Trial Outcomes & Findings for Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection (NCT NCT02046902)

NCT ID: NCT02046902

Last Updated: 2019-08-06

Results Overview

The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than "doctor alone" in response to the question "Who chose the type of stent?"

Recruitment status

COMPLETED

Target enrollment

586 participants

Primary outcome timeframe

30 months

Results posted on

2019-08-06

Participant Flow

Between May 2014 and December 2016, patients were recruited from 2 percutaneous coronary intervention (PCI) centers, Saint Luke's Mid America Heart Institute (MAHI) and Truman Medical Center (TMC), following institutional review board (IRB) approval at each site.

Participant milestones

Participant milestones
Measure	Pre-Implementation Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.	Post-implementation With Decision Coaching Patients received the consent form, the SDM tool for stent selection, and decision coaching	Post-implementation Without Decision Coaching Patients received the consent form and the SDM tool, but no decision coaching
Overall Study STARTED	336	113	137
Overall Study COMPLETED	336	113	137
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 30 months

Outcome measures

Outcome measures
Measure	Pre-Implementation n=336 Participants Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.	Post-implementation With Decision Coaching n=113 Participants Patients received the consent form, the SDM tool for stent selection, and decision coaching	Post-implementation Without Decision Coaching n=137 Participants Patients received the consent form and the SDM tool, but no decision coaching
Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching You alone	8 Participants	6 Participants	1 Participants
Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching Doctor Alone	235 Participants	45 Participants	106 Participants
Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching Mostly Doctor	51 Participants	19 Participants	20 Participants
Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching Mostly you	2 Participants	11 Participants	6 Participants
Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching Doctor and you equally	40 Participants	32 Participants	4 Participants

SECONDARY outcome

Timeframe: 30 months

Secondary outcomes included patients' recall of individual aspects of the stent discussion, stent knowledge score, patient preference for stent type, perceived autonomy support from their providers ,and concordance of patient stent preference and type of stent received. Patients were categorized as having voiced a stent preference if they answered anything other than "I don't care" or "I don't know" in response to the question "After reviewing the risks and benefits of both types of stents, which type of stent did you want?"

Outcome measures

Outcome measures
Measure	Pre-Implementation n=336 Participants Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.	Post-implementation With Decision Coaching n=113 Participants Patients received the consent form, the SDM tool for stent selection, and decision coaching	Post-implementation Without Decision Coaching n=137 Participants Patients received the consent form and the SDM tool, but no decision coaching
Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. Drug eluting stent	83 Participants	49 Participants	23 Participants
Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. Bare metal stent	36 Participants	29 Participants	2 Participants
Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. I don't care	119 Participants	29 Participants	69 Participants
Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. I don't know	98 Participants	6 Participants	43 Participants

Adverse Events

Pre-Implementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Post-implementation With Decision Coaching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Post-implementation Without Decision Coaching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carole Decker

Saint Luke's Mid America Heart Institute

Phone: (816) 932-5440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Pre-Implementation n=336 Participants Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.	Post-implementation With Decision Coaching n=113 Participants Patients received the consent form, the SDM tool for stent selection, and decision coaching	Post-implementation Without Decision Coaching n=137 Participants patients received the consent form and the SDM tool, but no decision coaching	Total n=586 Participants Total of all reporting groups
Age, Continuous	66.1 years STANDARD_DEVIATION 11.8 • n=333 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	67.6 years STANDARD_DEVIATION 12.9 • n=113 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	68.6 years STANDARD_DEVIATION 11.6 • n=137 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	67.43 years STANDARD_DEVIATION 12.1 • n=583 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Sex: Female, Male Female	93 Participants n=259 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	39 Participants n=110 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	49 Participants n=137 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	181 Participants n=506 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Sex: Female, Male Male	166 Participants n=259 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	71 Participants n=110 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	88 Participants n=137 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	325 Participants n=506 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=327 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=112 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=135 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=574 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Race (NIH/OMB) Asian	0 Participants n=327 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=112 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	1 Participants n=135 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	1 Participants n=574 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=327 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=112 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=135 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=574 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Race (NIH/OMB) Black or African American	77 Participants n=327 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	21 Participants n=112 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	18 Participants n=135 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	116 Participants n=574 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Race (NIH/OMB) White	250 Participants n=327 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	91 Participants n=112 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	116 Participants n=135 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	457 Participants n=574 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Race (NIH/OMB) More than one race	0 Participants n=327 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=112 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=135 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=574 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=327 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=112 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=135 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=574 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Race/Ethnicity, Customized Hispanic Ethnicity	5 Participants n=291 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	2 Participants n=112 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	3 Participants n=132 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	10 Participants n=535 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Site Mid America Heart Insitute	191 Participants n=336 Participants	86 Participants n=113 Participants	132 Participants n=137 Participants	409 Participants n=586 Participants
Site Truman Medical Center/Univ. of Missouri KC	145 Participants n=336 Participants	27 Participants n=113 Participants	5 Participants n=137 Participants	177 Participants n=586 Participants
Diabetes	152 Participants n=335 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	49 Participants n=113 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	69 Participants n=131 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	270 Participants n=579 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Hypertension	266 Participants n=336 Participants	92 Participants n=113 Participants	106 Participants n=137 Participants	464 Participants n=586 Participants
Peripheral arterial disease	29 Participants n=331 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	22 Participants n=113 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	20 Participants n=121 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	71 Participants n=565 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Prior Coronary Artery Bypass Graft	53 Participants n=334 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	20 Participants n=113 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	28 Participants n=127 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	101 Participants n=574 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Prior Percutaneous Coronary Intervention	137 Participants n=333 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	50 Participants n=113 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	66 Participants n=133 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	253 Participants n=579 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Admission Status Inpatient	116 Participants n=326 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	44 Participants n=111 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	57 Participants n=129 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	217 Participants n=566 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Admission Status Outpatient	189 Participants n=326 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	67 Participants n=111 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	71 Participants n=129 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	327 Participants n=566 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.
Admission Status Emergent	21 Participants n=326 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	0 Participants n=111 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	1 Participants n=129 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.	22 Participants n=566 Participants • Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.