NCT02386189

Pilot Study to Improve Care Coordination

Completed NA Results posted Last updated 28 August 2019

What this trial tests

NA trial testing Patient Care Coordination Training in Chronic Illness in 63 participants. Completed in 31 March 2017.

Timeline

2 March 2015

Primary endpoint
1 March 2017

31 March 2017

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	63
Start date	2 March 2015
Primary completion	1 March 2017
Estimated completion	31 March 2017
Sites	1 location across United States

Drugs / interventions tested

• Patient Care Coordination Training

Conditions studied

• Chronic Illness — all drugs for Chronic Illness →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Chronic Illness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Perceived Continuity of Care From Multiple Providers- Management Continuity Primary · The time frame is from baseline assessment to 12 months post baseline during which at least one VA and one Community medical visit occurred.

Patient Perceived Continuity of Care was assessed using Haggerty's measure of the same title. Management continuity refers to the patient being able to identify one provider who is the main coordinator and assures all the links within the health care team. The possible range on this measure was between 5 and 40 and the analysis was conducted on the pre-post difference on Management Continuity, subtracting the baseline score from the post-intervention score. More positive score indicated greater perceived management continuity and greater improvement in perceived management continuity.

Group	Value	95% CI
Usual Care	-0.65	± 6.4
Care Coordination	4.0	± 8.1

Patient Perceived Continuity of Care From Multiple Clinicians - Informational Continuity Primary · Baseline to 12-month follow-up

Patient Perceived Continuity of Care was assessed using Haggerty's measure of the same title. Informational Continuity refers to whether patients experienced communication failures between providers. The possible range on this measure was between 12 and 36. The analysis was conducted on the pre-post difference on Informational Continuity, subtracting the baseline score from the post-intervention score. For this measure a lower score and a decline between post intervention and baseline scores (or a negative value) indicates more positive outcomes.

Group	Value	95% CI
Usual Care	2.3	± 5.6
Care Coordination	-0.59	± 5.3

Patient Perceived Continuity of Care From Multiple Clinicians- Role Continuity Primary · Baseline to 12-month follow-up

Patient Perceived Continuity of Care was assessed using Haggerty's measure of the same title. Role Continuity refers to the role of all clinicians being clear to the patient and to the providers on the treatment team. The possible range on this measure was between 6 and 30, and the analysis was conducted on the pre-post difference on this measure. More positive score indicated greater perceived role clarity and, when comparing pre and post score, a more positive score indicated greater improvement in perceived role clarity.

Group	Value	95% CI
Usual Care	-0.04	± 2.7
Care Coordination	-0.32	± 2.8

Number of Participants With Duplication of Laboratory Tests Secondary · Baseline assessment to 12 months post-baseline, where a laboratory duplication is only counted if the medical visits occurred within three months of each other.

Participants had at least one VA medical visit and one community medical visit. Medical records were obtained from both visits and compared. Patients were considered to have a laboratory duplication if the same labs were drawn at both visits and the two visits occurred within three months of each other.

Group	Value	95% CI
Usual Care	4
Care Coordination	1

Proportion of Medication Concordance Secondary · Time frame between two medical visits occuring within the one year study period

All participants had at least one VA medical visit and one community medical visit. Medical records were obtained from both visits. Medication lists were obtained from both visits. A medication concordance metric (proportion) was calculated where the denominator was the total number of unique medications identified on both the VA medication list and the community provider medication list. The numerator was the total number of medications (including dose and frequency) that were concordant between the medication lists. This comparison did not include over the counter medications.

Group	Value	95% CI
Usual Care	0.33	± 0.15
Care Coordination	0.34	± 0.14

Relational Coordination- VA Providers Secondary · Providers completed the coordination measure at the time of the medical visit which could occur at any point in the 12 month follow-up period.

Relational Coordination was assessed using Gittell's 7-item measure as described Relational coordination amongst health professionals involved in insulin initiation for people with type 2 diabetes in general practice: an exploratory survey. This was assessed by providers seeing patients enrolled in this study, and this outcome is based on VA providers assessment of Relational Coordination. The scale total score could range from 7 to 35 with higher scores indicating greater relational coordination.

Group	Value	95% CI
Usual Care	14.9	± 6.8
Care Coordination	18.6	± 7.3

Relational Coordination Community Providers Secondary · Providers completed the coordination measure at the time of the medical visit which could occur at any point in the 12 month follow-up period.

Relational Coordination was assessed using Gittell's 7-item measure as described iRelational coordination amongst health professionals involved in insulin initiation for people with type 2 diabetes in general practice: an exploratory survey. The scale total score could range from 7 to 35 with higher scores indicating greater relational coordination.

Group	Value	95% CI
Usual Care	13.5	± 9.2
Care Coordination	14.0	± 8.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 month period. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Usual Care

Serious: 1/26 (4%)

Deaths: 1/26

Care Coordination

Serious: 0/30 (0%)

Deaths: 0/30

Serious adverse events (1 terms)

Reaction	System	Usual Care	Care Coordination
death	General disorders	—	—

Most-reported serious reactions: death.

Data from ClinicalTrials.gov NCT02386189 adverse events section.

Sponsor's own description

The purpose of this study is 1) to learn how VA patients can help share their health information between their VA providers and providers outside the VA and 2) if sharing this information is useful to providers and improves care received.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.