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PROSENIOR. Prevention of Pressure Ulcers, Malnutrition, Poor Oral Health and Falls Among Older Persons Receiving Municipal Health Care and Are Registered in the Quality Registry Senior Alert

Primary Purpose

Fall, Pressure Ulcer, Malnutrition

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Care process for assessements of risks
Sponsored by
Malmö University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fall focused on measuring Prevention, Older people, Nursing care, Complex intervention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Nursing homes registering in Senior Alert, which is a national quality registry

Exclusion Criteria:

  • not meetin inclusion criteria

Sites / Locations

  • Malin AxelssonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it.

Continue with usual care.

Outcomes

Primary Outcome Measures

Risk assessments and prevention care interventions focusing on falls.
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Risk assessments and prevention care interventions focusing on pressure ulcers.
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Risk assessments and prevention care interventions focusing on malnutrition.
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Risk assessments and prevention care interventions focusing on poor oral health
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Risk assessments and prevention care interventions focusing on falls.
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Risk assessments and prevention care interventions focusing on pressure ulcers.
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Risk assessments and prevention care interventions focusing on malnutrition.
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Risk assessments and prevention care interventions focusing on poor oral health.
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Risk assessments and prevention care interventions focusing on falls.
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Risk assessments and prevention care interventions focusing on pressure ulcers.
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Risk assessments and prevention care interventions focusing on malnutrition.
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Risk assessments and prevention care interventions focusing on poor oral health.
Registry data from Senior Alert based on the following assessment: the Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Risk assessments and prevention care interventions focusing on falls.
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Risk assessments and prevention care interventions focusing on pressure ulcers.
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Risk assessments and prevention care interventions focusing on malnutrition.
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Risk assessments and prevention care interventions focusing on poor oral health.
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.

Secondary Outcome Measures

Perceived Stress Scale stress (PSS)
Among nursing staff. 10 items scaled 0-4, higher scores indicate higher level of stress
Stress of Conscience (SCQ),
Among nursing staff. 9 items scaled 0-5, higher scores indicate higher level of SCQ.
Psychosocial Aspects of Job Satisfaction Questionnarie
Among nursing staff. 49 items, scaled 0-4, higher scores indicate higher level of psychosocial job satisfaction

Full Information

First Posted
February 23, 2022
Last Updated
February 2, 2023
Sponsor
Malmö University
Collaborators
Malmö City
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1. Study Identification

Unique Protocol Identification Number
NCT05308862
Brief Title
PROSENIOR. Prevention of Pressure Ulcers, Malnutrition, Poor Oral Health and Falls Among Older Persons Receiving Municipal Health Care and Are Registered in the Quality Registry Senior Alert
Official Title
Prevention of Pressure Ulcers, Malnutrition, Poor Oral Health and Falls Among Older Persons Receiving Municipal Health Care and Are Registered in the Quality Registry Senior Alert
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Malmö University
Collaborators
Malmö City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Inclusion criteria for study I and II is nurse aides, registered nurses and managers working in nursing homes who register in Senior Alert. To develop an intervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted in collaboration with nurse aides, registered nurses and managers (study I). Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it (study II). The remaining nurse aides, registered nurses and managers working in nursing homes in the control group continue with regular care.
Detailed Description
Study I The workshops (tentative plan) Groups of one-two nurse aides, one-two registered nurses and one-two managers from the nursing homes in the intervention group will form a workshop. In total, four-five workshops will be conducted. Each workshop will begin with an introductory framing of the workshop followed by addressed activities in four stations. The activities in the four stations are designed to give the participants possibility to be active in order to develop the intervention. The participants will write down conclusions of the discussions and the discussions will be audio recorded. The written documentation and the recorded discussions will constitute data and will be analyzed using content analysis. Station one: the participants will discuss beforehand written questions based on the results of our previous studies, and literature in order to stimulate reflection and discussion. The participants will discuss how to work in a better/different way with risk assessments, care interventions and follow-ups that can contribute to improve the preventive work so that older persons are risk assessed, get the right care interventions planned, performed and evaluated to a greater extend. They will also discuss how the organization/routines around the preventive care process be developed. The participants will write down conclusions of the discussion. Station two: the participants will discuss beforehand written questions concerning the preventive care process according to Senior Alert. The participants will work creatively to identify barriers and challenges in the preventive care process according to Senior Alert and how this process could be done in a smoother way. The participants will write down conclusions of the discussion. Station three: the participants will discuss how the intervention could be design. Focus of the discussion will be on the core components of the intervention, e.g. context, activity, participants, time required and implementation. The participants will write down the discussion. Station four: summary of the workshop. The intervention (tentative plan) The intervention will be written out in detail after the workshops have been conducted, but below is a short description in accordance with the one in the Ethical approval. The content of the intervention will focus on the importance of prevention of the risk for pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes and the preventive process in accordance with Senior Alert. The intervention could consist of; a work sheet to facilitate clinical decisions, new way of working, educational support, films or lectures, to meet nurse aides´, registered nurses´ and managers´ educational needs, fit into their organization and facilitate the preventive nursing care regarding these health risks. Study II Feasibility/pilot testing the intervention The most suitable method will be applied to test and evaluate the intervention. A feasibility study could be carried out to evaluate if there are any uncertainties around the recruitment, data collection and retention or the intervention itself around the optimal content, delivery and acceptability. A pilot study could be carried out to address the main uncertainties in the development work and to indicate if further evaluation should be preceded or the intervention needs to be refined. Evaluating the intervention To evaluate primary outcome measures, register data is going to be extracted from Senior Alert six months prior and one and six months after the intervention. Data on risk assessments and preventive interventions from the instruments available in Senior Alert (described in our previous studies) will be extracted. Additionally, background data regarding older persons in terms of biological sex, age and type of health care setting will be gathered from the registry. Descriptive and analytic analysis will be performed in IBM SPSS Statistics Windows, Version 25 (Armonk, NY: IBM Corp) for comparisons between and within the intervention and control group. To evaluate secondary outcome measurers all the nurse aides and registered nurses working in all the nursing homes included (both the intervention and the control group) will be invited to fill in questionnaires: the Psychosocial Aspects of Job Satisfaction questionnaire, the Perceived Stress Scale stress and the Stress of Conscience Questionnaire, at baseline (prior to the workshops) and six months after the intervention. Background data as age, gender, years of work experience and educational level will be collected. For comparisons between and within the intervention and control group before and after tests will be performed. IBM SPSS Statistics for Windows, Version 25 (Armonk, NY: IBM Corp) will be used to calculate descriptive and analytic statistics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall, Pressure Ulcer, Malnutrition, Oral Health
Keywords
Prevention, Older people, Nursing care, Complex intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Continue with usual care.
Intervention Type
Behavioral
Intervention Name(s)
Care process for assessements of risks
Intervention Description
Intervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted in collaboration with nurse aides, registered nurses and managers. Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it .
Primary Outcome Measure Information:
Title
Risk assessments and prevention care interventions focusing on falls.
Description
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Time Frame
Baseline 6 months prior to intervention
Title
Risk assessments and prevention care interventions focusing on pressure ulcers.
Description
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Time Frame
Baseline 6 months prior to intervention
Title
Risk assessments and prevention care interventions focusing on malnutrition.
Description
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Time Frame
Baseline 6 months prior to intervention
Title
Risk assessments and prevention care interventions focusing on poor oral health
Description
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Time Frame
Baseline 6 months prior to intervention
Title
Risk assessments and prevention care interventions focusing on falls.
Description
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Time Frame
1 month after intervention
Title
Risk assessments and prevention care interventions focusing on pressure ulcers.
Description
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Time Frame
1 month after intervention
Title
Risk assessments and prevention care interventions focusing on malnutrition.
Description
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Time Frame
1 month after intervention
Title
Risk assessments and prevention care interventions focusing on poor oral health.
Description
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Time Frame
1 month after intervention
Title
Risk assessments and prevention care interventions focusing on falls.
Description
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Time Frame
6 months after intervention
Title
Risk assessments and prevention care interventions focusing on pressure ulcers.
Description
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Time Frame
6 months after intervention
Title
Risk assessments and prevention care interventions focusing on malnutrition.
Description
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Time Frame
6 months after intervention
Title
Risk assessments and prevention care interventions focusing on poor oral health.
Description
Registry data from Senior Alert based on the following assessment: the Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Time Frame
6 months after intervention
Title
Risk assessments and prevention care interventions focusing on falls.
Description
Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.
Time Frame
12 months after intervention
Title
Risk assessments and prevention care interventions focusing on pressure ulcers.
Description
Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.
Time Frame
12 months after intervention
Title
Risk assessments and prevention care interventions focusing on malnutrition.
Description
Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.
Time Frame
12 months after intervention
Title
Risk assessments and prevention care interventions focusing on poor oral health.
Description
Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.
Time Frame
12 months after intervention
Secondary Outcome Measure Information:
Title
Perceived Stress Scale stress (PSS)
Description
Among nursing staff. 10 items scaled 0-4, higher scores indicate higher level of stress
Time Frame
Baseline and six months after intervention
Title
Stress of Conscience (SCQ),
Description
Among nursing staff. 9 items scaled 0-5, higher scores indicate higher level of SCQ.
Time Frame
Baseline and six months after intervention
Title
Psychosocial Aspects of Job Satisfaction Questionnarie
Description
Among nursing staff. 49 items, scaled 0-4, higher scores indicate higher level of psychosocial job satisfaction
Time Frame
Baseline and six months after intervention
Other Pre-specified Outcome Measures:
Title
Feasibility test of the co-created intervention designed to reduce the evidence-base practice gap regarding prevention of the risk for pressure ulcer, malnutrition, poor oral health and falls using questionnaire data
Description
Data collected by a questionnaire specifically developed for evalutation of the co-created intervention called Evaluation of the intervention. The questionnaire contains 12 items on a dichtomous scale and two open questions.
Time Frame
Directly post intervention
Title
Feasibility test of the co-created intervention designed to reduce the evidence-base practice gap regarding prevention of the risk for pressure ulcer, malnutrition, poor oral health and falls using interview data
Description
Individual and focus group interviews
Time Frame
Directly post intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Nursing homes registering in Senior Alert, which is a national quality registry Exclusion Criteria: not meetin inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Malin Axelsson, Phd
Phone
+46406657960
Email
malin.axelsson@mau.se
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Kumlien, Phd
Phone
+466657430
Email
christine.kumlien@mau.se
Facility Information:
Facility Name
Malin Axelsson
City
Malmö
ZIP/Postal Code
205 06
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malin Axelsson, PhD
Phone
+46 406657960
Email
malin.axelsson@mau.se
First Name & Middle Initial & Last Name & Degree
Christine Kumlien, PhD
Phone
+46406657430
Email
christine.kumlien@mau.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PROSENIOR. Prevention of Pressure Ulcers, Malnutrition, Poor Oral Health and Falls Among Older Persons Receiving Municipal Health Care and Are Registered in the Quality Registry Senior Alert

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