1.2.04 Information material for patients

1 Purpose and objective

At the beginning of the treatment and during the course of it, the practitioner must explain to the patient in a comprehensible manner all the circumstances that are important for the treatment.

Written or graphic information in the form of "instructions accompanying the product" should be provided to patients. This is intended to provide patients with knowledge about their own illness, the necessary behaviour and the attitude of their environment towards the illness. Access to information material on illnesses and treatment procedures in general. Improving compliance after inpatient treatment, advice on behaviour in hospital, e.g. paying attention during treatment.

The duty to inform the patient (Section 630c (2) sentence 1 BGB) goes beyond the duty to provide information prior to medical interventions. While the latter concerns information that is necessary for the decision on the intervention, this refers to general information about the entire treatment (therapeutic information and safety information). Written or graphic information serves to provide information accompanying the product. They should be handed out before the treatment. The aim is to provide patients with knowledge about their own illness, the necessary behaviour and the attitude of their environment to the illness.

Information on medication and behaviour in the event of adverse drug reactions. Use of the WHO mobile phone app MedSafe (5 Moments for Medication Safety tool).

On discharge, the patient receives information about the diagnosis, the type of treatment, recommendations on behaviour and follow-up measures (re-presentation, follow-up examination, rehabilitation).

Information must be provided on the costs of treatment, especially if the insurance cover does not extend to the services offered

The duty to provide information in the event of recognisable treatment errors must be observed (see also VA 5.3.18).

2 Scope of application

List of treatment procedures for which product instructions have been prepared. The aim is to have instructions for all major operations and for all lengthy, lifestyle-altering or complex treatments. Provision of information material on individual treatment procedures.

3 Description

3.1 General information

The duty to inform the patient (Section 630c (2) sentence 1 BGB) goes beyond the duty to provide information prior to medical interventions. While the latter concerns information that is necessary for the decision on the intervention, this refers to general information about the entire treatment (therapeutic information and safety information). Written or graphic information is used to provide information accompanying the product. They should be handed out before the treatment. The aim is to provide patients with knowledge about their own illness, the necessary behaviour and the attitude of their environment towards the illness.

Information on medication and behaviour in the event of adverse drug reactions. Use of the WHO mobile phone app MedSafe (5 Moments for Medication Safety tool).

On discharge, the patient receives information about the diagnosis, the type of treatment, recommendations on behaviour and follow-up measures (re-presentation, follow-up examination, rehabilitation).

Information must be provided on the costs of treatment, especially if the insurance cover does not extend to the services offered

The duty to provide information in the event of recognisable treatment errors must be observed (see also VA 5.3.18).

It is well known that compliance (or better: adherence, concordance, agreement) of a patient's behaviour with the doctor's instructions can be improved through information in discussions and instructions. They are necessary but not sufficient information for the patient. It is well known that even simple explanations are forgotten after a short time. The continuity of treatment can be improved if patients receive written and visualised information during their stay in hospital and on discharge.

3.2 Patient dialogue

The most convincing and lasting information is conveyed during the medical consultation. On discharge, a formal discussion should be held with the patient about what needs to be considered in detail. A checklist can be created for this purpose. It is recommended to follow the contents of the patient letter, which then serves both as a protocol and a reminder. Like all people in decision-making situations, patients check the information given to them. Only confirmation from several people or media will generate the necessary trust. Further enquiries or the mere desire to do so should therefore not be misunderstood as mistrust. You should consciously encourage the listener during the conversation and reassure them that "all serious experts will confirm what has been said" or explicitly point out any dissenting opinions.

3.3 Patient letter

For most standard procedures, patients receive a clear description of their treatment with instructions for behaviour after discharge. The letter contains a description of the treatment procedure, recommendations for aftercare and further lifestyle. It should always include information on exercise, diet (or advice that this is not necessary), necessary rest, further consultations with doctors, possible follow-up appointments. - Information for special diseases: when sexual intercourse, lifting and carrying, sport, etc. are possible.

- What further developments can be expected?

- If medication is prescribed, the name of the medication, its active pharmaceutical ingredient, the pharmaceutical form, the name of the manufacturer or reference to the interchangeability of comparable preparations, a note to read the package leaflet, the dosage (amount of the single dose, dosage interval, preferably with time of day, method and route of administration, duration of treatment)

- Precautions for use, warnings, interactions and side effects, - Advice in the event of overdose, failure to take - What to do with leftover medication, information on expiry date - What complications can occur

- What to do in the event of a complication

- Contact address in case of problems This information may be omitted if instructions for use can be provided in accordance with Section 11 (1) AMG and the instructions do not deviate from this.

The patient letter should be generally understandable in German (or authorised translation), in a legible font, not too long and designed in an acceptable graphic style. Information leaflets for healthcare professionals should be adapted accordingly.

3.4 Patient brochures

Many companies provide guides and themed brochures on general topics (e.g. intensive care unit, diabetes mellitus) and on specific problems (thrombosis prophylaxis with heparin, care with breast prostheses). The range of material on offer should be reviewed, suitable material selected and displayed in an accessible location. A decision should be made as to which brochures should be given to patients on which occasion.

3.5 Internet access

Internet access should be provided in the hospital. Access can restrict access to "recognised" information sites or offer assistance in searching for and evaluating information. Here too, a formal selection or regulation should be made 

http://www2.ct-arzneimittel.de/cta/de/dep/ratgeber.cfm 

http://www.gesundheitsinformation.de/index.html

3.6 Library (media centre)

Some hospitals offer a complete scientific library for self-study in the case of particularly invasive and controversial therapeutic procedures (e.g. oncology). The handling of scientific literature is being mastered by ever larger circles nowadays. As the literature is usually kept in-house anyway, only access needs to be organised. The impression should never be created that the clinic has something to hide or wants to cut off generally accessible information - the offer is rarely used, but refusal of access is always met with suspicion! Other media such as picture atlases and video films should be made available. Playback devices (video recorder, television, DVD player) should be available. The room should make a longer stay pleasant: Reading table, reading chair, attractive bright lighting.

Extensive library of decision aids from the Ottawa Hospital, Canada

3.7 Training programmes

Detailed training programmes are available for some diseases (diabetes mellitus). Access to these programmes should be made available.

3.8 General information on hospitalisation

On admission, patients should be given advice on behaviour in hospital that goes beyond the house rules, e.g. tips on avoiding mistakes, waiting times, taking medication, eating and drinking outside the hospital menu.

4 Resources

Patient letters for frequent procedures. They can usually be derived from the patient information leaflet. One-off creation, subsequent maintenance of content, printout for patients, collection, viewing and provision of patient brochures, room for media library with screen, DVD player, Internet access, specialist books. Training programme

5 Documentation

All information media given to patients should be formally authorised by the head of department/director of the clinic. The information materials should take into account the empirically determined information needs (e.g. for rheumatism, breast cancer, etc.)

6 Responsibilities

Drafting, writing, maintaining patient information, collecting patient brochures: a named specialist from the department Approval: clinic management Explanation in discussion: Doctor, nursing staff QM: possibly testing for comprehensibility

7 Notes and comments

Patient information goes beyond the information provided before consenting to a medical procedure. It supplements this, but cannot replace the discussion. Patient information does not simply provide information in order to make a decision. It aims to influence the patient's behaviour. It serves as a reminder and argumentation aid after discharge from hospital. The comprehensibility of patient information depends on the patient's reading ability, the number of technical words (or technical jargon) in the text, their emotional state and their command of the German language. Patient information is not an activity that can be mastered without training - even if most people consider themselves sufficiently convincing! Access to the media should also be open to relatives.

8 Applicable documents

8.1 Literature, regulations

Canadian Public Health Association - National Literacy and Health Programme Directory of Plain Language Health Information, Ottawa, Canada 1999 Abt-Zegelin, Angelika Patientenedukation Die Schwester/der Pfleger 39 (2000) p. 56 - 60 Examples: Paulus, W; Reimers, CD; Steinhoff, BJ Recommendations for patient information, Steinkopff Verlag Darmstadt 2000, 249 pages, ring binder
Extensive library of decision aids from the Ottawa Hospital, Canada

BGB § 630 c para. 2 sentence 1; BGB § 630 c para. 2 sentence 1; KHGG NRW § 7, para. 3; QM-RL G-BA:2015 § 4 sentence 4, 12; JCI ACC 3.2, ACC 4; DIN 5.1.2; 8.2.1 a); KTQ 1.1.3.3

8.2 Terms

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