Therapeutic rehabilitative care in a multi-professional team
| ISRCTN | ISRCTN11686133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11686133 |
| Secondary identifying numbers | 01 |
- Submission date
- 24/03/2023
- Registration date
- 27/03/2023
- Last edited
- 27/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Currently, around 2.4 million people in Germany depend on formal or informal care. By 2030, approximately 3.4 million people will be in need of long-term care. Especially after hospitalization, the risk of permanent inpatient care is high. Despite improvements in discharge and quality management, there is still a massive deficit regarding rehabilitative approaches for residents in inpatient care. Own preliminary analyses of a regional best-practice model of therapeutic-rehabilitative care (Haus Ruhrgarten, Mülheim, Germany) showed significantly lower values for treatment costs and the number and duration of hospital stays than in comparable nursing homes. Based on this best-practice model, this study aims to implement an innovative therapeutic-rehabilitative intervention in nursing homes to improve the residents’ activities of daily living skills, cognitive performance and quality of life, as well as improve the job satisfaction of healthcare employees and the quality of life of residents’ relatives. Furthermore, the intervention aims to reduce the use of inadequate pharmaceuticals and the re-hospitalization rate as well as to increase the number of people who can return to their own homes. The innovative program comprises an extended therapy offer as well as the structured integration of therapeutic elements into the daily care routine, thereby enhancing interdisciplinary cooperation and improving communication with relatives.
Who can participate?
Residents, aged 65+ years old, in 12 nursing homes in the federal states of North Rhine-Westphalia and Hamburg (Germany), 1 relative per participating resident, and employees in the facility
What does the study involve?
The study follows a stepped-wedge design with one 6-month control period followed by three 6-month periods where participating nursing homes successively begin with the intervention. The study includes quantitative assessments with residents, relatives and staff members, a health economics analysis, as well as a qualitative process and results evaluation.
Control group participants receive nursing and therapeutic treatment as usual. Participants involved in the intervention group receive additional care that includes therapeutic-rehabilitative and biography-related elements in all nursing activities. Furthermore, the participants in the intervention group receive additional therapeutic treatments in the areas of physiotherapy, occupational therapy and music or art therapy. The nursing and therapeutic needs and the evaluation of the progress are regularly discussed in multi-professional team meetings with the participation of the nursing team, therapists, a general practitioner and/or a gerontological psychiatrist/neurologist, and a pharmacist. The aim is to ensure multi-professional and resident-oriented care with reduced polypharmacy and administration of psychotropic drugs. Relatives of participating residents in the intervention group receive improved communication with staff members. For the duration of the intervention therapeutic, nursing, and social care staff ratios will be raised. Staff members receive a training programme for therapeutic-rehabilitative nursing practice as well as team supervision.
What are the possible benefits and risks of participating?
Possible benefits include better staffing and higher work motivation, improved care and quality of life for residents in the intervention group and better communication and quality of life for their relatives. Furthermore, all participants (control and intervention group participants) can contribute to the improvement of the healthcare situation in general. For residents in the intervention group, minor risks are associated with participation due to increased therapy and possible medication changes. A possible reduction of medication is only considered in detailed medical examination by the general practitioner, psychiatrist/neurologist and pharmacist and in communication with residents. Residents’ well-being is the main priority at all times.
Where is the study run from?
The University of Potsdam (Germany)
When is the study starting and how long is it expected to run?
July 2022 to June 2026
Who is funding the study?
German Innovation Fund (Gemeinsame Bundesausschuss; 01NVF21108) (Germany)
Who is the main contact?
Prof. Dr. Dr. M. Rapp, michael.rapp@uni-potsdam.de (Universität Potsdam) (Germany)
Contact information
Principal Investigator
University of Potsdam
Campus Golm
Haus 62, Raum 2.07 (H-Lab)
Am Mühlenberg 9
Potsdam
14476
Germany
 ORCID ID |
0000-0003-0106-966X |
|---|---|
| Phone | +49 (0) 331 977 4095 |
| michael.rapp@uni-potsdam.de |
Scientific
University of Potsdam
Campus Golm
Haus 62 (H-Lab)
Am Mühlenberg 9
Potsdam
14476
Germany
| ORCID ID |
0000-0003-1963-8373 |
|---|---|
| Phone | +49 (0) 331 977 4185 |
| andreas.haeusler@uni-potsdam.de |
Public
Press spokesperson AOK
AOK Rheinland/Hamburg – die Gesundheitskasse
Kasernenstraße 61
Düsseldorf
40213
Germany
| Phone | +49 (0) 211 8791 28474 |
|---|---|
| presse@rh.aok.de |
Study information
| Study design | A multicenter stepped wedge cluster randomized interventional study with embedded qualitative evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Care home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Cross-sectoral gerontopsychiatric treatment and rehabilitation in nursing homes (Sektorenübergreifende gerontopsychiatrische Behandlung und Rehabilitation in Pflegeheimen) |
| Study acronym | SGB Reha |
| Study objectives | The implementation of the rehabilitation concept will lead to: 1. An improvement of residents’ activities of daily living skills 2. An increase in job satisfaction among the nursing staff and increase in quality of life among residents and their relatives 3. A reduction of hospitalizations and treatment costs 4. A reduction of pharmaceuticals 5. A higher number of residents returning to their own homes |
| Ethics approval(s) | Approved 19/12/2022, Ethics committee of the Brandenburg Medical School Theodor Fontane (Ethikkommission Medizinische Hochschule Brandenburg Theodor Fontane [Ethics Committee of the Brandenburg Medical School Theodor Fontane] Haus O, DG, Raum 311, Fehrbelliner Str. 38, 16816 Neuruppin, Germany; +49 (0) 3391 39-14663; ethikkommission@mhb-fontane.de), ref: E-02-20220930 |
| Health condition(s) or problem(s) studied | Elderly, multimorbid long-term residents of nursing homes, independently living relatives, nursing home staff working with nursing homes residents |
| Intervention | The intervention includes a complex of multimodal cross-sectoral rehabilitative measures for nursing home residents. The intervention involves residents older than 65 years, (re-)admitted in the last 12 months, publicly health insured and without major cognitive impairment (MMSE >11 or comparable instrument) in nursing homes. The intervention includes the following components: 1. Interprofessional extended team meetings for individualized resident-centered care and rehabilitation planning 2. Training on therapeutic-rehabilitative care concepts and practice for facility staff including therapists, nurses, housekeeping, and social workers 3. Extended therapy offers (physio-, occupational, music/art) 4. Individual advice for nurses provided by therapists, to include therapeutic elements into daily nursing practice, 5. Implementation of the person-centered multi-professional rehabilitation concept as well as the continuation of therapeutic-rehabilitative measures by nursing and caregivers, under the direction of residents’ respective primary nurses 6. Strengthening of social and day-structuring activities through social assistance 7. Team supervision 8. Increased communication between staff and residents’ relatives Prior to the start of the intervention, the employees from the areas of nursing, social care, therapy and, if necessary, housekeeping of each nursing home will be individually trained in two-day training sessions regarding therapeutic-rehabilitative care, resident orientation, activation and social integration, as well as multi-medication and psychotropic drugs. The study follows a stepped-wedge design: After a control phase of 6 months without intervention in all nursing homes, 4 randomly selected facilities (3 urban and 1 rural) will proceed with the intervention consisting of 3 stages at 6-month intervals. After another 6 months, the next 4 randomly selected facilities will begin with the intervention consisting of 2 stages at 6-month intervals. After another 6 months, the last 4 facilities will join the intervention phase for one 6-month period. The inclusion of the residents takes place during the first four weeks of each period. Secondary outcome measures include the Tilburg Frailty Indicator (TFI), the Montreal-Cognitive-Assessment-Test (MOCA), 20 Coins Test (20-C-T), Short Form Health Survey (SF-12), WHO Quality of Life (WHOQOL-OLD), Mini Nutritional Assessment (MNA-SF), Charleston Comorbidity Index (CCI), Copenhagen Psychosocial Questionnaire (COPSOQ) (for staff) and the WHOQOL-BREF (for relatives). The number of hospitalisations, psychopharmacological medication in defined daily dosage, polypharmacy and proportion of patients discharged to their own are measured as well. In addition, health economic data (e.g. hospital stays, medical aids, travel costs) are assessed at the resident and nursing home level. For the subgroup of AOK insured, costs at the resident level and cost-effectiveness are assessed. The study includes a qualitative process evaluation as well as a qualitative evaluation of intervention effects. The goal of both qualitative evaluations is to refine a preliminary theory of change model developed for the SGB Reha intervention and to contextualize the results of the quantitative and health economics analyses. The process evaluation involves 4 phases of participant observation (1 before implementation in all 12 nursing homes, 3 after implementation in the respective intervention nursing homes in accordance with the stepped-wedge design). In each observation phase, the respective nursing home will be visited for one week and intervention-related practices will be observed (team meetings, nursing, therapy, and social activities). Each observation week includes subsequent semi-structured telephone or online interviews with 5-10 staff members per nursing home and the Organizational Readiness for Implementing Change (ORIC) questionnaire. The process evaluation’s aim is to analyse infrastructure, motivation for change, organizational culture, and barriers to intervention implementation in order to develop strategies for optimal implementation. The qualitative evaluation of intervention effects involves 3 phases of participant observation (at the end of each 6-month intervention period in the respective nursing homes). Each observation phase includes one-week visits in the same manner as the process evaluation. Semi-structured interviews with intervention residents, their relatives, and staff members (3-5 each) will be conducted on-site or via telephone or video call after each observation week for each nursing home. The qualitative evaluation of intervention results aims to analyse the effects of the intervention components from residents’, relatives’ and staff members’ subjective perspectives. |
| Intervention type | Mixed |
| Primary outcome measure | Basal and instrumental daily living skills with the Scores of Independence for Neurologic and Geriatric Rehabilitation (SINGER) at baseline, 3 and 6 months |
| Secondary outcome measures | The following secondary outcome measures for nursing home residents are assessed at baseline, and after 3 and 6 months: 1. Frailty measured using the Tilburg Frailty Indicator (TFI) 2. Cognitive Function measured using the Montreal-Cognitive-Assessment-Test (MOCA) 3. Hand mobility measured using the 20 Coins Test (20-C-T) 4. Overall health status and quality of life measured using the Short Form Health Survey (SF-12) 5. Quality of Life for elderly individuals measured using the WHO Quality of Life (WHOQOL-OLD) 6. Nutritional Status of older individuals measured using the Mini Nutritional Assessment (MNA-SF) 7. Comorbidity burden measured using the Charleston Comorbidity Index (CCI) (at baseline only) 8. The number of hospitalisations (during 6 months), psychopharmacological medication defined daily dosage (at baseline, 3 and 6 months), polypharmacy (at baseline, 3 and 6 months) and proportion of patients discharged to their own home (during 6 months) measured using information from the nursing home residents´ file 9. Health economic data (e.g. hospital stays, medical aids, travel costs) measured at the resident and nursing home levels. For the subgroup of AOK insured, costs at the resident level and cost-effectiveness are assessed. Other secondary measures for different participant groups comprise the following methods: 10. Job Satisfaction of nursing home staff with the Copenhagen Psychosocial Questionnaire (COPSOQ) at baseline, and after 6, 12, 18 and 24 months. 11. Quality of life of residents´ relatives with the WHOQOL-BREF at baseline and after 6 months. |
| Overall study start date | 01/07/2022 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 720 residents, 720 relatives and 180 employees of the nursing homes |
| Key inclusion criteria | Residents: 1. Residents of the participating nursing homes aged over 65 years old 2. Newly admitted in the nursing home after recent hospitalisation within the last 12 months or 3. Not longer than 12 months resident of the nursing home 4. At least level 2 of care (by § 15 SGB XI) 5. Declaration of consent Relatives: 1. Being a participating resident’s relative (defined as a person with at least weekly contact) 2. Provide informed consent Employees of nursing homes: 1. Working on wards that are part of the intervention 2. Provide informed consent |
| Key exclusion criteria | Residents: 1. Severe dementia (MMSE <=11) 2. Lack of capacity to consent / not providing consent 3. Residents with legal care 4. Residents with private health insurance (funder requirement) Relatives: 1. Relatives of excluded residents 2. Not providing consent Employees: 1. Working on wards that are not part of the intervention 2. Not providing consent |
| Date of first enrolment | 01/04/2023 |
| Date of final enrolment | 01/12/2024 |
Locations
Countries of recruitment
- Germany
Study participating centres
Hamburg
22359
Germany
Hamburg
22391
Germany
Hilden
40723
Germany
Hamburg
22459
Germany
Rösrath
51503
Germany
Aachen
52070
Germany
Bonn
53127
Germany
Düren
52349
Germany
Essen
45276
Germany
Wadersloh
59329
Germany
Krefeld
47809
Germany
Krefeld
47809
Germany
Sponsor information
Industry
Organisation Allgemeine Ortskrankenkasse (AOK)
Kasernenstraße 61
Düsseldorf
40213
Germany
| Phone | +49 211-87911083 |
|---|---|
| matthias.mohrmann@rh.aok.de | |
| Website | https://www.aok.de/ |
"ROR" |
https://ror.org/004cmqw89 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Joint Committee, G-BA
- Location
- Germany
Results and Publications
| Intention to publish date | 01/08/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
27/03/2023: Trial's existence confirmed by the Ethics Committee of the Brandenburg Medical School Theodor Fontane (Germany).
