Trial Outcomes & Findings for Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections (NCT NCT02767011)

Results Overview

Yes/No was patient readmitted? Patients were monitored for 30 days to see if they were re-admitted to the hospital for any reason. Percentage of patients with 30-day readmission.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

30-day

Results posted on

2019-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	THEM Intervention Group. Received Tele-health monitoring	Control Control Group (received standard of care)
Overall Study STARTED	16	14
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	THEM n=16 Participants Intervention Group. Received Tele-health monitoring	Control n=14 Participants Control Group (received standard of care)	Total n=30 Participants Total of all reporting groups
Age, Continuous	62.5 years STANDARD_DEVIATION 7.2 • n=5 Participants	65.7 years STANDARD_DEVIATION 7.3 • n=7 Participants	64.0 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI	27.7 kg/m^2 STANDARD_DEVIATION 4.3 • n=5 Participants	29.1 kg/m^2 STANDARD_DEVIATION 7.1 • n=7 Participants	28.3 kg/m^2 STANDARD_DEVIATION 5.7 • n=5 Participants

PRIMARY outcome

Timeframe: 30-day

Yes/No was patient readmitted? Patients were monitored for 30 days to see if they were re-admitted to the hospital for any reason. Percentage of patients with 30-day readmission.

Outcome measures

Outcome measures
Measure	THEM n=16 Participants Intervention Group. Received Tele-health monitoring	Control n=14 Participants Control Group (received standard of care)
30-Day Readmission (Any)	4 Participants	2 Participants

PRIMARY outcome

Timeframe: 30-day

Yes/No was patient readmitted for wound infection? Patients were monitored for 30 days to see if they were re-admitted to the hospital for wound infection. Percentage of patients with 30-day readmission for wound infection.

Outcome measures

Outcome measures
Measure	THEM n=16 Participants Intervention Group. Received Tele-health monitoring	Control n=14 Participants Control Group (received standard of care)
30-day Wound Readmission	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 30-day

Population: Percentage of patients with access site infections.

Yes/No did patient any access site or would infections? Access site wounds for the patients were monitored for 30 days for any wound infections.

Outcome measures

Outcome measures
Measure	THEM n=16 Participants Intervention Group. Received Tele-health monitoring	Control n=14 Participants Control Group (received standard of care)
Access Site/Wound Infections.	5 Participants	1 Participants

SECONDARY outcome

Timeframe: 30-day

The Difference between baseline and 30-day quality of life (Short-Form 8) Physical summary T-scores. The short-form (SF-8) Health Survey is an 8-item survey designed to measure quality of life. The SF-8 has 8 questions that first measures eight ordinal items (i.e., 1-5 Likert scale): general health, physical health functioning, role physical, bodily pain, vitality, social functioning, mental health and emotional roles. Summing the responses of the 8 items can be used to report an overall measure of physical and mental functioning. The raw Likert scale scores are converted to normalized standard T scores with a mean of 50 and standard deviation of 10. Measuring physical and mental health both before and after an intervention, as continuous summary scores can indicate better self-reported quality of life with higher scores. A difference score of 0 would indicate no change, while a larger positive difference score would indicate an increase in self-reported quality of life.

Outcome measures

Outcome measures
Measure	THEM n=16 Participants Intervention Group. Received Tele-health monitoring	Control n=14 Participants Control Group (received standard of care)
The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score Baseline Physical Summary Score	27.76 T-scores Standard Deviation 7.38	30.14 T-scores Standard Deviation 11.28
The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score 30-day Physical Summary Score	36.83 T-scores Standard Deviation 8.58	34.61 T-scores Standard Deviation 10.69
The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score Difference (30-day - baseline) Summary Score	9.07 T-scores Standard Deviation 6.02	4.47 T-scores Standard Deviation 7.63

SECONDARY outcome

Timeframe: 30-day

Patients' satisfaction was compared using the General Satisfaction sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18). The PSQ-18 contains 18 items (questions) that can measure seven dimensions of satisfaction: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Responses to the PSQ-18 require a selection on a Likert scale from 1 Strongly Agree to 5 Strongly Disagree with some of the questions worded in such a manner that agreement reflects greater satisfaction (1, 2, 3, 5, 6, 8, 11, 15 \& 18). These responses were "re-coded" in order for a larger number to reflect greater satisfaction. Next, two individual items (3 and 17) are summed and averaged to produce the general satisfaction sub-scale. A larger number reflects greater satisfaction, with a range of 1 to 5.

Outcome measures

Outcome measures
Measure	THEM n=16 Participants Intervention Group. Received Tele-health monitoring	Control n=14 Participants Control Group (received standard of care)
Patient Satisfaction as Measured by the General Satisfaction Sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18)	4.0 units on a scale Interval 4.0 to 4.5	3.75 units on a scale Interval 2.87 to 4.5

SECONDARY outcome

Timeframe: 30-day

Yes/No did the patient have (any) home nursing visits during the 30-day follow-up period.

Outcome measures

Outcome measures
Measure	THEM n=16 Participants Intervention Group. Received Tele-health monitoring	Control n=14 Participants Control Group (received standard of care)
Number of Participants With Home Nursing Visits	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 30-day

Yes/No did patient have a stroke. Patients were monitored for 30 days for stroke.

Outcome measures

Outcome measures
Measure	THEM n=16 Participants Intervention Group. Received Tele-health monitoring	Control n=14 Participants Control Group (received standard of care)
Stroke	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30-day

Yes/No did patient have myocardial infarction. Patients were monitored for 30 days for myocardial infarction.

Outcome measures

Outcome measures
Measure	THEM n=16 Participants Intervention Group. Received Tele-health monitoring	Control n=14 Participants Control Group (received standard of care)
Myocardial Infarction	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30-day

Yes/No Did patient die? Patients for monitored for 30 days for death.

Outcome measures

Outcome measures
Measure	THEM n=16 Participants Intervention Group. Received Tele-health monitoring	Control n=14 Participants Control Group (received standard of care)
Death	0 Participants	0 Participants

Adverse Events

THEM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Mike Broce

Charleston Area Medical Center Research Institute

Phone: 304-388-9923

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place