasks are summarized by the DCM in a semi-standardized GP- information letter that contains (1) a cover letter that gives a brief description of the patient's social, physical, and mental needs and resources as well as some prioritized suggestions for intervention, (2) a standardized report of the most important outcomes of baseline and in-depth assessments, and (3) a list of recommended intervention tasks. This letter is then discussed between GP and DCM to establish an individual treatment plan. Finally the GP decides whether s/he will conduct a suggested intervention task, delegate a task to the DCM, or rate a task as “not necessary.”

The GP-information letter is the main instrument for communication and coordination of DCM and GP and ensures that the GP plays a key role in the context of the DelpHi-Intervention.

During the first six months of the intervention period, the DCM conducts home visits at least monthly, taking all necessary steps to carry out her designated intervention tasks in close cooperation with the caregiver, the GP, and various healthcare and social service professionals and facilities.

The subsequent six months the DCM monitors the completion of all intervention tasks, mainly by telephone, but also in additional home visits if necessary.

Follow-up assessment

The intervention period is completed with the follow-up assessment after one year, which is conducted in the control group as well. To assess long-term effects of the intervention, annual follow-up assessments will be conducted in both groups for at least five years.