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Patient-oriented training practice in orthopaedic rehabilitation through dissemination of an evaluated training program

Organizational Data

DRKS-ID:
DRKS00004835
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2013-03-19
Last update in DRKS:
2023-01-31
Registration type:
Retrospective

Acronym/abbreviation of the study

none

URL of the study

http://forschung-patientenorientierung.de/index.php/projekte/zweite-foerderphase/modul-zwei-phase-2/patientenorientierte-schulungspraxis-...-meng.html

Brief summary in lay language

Many patient education programs in medical rehabilitation still lack certain quality requirements, such as the use of manuals, patient-oriented methods, and proof of effectiveness. Their implementation represents a challenge for routine clinical practice and is frequently not entirely successful. Programs are only partially implemented or modified, which calls their effectiveness in routine practice into question. The aim of the study is (Part A) to evaluate the implementation effectiveness and costs of two strategies - trainer course and written guideline - for a new back school for chronic back pain patients in inpatient orthopaedic rehabilitation as well as (Part B) to evaluate the effectiveness of the back school for patient-oriented application, patient rehabilitation success and treatment costs in routine-use. The main research questions are: (Part A) With which strategy – trainer course or written guidelines – can a better implementation of the new back school program be achieved regarding contents and patient-oriented application as well as a higher patient satisfaction? (Part B) After the implementation of the new back school in routine practice, can better training effects be achieved after the rehabilitation in the short, medium and long term? Part A is conducted in 10 orthopaedic rehabilitation clinics. Clinics are assigned to either the trainer course or written guidelines. Trainers evaluate the implementation processes of the back school program as well as their routine application of the new program with several questionnaires. Patients evaluate their satisfaction with the education practice with short questionnaires. Part B is conducted with 4 of the 10 rehabilitation clinics. Participants are 540 rehabilitands with low back pain, who participate in the back school. First, 270 patients are assessed who receive the traditional back school program of the clinics before implementation of the new back school program. Afterwards, 270 patients who receive the new back school after implementation into routine-use. Data will be assessed with questionnaires at admission and discharge of rehabilitation as well as after 6- and 12-months.

Brief summary in scientific language

The aim of the study is (A) to evaluate the implementation effectiveness and costs of two imple-mentation strategies (i.e. trainer seminar and implementation guideline) for a standardized back school for chronic back pain patients in inpatient orthopaedic rehabilitation as well as (B) to evaluate the effectiveness of the back school for patient-oriented didactics, patient outcomes and efficiency in routine-use. Effectiveness and integrated dissemination trial. (A) A dissemination study in 10 orthopaedic rehabilitation clinics (approx. 130 trainers, 300 patients, and 30 back schools) will be evaluated regarding combined quantitative and qualitative methods for structure and needs analysis, process evaluation, and outcome research. (B) Assessment of the effectiveness within routine care will occur in a multi-centre, quasi-experimental controlled study of 540 patients with low back pain in 4 rehabilitation clinics, with data collection at admission and discharge as well as after 6- and 12-months. Control patients receive the traditional back school program of the hospital before implementation of the new program; intervention patients receive the new standardized back school after implementation into routine-use. Clinical and economic outcomes will be assessed. Materials for the implementation will be generated (manual for the trainer course, implementation guideline), which can then be used by orthopaedic rehabilitation clinics for further program implementation, dissemination and trainer education. Controlled data for the comparison of both strategies and their implementation effectiveness will be established. The results can be applied to further dissemination recommendations for patient education programs. Results of the effectiveness trial can be discussed with regard to other standardized, evaluated programs.

Health condition or problem studied

ICD10:
M51 - Other intervertebral disc disorders
ICD10:
M53 - Other dorsopathies, not elsewhere classified
ICD10:
M54 - Dorsalgia
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Intervention patients receive the new standardized back school "Curriculum Rückenschule" (Meng et al., 2009; 2011) after implementation into routine-use. The back school program consists of 7 patient-oriented, interactive sessions of 55 minutes, which are held in small groups of a closed format (15 participants or less). The program is manual-based and interdisciplinary with sessions led by a physiotherapist (five sessions), an orthopedist (one session) and a psychologist (one session). In each session, patients are actively involved in the educational process by the trainers using a combination of methods (short lectures, group discussion, small group work, practice, and individual work). Didactic materials included PowerPoint presentations, flipcharts, handouts and work sheets. To promote physical activity, a theory-based intervention is applied. Contents of the lessons included basic knowledge about back pain (e.g. epidemiology, risk factors, development, disorders, therapy) with regard to physical, psychological (fear-avoidance-endurance model, coping behavior) and social aspects. Spine-related exercises (muscle training and active stabilization) and techniques to promote physical activity (e.g. motivation, self-regulation) are also part of the lessons. All sessions followed a common bio-psycho-social model. The back school program has been developed by an interdisciplinary group of health professionals and scientists. The superior effectiveness of the back school as compared to a traditional one has been demonstrated with regard to illness knowledge and self-management behaviors in short-, intermediate- and long-term (Meng et al., 2009, 2011). Internet ressource: http://www.psychotherapie.uni-wuerzburg.de/forschung/projekte-koop_12.html
Arm 2:
Control patients receive the traditional back school program of the hospitals before implementation of the new program (usual care). Traditional non-standardized back school programs (i.e. no closed, interdisziplinary group format, not manual-baded, less patient oriented didactics) with bio-mechanical orientation. Contents of the lessons include correct back posture and movements as well as back exercises, but no no theory-based intervention techniques to promote physical activity.

Endpoints

Primary outcome:
1) Illness knowledge about back pain and its treatment (short-term/discharge); Questionnaire "Illness knowledge" (Meng et al., 2009; 2011); Time frame: admission, discharge, after 6 and 12 months 2) Back exercises (long-term/12 months after discharge from rehabilitation); Questionnaire "Back exercises" (Göhner, 2003); Time frame: admission, after 6 and 12 months
Secondary outcome:
1) Physical activity; The Freiburger questionnaire on physical activity (Frey et al., 1999); Time frame: admission, after 6 and 12 months. 2) Motivational and volitional determinants of physical activity; HAPA-Questionnaires (Schwarzer et al., 2007; Sniehotta et al., 2005); Time frame: admission, discharge, after 6 and 12 months. 3) Fear-Avoidance-Beliefs; Fear-Avoidance Beliefs Questionnaire FABQ-D (Pfingsten et al., 1997); Time frame: admission, discharge, after 6 and 12 months. 4) Avoidance behavior; German version of the Pain Anxiety Symptoms Scale PASS (McCracken et al., 1992; Quint, 2007); Time frame: admission, discharge, after 6 and 12 months. 5) Pain coping strategies; German Pain Management Questionnaire FESV (Geissner, 2006); Time frame: admission, discharge, after 6 and 12 months. 6) Pain intensity; Numeric Rating Scale NRS (Pfingsten et al., 2007); Time frame: admission, discharge, after 6 and 12 months. 7) Funktional ability; Hannover Functional Ability Questionnaire FFbH-R (Kohlmann & Raspe, 1996); Time frame: admission, discharge, after 6 and 12 months. 8) Health related quality of live; German SF-12, a shortened version of the SF-36 Health Survey (Bullinger & Kirch-berger, 1998); Time frame: admission, discharge, after 6 and 12 months. 9) treatment satisfaction with the back school; Questionnaire (Meng et al., 2009); Time frame: discharge.

Study Design

Purpose:
Treatment
Allocation:
Non-randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Other
Sequence generation:
No Entry
Who is blinded:
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Klinik Bad Wörishofen, Deutsche Rentenversicherung Schwaben Bad Wörishofen
  • Medical center Reha-Zentrum Schömberg, Klinik Schwarzwald Schömberg
  • Medical center Präventions- und Rehabilitationszentrum Bad Bocklet Bad Bocklet
  • Medical center Sana Rheumazentrum, Rheinland-Pfalz AG Bad Kreuznach

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2011-05-02
Planned study completion date:
No Entry
Actual Study Completion Date:
2014-06-30
Target Sample Size:
540
Final Sample Size:
535

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
65 Years
Additional Inclusion Criteria:
chronic low back pain patients (main diagnosis: M51, M53, M54) in inpatient orthopedic rehabilitation clinics

Exclusion Criteria

(a) age below 18 or above 65 years, (b) inadequate German language ability, (c) severe visual or hearing impairment

Addresses

Primary Sponsor

Universität Würzburg, Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
Dr. Karin Meng
Klinikstr. 3
97070 Würzburg
Germany
Telephone:
0049 (0)9313182074
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universität Würzburg, Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
Dr. Karin Meng
Klinikstr. 3
97070 Würzburg
Germany
Telephone:
0049 (0)9313182074
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universität Würzburg, Arbeitsbereich Rehabilitationswissenschaften
Dr. Karin Meng
Klinikstr. 3
97070 Würzburg
Germany
Telephone:
0049 (0)9313182074
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universität Würzburg, Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
Dr. Karin Meng
Klinikstr. 3
97070 Würzburg
Germany
Telephone:
0049 (0)9313182074
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

BMBF - Projektträger im DLR
Heinrich-Konen-Str. 1
83227 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Universität Würzburg, Institut für Pharmakologie und Toxikologie
Versbacher Str. 9
97078 Würzburg
Germany
Telephone:
+49-931-3148315
Fax:
+49-931-3187520
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2011-02-23
Ethics committee number:
48/11
Vote of the Ethics Committee:
Approved
Date of the vote:
2011-03-25

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
abgeschlossen
Publikationen/Studienergebnisse:
Meng, K., Peters, S., Schultze, A., Pfeifer, K. & Faller, H. (2015). Der Einfluss von zwei Implementierungsinterventionen auf die Implementierungsgüte einer standardisierten Rückenschulung in der orthopädischen Rehabilitation. Die Rehabilitation, 54, 325-331.
Peters, S., Schultze, A., Pfeifer, K., Faller, H. & Meng, K. (2014). Akzeptanz der Einführung standardisierter Patientenschulungen durch das multidisziplinäre Reha-Team am Beispiel einer Rückenschule – Eine qualitative Studie. Das Gesundheitswesen. DOI: http://dx.doi.org/10.1055/s-0034-1390445
Meng, K., Peters, S., Schultze, A., Pfeifer, K. & Faller, H. (2014). Bedarfsorientierte Entwicklung und Teilnehmerbewertung von zwei Implementierungsinterventionen für eine standardisierte Rückenschulung in der stationären medizinischen Rehabilitation. Praxis Klinische Verhaltensmedizin und Rehabilitation, 94, 218-231.
Meng, K., Peters, S. & Faller, H. (2017). Effectiveness of a standardized back school program for patients with chronic low back pain after implementation in routine rehabilitation care. Patient Education and Counseling, 100, 1161-1168. http://dx.doi.org/10.1016/j.pec.2017.01.011
Neusser, S., Biermann, J., Meng, K., Faller, H., Wasem, J. & Neumann, A. (2017). Dissemination eines Schulungsprogramms bei chronischem Rückenschmerz - Kostenanalyse der Programmimplementierung. Die Rehabilitation, 56, 305-312. DOI: http://dx.doi.org/10.1055/s-0042-123424
Date of first publication of study results:
2012-03-05
DRKS entry published for the first time with results:
2016-03-11

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry