Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03118752
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2017-04-06
Brief Title:
Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety
Status:
COMPLETED
Status Verified Date:
2024-05
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:
The investigators will complete a pragmatic randomized trial N260 randomized participants of the 26-week blended collaborative care CC intervention compared to enhanced usual care eUC in patients admitted for acute coronary syndrome ACS or heart failure HF found to have current depression generalized anxiety disorder GAD or panic disorder PD The CC intervention will use a novel three-pronged approach to these high-risk patients Care managers will provide centralized care coordination and specific interventions targeting 1 the psychiatric disorders 2 cardiac health behaviors and 3 the cardiac illness The primary study outcome will be physical function at 26 weeks measured by the Duke Activity Status Index DASI given links between function and new cardiac events The investigators will also examine effects on numerous other outcomes important to patients and healthcare systems
Specific Aim 1 patient-centered outcomes-primary aim To compare between-group differences in the CC and eUC conditions on improvements in physical function health-related quality of life mental health patient satisfaction and other key patient-reported outcomes at 26 and 52 weeks
Specific Aim 2 adherence and medical outcomes To compare between-group differences on health behaviors physical activity diet smoking medication adherence and major adverse cardiac events
Specific Aim 3 cost To compare healthcare costs between groups and assess the cost-effectiveness of CC
Hypotheses The investigators expect this bolstered CC program to be associated with superior improvements in physical function health-related quality of life patient satisfaction and adherence at 26 weeks with promising effects on major adverse cardiac events The investigators likewise expect the intervention to be cost-effective 10000quality-adjusted life year over the study period
Specific Aim 1 patient-centered outcomes-primary aim To compare between-group differences in the CC and eUC conditions on improvements in physical function health-related quality of life mental health patient satisfaction and other key patient-reported outcomes at 26 and 52 weeks
Specific Aim 2 adherence and medical outcomes To compare between-group differences on health behaviors physical activity diet smoking medication adherence and major adverse cardiac events
Specific Aim 3 cost To compare healthcare costs between groups and assess the cost-effectiveness of CC
Hypotheses The investigators expect this bolstered CC program to be associated with superior improvements in physical function health-related quality of life patient satisfaction and adherence at 26 weeks with promising effects on major adverse cardiac events The investigators likewise expect the intervention to be cost-effective 10000quality-adjusted life year over the study period
Detailed Description:
Study VisitsContactsInterventions
Procedures for Participants in the Collaborative Care Intervention
In the hospital participants randomized to CC will work with the care manager to a define specific goals related to their psychiatric condition health behaviors and self-care b initiate care for their psychiatric condition and c make a plan for a health goal using a structured tool based on prior work with a specific and systematic focus on social functional financial and other barriers to behavior change
Following discharge all contact will be via phone with the same care manager completing phone sessions to enhance alliance and care continuity Contacts will last typically 30-45 minutes using a structured but highly flexible approach designed to manage acute issues and cover some aspect of all three care targets based on patient needspreferences without requiring care managers to complete all possible interventions at each call Care managers will prioritize topics to be addressed at each contact responding first to urgent concerns eg chest pain suicidal ideation Next the care manager will touch on all three aspects of the intervention with the depth of focus for each component based on prior sessions and current issues Heshe will review psychiatric symptoms and treatment The care manager will gauge progress on health behavior goals review motivationbarriers to goal completion and make an action plan for the next week Finally heshe will compare cardiac medication lists to guidelines and review weightblood pressure self-monitoring Calls will occur weekly for the first 6 weeks then may be spaced out in subsequent weeks based on the patients psychiatric symptoms progress toward health behavior goals and cardiovascular status Both the participant and care manager will agree upon the amount of time between calls after the first 6 weeks though participants will be encouraged to contact the care manager sooner if needed
1 Targeting multiple psychiatric conditions First the care manager will assist in the assessment and management of depression GAD andor PD using standardized scales At weekly team meetings care managers and supervising clinicians will review participants scores to allow iterative recommendations for treatment and supervision will be provided to care managers about psychotherapeutic content A treat-to-target approach will be used for psychiatric disorders with a goal of remission Treatments for moodanxiety disorders may include medications with selective serotonin reuptake inhibitors SSRIs typically recommended psychotherapy telephone-delivered cognitive behavioral therapy CBT sessions supplemented by CBT workbooks or relaxation response RR training
2 Targeting cardiac health behaviors The investigators will systematically target health behaviors primarily via motivational interviewing given its efficacy for a wide variety of behaviors in medical patients The investigators will focus on four specific health behaviors diet exercise smoking and medication adherence During admission care managers and participants will identify one behavior to target and set a specific goal aligned with ACSHF guidelines and the medical teams recommendations Care managers will utilize motivational interviewing techniques to assist participants in considering making and maintaining change toward that goal A focus on health behaviors will then continue throughout the 26 weeks
3 Targeting the cardiac condition First care managers will review the participants medication regimen and compare it to published guidelines for ACS and HF The care manager will discuss this with the study cardiologist and if the regimen appears suboptimal they will suggest to the patients physicians possible adjustments Second care managers will encourage participants to check blood pressure and weight daily and will review data at study calls if the readings deviate from targets eg HF patient gaining weight the care manager will review with the cardiologist and contact patients medical providers as indicated The investigators will provide commercially-available digital scales or automated blood pressure cuffs to participants in either group who need them
Procedures for Participants in Enhanced Usual Care
For participants randomized to eUC baseline psychiatric and medical assessments will be transmitted to the patients electronic health record During the enrollment admission the care manager will also inform the participant and treatment team about the specific symptoms on the study instruments and their clinical relevance and will alert teams to the data transmitted to the electronic health record eUC participants also will be free to receive any treatment for mental health or cardiac conditions throughout the study
At follow-up study assessments for eUC and CC participants at 26 and 52 weeks psychiatric symptom data will be transmitted to the electronic health record and providers will be alerted if psychiatric symptoms persist If acute safety concerns are identified at follow-ups or other contacts the study team will also arrange as-needed urgent care Finally the investigators will provide eUC participants with blood pressure cuffs andor scales if needed to ensure that outcome improvements in CC are not simply due to their provision
Study Endpoints
Functional HRQoL psychological and care process outcomes Specific Aim 1 The investigators will assess the interventions impact on multiple functional and psychological outcomes including physical function using the Duke Activity Status Index primary study outcome generic HRQoL Medical Outcomes Study SF-12 disease-specific HRQoL Kansas City Cardiomyopathy Questionnaire Seattle Angina Questionnaire depression SCL-20 anxiety Hospital Anxiety and Depression Scale - anxiety subscale optimism Life Orientation Test - Revised and participant satisfaction
Behavioral and medical outcomes Specific Aim 2 The investigators will assess the interventions impact on adherence to medications using the self-report medication adherence tool from the NHLBI Heart and Soul study diet using the MEDFICTS meats eggs dairy fried foods fat in baked goods convenience foods fats added at the table and snacks scale for saturated fat intake and the Scored Sodium Questionnaire for sodium intake physical activity using the International Physical Activity Questionnaire and smoking 7-day point prevalence smoking assessment The investigators also will monitor for major adverse cardiac events defined as admission for an ACS percutaneous intervention or acute HF or mortality
Cost and related outcomes Specific Aim 3 Finally the investigators will monitor medical utilization using Partners Healthcare records ahd the Massachusetts All Payer Claims Database For cost effectiveness the investigators will use the EuroQol five dimensions questionnaire EQ-5D health utilities scale which allows direct assessment of cost per quality-adjusted life year
Procedures for Participants in the Collaborative Care Intervention
In the hospital participants randomized to CC will work with the care manager to a define specific goals related to their psychiatric condition health behaviors and self-care b initiate care for their psychiatric condition and c make a plan for a health goal using a structured tool based on prior work with a specific and systematic focus on social functional financial and other barriers to behavior change
Following discharge all contact will be via phone with the same care manager completing phone sessions to enhance alliance and care continuity Contacts will last typically 30-45 minutes using a structured but highly flexible approach designed to manage acute issues and cover some aspect of all three care targets based on patient needspreferences without requiring care managers to complete all possible interventions at each call Care managers will prioritize topics to be addressed at each contact responding first to urgent concerns eg chest pain suicidal ideation Next the care manager will touch on all three aspects of the intervention with the depth of focus for each component based on prior sessions and current issues Heshe will review psychiatric symptoms and treatment The care manager will gauge progress on health behavior goals review motivationbarriers to goal completion and make an action plan for the next week Finally heshe will compare cardiac medication lists to guidelines and review weightblood pressure self-monitoring Calls will occur weekly for the first 6 weeks then may be spaced out in subsequent weeks based on the patients psychiatric symptoms progress toward health behavior goals and cardiovascular status Both the participant and care manager will agree upon the amount of time between calls after the first 6 weeks though participants will be encouraged to contact the care manager sooner if needed
1 Targeting multiple psychiatric conditions First the care manager will assist in the assessment and management of depression GAD andor PD using standardized scales At weekly team meetings care managers and supervising clinicians will review participants scores to allow iterative recommendations for treatment and supervision will be provided to care managers about psychotherapeutic content A treat-to-target approach will be used for psychiatric disorders with a goal of remission Treatments for moodanxiety disorders may include medications with selective serotonin reuptake inhibitors SSRIs typically recommended psychotherapy telephone-delivered cognitive behavioral therapy CBT sessions supplemented by CBT workbooks or relaxation response RR training
2 Targeting cardiac health behaviors The investigators will systematically target health behaviors primarily via motivational interviewing given its efficacy for a wide variety of behaviors in medical patients The investigators will focus on four specific health behaviors diet exercise smoking and medication adherence During admission care managers and participants will identify one behavior to target and set a specific goal aligned with ACSHF guidelines and the medical teams recommendations Care managers will utilize motivational interviewing techniques to assist participants in considering making and maintaining change toward that goal A focus on health behaviors will then continue throughout the 26 weeks
3 Targeting the cardiac condition First care managers will review the participants medication regimen and compare it to published guidelines for ACS and HF The care manager will discuss this with the study cardiologist and if the regimen appears suboptimal they will suggest to the patients physicians possible adjustments Second care managers will encourage participants to check blood pressure and weight daily and will review data at study calls if the readings deviate from targets eg HF patient gaining weight the care manager will review with the cardiologist and contact patients medical providers as indicated The investigators will provide commercially-available digital scales or automated blood pressure cuffs to participants in either group who need them
Procedures for Participants in Enhanced Usual Care
For participants randomized to eUC baseline psychiatric and medical assessments will be transmitted to the patients electronic health record During the enrollment admission the care manager will also inform the participant and treatment team about the specific symptoms on the study instruments and their clinical relevance and will alert teams to the data transmitted to the electronic health record eUC participants also will be free to receive any treatment for mental health or cardiac conditions throughout the study
At follow-up study assessments for eUC and CC participants at 26 and 52 weeks psychiatric symptom data will be transmitted to the electronic health record and providers will be alerted if psychiatric symptoms persist If acute safety concerns are identified at follow-ups or other contacts the study team will also arrange as-needed urgent care Finally the investigators will provide eUC participants with blood pressure cuffs andor scales if needed to ensure that outcome improvements in CC are not simply due to their provision
Study Endpoints
Functional HRQoL psychological and care process outcomes Specific Aim 1 The investigators will assess the interventions impact on multiple functional and psychological outcomes including physical function using the Duke Activity Status Index primary study outcome generic HRQoL Medical Outcomes Study SF-12 disease-specific HRQoL Kansas City Cardiomyopathy Questionnaire Seattle Angina Questionnaire depression SCL-20 anxiety Hospital Anxiety and Depression Scale - anxiety subscale optimism Life Orientation Test - Revised and participant satisfaction
Behavioral and medical outcomes Specific Aim 2 The investigators will assess the interventions impact on adherence to medications using the self-report medication adherence tool from the NHLBI Heart and Soul study diet using the MEDFICTS meats eggs dairy fried foods fat in baked goods convenience foods fats added at the table and snacks scale for saturated fat intake and the Scored Sodium Questionnaire for sodium intake physical activity using the International Physical Activity Questionnaire and smoking 7-day point prevalence smoking assessment The investigators also will monitor for major adverse cardiac events defined as admission for an ACS percutaneous intervention or acute HF or mortality
Cost and related outcomes Specific Aim 3 Finally the investigators will monitor medical utilization using Partners Healthcare records ahd the Massachusetts All Payer Claims Database For cost effectiveness the investigators will use the EuroQol five dimensions questionnaire EQ-5D health utilities scale which allows direct assessment of cost per quality-adjusted life year
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL133149-01A1 | NIH | None | httpsreporternihgovquickSearch1R01HL133149-01A1 |