Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 01GY1336A | Other Grant/Funding Number | German Federal Ministry of Education and Research | |
| 01GY1336B | Other Grant/Funding Number | German Federal Ministry of Education and Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Martin-Luther-Universität Halle-Wittenberg | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background: Physical restraints as bedrails and belts are still regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomized controlled trial, the efficacy of a guideline-based multicomponent intervention has been shown with a significant reduction in physical restraints use without adverse events. The present study aims to apply different versions of the original intervention in nursing home residents in four different regions throughout Germany in order to evaluate the effectiveness of the programme.
Methods/Design: Pragmatic cluster-randomized controlled trial comparing two intervention groups ((1) updated original programme and (2) brief version of the updated programme) with a control group (3) receiving printed study materials (optimized usual care). Intervention (1) consists of an information programme for all nurses, additional training and structured support for nominated key nurses, and provision of printed study material and other supportive material. For intervention (2) nurses' training is only optional carried out facultatively by key nurses who have received an additional train-the-trainer module. The control group (3) receives printed study material only. Overall, 120 nursing homes including approximately 10800 residents will be recruited, randomized to one of the three groups and followed up for 12 months. The primary outcome is defined as proportion of residents with at least one physical restraint at 12 months. Physical restraint use will be assessed by direct observation. Secondary outcomes are residents' quality of life as well as safety parameters as i.g. falls and fall-related fractures. Process and cost measures will also be assessed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Updated original programme | Experimental | Educational programme for all nurses (90 min. single information session); training and structured support for nominated key nurses (one-day training workshop); provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives); supportive material (poster, mugs etc.) |
|
| Concise updated programme | Experimental | Training and structured support for nominated key nurses (one-day training workshop); nurses' training will be carried out by key nurses as facultative option; key nurses receive an additional train-the-trainer module to apply the educational programme; provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives); supportive material (poster, mugs etc.) |
|
| Optimized usual care | Active Comparator | Provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives) only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational programme for all nurses | Other |
| ||
| Training and structured support for nominated key nurses |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Residents' quality of life (measured by QoL-AD) | Will be measured by QoL-AD for a randomly selected subgroup of 10% of residents | 12 Months |
| Falls and fall-related fractures | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Process evaluation | Different process parameters will be assessed as e.g. relatives' experiences, staff experiences, leaders' experiences and organizational culture | 12 Months |
Cluster level
Inclusion Criteria:
Exclusion Criteria:
Individual level
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sascha Köpke, Prof. Dr. | University of Lübeck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Witten/Herdecke University | Witten | North Rhine-Westphalia | 58448 | Germany | ||
| Martin-Luther-University Halle-Wittenberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31014546 | Derived | Abraham J, Kupfer R, Behncke A, Berger-Hoger B, Icks A, Haastert B, Meyer G, Kopke S, Mohler R. Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial. Int J Nurs Stud. 2019 Aug;96:27-34. doi: 10.1016/j.ijnurstu.2019.03.017. Epub 2019 Apr 4. | |
| 26195247 |
| Label | URL |
|---|---|
| project homepage | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| Facultative train-the-trainer module for key nurses | Other |
|
| Printed study material | Other |
|
| Supportive material (poster, mugs etc.) | Other |
|
| Costs within trial period (cost parameters related to the implementation of the intervention as well as outcome-related cost parameters) | For economic evaluation cost parameters related to the implementation of the intervention will be collected as well as outcome-related costparameters; explicit trial-associated will not be taken into account | 12 Months |
| Halle |
| Saxony-Anhalt |
| 06112 |
| Germany |
| University of Lübeck | Lübeck | Schleswig-Holstein | 23562 | Germany |
| University of Hamburg | Hamburg | 20146 | Germany |
| Abraham J, Mohler R, Henkel A, Kupfer R, Icks A, Dintsios CM, Haastert B, Meyer G, Kopke S. Implementation of a Multicomponent intervention to Prevent Physical Restraints In Nursing home residenTs (IMPRINT): study protocol for a cluster-randomised controlled trial. BMC Geriatr. 2015 Jul 21;15:86. doi: 10.1186/s12877-015-0086-0. |
| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided