Patient Priorities Aligned Discrete Decision Making for Older Adults With Multiple Chronic Conditions.

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Study arms

• Experimental
  AI Chatbot

  Behavioral: AI Chatbot

• Active comparator
  Control arm

  Behavioral: Control Arm (Educational Preparation Guide)

Interventions

• BehavioralAI Chatbot

  Participants receive a personalized web link by email . The link provides access to the Priorities AI chatbot on any internet-connected device. The chatbot guides participants through a structured conversation to identify their health priorities and goals related to their surgical decision,

• BehavioralControl Arm (Educational Preparation Guide)

  Participants will receive a Portable Document Format(PDF) educational preparation guide ("Preparing for Your Surgical Consultation") by email, with sufficient time before the scheduled surgical consultation to review the materials. Participants review the materials independently on their own schedule.

Primary outcomes

1. Decision regret as assessed by the Decision regret scale

   This is a 5 item questionnaire and each is scored from 0(no regret)-5 (high regret). Average of the item scores are calculated then 1 is subtracted and the final score is multiplied by 25 for a final metric from 0 to 100. Higher scores indicating worse outcome

   Time frame: 4 months after surgery

2. Self-identified health goals following elective hernia surgery, as measured by the Goal Attainment Scale (GAS)

   This is rated on a 5-point scale from -2 (much less than expected) to +2 (much better than expected), with 0 representing the expected level of goal attainment. Higher scores indicate greater attainment of individualized goals.

   Time frame: 4 months after surgery

Secondary outcomes

1. Decision-making quality in surgical consultations using the Shared Decision-Making Process (SDMP)Scale

   The Shared Decision-Making Process (SDMP) Scale is a 4-item, patient-reported measure. Maximum scores range from 0 to 4, with higher scores indicating greater shared decision-making.

   Time frame: 24 hours-72 hours after the intervention

2. Perceived involvement in care using the Perceived Involvement in Care Scale (PICS, binary format)

   This is a 13 item questionnaire and each is scored as 1(agree) or 0(disagree) for a total score 0-13, with higher scores indicating greater perceived involvement in care.

   Time frame: 24 hours-72 hours after the intervention

3. Decisional confidence using the SURE scale

   This is a 4 item questionnaire and each is scored as a 1(yes) or 0(no) for a maximum score of 0-4,higher score indicating greater decisional confidence

   Time frame: 24 hours-72 hours after the intervention

4. Acceptability as assessed by the Acceptability of Intervention Measure (AIM)

   This is a 4 item questionnaire and each is scored on a 5-point Likert scale from 1( completely disagree) to 5 (completely agree) for a maximum score of 4-20, higher scores indicate greater perceived acceptability

   Time frame: 24 hours-72 hours after the intervention

5. Appropriateness as assessed by the Intervention Appropriateness Measure (IAM),

   This is a 4 item questionnaire and each is scored on a 5-point Likert scale from 1( completely disagree) to 5 (completely agree) for a maximum score of 4-20, higher scores indicate greater perceived appropriateness

   Time frame: 24 hours-72 hours after the intervention

6. Feasibility as assessed by the Feasibility of Intervention Measure (FIM)

   This is a 4 item questionnaire and each is scored on a 5-point Likert scale from 1( completely disagree) to 5 (completely agree) for a maximum score of 4-20, higher scores indicate greater perceived feasibility

   Time frame: 24 hours-72 hours after the intervention

7. Assigned preparation approach on health-related quality of life using the Short Form (SF-12) Quality of Life Scale

   The SF-12 assesses physical and mental health across eight health concepts and generates two summary scores: the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12). Both scores are calculated using responses to all 12 items and are typically reported on a 0-100 scale, with higher scores indicating better health-related quality of life.

   Time frame: 4 months after surgery

8. Comfort and function following surgery using the Carolina's Comfort Scale (CCS)

   This is a 23 item questionnaire and each is scored from 0(no symptoms) to 5( disabling symptoms) for a score range of 0-115, higher score indicating worse postoperative comfort

   Time frame: 4 months after surgery

9. Satisfaction as assessed by the Satisfaction Measure

   This is a 1 item questionnaire and scored from 0(worst visit possible)-10 ( best visit possible) , higher value means better outcome

   Time frame: 24 hours-72 hours after the intervention

Individual participant data

Plan to share: No