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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Switzerland
      • Lausanne, Switzerland, 1010
        • Lausanne University Hospital (CHUV)
      • Morges, Switzerland, 1110
        • EHC (Hôpital de Morges)
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Usual care
Discharge teaching is usually not delivered in a systematic or consistenly way, nor by relying on a particular intervention model.
EXPERIMENTAL: Discharge teaching
Receiving tailored discharge teaching by nurses during hospital stay.
Behavioral: Nursing discharge teaching
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
change from hospital admission to the day of discharge and 7-10 days after discharge
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.
At the end of the hospital stay, an average of 7-10 days after admission
Readmission rate and time to readmission
Time Frame: 7-10 days after discharge
7-10-day readmission rate and time to readmission retrieved from medical charts
7-10 days after discharge
Discharge Care Experiences Survey (DICARES)
Time Frame: 7-10 days after discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Lausanne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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