- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04253665
Nursing Discharge Teaching for Multimorbid Inpatients
November 5, 2021 updated by: Dr. Sc. Cedric Mabire, RN PhD, University of Lausanne
Nursing Discharge Teaching for Multimorbid Inpatients to Self-manage Their Health at Home: a Pilot Study
The objective of this study is to estimate the effect size of a nursing discharge teaching intervention on multimorbid inpatients activation level, health confidence, readiness for hospital discharge, experience with discharge care and rate and time to 7-days readmission.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Seniors returning home from hospital have to manage several chronic conditions in addition to their daily tasks.
The teaching provided by nurses during hospitalization is essential care to prepare them to manage their health at home.
Nevertheless, there is often a gap between professionals' belief that the teaching they have provided to patients has met their needs, and patients' perceptions of the relevance of the teaching content to their home situation.
The time available to conduct this teaching is also short during the hospital stay and there is limited knowledge about how to adapt this teaching for patients who must manage multiple chronic conditions at the same time.
Thus, there is a real need to develop and test a new teaching nursing intervention to prepare for the return home that takes into account the unique and complex needs and characteristics of patients with multiple chronic conditions.
Tailoring teaching to seniors' life situation and level of activation (i.e., knowledge, skills and confidence in managing their health) would best meet the needs of these patients for managing their health at home.
An intervention that takes these characteristics into account has been developed and will be tested in this study.
Study Type
Interventional
Enrollment (Actual)
225
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Lausanne, Switzerland, 1010
- Lausanne University Hospital (CHUV)
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Morges, Switzerland, 1110
- EHC (Hôpital de Morges)
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Yverdon-les-Bains, Switzerland, 1318
- eHnv (Etablissements hospitaliers du nord vaudois)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 2 chronic diseases or more
- Being discharged home
- Able to speak, read and write in French
Exclusion Criteria:
- Insufficient capacity to consent assessed with the University of California San Diego Brief Assessment of Capacity to Consent (UBACC).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Usual care
Discharge teaching is usually not delivered in a systematic or consistenly way, nor by relying on a particular intervention model.
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|
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EXPERIMENTAL: Discharge teaching
Receiving tailored discharge teaching by nurses during hospital stay.
|
Nurses will provide multimorbid seniors inpatients with teaching related to self-management to prepare them to be discharged home.
The teaching delivery will be tailored to patients' activation level and priorities.
The intervention begins by determining the level of activation at which patients are and identifying priorities to address related to patients' life situation.
A Discharge Teaching Guide will be used by nurses to deliver the teaching and includes six domains of self-management.
For each domain, nurses first report whether a priority has been identified and what intervention they have proposed to address it.
Then for each domain, teaching objectives are described and differ according to the level of patient activation.
These six domains of self-management are found in the patient-oriented discharge summary, which is a document for the patient that summarizes what has been addressed in discharge teaching.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Patient Activation Measure (PAM)
Time Frame: change from hospital admission to the day of discharge and 7-10 days after discharge
|
The patient activation measure (PAM) is a 13-item self-report questionnaire to measure patient activation level.
Stages of activation are distributed as follows in the PAM items: items 1-2: believing an active role is important; items 3-8: having confidence and knowledge to take action; items 9-11: taking action; and items 12-13: continuing healthy behaviors under stress.
PAM raw score can be calculated by adding all of the responses to the 13 questions.
This score is then converted into an activation score ranging from 0 = no activation to 100 = high activation using a calibration table.
Psychometric properties of the PAM in hospitalized multimorbid patients showed a satisfying reliability (Cronbach's alpha = 0.88) and a content validity index of 0.91.
|
change from hospital admission to the day of discharge and 7-10 days after discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Health Confidence Score (HCS)
Time Frame: change from hospital admission to the day of discharge and 7-10 days after discharge
|
The Health Confidence Score (HCS) is an easy-to-obtain proxy measure for the patient activation construct.
The HCS is a short measure (4-items) of patients' confidence to manage their health and engage with healthcare providers.
Four dimensions are explored: Knowledge, Self-management, Access to help, Shared decision-making.
Items have four response options (3 = strongly agree, 2 = agree, 1 = neutral, 0 = disagree).
Scores are reported for each item and the higher they are, the higher the confidence is.
A summary score is calculated with a 13-point scale by adding the individual items scores, with a range from 0 (4×disagree) to the ceiling 12 (4×strongly agree).
This instrument has good internal consistency (Cronbach's alpha = 0.82) and construct validity.
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change from hospital admission to the day of discharge and 7-10 days after discharge
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Readiness for Hospital Discharge Scale-Short Form (RHDS-SF)
Time Frame: At the end of the hospital stay, an average of 7-10 days after admission
|
Readiness for hospital discharge is an estimate by the patient of having the ability to leave the hospital, to be ready to face the realities of everyday life at home and the needs generated by their new health condition.
The Readiness for Hospital Discharge Scale-Short Form (RHDS-SF) is an eight items self-reported questionnaire.
Four dimensions measure personal status, knowledge to manage the post-hospital period, the ability to adapt to new health needs and the expected support.
Each item is scored on a Likert scale from 0 to 10, with the highest score indicating a better perceived readiness.
A mean score greater than or equal to 7 indicates that the patient is ready for hospital discharge.
Content and construct validity of the RHDS-SF are missing so far.
Predictive validity was tested but results showed that the patient short form of the RHDS cannot predict 30-day readmissions and emergency department visits.
The RHDS has a Cronbach's alpha of 0.79.
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At the end of the hospital stay, an average of 7-10 days after admission
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Readmission rate and time to readmission
Time Frame: 7-10 days after discharge
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7-10-day readmission rate and time to readmission retrieved from medical charts
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7-10 days after discharge
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Discharge Care Experiences Survey (DICARES)
Time Frame: 7-10 days after discharge
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This 11-items instrument investigates three domains: coping after discharge (4 items), adherence to treatment (3 items) and participation in discharge planning (4 items).
The answer for each item ranges from 1 ("Not at all") to 5 ("To a very large extent"), with higher scores indicating more positive experience.
The psychometric evaluation of the DICARES in senior patients showed an excellent test-retest reliability (ICC = 0.76, CI 95%[0.70,
0.82]), satisfactory construct validity (r = 0.54, p <0.01) and an acceptable internal consistency (Cronbach's alpha = 0.82).
|
7-10 days after discharge
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cedric Mabire, Dr. Sc., Institute of Higher Education and Research in Healthcare, University of Lausanne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 13, 2020
Primary Completion (ACTUAL)
August 31, 2021
Study Completion (ACTUAL)
September 30, 2021
Study Registration Dates
First Submitted
January 23, 2020
First Submitted That Met QC Criteria
January 30, 2020
First Posted (ACTUAL)
February 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 8, 2021
Last Update Submitted That Met QC Criteria
November 5, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020_2201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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