Clinical trial NCT04437069: Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making
Official title: Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Decision Aids
Congenital Heart Disease
Congenital Heart Defect
Keywords: values clarification exercise
shared decision making
patient education
patient decision aids
congenital heart disease
congenital heart defect
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2020-06-18
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Parents randomized using simple randomization into two conditions: one group receives the patient decision aid, and one group receives the patient decision aid and the values clarification exercise. There is no stratified randomization. There are 4 survey time points: 1) Baseline, 2) Post-Viewing of the Decision Aid (or Decision Aid and Values Clarification Exercise), 3) Post-Decision, and 4) Three Months Post-Decision.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is a randomized clinical trial where participants (parents of a fetus or neonate diagnosed with a life-threatening congenital heart disease (CHD)) will randomly be assigned to either receiving a web-based decision aid (DA) alone, or receiving the decision aid that includes a values clarification exercise. Because of the novel use of decision aids in CHD in an acute setting, we will also compare participants receiving the DA in a randomized control trial to a prospective observational population of families faced with similar decisions without a DA (control group). We have designated the Brief Symptom Inventory Global Severity Index of Global Distress 3 months post-birth or death/termination as our primary outcome measure.

Detailed description: The diagnosis of a life-threatening pediatric heart condition impacts both the future of a child and the health and quality of life of the family. Parents of a child with this diagnosis are faced with the stress of comprehending extensive information about the diagnosis and treatment options, and are required to make immediate and profound choices about interventions that will have long-lasting repercussions. To provide the best care at this challenging time, it is crucial to find methods to improve parent-provider shared decision making (SDM) and to encourage the inclusion of both patient-centered and family-centered outcomes. One method commonly used to improve SDM are decision aids (DA). DAs are designed to 1) provide accurate and balanced information; 2) clarify patients' values; and 3) improve SDM skills. A Cochrane review showed that DAs contribute to effective SDM by: 1) increasing knowledge of the diagnosis and treatment options, 2) increasing patient and practitioner participation in SDM, 3) reducing uncertainty and decisional conflict, 4) improving concordance between preference and treatment received, and 5) improving patient-provider communication.

Values clarification exercises (VCE) are occasionally included in DAs to help patients clarify their values about the treatment decision. Although these exercises are often used, they are poorly tested. Previous systematic reviews have failed to identify rigorous research studies to answer questions regarding whether VCE improves patient decision making processes. This project aims to determine the impact of the DA with and without the VCE on longitudinal parent mental health, decision quality and perceptions of patient-provider communication. Specifically, we will test the impact of decision aids (DA vs. no DA, and DA with and without the VCE) on mental health outcomes (e.g., anxiety, complicated grief), decision quality (e.g., quality of the decision, parent-provider communication), and provider experience (e.g., satisfaction with interacting with patients who used the tool). In the development of the DA and VCE, we conducted focus groups and interviews in Utah, Illinois, Washington, D.C, and North Carolina with parents whose fetus/neonate had been diagnosed with complex CHD. The main goal of this study is to determine the impact of the DA with and without the VCE on longitudinal parent mental health, decision quality and provider experience.

Eligibility criteria: Inclusion Criteria:

* Parents whose fetus/neonate was diagnosed with a life-threatening CHD that meets eligibility criteria below without restriction based on gender, race, age, or socioeconomic status.
* We will request participation from both parents but will not disqualify families if only one parent participates.
* Eligibility Criteria: Parents whose fetus/neonate was diagnosed with a life-threatening CHD that are offered the choice between intervention and comfort care (and in some cases termination). This is limited to the following diagnoses: Truncus Arteriosus, Pulmonary Atresia with Intact Ventricular Septum, Complex Single Ventricle, Complex Single Ventricle with Heterotaxy, Hypoplastic Left Heart Syndrome (HLHS), and Ebstein's Anomaly of the Tricuspid Valve.

Exclusion Criteria:

* Patients with other types of CHD that are not listed above are not eligible.
* Participants must be 18 years of age or older

Primary outcomes:
measure: Change in the Brief Symptom Inventory (BSI) Global Severity Index of Global Distress
timeFrame: 1 week post baseline & 3 months post-decision
Secondary outcomes:
measure: Decision Quality - Values
timeFrame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
measure: Decision Quality - Knowledge
timeFrame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
measure: Perinatal Grief
timeFrame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
measure: Brief Symptom Inventory (BSI) Global Severity Index of Global Distress
timeFrame: 1 week Post-Decision Aid, 1 month post-decision
Other outcomes:
measure: Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE)
timeFrame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
measure: Preference for Shared Decision Making
timeFrame: 1 week from Baseline, 1 week post-Decision Aid, & 1 month post-decision
measure: Preparation for Decision Making
timeFrame: 1 week Post-Decision Aid
measure: Decision Self-Efficacy Scale
timeFrame: 1 week from Baseline, 1 week post-Decision Aid, & 1 month post-decision
measure: Decisional Conflict Scale
timeFrame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
measure: Decisional Regret
timeFrame: 3 months post-decision
measure: Treatment Choice and Treatment Received
timeFrame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
measure: Control Preference Scale
timeFrame: 1 week post baseline, 1 week post decision aid, 1 month post-decision
measure: Acceptability of the Decision Aid
timeFrame: 1 week post decision aid
measure: Consultation Quality
timeFrame: 1 week post baseline, 3 months post decision.
measure: SF-12
timeFrame: 1 week post Baseline, 3 months post decision
measure: Use of Information Sources
timeFrame: 1 week post decision aid
measure: Impact of a Child with Congenital Anomalies on Parents
timeFrame: 1 month post decision, 3 months post decision
Locations:
city: Salt Lake City
country: United States
facility: Primary Children's Hospital Fetal and Pediatric Cardiology Clinics or Cardiac or Neonatal Intensive Care Units
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Angela Fagerlin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ito M, Nakajima S, Fujisawa D, Miyashita M, Kim Y, Shear MK, Ghesquiere A, Wall MM. Brief measure for screening complicated grief: reliability and discriminant validity. PLoS One. 2012;7(2):e31209. doi: 10.1371/journal.pone.0031209. Epub 2012 Feb 14.
citation: Prigerson HG, Maciejewski PK, Reynolds CF 3rd, Bierhals AJ, Newsom JT, Fasiczka A, Frank E, Doman J, Miller M. Inventory of Complicated Grief: a scale to measure maladaptive symptoms of loss. Psychiatry Res. 1995 Nov 29;59(1-2):65-79. doi: 10.1016/0165-1781(95)02757-2.
citation: Toedter LJ, Lasker JN, Alhadeff JM. The Perinatal Grief Scale: development and initial validation. Am J Orthopsychiatry. 1988 Jul;58(3):435-49. doi: 10.1111/j.1939-0025.1988.tb01604.x.
citation: Allen KA. Parental decision-making for medically complex infants and children: an integrated literature review. Int J Nurs Stud. 2014 Sep;51(9):1289-304. doi: 10.1016/j.ijnurstu.2014.02.003. Epub 2014 Feb 20.
citation: Coulter A, Stilwell D, Kryworuchko J, Mullen PD, Ng CJ, van der Weijden T. A systematic development process for patient decision aids. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S2. doi: 10.1186/1472-6947-13-S2-S2. Epub 2013 Nov 29.
citation: Fagerlin A, Pignone M, Abhyankar P, Col N, Feldman-Stewart D, Gavaruzzi T, Kryworuchko J, Levin CA, Pieterse AH, Reyna V, Stiggelbout A, Scherer LD, Wills C, Witteman HO. Clarifying values: an updated review. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S8. doi: 10.1186/1472-6947-13-S2-S8. Epub 2013 Nov 29.
citation: Adams RC, Levy SE; COUNCIL ON CHILDREN WITH DISABILITIES. Shared Decision-Making and Children With Disabilities: Pathways to Consensus. Pediatrics. 2017 Jun;139(6):e20170956. doi: 10.1542/peds.2017-0956.
citation: Neubauer K, Williams EP, Donohue PK, Boss RD. Communication and decision-making regarding children with critical cardiac disease: a systematic review of family preferences. Cardiol Young. 2018 Oct;28(10):1088-1092. doi: 10.1017/S1047951118001233. Epub 2018 Jul 31.
citation: Kavanaugh K, Moro TT, Savage T, Mehendale R. Enacting a theory of caring to recruit and retain vulnerable participants for sensitive research. Res Nurs Health. 2006 Jun;29(3):244-52. doi: 10.1002/nur.20134.
citation: Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
citation: O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
citation: Zikmund-Fisher BJ, Smith DM, Ubel PA, Fagerlin A. Validation of the Subjective Numeracy Scale: effects of low numeracy on comprehension of risk communications and utility elicitations. Med Decis Making. 2007 Sep-Oct;27(5):663-71. doi: 10.1177/0272989X07303824. Epub 2007 Jul 24.
citation: Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O'Connor AM. Validation of a preparation for decision making scale. Patient Educ Couns. 2010 Jan;78(1):130-3. doi: 10.1016/j.pec.2009.05.012. Epub 2009 Jun 26.
citation: Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
citation: Fagerlin A, Zikmund-Fisher BJ, Ubel PA, Jankovic A, Derry HA, Smith DM. Measuring numeracy without a math test: development of the Subjective Numeracy Scale. Med Decis Making. 2007 Sep-Oct;27(5):672-80. doi: 10.1177/0272989X07304449. Epub 2007 Jul 19.
citation: Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
citation: Edwards A, Elwyn G, Hood K, Robling M, Atwell C, Holmes-Rovner M, Kinnersley P, Houston H, Russell I. The development of COMRADE--a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. Patient Educ Couns. 2003 Jul;50(3):311-22. doi: 10.1016/s0738-3991(03)00055-7.
citation: Bekker HL, Hewison J, Thornton JG. Applying decision analysis to facilitate informed decision making about prenatal diagnosis for Down syndrome: a randomised controlled trial. Prenat Diagn. 2004 Apr;24(4):265-75. doi: 10.1002/pd.851.
citation: Mazer P, Gischler SJ, Koot HM, Tibboel D, van Dijk M, Duivenvoorden HJ. Impact of a child with congenital anomalies on parents (ICCAP) questionnaire; a psychometric analysis. Health Qual Life Outcomes. 2008 Nov 23;6:102. doi: 10.1186/1477-7525-6-102.
citation: Delaney RK, Pinto NM, Ozanne EM, Stark LA, Pershing ML, Thorpe A, Witteman HO, Thokala P, Lambert LM, Hansen LM, Greene TH, Fagerlin A. 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. 2021 Dec 10;11(12):e055455. doi: 10.1136/bmjopen-2021-055455.