This study is a three-armed, prospective, controlled, randomized trial. Two of the study arms include an intervention (regular telephone contacts and telephone contacts with additional text-messages), the third arm is a control group. The interventions will be conducted during a time period of 6 months after discharge. Importantly, the interventions outlined below are all applied in addition to the individual outpatient treatment provided. Therefore, also the control group receives outpatient treatment (e.g. medication, short interventions by any GP or psychiatrist).
The outcomes described in the section research objectives will be compared between all three groups.
Recruiting and participants
It was planned to recruit a total of 90 patients, 30 in each arm of the study. The recruitment started September 2009. As the first participants were contacted to have their final interview after 6 months, the loss to follow up in the control group was about 20%. Therefore, we decided to continue the recruitment until a total of 120 participants included.
All participants are recruited from three psychiatric day hospitals in the region of Western Pomerania in the Northeast of Germany. The treating psychiatrists and psychotherapists select eligible patients before their discharge from the day hospital. The patients are informed about the project and are asked to provide informed consent.
The inclusion criteria are:
- a diagnosed depression, anxiety disorder, adjustment disorder or a somatoform disorder;
- eligibility to participate in the study, attested by the treating psychiatrist or psychotherapist.
Exclusion criteria are
- interval patients, defined as patients who return to the day hospital after 3-6 months to continue their therapy;
- patients who show a distinct emotional instability with recurrent suicide crises and self-injuring behaviour.
After the patients' agreement to participate in the study, the treating psychiatrist or psychotherapist from the day clinic completes a short standardized enrolment form with personal data of the patient (name, address, telephone number, date of birth), diagnoses, medication, and patients' individual therapy goals and/or themes, that were elaborated between the psychotherapist and the patient. Examples for therapy goals or themes are: exposure to critical factors (e.g. to use public transportation, to go shopping alone), to socialize with other people, to deal with family problems, to perform relaxation techniques regularly, to create a structural schedule for the day and the week, to concern about occupational rehabilitation. The enrolment form is transferred to the telemedical centre. Here, the patients are randomized to one of the three study arms.
Two telemedical interventions of different intensity will be applied during a time period of 6 months. The intervention of the first arm of the study consists of regular telephone contacts, conducted by specially trained nurses. The first month, the telephone contacts take place once a week, thereafter, once a month. If necessary, the frequency of the telephone contacts can be increased. It is also possible for the patients to contact the nurses by telephone during office hours (8 am - 4 pm).
The first part of the telephone calls consists of standardized questionnaires to enable the monitoring of important parameters over time:
- The Brief Symptom Inventory (BSI) is a standardized questionnaire to assess the severity of relevant symptoms, e.g. feelings of loneliness, melancholia, panic attacks, restlessness, suicidal thoughts, pain in heart and chest, sickness [23
- Contacts with physicians: assessment of the number of contacts with a general practitioner, an emergency physician, and various medical specialists and the reason for the last physician contact. Further, the patient is asked to evaluate his satisfaction with the contacts applying grades from 1 to 6.
- Inpatient stays: it is assessed whether the participants had inpatient stays in hospitals (separate for acute and planned admission), and rehab centres. The participants are asked for the number of stays, the total number of days, and the reason for admission. During the first telephone call, contacts with physicians and inpatients stays are assessed for the last 6 months, during the following contacts for the time since the last telephone contact.
- Standardized evaluation of the health situation of the participant by the nurse, it is possible to supplement this judgement by free text remarks.
The second part of the telephone call consists of asking for special or unusual occurrences and specific questions about the individual therapy themes as a guideline for the talk:
- Did anything special or unusual happen during the last weeks (e.g. regarding family, relationship, friends, job, health situation)? Was it positive or negative? Were you satisfied with your behaviour in or reaction on this situation?
- For each therapy goal or theme: in the day hospital, you formulated the following therapy goal or theme together with your psychotherapist. Could you work on it? Are you satisfied about how you worked on it (grade 1 to 6)? Do you think you can pursue this goal more intensively?
The third part of the telephone call deals with the medication of the participant. The following questions are asked for each drug separately:
- Do you take this drug in the same dosage as the last time we called (first telephone call: as you were discharged from the day hospital)? If no, why not? Did a physician change something about the dosage? If yes, what was changed?
- How do you assess the effect of this drug (free text)?
- How regular do you take this drug? Possible answers: always, mostly, rarely, never, don't know, don't want to answer
The telephone call is finalized by making an agreement about the next call and the question whether the patient wishes to include another topic.
The intervention of the second study arm consists of telephone contacts with the same content as the telephone contacts of the first study arm as described above. Additionally, once a week short text-messages are sent to the participating patients. These text-messages take up the individual therapy goals or themes (e.g. "Did you take the bus today?", Did your appointment with your boss go well?"). The participants can answer on these messages, and the nurses will react again if necessary or appropriate.
If the nurses recognize a (starting) crisis, they will increase the number of telephone contacts, make an appointment for a consultation with the treating psychotherapist or arrange a crisis intervention by the treating psychotherapist or by the hospital.
For the patients in the intervention arms of the study, evaluation data is collected mainly during the standardized part of the telephone calls (sociodemographic parameters, Brief Symptom Inventory, contacts with health services, medication assessment). Additionally, there is a short interview about acceptance of and satisfaction with the telemedical care concept [Table ].
Interview questions to assess acceptance and satisfaction of the patients
The patients of the control group have a baseline interview and a follow up interview after 6 months which includes the same standardized questionnaires as the intervention groups.
A flow chart of the study is shown in Figure .
Documentation, data storage and data security
Most of the data are documented during the telephone calls supported by a special developed computer aided documentation system.
Personal data of the patients, diagnoses, the first assessment of the medication, and the therapy themes are abstracted from the enrolment form and transferred to the project database. For the evaluation of contacts with health services, we will also apply for data from hospital-IT-systems of various hospitals within the region of Western Pomerania and the patients' statutory health insurances.
All data are stored in a central data management system, based on a mySQL-database. The system is built following actual standards for data security and availability. Since the system is mirrored, data collection, storage, and availability are not endangered in case of problems with the central system. Data security and availability are ensured anytime [24
All participating patients provide written informed consent after detailed information by the treating psychotherapist in the day hospital. The original forms are stored in a closed cabinet, the patients receive a copy.
If a patient withdraws his consent partly or fully, this is noted in the documentation and no new data (to the extent the patient defined) will be included. The patient's data will not be used in the analyses and, if this is the patient's wish, will be deleted from the project database. Only those data that have already used in analyses and project results are excluded.
Within the project database, identifying data is stored separately from the collected data. Only project staff with specifically conferred access rights has access to the identifying data.
After finalizing the data collection phase of the study, all the identifying variables will be physically separated from the other data. Data analysis will be conducted in a strictly pseudonymised way.
The study is conducted in compliance with ethical requirements as testified by the institutional ethics committee of the board of physicians Mecklenburg-Western Pomerania at the University of Greifswald (approval at 2009\06\30, reg. nr. BB 50/09)
This study is registered in the German Clinical Trials Register (DRKS00000662).