Trial Outcomes & Findings for Discharge Information and Support for Patients Receiving Outpatient Care in the Emergency Department (NCT NCT01717976)

NCT ID: NCT01717976

Last Updated: 2017-07-25

Results Overview

Number of Participants Experiencing Repeat ED Use

Recruitment status

COMPLETED

Study phase

Target enrollment

513 participants

Primary outcome timeframe

30 days

Results posted on

2017-07-25

Participant Flow

514 participants were randomized and assigned to either DISPO ED or usual care. One participant (UC arm) was found to be ineligible post-randomization and thus not included in analyses.

Participant milestones

Participant milestones
Measure	Intervention primary care based nurse telephone support DISPO ED: primary care based nurse telephone support	Control usual care
Overall Study STARTED	257	257
Overall Study COMPLETED	257	256
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention primary care based nurse telephone support DISPO ED: primary care based nurse telephone support	Control usual care
Overall Study Protocol Violation	0	1

Baseline Characteristics

Discharge Information and Support for Patients Receiving Outpatient Care in the Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=257 Participants primary care based nurse telephone support DISPO ED: primary care based nurse telephone support	Control n=256 Participants usual care	Total n=513 Participants Total of all reporting groups
Age, Continuous	58.7 years STANDARD_DEVIATION 12.7 • n=5 Participants	59.4 years STANDARD_DEVIATION 11.5 • n=7 Participants	59.1 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	54 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	197 Participants n=5 Participants	202 Participants n=7 Participants	399 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: 0 out of the 257 participants in the DISPO intervention group and 1 of the 256 participants in the Usual Care group were deceased at 30 days and not included in the primary outcome analysis.

Number of Participants Experiencing Repeat ED Use

Outcome measures

Outcome measures
Measure	Intervention n=257 Participants primary care based nurse telephone support DISPO ED: primary care based nurse telephone support	Control n=255 Participants usual care
Number of Participants Experiencing Repeat ED Use	64 Participants	59 Participants

SECONDARY outcome

Timeframe: Baseline

Population: 0 out of 257 in intervention group and 2 out of 256 participants in the usual care group had missing data at baseline for satisfaction due to non-response.

Satisfaction with health care determined by 9 or 10 on the CAHPS

Outcome measures

Outcome measures
Measure	Intervention n=257 Participants primary care based nurse telephone support DISPO ED: primary care based nurse telephone support	Control n=254 Participants usual care
Number of Participants Satisfied With Health Care	110 Participants	117 Participants

SECONDARY outcome

Timeframe: 30 days

Population: 24 out of 257 in intervention group and 38 out of 256 participants in the usual care group had missing data at the 30 day interview for satisfaction due to missing the 30-day interview or non-response to the satisfaction question at the 30 day interview.

Satisfaction with health care determined by 9 or 10 on the CAHPS

Outcome measures

Outcome measures
Measure	Intervention n=233 Participants primary care based nurse telephone support DISPO ED: primary care based nurse telephone support	Control n=218 Participants usual care
Number of Participants Satisfied With Health Care	117 Participants	109 Participants

SECONDARY outcome

Timeframe: 180 days

Population: 26 out of 257 in intervention group and 33 out of 256 participants in the usual care group had missing data at the 180 day interview for satisfaction due to missing the 180-day interview or non-response to the satisfaction question at the 180 day interview.

Satisfaction with health care determined by 9 or 10 on the CAHPS

Outcome measures

Outcome measures
Measure	Intervention n=231 Participants primary care based nurse telephone support DISPO ED: primary care based nurse telephone support	Control n=223 Participants usual care
Number of Participants Satisfied With Health Care	115 Participants	106 Participants

SECONDARY outcome

Timeframe: 180 days

Population: 0 out of 257 participants in the DISPO intervention group and 1 of 256 in the usual care group were deceased at 30 days and not included in the cost analysis.

Assessment of VA and VA purchased care costs in 2016 dollars within 180 days from emergency department visit

Outcome measures

Outcome measures
Measure	Intervention n=257 Participants primary care based nurse telephone support DISPO ED: primary care based nurse telephone support	Control n=255 Participants usual care
Total Costs to the VHA	38273.16 US Dollars Standard Deviation 57836.31	31696.00 US Dollars Standard Deviation 46294.63

Adverse Events

Intervention

Serious events: 18 serious events

Other events: 0 other events

Deaths: 2 deaths

Control

Serious events: 21 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Susan N. Hastings

Durham VA HSR&D

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention n=257 participants at risk primary care based nurse telephone support DISPO ED: primary care based nurse telephone support	Control n=256 participants at risk usual care
Blood and lymphatic system disorders Hospitalizations	0.39% 1/257 • Number of events 1 Adverse events were collected without regard to the specific Adverse Event Term.	0.00% 0/256 Adverse events were collected without regard to the specific Adverse Event Term.
Cardiac disorders Hospitalizations	1.9% 5/257 • Number of events 8 Adverse events were collected without regard to the specific Adverse Event Term.	2.3% 6/256 • Number of events 6 Adverse events were collected without regard to the specific Adverse Event Term.
Gastrointestinal disorders Hospitalizations	0.78% 2/257 • Number of events 2 Adverse events were collected without regard to the specific Adverse Event Term.	0.78% 2/256 • Number of events 2 Adverse events were collected without regard to the specific Adverse Event Term.
General disorders Hospitalizations	0.00% 0/257 Adverse events were collected without regard to the specific Adverse Event Term.	0.78% 2/256 • Number of events 2 Adverse events were collected without regard to the specific Adverse Event Term.
Infections and infestations Hospitalizations	0.00% 0/257 Adverse events were collected without regard to the specific Adverse Event Term.	0.78% 2/256 • Number of events 2 Adverse events were collected without regard to the specific Adverse Event Term.
Injury, poisoning and procedural complications Hospitalizations	1.2% 3/257 • Number of events 3 Adverse events were collected without regard to the specific Adverse Event Term.	0.39% 1/256 • Number of events 1 Adverse events were collected without regard to the specific Adverse Event Term.
Metabolism and nutrition disorders Hospitalizations	0.39% 1/257 • Number of events 1 Adverse events were collected without regard to the specific Adverse Event Term.	0.00% 0/256 Adverse events were collected without regard to the specific Adverse Event Term.
Musculoskeletal and connective tissue disorders Hospitalizations	0.00% 0/257 Adverse events were collected without regard to the specific Adverse Event Term.	0.39% 1/256 • Number of events 1 Adverse events were collected without regard to the specific Adverse Event Term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalizations	0.00% 0/257 Adverse events were collected without regard to the specific Adverse Event Term.	0.39% 1/256 • Number of events 1 Adverse events were collected without regard to the specific Adverse Event Term.
Psychiatric disorders Hospitalizations	0.39% 1/257 • Number of events 1 Adverse events were collected without regard to the specific Adverse Event Term.	1.2% 3/256 • Number of events 3 Adverse events were collected without regard to the specific Adverse Event Term.
Renal and urinary disorders Hospitalizations	0.00% 0/257 Adverse events were collected without regard to the specific Adverse Event Term.	0.39% 1/256 • Number of events 1 Adverse events were collected without regard to the specific Adverse Event Term.
Respiratory, thoracic and mediastinal disorders Hospitalizations	0.78% 2/257 • Number of events 2 Adverse events were collected without regard to the specific Adverse Event Term.	0.39% 1/256 • Number of events 1 Adverse events were collected without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Hospitalizations	0.00% 0/257 Adverse events were collected without regard to the specific Adverse Event Term.	0.78% 2/256 • Number of events 2 Adverse events were collected without regard to the specific Adverse Event Term.
Surgical and medical procedures Hospitalizations	0.39% 1/257 • Number of events 1 Adverse events were collected without regard to the specific Adverse Event Term.	1.6% 4/256 • Number of events 4 Adverse events were collected without regard to the specific Adverse Event Term.
Vascular disorders Hospitalizations	0.78% 2/257 • Number of events 2 Adverse events were collected without regard to the specific Adverse Event Term.	0.00% 0/256 Adverse events were collected without regard to the specific Adverse Event Term.