AHH: A Helping Hand Among Low-Income Patients
Study Details
Study Description
Brief Summary
Study Hypotheses (Ho) and Research Questions (RQ):
-
Ho1. AHH will significantly improve patient depression treatment acceptance/adherence and depression symptoms vs UC at 6 and 12 months post-baseline.
-
Ho2. A Helping Hand (AHH) will significantly improve and sustain patient self-care management in Self-Efficacy for Managing Chronic Disease (SEMCD) and Quality of Life vs UC at 6 and 12 months post-baseline.
-
RQ1. What is the association between depression symptoms and concurrent chronic illness self-care management over time by group?
-
RQ2. Will AHH reduce hospitalizations and Emergency Room visits and improve clinic appointment-keeping?
-
RQ3. Will patient care satisfaction and reported barriers to self-care management vary by study group?
-
RQ4. What factors are identified via qualitative assessments of patients, promotoras, Department of Health Services (DHS) medical and social work providers, and DHS clinic/organizational leadership regarding satisfaction with, sustainable uptake of, and suggested modifications of the AHH promotora delivery model?
-
RQ5. What potential technology applications would enhance promotoras delivering patient-centered self-care training and resource navigation, communicating and integrating care with DHS, and disseminating AHH?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Major depression, plus other chronic illness such as diabetes, coronary heart disease and heart failure is common among low-income, culturally diverse safety net care patients. Unfortunately, many of these patients are uncomfortable about either asking their doctor questions about their illness and treatment options and their illness self-care or informing their doctors about their treatment preferences. Lack of strong engagement with medical providers occurs because patients believe they lack the knowledge to ask questions or to understand and follow recommended self-care and their concern that their medical provider lacks understanding of their treatment preferences. These factors often result in patient worry, poor adherence to prescribed treatment, and worsening illness status and even early death. The study will be conducted by a university, the Los Angeles County Department of Health Services (DHS) and a community health worker organization research team. The study will be conducted within two DHS Patient-Centered Medical Home clinics, with each patient having a designated primary care team of physician, nurse, social worker and medical assistant. Study patients with major depression and other illnesses face numerous self-care management barriers: managing concurrent symptoms (depression, pain, anxiety etc.) and cultural influences (depression stigma, diet), difficulty in navigating primary and specialty doctor and treatment plans, while at the same time experiencing daily social and economic stress. The randomized comparative effectiveness study plans to recruit 350 patients with major depression and a concurrent chronic illness (i.e., diabetes, heart failure, coronary heart disease) from two DHS PCMH community health centers. To enhance patient-centered research community partnerships, patients will be provided A Helping Hand (AHH) in which a community organization- based promotora aims to activate patient-centered depression self-care training and practical assistance to: a) improve and personalize major depression self-care (e.g., medication or psychotherapy preference, treatment adherence, fatigue, pain, diet, activity, stress management, family/caregiver communication); b) activate patient-provider communication, clinic appointment keeping and treatment coordination; and c) and facilitate patient navigation and receipt of needed community resources. AHH aims to improve patient self-care management and patient-provider care management relationships among underserved low-income patients, who must simultaneously cope with major depression and chronic co-morbid physical illness. Study objectives aim to determine: 1) whether community health worker promotora care management training improves patient-centered outcomes, such as self-care need and management, treatment adherence, symptom improvement, and care satisfaction over the usual team care; 2) depression symptom improvement; and 3) patient hospitalizations and ER visits frequency.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A Helping Hand (AHH) Participants receive DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers. |
Behavioral: Self-care management
AHH behavioral intervention is provided by promotoras
|
| No Intervention: Usual Care (UC) Participants receive DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers. PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics. |
Outcome Measures
Primary Outcome Measures
- Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline [6- and12-month follow-ups]
The PHQ-9, which establishes provisional depressive disorder diagnosis as well as grades depressive symptom severity, will be obtained from all study subjects at recruitment and during the four waves of data collection (up to 12 months). The PHQ-9 scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day), with possible scores ranging from 0 to 27, with cut points of 5,10,15, and 20 representing the thresholds for mild, moderate, moderately severe, and severe depression. A validated Spanish version of the PHQ-9 will be used. Clinically meaningful improvement of depressive symptoms was assessed as a ≥50% score reduction since baseline assessment.
Secondary Outcome Measures
- Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS) [baseline, 6- and 12-month follow-ups]
The Physical Component Summary (PCS) is a norm-based score standardized to the general U.S. population with a mean of 50, and a SD of 10. Scores range from 0 to 100, a higher score indicating better physical health.
Other Outcome Measures
- Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score [baseline, 6- and 12-month follow-ups]
The Self-Efficacy for Managing Chronic Disease (SEMCD) contains 6 items that are common across chronic diseases: symptom control, role function, emotional functioning and communicating with physicians, rated in a scale 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the six items. Higher number indicates higher self-efficacy.
Eligibility Criteria
Criteria
Inclusion Criteria:
- age >=18 years, have a phone, meet PHQ-9 score of 10 or more, and have concurrent diabetes, CHD, or HF.
Exclusion Criteria:
- current suicidal ideation,inability to speak either English or Spanish fluently, a score of 2 or greater on the CAGE 4M alcohol assessment,recent use of lithium or antipsychotic medication, and cognitive impairment precluding informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | El Monte Comprehensive Health Center | El Monte | California | United States | 91731 |
| 2 | H. Claude Hudson Comprehensive Health Center | Los Angeles | California | United States | 90007 |
| 3 | Edward R. Roybal Comprehensive Health Center | Los Angeles | California | United States | 90022 |
Sponsors and Collaborators
- University of Southern California
Investigators
- Principal Investigator: Kathleen Ell, DSW, USC Suzanne Dworak-Peck School of Social Work
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AD-1304-7364
Study Results
Participant Flow
| Recruitment Details | Patients were identified from medical charts or referred by care providers at three LAC-DHS community clinics with Patient Centered Medical Home (PCMH) care model, screened and recruited between April 2014 to May 2015. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | A Helping Hand (AHH) | Usual Care (UC) |
|---|---|---|
| Arm/Group Description | Participants received PCMH depression care services from their respective county health clinic providers plus the AHH intervention. Promotoras provided 6 weekly in-person or via-telephone intervention followed by 3 monthly telephone sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers. | Participants received DHS Patient Centered Medical Home (PCMH) clinic usual care from their respective county health clinic providers. PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics. |
| Period Title: Overall Study | ||
| STARTED | 178 | 170 |
| COMPLETED | 122 | 122 |
| NOT COMPLETED | 56 | 48 |
Baseline Characteristics
| Arm/Group Title | A Helping Hand (AHH) | Usual Care (UC) | Total |
|---|---|---|---|
| Arm/Group Description | Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers. | Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers. PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics. | Total of all reporting groups |
| Overall Participants | 178 | 170 | 348 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
56.77
(8.79)
|
56.31
(8.47)
|
56.54
(8.63)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
152
85.4%
|
144
84.7%
|
296
85.1%
|
| Male |
26
14.6%
|
26
15.3%
|
52
14.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
176
98.9%
|
168
98.8%
|
344
98.9%
|
| Not Hispanic or Latino |
2
1.1%
|
2
1.2%
|
4
1.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
178
100%
|
170
100%
|
348
100%
|
| Depression Severity, Categorial (Count of Participants) | |||
| Moderate, PHQ-9 score 10-14 |
71
39.9%
|
62
36.5%
|
133
38.2%
|
| Moderately severe, PHQ-9 score 15-19 |
74
41.6%
|
73
42.9%
|
147
42.2%
|
| Severe, PHQ-9 score 20+ |
33
18.5%
|
35
20.6%
|
68
19.5%
|
Outcome Measures
| Title | Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline |
|---|---|
| Description | The PHQ-9, which establishes provisional depressive disorder diagnosis as well as grades depressive symptom severity, will be obtained from all study subjects at recruitment and during the four waves of data collection (up to 12 months). The PHQ-9 scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day), with possible scores ranging from 0 to 27, with cut points of 5,10,15, and 20 representing the thresholds for mild, moderate, moderately severe, and severe depression. A validated Spanish version of the PHQ-9 will be used. Clinically meaningful improvement of depressive symptoms was assessed as a ≥50% score reduction since baseline assessment. |
| Time Frame | 6- and12-month follow-ups |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analyses for hypothesis testing related to the evaluation of AHH effects were carried out according to the intention-to-treat rule consistent with standard practice in clinical trials. |
| Arm/Group Title | A Helping Hand (AHH) | Usual Care (UC) |
|---|---|---|
| Arm/Group Description | Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers. | Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers. PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics. |
| Measure Participants | 130 | 133 |
| 6-Month |
69
38.8%
|
68
40%
|
| 12-Month |
67
37.6%
|
60
35.3%
|
| Title | Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS) |
|---|---|
| Description | The Physical Component Summary (PCS) is a norm-based score standardized to the general U.S. population with a mean of 50, and a SD of 10. Scores range from 0 to 100, a higher score indicating better physical health. |
| Time Frame | baseline, 6- and 12-month follow-ups |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC). |
| Arm/Group Title | A Helping Hand (AHH) | Usual Care (UC) |
|---|---|---|
| Arm/Group Description | Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers. | Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers. PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics. |
| Measure Participants | 178 | 170 |
| Baseline |
38.28
(10.45)
|
38.27
(11.14)
|
| 6-Month |
37.85
(11.2)
|
36.33
(11.35)
|
| 12-Month |
37.63
(10.73)
|
37.1
(11.68)
|
| Title | Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score |
|---|---|
| Description | The Self-Efficacy for Managing Chronic Disease (SEMCD) contains 6 items that are common across chronic diseases: symptom control, role function, emotional functioning and communicating with physicians, rated in a scale 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the six items. Higher number indicates higher self-efficacy. |
| Time Frame | baseline, 6- and 12-month follow-ups |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC). |
| Arm/Group Title | A Helping Hand (AHH) | Usual Care (UC) |
|---|---|---|
| Arm/Group Description | Participants received DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers. | Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers. PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics. |
| Measure Participants | 178 | 170 |
| Baseline |
6.22
(3.1)
|
5.8
(2.62)
|
| 6-Month |
7.2
(2.73)
|
6.85
(2.89)
|
| 12-Month |
7.23
(2.68)
|
6.79
(3.0)
|
Adverse Events
| Time Frame | 1 year | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The study intervention provided only educational sessions, thus no serious and other non-serious adverse events were collected or assessed systematically. However, we documented event information revealed by family member of participants, if any. | |||
| Arm/Group Title | A Helping Hand (AHH) | Usual Care (UC) | ||
| Arm/Group Description | Participants received PCMH depression care services from their respective county health clinic providers plus the AHH intervention. Promotoras provided 6 weekly in-person or via-telephone intervention followed by 3 monthly telephone sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers. | Participants received DHS Patient Centered Medical Home (PCMH) clinic usual care from their respective county health clinic providers. PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics. | ||
All Cause Mortality |
||||
| A Helping Hand (AHH) | Usual Care (UC) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/178 (0%) | 1/170 (0.6%) | ||
Serious Adverse Events |
||||
| A Helping Hand (AHH) | Usual Care (UC) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/178 (1.1%) | 2/170 (1.2%) | ||
| General disorders | ||||
| Death | 0/178 (0%) | 0 | 1/170 (0.6%) | 1 |
| Hospitalization | 1/178 (0.6%) | 1 | 1/170 (0.6%) | 1 |
| Resided in a nursing home | 1/178 (0.6%) | 1 | 0/170 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| A Helping Hand (AHH) | Usual Care (UC) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/178 (0%) | 0/170 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Kathleen Ell, DSW, Principle Investigator |
|---|---|
| Organization | USC Suzanne Dworak-Peck School of Social Work |
| Phone | 760-399-0263 |
| ell@usc.edu |
- AD-1304-7364