Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect
Introduction Parents who receive the diagnosis of a life-threatening, complex heart defect in their fetus or neonate face a difficult choice between pursuing termination (for fetal diagnoses), palliative care or complex surgical interventions. Shared decision making (SDM) is recommended in clinical...
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BMJ Publishing Group
2021-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/12/e055455.full |
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| author | Holly O Witteman Angela Fagerlin Elissa M Ozanne Praveen Thokala Nelangi M Pinto Rebecca K Delaney Louisa A Stark Mandy L Pershing Alistair Thorpe Linda M Lambert Lisa M Hansen Tom H Greene |
| author_facet | Holly O Witteman Angela Fagerlin Elissa M Ozanne Praveen Thokala Nelangi M Pinto Rebecca K Delaney Louisa A Stark Mandy L Pershing Alistair Thorpe Linda M Lambert Lisa M Hansen Tom H Greene |
| author_sort | Holly O Witteman |
| collection | DOAJ |
| description | Introduction Parents who receive the diagnosis of a life-threatening, complex heart defect in their fetus or neonate face a difficult choice between pursuing termination (for fetal diagnoses), palliative care or complex surgical interventions. Shared decision making (SDM) is recommended in clinical contexts where there is clinical equipoise. SDM can be facilitated by decision aids. The International Patient Decision Aids Standards collaboration recommends the inclusion of values clarification methods (VCMs), yet little evidence exists concerning the incremental impact of VCMs on patient or surrogate decision making. This protocol describes a randomised clinical trial to evaluate the effect of a decision aid (with and without a VCM) on parental mental health and decision making within a clinical encounter.Methods and analysis Parents who have a fetus or neonate diagnosed with one of six complex congenital heart defects at a single tertiary centre will be recruited. Data collection for the prospective observational control group was conducted September 2018 to December 2020 (N=35) and data collection for two intervention groups is ongoing (began October 2020). At least 100 participants will be randomised 1:1 to two intervention groups (decision aid only vs decision aid with VCM). For the intervention groups, data will be collected at four time points: (1) at diagnosis, (2) postreceipt of decision aid, (3) postdecision and (4) 3 months postdecision. Data collection for the control group was the same, except they did not receive a survey at time 2. Linear mixed effects models will assess differences between study arms in distress (primary outcome), grief and decision quality (secondary outcomes) at 3-month post-treatment decision.Ethics and dissemination This study was approved by the University of Utah Institutional Review Board. Study findings have and will continue to be presented at national conferences and within scientific research journals.Trial registration number NCT04437069 (Pre-results). |
| format | Article |
| id | doaj-art-ff2e17d41f5643c6899babadd5bcecf7 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-ff2e17d41f5643c6899babadd5bcecf72025-08-20T02:38:58ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-055455Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defectHolly O Witteman0Angela Fagerlin1Elissa M Ozanne2Praveen Thokala3Nelangi M Pinto4Rebecca K Delaney5Louisa A Stark6Mandy L Pershing7Alistair Thorpe8Linda M Lambert9Lisa M Hansen10Tom H Greene11Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada8Department of Population Health Sciences, University of Utah Spencer Fox Eccles School of Medicine, Salt Lake City, UtahPopulation Health Sciences, The University of Utah School of Medicine, Salt Lake City, Utah, USASchool of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UKPediatrics, University of Utah Health, Salt Lake City, Utah, USAPopulation Health Sciences, The University of Utah School of Medicine, Salt Lake City, Utah, USAHuman Genetics, University of Utah School of Medicine, Salt Lake City, Utah, USADepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAPopulation Health Sciences, The University of Utah School of Medicine, Salt Lake City, Utah, USAPediatrics, University of Utah Health, Salt Lake City, Utah, USAPediatrics, University of Utah Health, Salt Lake City, Utah, USAPopulation Health Sciences, The University of Utah School of Medicine, Salt Lake City, Utah, USAIntroduction Parents who receive the diagnosis of a life-threatening, complex heart defect in their fetus or neonate face a difficult choice between pursuing termination (for fetal diagnoses), palliative care or complex surgical interventions. Shared decision making (SDM) is recommended in clinical contexts where there is clinical equipoise. SDM can be facilitated by decision aids. The International Patient Decision Aids Standards collaboration recommends the inclusion of values clarification methods (VCMs), yet little evidence exists concerning the incremental impact of VCMs on patient or surrogate decision making. This protocol describes a randomised clinical trial to evaluate the effect of a decision aid (with and without a VCM) on parental mental health and decision making within a clinical encounter.Methods and analysis Parents who have a fetus or neonate diagnosed with one of six complex congenital heart defects at a single tertiary centre will be recruited. Data collection for the prospective observational control group was conducted September 2018 to December 2020 (N=35) and data collection for two intervention groups is ongoing (began October 2020). At least 100 participants will be randomised 1:1 to two intervention groups (decision aid only vs decision aid with VCM). For the intervention groups, data will be collected at four time points: (1) at diagnosis, (2) postreceipt of decision aid, (3) postdecision and (4) 3 months postdecision. Data collection for the control group was the same, except they did not receive a survey at time 2. Linear mixed effects models will assess differences between study arms in distress (primary outcome), grief and decision quality (secondary outcomes) at 3-month post-treatment decision.Ethics and dissemination This study was approved by the University of Utah Institutional Review Board. Study findings have and will continue to be presented at national conferences and within scientific research journals.Trial registration number NCT04437069 (Pre-results).https://bmjopen.bmj.com/content/11/12/e055455.full |
| spellingShingle | Holly O Witteman Angela Fagerlin Elissa M Ozanne Praveen Thokala Nelangi M Pinto Rebecca K Delaney Louisa A Stark Mandy L Pershing Alistair Thorpe Linda M Lambert Lisa M Hansen Tom H Greene Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect BMJ Open |
| title | Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect |
| title_full | Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect |
| title_fullStr | Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect |
| title_full_unstemmed | Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect |
| title_short | Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect |
| title_sort | study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life threatening congenital heart defect |
| url | https://bmjopen.bmj.com/content/11/12/e055455.full |
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