Trial Outcomes & Findings for Connecting Healthy Women: Examining the Effect of an Intervention From the Effect of Being Reachable (NCT NCT02157168)
NCT ID: NCT02157168
Last Updated: 2019-04-05
Results Overview
The number and percentage of new members who had at least one visit with a primary care provider during their first 6 months of enrollment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2267 participants
Primary outcome timeframe
6 months
Results posted on
2019-04-05
Participant Flow
Each month all newly enrolled female health plan members were randomly picked by the health plan (according to a randomization scheme provided by the study team) to be invited to work with a community health worker (CHW). Those not invited constituted the usual care control group. Recruitment began March 2015 and ended May 2016.
Participant milestones
| Measure |
Control Group (CG)
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
|
Intervention Group (IG1)
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.
|
Intervention Group (IG2)
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.
|
|---|---|---|---|
|
Overall Study
STARTED
|
746
|
159
|
1362
|
|
Overall Study
COMPLETED
|
746
|
159
|
1362
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Connecting Healthy Women: Examining the Effect of an Intervention From the Effect of Being Reachable
Baseline characteristics by cohort
| Measure |
Control Group (CG)
n=746 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group..
|
Intervention Group (IG1)
n=159 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.
|
Intervention Group (IG2)
n=1362 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.
|
Total
n=2267 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
746 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
1362 Participants
n=5 Participants
|
2267 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
28.5 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
27.0 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
746 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
1362 Participants
n=5 Participants
|
2267 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
218 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
719 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
423 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
736 Participants
n=5 Participants
|
1221 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
105 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
327 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
41 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
38 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
61 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
523 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
961 Participants
n=5 Participants
|
1606 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
105 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
327 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
746 participants
n=5 Participants
|
159 participants
n=7 Participants
|
1362 participants
n=5 Participants
|
2267 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe number and percentage of new members who had at least one visit with a primary care provider during their first 6 months of enrollment.
Outcome measures
| Measure |
Control Group (CG)
n=746 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
|
Intervention Group (IG1)
n=159 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.
|
Intervention Group (IG2)
n=1362 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.
|
|---|---|---|---|
|
Identify and Utilization of Primary Care Provider (PCP)
|
426 Participants
|
114 Participants
|
771 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe number and percentage of new members who had at least one preventive visit (i.e., well woman visit, cervical cancer screening, sexually transmitted infection (STI) screening, STI counseling, contraception counseling or immunizations) during their first 6 months of enrollment.
Outcome measures
| Measure |
Control Group (CG)
n=746 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
|
Intervention Group (IG1)
n=159 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.
|
Intervention Group (IG2)
n=1362 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.
|
|---|---|---|---|
|
The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services
|
189 Participants
|
52 Participants
|
366 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Members who had an ED visit during the first 6 months of their enrollment.
The number and percentage of new members who had avoidable emergency department (ED) visits during their first 6 months of enrollment.
Outcome measures
| Measure |
Control Group (CG)
n=467 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
|
Intervention Group (IG1)
n=88 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.
|
Intervention Group (IG2)
n=767 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.
|
|---|---|---|---|
|
The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits
|
135 Participants
|
23 Participants
|
220 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Members who had a hospital visit during the first 6 months of enrollment.
The number and percentage of new members who had avoidable hospitalizations during their first 6 months of enrollment.
Outcome measures
| Measure |
Control Group (CG)
n=76 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
|
Intervention Group (IG1)
n=24 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.
|
Intervention Group (IG2)
n=167 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.
|
|---|---|---|---|
|
The Impact of the Intervention on Preventable Hospital Stays
|
13 Participants
|
4 Participants
|
25 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 monthsPopulation: IG1 group members that completed the baseline and 6-month survey and CG and IG2 group members that complete the 6-month survey.
The short form of the Patient Activation Measure (PAM), a measure of patient engagement in their healthcare. PAM levels of engagement with Level 4 being the highest level.
Outcome measures
| Measure |
Control Group (CG)
n=101 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.
|
Intervention Group (IG1)
n=101 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.
|
Intervention Group (IG2)
n=111 Participants
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.
The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.
|
|---|---|---|---|
|
Informed Decision Making Regarding the Healthcare System and Their Health
1: Believes active role important
|
8 Participants
|
1 Participants
|
2 Participants
|
|
Informed Decision Making Regarding the Healthcare System and Their Health
2: Confidence and knowledge to take action
|
7 Participants
|
6 Participants
|
8 Participants
|
|
Informed Decision Making Regarding the Healthcare System and Their Health
3: Taking action
|
38 Participants
|
41 Participants
|
36 Participants
|
|
Informed Decision Making Regarding the Healthcare System and Their Health
4: Staying the course under stress
|
48 Participants
|
53 Participants
|
65 Participants
|
Adverse Events
Control Group (CG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group (IG1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group (IG2)
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
Dr. Ada Wilkinson-Lee, Co-Investigator
University of Arizona
Phone: (520) 626-7766
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place