The Program for the Study of Health Care Relationships funded 11 researchers in CT to study various aspects of health care relationships and adherence. The individuals listed below each received grants for one year (2001-02). They were awarded funds on the basis of a competitive review process and the scientific merit of their proposals. The wide range of disciplines they represent and their research interests demonstrated the diversity and complexity inherent in studying health care relationships.

• Development of an Instrument to Measure Patients' Trust of Health Care Providers
• Exploration of the Effect of Nausea, Self-Efficacy, and Health Care Relationships on Medication Adherence in HIV/AIDS Patients
• Advance Care Planning: A Team Approach
• Assisting Older Adults To Communicate Their Pain After Surgery
• The Effect of a Specialized RN Intervention Designed to Maximize Patient-Provider Relationships on Adherence to Anti-Depressant Medication
• Pilot Study of Rapid Electronic Adherence Reporting with Provider Feedback on Adherence to Antiretroviral Therapy (HCR 01-12)
• Development of a Measure of Family Management of Childhood Chronic Illness
• The Contribution of Health Care Professionals to Parent and Child Self-Management of Type 1 Diabetes
• Enhancing Treatment Access and Adherence among Women of Hispanic Origin: The Roles of Relationships and Cultural Responsiveness in Behavioral Health Care
• Elicitation of Patient with Adaptive Conjoint Analysis

The Effect of a Specialized RN Intervention Designed to Maximize Patient-Provider Relationships on Adherence to Anti-Depressant Medication

Cathy Yavinsky, RN, MSN, Principal Investigator; Cynthia O'Brien, RN, BSN, Co-Investigator; Louise Reagan, APRN, Co-Principal Investigator; Ilene Staff, Ph.D., Co-Investigator; Rose Maljanian, RN, MBA, Co-Investigator; Edward Jaroszewski, MD, Co-Investigator

Problem Statement
Depression affects 5%-20% of primary care patients. Not only is depression associated with significant morbidity and functional impairment, patients with major and minor depression tend to have higher medical costs, multiple unexplained symptoms and greater social and vocational disability.1-2 Almost half of patients with major depression have received no mental health care in the last year and primary care physicians remain the predominant care givers.3 Patients at risk (minorities and the uninsured) are most likely to report not receiving adequate care. Even when patients are able to access mental health care, effective treatment plans have been difficult or impossible to implement and outcomes are not encouraging. When referred to mental health specialists, half do not complete the referral. After three months, only about 40%-55% of patients are adhering to their prescribed use of antidepressant medications.4-7

Hypothesis
Patients with depression, cared for in a primary care practice, who receive an additional RN intervention focused on relationship and self-management skills building will report higher rates of adherence to antidepressant medication, greater improvement in depressive symptoms and Health-related Quality of Life, and greater satisfaction with care than patients receiving usual care (primary care provider and the crisis intervention team).

Conceptual Base/Literature Review
The provider/patient relationship is cited as an influencing factor in adherence. Numerous studies link adherence and perception of quality of life with patient participation in decision making in their own care. The experimental visit in this study is designed as a nurse/client transactional intervention to strengthen the relationship and improve adherence. Based on King's goal attainment theory, and utilizing a mutual participation model, the nurse contact will focus on enhancing the nurse/patient relationship.8 The framework for the specific nurse/patient intervention was based on a mutual participation model that makes the following assumption

• both patient and nurse are equal partners
• both patient and nurse work together, share information and establish goals
• the patient is an active participant in decision making
• the patient's own experience provides cues for the treatment plan
• the nurse acts as facilitator, as well as educator, for the plan

Method/Design
The study employed a prospective, repeated measures, experimental design with random assignment to either a RN Intervention or Usual Care group. Outcome measures included symptoms of depression (CESD-10)9, Health-related Quality of Life (SF-12)10, the Caring Behaviors Inventory11, and two Likert items ratings of satisfaction with care and trust of caregivers. Measures of adherence included two retrospective self report instruments, the 4 item Self Report Medication Taking Scale12; and the Three Day Medication Recall including Likert scale item for the last time medication was missed13. The use of a prospective measure, a medication diary for each week in the study, was also explored. Baselines were established for the CESD and SF-12 measures; all measures were collected at the end of the intervention period (3 months) and follow-up (6 months). Medication diaries were collected throughout the six months of study participation.

Sample Description
Eligibility criteria included over age 18, diagnosis of mild to moderate depression (CES-D > 4), prescription for antidepressants; exclusion criteria included other psychiatric issues (except anxiety), and drug or alcohol abuse. A total of 172 were enrolled, 104 completed the study including the 6 month follow-up; 118 completed the three month data collection; 54 were lost to follow-up or withdrawn (39%). Patients in the two groups were compatible on ethnicity, gender, and the baseline characteristics for HRQL and symptoms of depression. Patients in the intervention group were significantly younger and less likely to be taking anti-depressant medication at enrollment. Those with follow-up data at 3 months and those lost to follow-up differed only with respect to age Ð older patients were more likely to complete the study.

Procedures
All primary practice patients were screened for depression. Eligible patients were consented and enrolled. Patients in the Intervention group had 4-6 additional visits with an RN during the first 3 months. All patients were asked to keep a daily diary of when they took their antidepressant medication and were reminded by a call from a research assistant every other week. All patients had PCP follow-up visits scheduled at or near the 3 and 6-month dates.

Data Analysis
Data collection for the diaries was not successful: only 54% of the weekly diaries were submitted on time; 13% were not submitted; 21% were submitted late and 12% were submitted in advance. The level of adherence reported was very high and not at all correlated with the other adherence measures. Due to these issues of accuracy, the diary data were not used in the outcomes analysis. The highest correlations among the adherence measures were between the "last missed" question on the 3 Day Recall and the Self Report Medication Taking Scale total score. A composite dichotomous measure (high versus low adherence) was generated from these two measures. Medication change was significantly more likely for patients in the intervention group than in the control group (57% vs. 25%). Age, prior medication at enrollment, and medication change were all possible confounds for the analysis and therefore were used as covariates for the outcome analyses. Baseline scores were used as covariates for CESD and SF12 analysis at 3 and 6 months.

Findings
Participants in the intervention group reported greater adherence to medication for the three days prior to their 3 month visit (2.90 days compared to 2.34 days, adjusted for covariates; p <.004) and fewer/milder side effects (.26 vs. .77 on a 0-3 scale adjusted for covariates; p <.007). There were similar trends for the Medication Taking Scale. There were no group differences for adherence at the 6 month follow-up. Patients in the intervention group reported fewer symptoms of depression (lower CES-D scores) at three months than those in control group but when adjusted for the effect of prior medication and medication change, the difference (5.79 vs. 6.79) was not statistically significant (p < .09). There were no differences between the groups on the Caring Behaviors Inventory, satisfaction with quality of care or trust of caregivers. There were no significant differences at the six month follow-up for symptoms of depression or HRQL. Across both treatment groups, participants who reported high adherence on the composite measure scored significantly higher on the Mental Component Summary of the SF12 at three months (43.0 vs. 35.4 adjusted for covariates; p < .003); the same pattern was evident at six months but the difference was not statistically significant.

Discussion
Nursing intervention did increase rates of reported adherence as hypothesized, but the expected effect on symptoms of depression was too small to be found with current study's limited sample size and power. The greater likelihood of medication change among patients who received nursing intervention suggests more careful monitoring of patient progress.

Practical Benefits
Results of this study suggest RNs can play an important role in improving medication adherence and reducing the symptoms of depression. Establishing a therapeutic nurse-patient relationship facilitates patient education, goal setting and interdisciplinary chronic disease management. This has enormous implications given the limited access to mental health services for at risk populations, the growing number of individuals with a high incidence of depression and the need to maximize cost effective utilization of healthcare resources.

References

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2. Simon GE, Ormel J, Von Korff N, Barlow W. Health Care Costs Associated with Depressive and Anxiety Disorders in Primary Care. Am J Psychiatry, 1995, 152(3), 352-357.
3. Ford D. Managing Patients with Depression: Is Primary Care Up to the Challenge? Journal of General Internal Medicine, 2000, 15, 301-310.
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7. Peveler R, George C, Kinmouth A, Campbell M, and Thompson C. Effects of antidepressant drug counseling and information leaflets on adherence to drug treatment in primary care: randomised controlled trial. British Medical Journal, 1999, 319, 612-615.
8. King I. A Theory for Nursing. New York: Wiley Medical Publication, 1981.
9. Radloff LS, Teri L. Use of the Center for Epidemiological Studies-Depression Scale with Older Adults. Clinical Gerontology, 1986, 5, 119 Ð 136.
10. Ware JE, Kosinski M, and Keller SD. A 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity. Medical Care, 1996; 34 (3):220-233.
11. Wolf Z. Concept of Caring: Beginning Exploring. Candidacy paper. University of Pennsylvania School of Nursing, Philadelphia, Pa. 1981.
12. Morisky DE, Green LW, and Levine DM. Concurrent and Predictive Validity of a Self Reported Measure of Medication Adherence. Medical Care, 1986, 24 (1), 67-74.
13. Williams AB. 3 Day Self Report Recall of Medication Adherence. Athena Project. Used and modified with permission.

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