Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03500250
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2018-04-09
Brief Title:
Feasibility of the Post-Stroke Depression-toolkit
Sponsor:
University of Applied Sciences Utrecht
Organization:
University of Applied Sciences Utrecht
Study Overview
Official Title:
Feasibility of a Nurse-led Intervention for the Early Management of Depression After Stroke in Hospital
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rationale Depression is a frequent complication after a stroke In stroke guidelines several recommendations focus on early screening and treatment off depression after stroke Introducing clinical practice guidelines into routine daily practice however is a difficult process In order to make the recommendations applicable to clinical practice a toolkit was developed the Post Stroke Depression-toolkit which provides assessment tools for the early detection of depression after stroke and a set of interventions in case of a positive screening for risk on depressive symptoms
Objective to investigate the feasibility of the Post Stroke Depression-toolkit in daily practice
Study design An explanatory mixed-methods before-and-after study design Study population Nurses working on the neurological wards of one university hospital and two general hospitals in the Netherlands were included in the study Additionally data were obtained from patient charts
Objective to investigate the feasibility of the Post Stroke Depression-toolkit in daily practice
Study design An explanatory mixed-methods before-and-after study design Study population Nurses working on the neurological wards of one university hospital and two general hospitals in the Netherlands were included in the study Additionally data were obtained from patient charts
Detailed Description:
Worldwide approximately 50 million people who survived a stroke cope with physical cognitive and emotional impairments and many of these survivors depend on caregivers to manage activities of daily living Miller et al 2010 Stroke is the third leading cause of disability Johnson et al 2016 Depression is a frequent and serious complication after stroke impeding rehabilitation outcome and is associated with a higher mortality risk and a lower quality of life Kutlubaev Hackett 2014 Robinson Jorge 2015
There is growing evidence for successful treatment of depression after stroke Robinson Jorge 2015 Recommendations of stroke guidelines on the early management of depressive symptoms have not been structurally implemented in current practice and only a minority of the acute care stroke teams assess mood on a systematic way in daily care Hart Bowen 2008 Bowen et al 2005 Hence depression is still one of the most underdiagnosed and undertreated complications after stroke Miller et al 2010 resulting in worse patient outcomes and delayed recovery Robinson Jorge 2015 In a feasibility study of the Nursing Rehabilitation Guideline for Stroke Hafsteinsdóttir Schuurmans 2009 it was suggested that simplifying the guideline and integrating the recommendations into a stroke care pathway could gain a more positive attitude towards the guideline and improve its feasibility Hafsteinsdóttir et al 2013 Therefore the Post-Stroke Depression toolkit PSD toolkit an intervention for the early management of depression after stroke has been developed
The feasibility of this intervention was tested following phase two of the British Medical Research Council MRC guidelines Craig et al 2013 In this study feasibility Polit Beck 2008 is measured in terms of 1 fidelity defined as the extent to which the components of the PSD toolkit are delivered as intended and 2 acceptability defined as whether the PSD toolkit is judged suitable and satisfactory by the nurses Gearing et al 2011 After evaluating implementation the sustainability of the PSD toolkit requires evaluation as well Scheirer 2005 Sustainability is defined as fidelity to the PSD toolkit six months after completing implementation
The aims of the study were 1 to explore the feasibility of the PSD toolkit in terms of fidelity and acceptability in three phases-a pre-implementation phase an implementation phase and a sustainability phase six month after-and 2 to identify elements for further refinement and improvement in the toolkit to enhance its feasibility in daily stroke care during the hospital stay
Design An explanatory mixed-methods before-and-after study designCreswell 2008
Data were collected by patient chart audits and surveys among nurses Individual and focus group interviews with nurses followed the quantitative data collection to explain the findings Creswell 2008
Data were collected pre-implementation in March and April 2012 during implementation from April 2012 until December 2012 and during the sustainability phase from December 2012 until June 2013
A team with expertise in stroke care consisting of two researchers and five nurses from the participating nursing teams guided the implementation
Participants and setting Nurses working on the neurological wards of one university hospital and two general hospitals in the Netherlands were included in the study Additionally data were obtained from patient charts
Implementation strategies Evidence-based implementation strategies were used to facilitate the implementation of the PSD toolkit 1 education and training of the nurses in applying the PSD toolkit 2 opinion leaders and 3 audit and feedback by the researcher Van Achterberg et al 2008
Data collection Baseline data To gain insight into the patients in whom the toolkit was used data on gender age marital status living arrangements type of stroke length of hospital stay and discharge destination were collected The demographics collected on the nurses included gender age education years working on the ward and full-time equivalent
Patient chart audit Fidelity was measured in terms of the extent to which the components of the PSD toolkit were applied as intended patient chart audits were performed to establish the number of patients who were screened for depressive symptoms and who received nursing interventions in the case of a positive screening
The Barriers and Facilitators Assessment Instrument To obtain a thorough understanding of the experiences and opinions of the nurses that influence fidelity perceived barriers were evaluated using the Barriers and Facilitators Assessment Instrument BFAI Peters et al 2002consisting of 18 statements both positively and negatively formulated One of the authors of the original questionnaire reviewed and approved the adaptations confirming the content validity The nurses indicated on a five-point Likert scale if they disagreed with a statement The scale ranged from 5 strongly agree to 1 strongly disagree To identify barriers the percentage who agreed and strongly agreed with the positively formulated statements were recoded into disagree and strongly disagree an item score of 3 agreestrongly agree indicating a barrier
The Clinical Utility Questionnaire Acceptability was measured in terms of the clinical utility Harris Warren 1995 of the PSD toolkit as perceived by the nurses Clinical utility was assessed using an adapted version of the Clinical Utility Questionnaire including 19 items addressing nurses views on the toolkit focussing on item clarity acceptability of time investment utility of the instruments and relevance and utility of the nursing interventions The content validity of the adapted questionnaire was assessed by one of the authors of the original questionnaire de Man-van Ginkel et al 2012
Interviews with nurses To explain the results of the audits BFAI and the Clinical Utility Questionnaire semi-structured with the nurses on the participating wards were performed at the end of the implementation phase and three focus group interviews were conducted at the end of the sustainability phase The interview guides consisted of the following topics derived from results of the audits and questionnaires 1 presentation of the quantitative results 2 possible explanations for the changes decreaseincrease in fidelity 3 nurses views on barriers or facilitators to use of the PSD toolkit and its clinical utility and 4 suggestions to further improve the toolkit
Procedure Pre-implementation phase Data was collected on daily nursing care regarding the management of depressive symptoms after stroke The researchers examined the charts of all patients admitted to the participating wards using a data extraction form
Furthermore all nurses and nursing students received education and training sessions totalling three hours which covered 1 depression after stroke causes consequences and the importance of early detection of depressive symptoms evidence-based nursing interventions and 2 the content and procedures of the PSD toolkit
Implementation phase The researcher visited the participating wards four times per week for patient chart audits to collect baseline data and data on fidelity of the PSD toolkit by registering the frequency of delivery of the components of the PSD toolkit by the nurses The researchers sent the results of the patient chart audit eg the proportion of patients who were screened for depressive symptoms and who received nursing interventions to the opinion leaders Subsequently the opinion leaders used this overview to provide feedback and to remind the nurses to screen a patient for depressive symptoms and apply appropriate nursing interventions
At the end of the implementation phase the researchers sent the BFAI and Clinical Utility Questionnaire to the nurses After two weeks a reminder was sent to all non-respondents Subsequently the researchers conducted individual interviews with a random sample of five nurses from each of the participating nursing teams to explain fidelity to and acceptability of the toolkit by discussing the outcomes of the audit the BFAI and the Clinical Utility Questionnaire
Sustainability phase During the sustainability phase the same procedure was used as in the implementation phase however no implementation strategies such as feedback and reminders were used by the opinion leaders At the end of the sustainability phase three explanatory focus group interviews one with each team consisting of 10 12 and 6 participants were conducted with a randomly selected group of nurses to explain the data on fidelity to and acceptability of the PSD toolkit The focus group interviews were moderated by a researcher who was not involved in implementation The researchers and the research assistants observed took notes and handled the recording devices
Data analysis
the baseline data the audit data and the results of the BFAI and Clinical Utility Questionnaire Frequencies means standard deviations and percentages
comparison of differences in patient groups the Chi-square test for categorical baseline data and t-tests
BFAI numbers with the corresponding percentage of nurses who agreed and strongly agreed with an item on the questionnaire
the Clinical Utility Questionnaire a percentage of agreement with each item
A change of -10 in fidelity and acceptability was used to indicate an increase or decrease McCluskey Middleton 2010 SPSS version 23 SPSS Inc Chicago IL USA was used for quantitative data analysis
The individual and focus group interviews with the nurses were analysed according to predefined codes based on the topics in the interview guides All interviews as well as the focus groups were audiotaped and transcribed verbatim The transcripts were studied and initial items were identified by a researcher and subsequently the items were discussed between two researchers Based on consensus the final items that explained the quantitative results on fidelity and acceptability of the PSD toolkit were established
Ethical considerations This study received ethics approval from the Medical Ethics Committee of a University Medical Center 12-081C and the local medical ethics committees of the participating hospitals Informed consent was obtained from all participants
There is growing evidence for successful treatment of depression after stroke Robinson Jorge 2015 Recommendations of stroke guidelines on the early management of depressive symptoms have not been structurally implemented in current practice and only a minority of the acute care stroke teams assess mood on a systematic way in daily care Hart Bowen 2008 Bowen et al 2005 Hence depression is still one of the most underdiagnosed and undertreated complications after stroke Miller et al 2010 resulting in worse patient outcomes and delayed recovery Robinson Jorge 2015 In a feasibility study of the Nursing Rehabilitation Guideline for Stroke Hafsteinsdóttir Schuurmans 2009 it was suggested that simplifying the guideline and integrating the recommendations into a stroke care pathway could gain a more positive attitude towards the guideline and improve its feasibility Hafsteinsdóttir et al 2013 Therefore the Post-Stroke Depression toolkit PSD toolkit an intervention for the early management of depression after stroke has been developed
The feasibility of this intervention was tested following phase two of the British Medical Research Council MRC guidelines Craig et al 2013 In this study feasibility Polit Beck 2008 is measured in terms of 1 fidelity defined as the extent to which the components of the PSD toolkit are delivered as intended and 2 acceptability defined as whether the PSD toolkit is judged suitable and satisfactory by the nurses Gearing et al 2011 After evaluating implementation the sustainability of the PSD toolkit requires evaluation as well Scheirer 2005 Sustainability is defined as fidelity to the PSD toolkit six months after completing implementation
The aims of the study were 1 to explore the feasibility of the PSD toolkit in terms of fidelity and acceptability in three phases-a pre-implementation phase an implementation phase and a sustainability phase six month after-and 2 to identify elements for further refinement and improvement in the toolkit to enhance its feasibility in daily stroke care during the hospital stay
Design An explanatory mixed-methods before-and-after study designCreswell 2008
Data were collected by patient chart audits and surveys among nurses Individual and focus group interviews with nurses followed the quantitative data collection to explain the findings Creswell 2008
Data were collected pre-implementation in March and April 2012 during implementation from April 2012 until December 2012 and during the sustainability phase from December 2012 until June 2013
A team with expertise in stroke care consisting of two researchers and five nurses from the participating nursing teams guided the implementation
Participants and setting Nurses working on the neurological wards of one university hospital and two general hospitals in the Netherlands were included in the study Additionally data were obtained from patient charts
Implementation strategies Evidence-based implementation strategies were used to facilitate the implementation of the PSD toolkit 1 education and training of the nurses in applying the PSD toolkit 2 opinion leaders and 3 audit and feedback by the researcher Van Achterberg et al 2008
Data collection Baseline data To gain insight into the patients in whom the toolkit was used data on gender age marital status living arrangements type of stroke length of hospital stay and discharge destination were collected The demographics collected on the nurses included gender age education years working on the ward and full-time equivalent
Patient chart audit Fidelity was measured in terms of the extent to which the components of the PSD toolkit were applied as intended patient chart audits were performed to establish the number of patients who were screened for depressive symptoms and who received nursing interventions in the case of a positive screening
The Barriers and Facilitators Assessment Instrument To obtain a thorough understanding of the experiences and opinions of the nurses that influence fidelity perceived barriers were evaluated using the Barriers and Facilitators Assessment Instrument BFAI Peters et al 2002consisting of 18 statements both positively and negatively formulated One of the authors of the original questionnaire reviewed and approved the adaptations confirming the content validity The nurses indicated on a five-point Likert scale if they disagreed with a statement The scale ranged from 5 strongly agree to 1 strongly disagree To identify barriers the percentage who agreed and strongly agreed with the positively formulated statements were recoded into disagree and strongly disagree an item score of 3 agreestrongly agree indicating a barrier
The Clinical Utility Questionnaire Acceptability was measured in terms of the clinical utility Harris Warren 1995 of the PSD toolkit as perceived by the nurses Clinical utility was assessed using an adapted version of the Clinical Utility Questionnaire including 19 items addressing nurses views on the toolkit focussing on item clarity acceptability of time investment utility of the instruments and relevance and utility of the nursing interventions The content validity of the adapted questionnaire was assessed by one of the authors of the original questionnaire de Man-van Ginkel et al 2012
Interviews with nurses To explain the results of the audits BFAI and the Clinical Utility Questionnaire semi-structured with the nurses on the participating wards were performed at the end of the implementation phase and three focus group interviews were conducted at the end of the sustainability phase The interview guides consisted of the following topics derived from results of the audits and questionnaires 1 presentation of the quantitative results 2 possible explanations for the changes decreaseincrease in fidelity 3 nurses views on barriers or facilitators to use of the PSD toolkit and its clinical utility and 4 suggestions to further improve the toolkit
Procedure Pre-implementation phase Data was collected on daily nursing care regarding the management of depressive symptoms after stroke The researchers examined the charts of all patients admitted to the participating wards using a data extraction form
Furthermore all nurses and nursing students received education and training sessions totalling three hours which covered 1 depression after stroke causes consequences and the importance of early detection of depressive symptoms evidence-based nursing interventions and 2 the content and procedures of the PSD toolkit
Implementation phase The researcher visited the participating wards four times per week for patient chart audits to collect baseline data and data on fidelity of the PSD toolkit by registering the frequency of delivery of the components of the PSD toolkit by the nurses The researchers sent the results of the patient chart audit eg the proportion of patients who were screened for depressive symptoms and who received nursing interventions to the opinion leaders Subsequently the opinion leaders used this overview to provide feedback and to remind the nurses to screen a patient for depressive symptoms and apply appropriate nursing interventions
At the end of the implementation phase the researchers sent the BFAI and Clinical Utility Questionnaire to the nurses After two weeks a reminder was sent to all non-respondents Subsequently the researchers conducted individual interviews with a random sample of five nurses from each of the participating nursing teams to explain fidelity to and acceptability of the toolkit by discussing the outcomes of the audit the BFAI and the Clinical Utility Questionnaire
Sustainability phase During the sustainability phase the same procedure was used as in the implementation phase however no implementation strategies such as feedback and reminders were used by the opinion leaders At the end of the sustainability phase three explanatory focus group interviews one with each team consisting of 10 12 and 6 participants were conducted with a randomly selected group of nurses to explain the data on fidelity to and acceptability of the PSD toolkit The focus group interviews were moderated by a researcher who was not involved in implementation The researchers and the research assistants observed took notes and handled the recording devices
Data analysis
the baseline data the audit data and the results of the BFAI and Clinical Utility Questionnaire Frequencies means standard deviations and percentages
comparison of differences in patient groups the Chi-square test for categorical baseline data and t-tests
BFAI numbers with the corresponding percentage of nurses who agreed and strongly agreed with an item on the questionnaire
the Clinical Utility Questionnaire a percentage of agreement with each item
A change of -10 in fidelity and acceptability was used to indicate an increase or decrease McCluskey Middleton 2010 SPSS version 23 SPSS Inc Chicago IL USA was used for quantitative data analysis
The individual and focus group interviews with the nurses were analysed according to predefined codes based on the topics in the interview guides All interviews as well as the focus groups were audiotaped and transcribed verbatim The transcripts were studied and initial items were identified by a researcher and subsequently the items were discussed between two researchers Based on consensus the final items that explained the quantitative results on fidelity and acceptability of the PSD toolkit were established
Ethical considerations This study received ethics approval from the Medical Ethics Committee of a University Medical Center 12-081C and the local medical ethics committees of the participating hospitals Informed consent was obtained from all participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None